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  • drug2505: Placebo
  • Placebo (462) Hydroxychloroquine (99) Azithromycin (37) Standard of Care (37) Tocilizumab (36) Placebo oral tablet (31) Questionnaire (30) Convalescent Plasma (27) Ivermectin (22) Remdesivir (22) No intervention (21) Standard of care (21) Convalescent plasma (20) Favipiravir (20) Placebos (17) Survey (15) Enoxaparin (14) Methylprednisolone (14) placebo (14) Nitazoxanide (13) Vitamin C (13) Hydroxychloroquine Sulfate (12) Colchicine (11) Blood sample (10) Control (10) Lopinavir/ritonavir (10) Dexamethasone (9) Ruxolitinib (9) Saline (9) Usual Care (9) Anakinra (8) Losartan (8) Standard care (8) Vitamin D (8) Zinc (8) blood sample (8) no intervention (8) Baricitinib (7) Camostat Mesilate (7) Chloroquine (7) Oseltamivir (7) Questionnaire Administration (7) Questionnaires (7) Clazakizumab (6) DAS181 (6) LY3819253 (6) Prednisone (6) Saliva collection (6) Standard treatment (6) Vitamin D3 (6) blood sampling (6) survey (6) Best Practice (5) COVID-19 Convalescent Plasma (5) COVID-19 convalescent plasma (5) Cyclosporine (5) Doxycycline (5) Hydroxychloroquine (HCQ) (5) Lopinavir / Ritonavir (5) Lung ultrasound (5) Midazolam (5) Nasopharyngeal swab (5) Normal Saline (5) Normal saline (5) Online Survey (5) Rivaroxaban (5) Sarilumab (5) Standard Medical Treatment (5) Standard of Care (SOC) (5) UC-MSCs (5) convalescent plasma (5) questionnaire assesment (5) Acalabrutinib (4) Ad26.COV2.S (4) Alirocumab (4) Ascorbic Acid (4) BCG Vaccine (4) Blood draw (4) Cholecalciferol (4) Colchicine Tablets (4) Evolocumab (4) Famotidine (4) HCQ (4) Hydrocortisone (4) Interferon Beta-1A (4) Interferon beta-1a (4) Lopinavir/Ritonavir (4) Mavrilimumab (4) Mepolizumab (4) Methotrexate (4) Nitric Oxide (4) Online questionnaire (4) Online survey (4) Ontamalimab (4) Opaganib (4) Oxygen (4) Peginterferon beta-1a (4) Placebo Administration (4) Povidone-Iodine (4) Presatovir (4) Prone position (4) Quality-of-Life Assessment (4) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (4) Reslizumab (4) Rifampin (4) Standard Care (4) Telemedicine (4) Telerehabilitation (4) Yoga (4) anti-SARS-CoV-2 convalescent plasma (4) hydroxychloroquine (4) questionnaire (4) standard care (4) 3D Telemedicine (3) ACE inhibitor (3) AG0302-COVID19 (3) Allopurinol (3) Anti-SARS-CoV2 Serology (3) Aspirin (3) BCG vaccine (3) BI 894999 (3) BNT162b1 (3) Best Supportive Care (3) Biospecimen Collection (3) Blood sampling (3) COVID-19 (3) COVID-19 RT-PCR (3) COViage (3) Chloroquine or Hydroxychloroquine (3) Chloroquine phosphate (3) Clinical data (3) Control group (3) Data collection (3) EIDD-2801 (3) Echocardiography (3) Eltrombopag (3) Exercise (3) Gam-COVID-Vac (3) Heparin (3) Interferon Beta-1B (3) Interview (3) Itraconazole (3) Lanadelumab (3) Matching placebo (3) Melatonin (3) Mesenchymal Stromal Cells (3) Nafamostat Mesilate (3) Nitric Oxide Gas (3) Nivolumab (3) No Intervention (3) No intervention, observational study (3) Observational (3) Phase 2 (3) Placebo oral capsule (3) Plasma (3) Probiotic (3) Prone Positioning (3) Prone positioning (3) Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health (3) Relamorelin (3) Remestemcel-L (3) Ribavirin (3) SARS-CoV-2 convalescent plasma (3) Sargramostim (3) Selinexor (3) Serological test (3) SnPP Protoporphyrin plus Sunlight exposure (3) Supportive Care (3) Survey Administration (3) Suspension of heat killed (autoclaved) Mycobacterium w (3) TAK-788 (3) Telmisartan (3) Usual care (3) VPM1002 (3) Verinurad (3) Vitamin Super B-Complex (3) blood donation SMS (3) exhaled breath sampling (3) observational (3) self-administered questionnaire (3) standard of care (3) standard therapy (3) 100 mg/mL Virazole (2) 2D Telemedicine (2) 50 mg/mL Virazole (2) AG0301-COVID19 (2) ARB (2) ATI-450 (2) AZD1222 (2) Abatacept (2) Abidol hydrochloride (2) Acalabrutinib Treatment A (2) Acalabrutinib Treatment B (2) Acalabrutinib Treatment C (2) Aeonose (2) Angiotensin II (2) Arbidol (2) Assessment of behavioral response to emotional stimulation (2) Assessment of work-related stress (2) Ayurveda (2) Azithromycin Tablets (2) BAY1817080 (2) BCG-Denmark (2) BI 474121 (2) BI 764198 (2) BIIB091 (2) BNT162b2 (2) Bacille Calmette-Guérin (BCG) (2) Baloxavir Marboxil (2) Baricitinib Oral Tablet (2) Bemiparin (2) Bevacizumab Injection (2) Bicalutamide 150 Mg Oral Tablet (2) Biological data (2) Biological sample collection (2) Blood samples (2) Blood test (2) Blood tests (2) Breath Biopsy face masks with removable filters and fitted PVA strip (2) Brief cognitive intervention (2) Bucillamine (2) CELLECTRA® 2000 (2) COVID Convalescent Plasma (2) COVID-19 Serology (2) COVID-19 Therapeutic Vaccine - Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection (2) COVID-19 pandemic (2) COVID-19 patients (2) CT-Scan (2) CYT107 (2) Cabotegravir Tablets (2) Canakinumab (2) Cannabidiol (2) Carboplatin (2) Cardiac and electrodermal recordings (2) ChAdOx1 MERS (2) ChAdOx1 nCoV-19 (2) Chemotherapy (2) Chloroquine Sulfate (2) Chloroquine or hydroxychloroquine (2) Ciclesonide (2) Clinical Examination (2) Clinical assessment (2) Clopidogrel (2) Cognitive Behavioral Therapy (2) Convalescent COVID 19 Plasma (2) Convalescent Plasma (CP) (2) Convalescent Plasma (anti-SARS-CoV-2 plasma) (2) Convalescent Plasma Transfusion (2) Conventional treatment (2) Corticosteroid (2) DWRX2003 (2) Daclatasvir (2) Data Collection (2) Data record (2) Deferoxamine (2) Dexamethasone injection (2) Dornase Alfa Inhalation Solution [Pulmozyme] (2) Duvelisib (2) ECG (2) EDP1815 (2) Early-Dexamethasone (2) Ebselen (2) Eculizumab (2) Electronic questionnaire (2) Enhanced Usual Care (2) Enoxaparin 40 Mg/0.4 mL Injectable Solution (2) Ensifentrine (2) Exposure (2) Famotidine 20 MG (2) Favipiravir Placebo (2) Fiberoptic Endoscopic Evaluation of Swallowing (2) Fisetin (2) Flow cytometric analysis (2) Follow up (2) Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale (2) GLS-5300 (2) GSK3640254 (2) Guduchi Ghan Vati (2) HB-adMSCs (2) HFNC (2) High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule (2) Human immunoglobulin (2) Hydroxychloroquine + azithromycin (2) Hydroxychloroquine - Weekly Dosing (2) Hydroxychloroquine 200 Mg Oral Tablet (2) Hydroxychloroquine Sulfate 200 MG (2) Hydroxychloroquine Sulfate 200 MG [Plaquenil] (2) Hydroxychloroquine Sulfate Loading Dose (2) Hydroxychloroquine Sulfate Regular dose (2) Hydroxychloroquine Sulfate Tablets (2) Hydroxychloroquine and Azithromycin (2) Hypothermia (2) IMU-838 (2) INO-4800 (2) Ibrutinib (2) Icosapent ethyl (2) Imatinib (2) Inactivated SARS-CoV-2 Vaccine (Vero cell) (2) Interferon beta-1b (2) Interleukin-7 (2) Iodine Complex (2) Ivermectin Oral Product (2) Ivermectin Pill (2) Ivermectin and Doxycycline (2) Ixazomib (2) KB109 + Self Supportive Care (SSC) (2) Ketogenic diet (2) L-ascorbic acid (2) LY3832479 (2) Leflunomide (2) Lenzilumab (2) Leronlimab (700mg) (2) Lopinavir-Ritonavir (2) Low Dose Radiation Therapy (2) Low Dose Radiotherapy (2) Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule (2) Low molecular weight heparin (2) M5049 (2) MagPro X100 Stimulator, B70 Fluid-Cooled Coil (2) Matched Placebo (2) Meaning Centered Psychotherapy for Latinos (2) Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients (2) Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule (2) Mesenchymal stromal cells (2) Methylprednisolone Sodium Succinate (2) Mindfulness (2) Moxifloxacin (2) N-Acetyl cysteine (2) N-acetylcysteine (2) NORS (Nitric Oxide Releasing Solution) (2) Nasal swab (2) Neuromuscular Blocking Agents (2) Niclosamide Oral Tablet (2) Nigella Sativa / Black Cumin (2) Nitrogen gas (2) Observation (2) Olokizumab 64 mg (2) PLACEBO (2) PUL-042 Inhalation Solution (2) Paracetamol (2) Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances (2) Peginterferon Lambda-1A (2) Pembrolizumab (2) Pentoxifylline (2) Peripheral blood draw (2) Phase 1 (2) Phone call (2) Physiotherapy (2) Placebo Comparator (2) Placebo on a 0- and 28-day schedule (2) Postcard (2) Povidone-Iodine Nasal Spray and Gargle (2) Practice details (2) Prazosin (2) Pre-assessment questionnaire (2) Psychoeducation (2) Pulmozyme (2) RECOP unit patient (2) REGN10933+REGN10987 combination therapy (2) RLF-100 (aviptadil) (2) RT-PCR (2) Rabeprazole (2) Radiation therapy (2) Radiotherapy (2) Ravulizumab (2) Recombinant new coronavirus vaccine (CHO cell) low-dose group (2) Recombinant new coronavirus vaccine (CHO cells) high-dose group (2) Recombinant new coronavirus vaccine (CHO cells) placebo group (2) Remdesivir placebo (2) Rifampicin (2) Rilpivirine Tablets (2) Rosuvastatin (2) Routine care for COVID-19 patients (2) Ruxolitinib Oral Tablet (2) SAB-185 (2) SARS-CoV-2 (2) SARS-CoV-2 diagnostic rapid test (2) SARS-Cov2 testing (2) SOC + Placebo (2) Saline solution (2) Saliva sample collection (2) Sample collection (2) Sampling (2) Self Supportive Care (SSC) Alone (2) Seraph 100 (2) Sevoflurane (2) Siltuximab (2) Simvastatin (2) Single Dose of Hydroxychloroquine (2) Sirolimus (2) SivoMixx (200 billion) (2) Spirometry (2) Standard of care (SOC) (2) Standard of care treatment (2) Stellate Ganglion Block (2) T3011 (2) TD-0903 (2) Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. (2) Telehealth (2) Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg (2) Tezepelumab (2) Therapeutic Plasma Exchange (2) Therapeutic anticoagulation (2) Throat swab (2) Thymalfasin (2) Tocilizumab (TCZ) (2) Tocilizumab Injection (2) Tofacitinib (2) Tofacitinib 10 mg (2) Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit (2) Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (2) Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (2) Two doses of placebo at the schedule of day 0,28 (2) Unfractionated heparin (2) Volitional help sheet (2) Vonoprazan (2) basic treatment (2) blood draw (2) blood samples (2) blood test (2) mRNA-1273 (2) nasopharyngeal swab (2) other (2) oxygen therapy (2) placebo for risankizumab (2) pregnant women with laboratory-confirmed 2019-n-CoV (2) prone position (2) retrospective analysis (2) rhTPO (2) risankizumab IV (2) risankizumab SC (2) serology (2) survey work (2) tabelecleucel (2) tocilizumab (2) unfractionated Heparin (2) venous ultrasound (2) vv-ECMO + cytokine adsorption (Cytosorb adsorber) (2) vv-ECMO only (no cytokine adsorption) (2) "Calm" is a mindfulness meditation mobile app (1) "Vernonia amygdalina" (1) (Standard of Care) SoC (1) - Synthetic anti-malarial drugs (1) 0.12% Chlorhexidine oral/nasal rinse (1) 0.5% Povidone/Iodine oral/nasal rinse (1) 0.9% Saline (1) 0.9% Sodium-chloride (1) 0.9% saline (1) 0.9% sodium chloride (normal saline) (1) 0.9%NaCl (1) 0.9%sodium chloride (1) 1. Characterize the immune response after infection with SARS-CoV-2 (1) 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse (1) 12-page health warning leaflet (1) 14C-lazertinib (1) 150 ppm Nitric Oxide delivered through LungFit Delivery System (1) 18F-DX600 PET/CT (1) 18F-GP1 PET CT (1) 18F-αvβ6-BP (1) 1: ILT101 (1) 1: Naproxen (1) 1: Prone positioning (1) 1: Usual practice (1) 1: discontinuation of RAS blocker therapy (1) 1D (1) 20 Mg Prednisone for 14 days (1) 20 mg MitoQ (1) 2019-nCoV IgG/IgM Rapid Test Cassette (1) 2019-nCoV PCR (1) 25-OH cholecalciferol (1) 2: No instruction regarding positioning (1) 2: Placebo Comparator (1) 2: Standard of care (1) 2: Usual practice + SYMBICORT RAPIHALER (1) 2: continuation of RAS blocker therapy (1) 30 Gy over 3 weeks (1) 300 mg of omega3-FA (1) 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) (1) 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) (1) 38 questions questionnaire (1) 38-questions questionnaire (1) 3D (1) 40mg of MitoQ (1) 40ml blood sample (1) 4Plants/Azythromycin (1) 5-ALA-Phosphate + SFC (5-ALA + SFC) (1) 50 Gy Radiation Therapy (1) 55 Gy Radiation Therapy (1) 5Fluorouracil (1) 6 minute walk test (1) 60 Gy Radiation Therapy (1) 68Ga-DX600 PET/CT (1) 7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted) (1) 80 ppm Nitric Oxide delivered through LungFit Delivery System (1) A short video intervention (1) A vignette intervention (1) AAZ Covid-19 rapid test (1) ABC/3TC (1) ABPM (1) ABTL0812 (1) ABX464 (1) ACE Inhibitors and Calcium Channel Blockers (1) ACE inhibitor, angiotensin receptor blocker (1) ACEI (1) ACEI/ARB (1) ACEIs (1) ACT-20-CM (1) ACT-20-MSC (1) ACT-541478 10 mg (1) ACT-541478 100 mg (1) ACT-541478 1000 mg (1) ACT-541478 30 mg (1) ACT-541478 300 mg (1) ACT-541478 dose E1 (1) ACT-541478 high or low dose (or placebo) (1) ADAM Sensor (1) ADCT-301 (1) AI model (1) AK119 (1) ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (1) ALX148 (1) AMA Acknowledgement Drug Pricing (1) AMY-101 (1) APL-9 (1) APPS (1) ARALAST NP (1) ARBIDOL 100 MG KAPSUL (1) ARBOX (1) ARBs and/or ACE inhibitors (1) ARCT-021 Dose 1 (1) ARCT-021 Dose 2 (1) ARCT-021 Dose 3 (1) ARCT-021 Dose 4 (1) ARCT-021 Dose Regimen 1 (1) ARCT-021 Dose Regimen 2 (1) ARDSNet (1) ARFC mask (1) ARGX-117 (1) ARGX-117 + rHuPH20 (1) ASC09/ritonavir group (1) ASC09F+Oseltamivir (1) ASP0367 (1) ASP2390 (1) ASP7317 (1) ASP8374 (1) ASSIST (1) ASTX660 (1) AT-001 (1) AT-527 (1) ATAFENOVIR 200 MG KAPSUL (1) ATV (1) ATYR1923 1 mg/kg (1) ATYR1923 3 mg/kg (1) AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong (1) AV-COVID-19 (1) AVIGAN (1) AVIGAN 200 MG Film Tablets (1) AVIGAN 200 mg FT (1) AVIGAN 200 mg Film Tablets (1) AVM0703 (1) AWARD advice (1) AWARD plus COVID-specific advice (1) AZD1390 (1) AZD1656 (1) AZD5718 (1) AZD7442 (1) AZD8154 Monodose DPI presented in capsules (1) AZD8154 Placebo Monodose DPI presented in capsules (1) AZD8154 nebuliser (1) AZD9567 (1) AZD9833 Oral Solution (1) AZD9833 film-coated tablet A Dose 1 (1) AZD9833 film-coated tablet A Dose 2 (1) AZD9833 film-coated tablet B Dose 1 (1) AZD9833 film-coated tablet B Dose 2 (1) Abdominal ultrasound (1) Abidol Hydrochloride combined with Interferon atomization (1) Abiraterone Acetate (1) Abivertinib (1) Acacia Senegal (1) Acalabrutinib Treatment D (1) Acceptability questionnaire (1) Access to training facility (1) Accuchek Inform II platform (1) Acetazolamide + supplemental oxygen + PAP therapy (1) Acetylsalicylic acid (1) Acknowledgement Racial Injustice AMA (1) Acthar Gel (1) Actigraph (1) Active COVID-19 disease (1) Active Choice (1) Active Comparator (1) Active Control (1) Active PBMT/sMF (1) Active control condition (1) Active control:Healthy Living (1) Activity (1) Acyclovir (1) Ad26.ZEBOV (1) Ad5-nCoV (1) Ad5FGF-4 (1) Adalimumab (1) Additional biological samples (1) AdimrSC-2f (1) Admission to ICU for COVID-19 (1) Adsorbed COVID-19 (inactivated) Vaccine (1) Aerobic Exercise Training (1) Aerolized Hydroxychloroquine Sulfate (1) Aerosol Box (1) Aerosol-reducing Mask (1) Aerosolized 13 cis retinoic acid (1) Aerosolized All trans retinoic acid (1) Aerosolized Isotretinoin plus Tamoxifen (1) African American Sender Acknowledgement (1) African American Sender in Informational Videos. (1) After COVID-19 Pandemic (1) AirGo Respiratory Monitor (1) Airwave Oscillometry (1) Airway pressure release ventilation (1) Albendazole (1) Albuterol - Control (1) Albuterol - Experimental (1) Alcohol (1) Alcohol brief intervention (1) Alexa Amazon (1) Alferon LDO (1) Algorithm-based recommendation (1) AlloStim (1) Allocetra-OTS (1) Allogeneic NK transfer (1) Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells (1) Allogenic pooled olfactory mucosa-derived mesenchymal stem cells (1) Almitrine (1) Alteplase 100 MG [Activase] (1) Alteplase 50 MG [Activase] (1) Alternating face-to-face medical visits and video medical consultations (1) Aluminum adjuvant (1) Aluminum hydroxide (1) Aluminum hydroxide adjuvant (Alhydrogel®) (1) Alvelestat (1) Ambrisentan (1) Amiodarone (1) Amlodipine (1) Amlodipine 2.5 mg/indapamide 1.25 mg (1) Amoxicillin-clavulanate (1) Ampion (1) An auto-questionnaire comprising three psychometric scales (1) Anakinra +/- Ruxolitinib (stages 2b/3) (1) Anakinra 100Mg/0.67Ml Inj Syringe (1) Anakinra 149 MG/ML Prefilled Syringe [Kineret] (1) Anakinra Prefilled Syringe (1) Anakinra alone (stages 2b/3) (1) Anakinra and Ruxolitinib (Advanced stage 3) (1) Anakinra and Ruxolitinib (overcome stage 3) (1) Anakinra and Zinc (1) Anakinra plus oSOC (1) Analogs, Prostaglandin E1 (1) Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage. (1) Anatomic Pulmonary Resection (1) Anger message (1) Angiography (1) Angiography scanner (1) Angiotensin 1-7 (1) Angiotensin Receptor Blockers (1) Angiotensin converting enzyme inhibitor (1) Angiotensin receptor blocker (1) Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) (1) Anluohuaxian (1) Anthocyanins (1) Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients (1) Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients (1) Anti- SARS-CoV-2 Plasma (1) Anti-COVID-19 human immunoglobulin (1) Anti-Human Thymocyte Immunoglobulin, Rabbit (1) Anti-SARS-CoV-2 Human Convalescent Plasma (1) Anti-SARS-CoV-2 IgT seropositivity (1) Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) (1) Anti-SARS-CoV2 serological controls and serum neutralization (1) Anti-Sars-CoV-2 Convalescent Plasma (1) Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients (1) Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients (1) Antibiotics (1) Antibody Test (1) Antibody test (SARS-CoV2) (1) Antibody testing (1) Antibody titration (1) Antibody-Rich Plasma from COVID-19 recovered patients (1) Anticoagulant Therapy (1) Anticoagulation Agents (Edoxaban and/or high dose LMWH) (1) Antihemophilic Factor (Recombinant) (1) Antihypertensive Agents (1) Antioxidation Therapy (1) Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19 (1) Antroquinonol (1) Anxiety Reduction Training (1) Any drug used to treat Covid-19 (1) Apilimod Dimesylate Capsule (1) Apixaban (1) Apixaban 2.5 MG (1) Apixaban 5MG (1) Apo-Hydroxychloroquine (1) Appeals (1) Appendectomy (1) Apple Watch Series 5 (1) Application of tele-rehabilitation (1) Apramycin injection (1) Apremilast (1) Aprepitant injectable emulsion (1) Aprotinin (1) Arbidol Hydrochloride Granules (1) Argatroban (1) Arm exercise electrocardiographic stress test (1) Artemesia annua (1) ArtemiC (1) Artemisia Annua Leaf (1) Artemisinin / Artesunate (1) Arterial Blood Gas test (ABG) (1) Artesunate-amodiaquine (1) Ascorbic Acid and Zinc Gluconate (1) Aspirin 100mg (1) Aspirin 75mg (1) Aspirin 81 mg (1) Assembled mask (1) Assessing antibody responses, neutralizing capacity and memory B-cell function (1) Assessing impact of COVID19 (1) Assessment of Dietary Changes in Adults in the Quarantine (1) Assessment of cardiovascular diseases and cardiovascular risk factors (1) Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery (1) Assessment of ventilator-associated pneumonia criteria (1) Assigned Strategies: Active Choice (1) Assigned Strategies: Enhanced Active Choice (1) Assigned Strategies: Opt-in (1) Association of diltiazem and niclosamide (1) Asthma controller therapies (incl. prednisone/prednisolone) (1) Asthma reliever therapies (1) AstroStem-V (1) Asunercept (1) Asynchronies detection (1) Atazanavir (1) Atazanavir and Dexamethasone (1) Atezolizumab (1) Atomoxetine hydrochloride (1) Atorvastatin (1) Atorvastatin 20 Mg Oral Tablet (1) Atorvastatin 20mg (1) Atorvastatin 40mg (1) Atovaquone/Azithromycin (1) Attention Bias Modification (ABM) (1) Attention Control Group (1) Attention Control Intervention 4 (1) Attention Placebo (1) Attention Training Program (1) Audit and Feedback (1) Auditory Evoked Potentials (AEP) (1) Auricular neuromodulation (1) Auricular percutaneous neurostimulation (1) Auto-questionnaires (patients co infected HIV Sras-CoV-2) (1) Autologous Adipose MSC's (1) Autologous Bone Graft (1) Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) (1) Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells (1) Automated oxygen administration - FreeO2 (1) Auxora (1) Avdoralimab (1) Aviptadil 67μg (1) Aviptadil by intravenous infusion + standard of care (1) Awake Prone Positioning (1) Awake Proning (1) Awake prone positioning (1) Awake proning (1) Ayurvedic Kadha (1) Azacitidine (1) Azinc (1) Azithromycin (Azithro) (1) Azithromycin 250 MG (1) Azithromycin 250 MG Oral Capsule (1) Azithromycin 500 milligram (mg) oral Tablet (1) Azithromycin 500Mg Oral Tablet (1) Azithromycin Capsule (1) Azithromycin and hydroxychloroquine (1) Azithromycin with amoxicillin/clavulanate (1) Açaí palm berry extract - natural product (1) BACMUNE (MV130) (1) BAT (1) BAT + Calcifediol (1) BAT2020 (1) BAX 888 (1) BAY1237592 (1) BAY2328065 LSF (1) BAY2328065 tablet (1) BBV152A (1) BBV152B (1) BBV152C (1) BCG (1) BCG GROUP (1) BCG vaccine (Freeze-dried) (1) BDB-001 Injection (1) BGB DXP593 (1) BGB-DXP593 (1) BI 1015550 (1) BI 1569912 (1) BI 425809 (1) BI 706321 (1) BIKTARVY Tablets (BIK) (1) BIO 300 Oral Suspension (1) BIO101 (1) BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM (1) BIOVITALS (1) BLAfit® (1) BLD-2660 (1) BM-Allo.MSC (1) BM-MSCs (1) BMS-986253 (1) BMS-986256 (1) BMS-986259 (1) BMS-986322 (1) BMS-986322 Placebo (1) BMS-986337 (1) BMS-986337 Placebo (1) BNT162a1 (1) BNT162b3 (1) BNT162c2 (1) BR (1) BRII-196 (1) BRII-198 (1) BTL-TML-COVID (1) BVA-100 (1) BVRS-GamVac (1) BVRS-GamVac-Combi (1) Bacillus Calmette-Guerin (BCG) (1) Back Side of the Moon (1) Background questionnaire (1) Bactek-R (1) Bacterial species isolated (1) Bardoxolone methyl (1) Bariatric procedures (1) Baricitinib (janus kinase inhibitor) (1) Baricitinib 4 MG Oral Tablet (1) Baricitinib or Anakinra (1) Barrier box (1) Base therapy (1) Baseline message (1) Basic Body Awareness Therapy (1) Basic Go NAPSACC (1) Beck Depression Inventory (BDI) (1) Bedside lung ultrasound (1) Behavioral Activation in real-life (1) Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material (1) Behavioral: OCAT (1) Behavioral: OCAT-sham (1) Behaviour Change Technique Intervention to Improve Quality of Life (1) Berberine (1) Berzosertib (1) Best Available Therapy (1) Best Message + Augmented Message or Implementation Strategy (1) Best Message Alone (1) Best Standard of Care (1) Best Standard of Care + CARDIO (1) Best available care (1) Best available treatment (1) Best standard of care (1) Best supportive care" which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy (1) Bevacizumab (1) BioMedomics COVID-19 IgM-IgG Rapid Test (1) Biocontainment Device For Aerosol Generating Procedures (Biobox) (1) Biological (1) Biological Sample Collection (1) Biological collection (patients co infected HIV Sras-CoV-2) (1) Biological sample and clinical data collection (1) Biological samples specific to research (1) Biological sampling (1) Biological test (1) Biological/Vaccine: Angiotensin peptide (1-7) derived plasma (1) Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group (1) Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group (1) Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group (1) Biological: COVID-19 convalescent plasma (1) Biological: mRNA-1273: 100 mcg (1) Biological: mRNA-1273: 50 mcg (1) Biological: oral polio vaccine (1) Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT) (1) Biomarkers expression (1) Biosensor (1) Biosensors (1) Biospecimen collection (1) Bivalirudin Injection (1) Blink and Masseter Inhibitory Reflex (1) Blood Collection (1) Blood D-dimer assay (1) Blood Sample (1) Blood Test (1) Blood Transfusion (1) Blood and derivatives. (1) Blood collection (1) Blood collection on admission and longitudinally (1) Blood collection on their first consultation and 10 to 14 days later (1) Blood donation from convalescent donor (1) Blood for anti-drug antibody (ADA) (1) Blood for pharmacokinetic samples (1) Blood for research purposes (1) Blood group determination (1) Blood plasma (1) Blood sample and data record (1) Blood sample collection (1) Blood sample for serological test (1) Blood sample for serology to measure past infection with SARS-CoV-2 (1) Blood sample for whole genome sequencing (1) Blood samples (collection of 5 mL of blood in a dry tube) (1) Blood samples collection (1) Blood tests sputum, nasal lavage and brushing (1) Bloodwork (1) Body Project (BP) (1) Bolus placebo (1) Bolus vitamin D3 (1) Bone Marrow Harvest (1) Bone conduction headphones (1) Bovine Lactoferrin (1) Bovine Lipid Extract Surfactant (1) Brain Health Education (BHE) (1) Brain MRI (1) Brain MRI scan (1) Brainstem Responses Assessment Sedation Score (BRASS) (1) Brazilian Green Propolis Extract (EPP-AF) (1) Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application (1) Breath Test & Cheek Swab (1) Breath sample (1) Breath test (1) Brequinar (1) Brexanolone (1) Bridge therapy (1) Brief Behavioral Activation Treatment (1) Brief Behavioral Activation with Mental Imagery (1) Brief Psychiatric Rating Scale (1) Brief Skills for Safer Living (1) Brief cognitive behavioral therapy (1) Brief educational video (1) Brief informational infographic (1) Bromhexine 8 MG (1) Bromhexine Hydrochloride (1) Bromhexine Hydrochloride Tablets (1) Bromhexine Oral Tablet and/or hydroxychloroquine tablet (1) Bromhexine and Spironolactone (1) Broncho-Vaxom® (1) Bronchoalveolar Lavage (BAL) (1) Budesonide (1) Budesonide Nasal (1) Budesonide dry powder inhaler (1) Buprenorphine Sublingual Product (1) Burnout (1) Buspirone + PAP therapy (1) Butterfly (1) C-reactive protein (1) C21 (1) C2Rx (1) C3+ Holter Monitor (1) CAG length <22 (1) CAG length >=22 (1) CAM2038 (1) CAP-1002 Allogeneic Cardiosphere-Derived Cells (1) CAPABLE Transitions (1) CAStem (1) CBT-OSA (1) CCP (1) CCTP (1) CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc (1) CD24Fc (1) CD55 (1) CDX-0159 (1) CERC-002 (1) CETA Short Session (CSS) (1) CFTR Modulators (1) CFZ533 (1) CGB-S-100 (1) CHEST CT SCAN (1) CHLORPROMAZINE (CPZ) (1) CHMI (1) CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) (1) CIG Axial (1) CIG Tilted (1) CK0802 (1) CLBS119 (1) CLIA of IgG and IgM against SARS-Cov-2 (1) CME (active control) (1) CMR with T1 and T2 mapping (1) CNS magnetic resonance imaging (MRI) imaging (1) COM-COVID anonimous survey (1) COMPASS (1) CONTROL GROUP (1) CONVALESCENT PLASMA (1) COPAN swabbing and blood sample collection (1) COSH Self-help smoking cessation booklet (1) COVI-GUARD (1) COVICU (1) COVID 19 Convalescent Plasma (1) COVID 19 Diagnostic Test (1) COVID 19 Self-Questionnaire (1) COVID 19 diagnostic test by PCR (1) COVID 19 impact (1) COVID 19 serology (1) COVID positive via testing (1) COVID visitation restrictions (1) COVID-19 Androgen Sensitivity Test (CoVAST) (1) COVID-19 Antibody testing (1) COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support (1) COVID-19 Breastfeeding Support (1) COVID-19 Convalescent Plasma (CCP) (1) COVID-19 Convalscent Plasma (1) COVID-19 FACILITY (1) COVID-19 IgG / IgM rapid test (whole blood, serum, plasma) (1) COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA) (1) COVID-19 PCR (1) COVID-19 PCR Swab (1) COVID-19 PCR and Serology (1) COVID-19 PCR and serology testing (1) COVID-19 Pandemic (1) COVID-19 Pneumonia (1) COVID-19 Specific T Cell derived exosomes (CSTC-Exo) (1) COVID-19 Swab (1) COVID-19 and Intensive Care (1) COVID-19 antibodies testing (1) COVID-19 antibody point of care test kit (1) COVID-19 barrier box (1) COVID-19 convalescent hyperimmune plasma (1) COVID-19 convalescent plasma (CCP) plus standard of care (SOC) (1) COVID-19 diagnostic PCR (1) COVID-19 diagnostic test (1) COVID-19 e-package: Psychological wellbeing for healthcare workers (1) COVID-19 experience surveys (1) COVID-19 exposure (1) COVID-19 infection (1) COVID-19 infection status (1) COVID-19 positive via testing (1) COVID-19 related health warning leaflet (1) COVID-19 standard care (1) COVID-19 survey (1) COVID-19 swap test PCR (1) COVID-19 test, polymerase chain reaction for SARS-CoV-2 (1) COVID-19 treatment (1) COVID-19 treatments (1) COVID-19+ observational (1) COVID-surgRES questionaire (1) COVID19 (1) COVID19 convalescent plasma infusion (1) COVID19 vaccine (1) COVIDSeq Test (1) COVSurf Drug Delivery System (1) CPAP (1) CPAP treatment (1) CPI-006 (1) CRI management (1) CSL324 (1) CT of the chest (1) CT score (1) CT-P59 (1) CT-V (1) CT-imaging (1) CT-scan (1) CT-scan with minimal invasive autopsy (1) CTUS examination (1) CUROSURF® (poractant alfa) (1) CVnCoV (Dose level confirmed in Part 1) (1) CVnCoV 6 μg (1) CVnCoV 8 μg (1) CVnCoV 8 μg (4 μg double dose) (1) CVnCoV Vaccine (1) CYNK-001 (1) CYP 450 Substrates (1) CYP-001 (1) Cabotegravir 200 mg/mL (1) Cabotegravir 400 mg/mL (1) Cabotegravir Injectable Suspension (CAB LA) (1) Cabotegravir extended release suspension for injection (long-acting) (1) Cabotegravir sodium (Oral Lead In) (1) Caffeine 200 mg (1) Calcium Channel Blockers (1) Calm Meditation App (1) Cambridge Validated Viral Detection Method (1) Camidanlumab Tesirine (1) Camostat (1) Camostat Mesylate (1) Canakinumab 150 MG/ML [Ilaris] (1) Canakinumab Injection 300mg (1) Canakinumab Injection 600mg (1) Candesartan (1) Cannabidivarin (1) Cannabis, Medical (1) Capillary and salivary sampling (1) Caption AI (1) Cardiac surgery (1) Cardiopulmonary resuscitation (1) Caring Contacts (1) Carotid Artery Reactivity Testing (1) Carrimycin (1) Case fatality rate (1) Cash transfer (1) Ceftaroline (1) Ceftriaxone (1) Cell therapy protocol 1 (1) Cell therapy protocol 2 (1) Cellectra 2000 Electroporation (1) Cellular response (1) Cenicriviroc (1) Cenicriviroc (CVC) (1) Cenobamate (1) Centricyte 1000 (1) Centrum Adult (under 50) multivitamin (1) Ceralasertib (1) Cerebral compliance and hemodynamics monitoring (1) Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies (1) Certified cloth face mask plus preventive information (1) ChAdOx1 nCoV-19 (Abs 260) (1) ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost (1) ChAdOx1 nCoV-19 (qPCR) (1) ChAdOx1 nCoV-19 0.5mL boost (1) ChAdOx1 nCoV-19 full boost (1) ChAdOx1 nCoV-19 half boost (1) ChAdOx1 nCoV-19 plus 5x10^10vp boost (qPCR) (1) ChAdOx1 nCoV-19 single dose (1) ChAdOx1 nCoV-19 two dose (1) ChAdox1 n-CoV-19 (Abs 260) vaccine low dose (1) Change in knowledge, motivation, skills, resources (1) Change in preference to surgery under COVID-19 pandemic. (1) Chat-based instant messaging support (1) Chat-based support (1) Chest MRI (1) Chest computed tomography (CT) (1) Chest physiotherapy using a non-invasive oscillating device (1) Chinese Herbal Medicine (1) Chinese medicine treatment (1) Chlorhexidine Gluconate (1) Chloroquine Diphosphate (1) Chloroquine Phosphate Tablets (1) Chloroquine analog (GNS651) (1) Chloroquine diphosphate (1) Chlorpromazine (1) Choice of Assignment: Active Choice (1) Choice of Assignment: Enhanced Active Choice (1) Choice of Assignment: Opt-in (1) Choices and judgements (1) Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument (1) Ciclesonide Inhalation Aerosol (1) Ciclesonide Metered Dose Inhaler [Alvesco] (1) Cimetidine (1) Cisplatin (1) Clarithromycin (1) Clazakizumab 12.5 mg (1) Clazakizumab 25 mg (1) Clevudine (1) Clinical diagnosis of COVID-19 by a health care professional (1) Clinical examination (1) Clinical interview (1) Clinical, laboratory and imaging characteristics of pneumonia (1) Clinolipid (1) CloSYS mouthwash (1) Clofazimine (1) Clopidogrel 75mg (1) Closed-loop control of oxygen supplementation by O2matic (1) Cloth Face Mask (1) Clungene rapid test cassette (1) Co-mestring (co-coping) (1) CoYoT1 Care (1) Coala Heart Monitor (1) Cobicistat (1) Cognitive Behavioural Group Therapy for Perinatal Anxiety (1) Cognitive Stimulation (1) Cognitive Training (1) Cognitive and behavioral intervention. (1) Cognitive behavioral therapy (CBT) (1) Cognitive testing (1) Cohort (1) Colchicine 0.5 MG (1) Colchicine 1 MG Oral Tablet (1) Colchicine plus symptomatic treatment (paracetamol) (1) ColdZyme® mouth spray (1) Coldamaris lozenges (1) Colgate Peroxyl mouthwash (1) Colgate Total mouthwash (1) Colgate periogard mouthwash (1) Collagen-Polyvinylpyrrolidone (1) Collection of Biological Samples (1) Collection of blood samples in order to create a biocollection (1) Collection of breath sample (1) Collection of odour samples (1) Collection of samples (1) Colorectal resection (1) Combination (1) Combination of Lopinavir /Ritonavir and Interferon beta-1b (1) Combination of oral polio vaccine and NA-831 (1) Combined ART/hydroxychloroquine (1) Combined use of a respiratory broad panel multiplex PCR and procalcitonin (1) Communication type (1) Community Referral as appropriate (1) Community based combination HIV prevention package (1) Community interest message (1) Community-driven messages to promote COVID-19 testing (1) Comparable Placebo (1) Comparable Placebo of Oral Polio Vaccine and Placebo of drug (1) Comparable Placebo of drug (1) Compassion focused intervention (1) Complement dosage (1) Complete thrombophilic profile testing by multiplex PCR (1) Completion of post telemedicine encounter survey (1) Completion of pre-pandemic survey (1) Completion of survey after peak of pandemic (1) Complex diagnostic panel (1) Comprehensive treatment (1) Computer Based Response Training Weight Loss Intervention (1) Computer task questionnaires (1) Computerized Talking Touchscreen (1) Conestat alfa (1) Confinement and Communication During the COVID-19 Pandemic (1) Conjunctival swab and nasopharyngeal swab (1) Connected devices measurements (1) Connor-Davidson Resilience Scale 10 items (CD-RISC 10) (1) Contain COVID Anxiety SSI (1) Continuation of ACEi/ARB (1) Continuation of ARB/ACEI (1) Continuation of anti-TNF treatment (1) Continuous Positive Airway Pressure (1) Continuous renal replacement therapy (1) Control (albumin 5%) (1) Control Blend (1) Control Group (pharmacotherapy and/or psychotherapy, n=10) (1) Control Intervention (1) Control Period (1) Control arm (1) Control for aerosol generating procedures (1) Control message (1) Control swab (1) Control-EDI (1) Convalescent Immune Plasma (1) Convalescent Plasma 1 Unit (1) Convalescent Plasma 2 Units (1) Convalescent Plasma as Therapy for Covid-19 patients (1) Convalescent Plasma from COVID-19 donors (1) Convalescent Plasma of patients with COVID-19 (1) Convalescent SARS COVID-19 plasma (1) Convalescent Serum (1) Convalescent anti-SARS-CoV-2 MBT Plasma (1) Convalescent anti-SARS-CoV-2 plasma (1) Convalescent plasma (CP) (1) Convalescent plasma transfusion (1) Convalesscent Plasma (1) Conventional N95 respirator (1) Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) (1) Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules (1) Conventional therapy first (1) Cooking Training (1) Coping strategies video (1) Cord Tissue Mesenchymal Stromal Cells (1) Cordio App (1) Core Warming (1) CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test (1) Coronary artery calcium score and cardiac computed tomographic angiography (1) Coronavirus Disease 2019 (1) Corticosteroid injection (1) Cospherunate/Azythromycine (1) Cospherunate/Phytomedicine/Azythromycien (1) Counter Attitudinal Therapy (1) Couples' Intervention (1) CovX (1) Covax-19™ (1) Covid ICU containment measures (1) Covid-19 + patients (1) Covid-19 Antibody testing (IgG and IgM) (1) Covid-19 Rapid Test Kit (RAPG-COV-019) (1) Covid-19 Standard of Care (1) Covid-19 presto test (1) Covid-19 swab PCR test (1) Covid19 (1) Covidfree@home (1) Crest Pro-Health Multi-Protection mouthwash (1) Crisis intervention therapy (1) Crisis management coaching (1) Crizanlizumab (1) Cross Sectional study using scientifically validated psychometric Scales (1) Cross-sectional observational study (1) Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms (1) Cross-sectional study investigating the association of NPIs with mental health (1) Curently used therapy for COVID-19 non-critical patients (1) Current care per UCLA treating physicians (1) Customized questionnaire (1) Cyclosporin A (1) CytoSorb (1) CytoSorb 300 mL device (1) CytoSorb-Therapy (1) Cytochrome P450 (CYP) Substrates (1) Cytokine Adsorption (1) Cytokines dosage (1) Cytokines measurement (1) D-dimer,CBC.ESR,CRP, (1) DAS181 COVID-19 (1) DAS181 OL (1) DASS-21 instrument (depression and anxiety) (1) DAXI for injection Dose HIGH DOSE (1) DAXI for injection dose LOW DOSE (1) DAXI for injection dose MEDIUM DOSE (1) DB-001 (1) DFV890 (1) DIG Axial (1) DIG Tilted (1) DPPFit (1) DRV (1) DUR-928 (1) DWJ1248 (1) Dabigatran etexilate (1) Dabigatran etexilate + BI 1323495 (1) Daclatasvir 120 mg (1) Daclatasvir 60 mg (1) Daily Coping Toolkit (1) Daily Monitoring (1) Daily Vitamin D3 (1) Daily placebo (1) Danoprevir+Ritonavir (1) Dapagliflozin (1) Dapagliflozin 10 MG (1) Dapagliflozin 10 mg (1) Darunavir and Cobicistat (1) Darunavir/Cobicistat (1) Darvadstrocel (1) Data Collection: Clinical Care Assessments (1) Data collection and clinical testing of subjects (1) Data collection and rhinopharyngeal swab (1) Data collection from blood draw (1) Data collection from lumbar puncture (1) Data collection from medical files (1) Data collection up to 1 year (1) Data monitoring for 48h within the first 12 hours of admission for COVID-19 (1) Data registry (1) Data research, database analysis (1) Ddrops® products, 50,000 IU, Oral (1) Decidual Stromal Cells (DSC) (1) Decitabine (1) Deep Breathing training (1) Deep Venous Disease Diagnostic (1) Defibrotide (1) Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days (1) Defibrotide Injection (1) Degarelix (1) Delayed diagnostics Anyplex TMII RV16 Detection (1) Delivery of iStride™ device gait treatment using telemedicine (1) DeltaRex-G (1) Dental pulp mesenchymal stem cells (1) Depression, Anxiety and Stress Scale (1) Descartes 30 (1) Description of groups caracteristics (1) Desferal 500 MG Injection (1) Desidustat (1) Detection of anti-COVID-19 antibody level (1) Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus. (1) Device used to record voice for screening (1) Dexamethasone (high dose) (1) Dexamethasone and Hydroxychloroquine (1) Dexcom G6 (1) Dexmedetomidine Injectable Product (1) Dexmethylphenidate (1) DiaNose (1) Diabetes type 2 (1) Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta (1) Diagnostic Laboratory Biomarker Analysis (1) Diagnostic Test: serology test for COVID-19 (1) Diagnostic examination for venous thromboembolism (1) Diagnostic mammography (1) Diagnostic test (1) Diagnostic test Covid-19 (1) Diagnostic test for SARS-Cov2 for patients and health staff (1) Diagnostic test for detection of SARS-CoV-2 (1) Dialectical Behavioral Therapy (DBT) Skills (1) Dialyzable Leukocyte Extract (1) Diet tracking and survey (1) Dietary Intervention (1) Dietary Supplement containing resistant starch (1) Dietary advice (1) Dietary advice and advice on timing (1) Dietary counselling on Food Groups according to IYC Feeding practices, WHO (1) Dietary intake, body composition, lifestyle, and CVD risk factors (1) Differences in triage (1) Difficulties lived by disabled children's parents in the period of COVID-19 pandemic (1) Diffusing capacity of carbon monoxide (1) DigiVis visual acuity app (1) Digital Health Online Platform (1) Digital cardiac Counseling (1) Digital intervention (1) Digoxin (1) Digoxin 0.25 mg (1) Diphenhydramine (1) Dipyridamole (1) Dipyridamole 100 Milligram(mg) (1) Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care (1) Direct laryngoscope (1) Direct laryngoscopy (1) Discontinuation of ACEi/ARB (1) Discontinuation of ARB/ACEI (1) Discontinuation of anti-TNF treatment (1) Discussion Board for Social Support +Basic Feedback (1) Discussion Board for Social Support+Personalized Feedback (1) Distilled water (1) Disulfiram (1) Docetaxel (1) Dociparastat sodium (1) Doctella telehealth monitoring (1) Doctor Spot (1) Dolutegravir (1) Doppler Echo (1) Dornase Alfa (1) Dornase Alfa Inhalation Solution (1) Dose Finding Phase (MTD) (1) Dose of Tinzaparin or Dalteparin (1) Double-Blind NT-I7 (1) Double-Blind Placebo (1) Double-Trunk Mask (1) Doxycycline Hcl (1) Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment (1) Drug: GS-5734 - 1.00 mg/kg (1) Drug: GS-5734 - 2.00 mg/kg (1) Drug: Isotretinoin plus Tamoxifen (1) Drug: NA-831 (1) Drug: NA-831 - 0.10 mg/kg (1) Drug: NA-831 - 0.20 mg/kg (1) Drugs and supportive care (1) Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) (1) Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) (1) DuACT (1) Duodenal biopsy (1) Dupilumab (SAR231893/REGN668) (1) Duplex ultrasound and Computed Tomography Angiography (1) During COVID-19 Pandemic (1) Durvalumab (1) Dutasteride (1) DynamX Bioadaptor (1) Dynamic 3D bone motion capture (1) E-cigarette ad exposure (1) EC-18 (1) ECCO2R (1) ECG-Holter (1) ECMO Implantation (1) EEG (1) EG-HPCP-03a (1) EG-HPCP-03a Placebo (1) EHR-based Clinician Jumpstart (1) EIT-Group (1) ELISA (1) ELISA and Rapid test to detect antibodies against COVID-19 (1) ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB. (1) ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY (1) ELMO PROJECT AT COVID-19: STUDY IN HUMANS (1) EMPOWER (1) ENT exam (1) EP (1) EPDS (Edinburgh Postnatal Depression Scale) (1) ESOGER (1) ESPRIMO (1) ESPRIT™ BTK Device (1) EU-approved RoActemra (1) EUROIMMUN assay (1) EXN407 (1) EXO 1 inhalation (1) EXO 2 inhalation (1) EarSats Pulse Oximeter Probe (1) Early Aggressive Therapy or Traditional Therapy (1) Echo-Doppler (1) Economic benefit message (1) Economic freedom message (1) Edinburgh Postnatal Depression Scale (EDPS) (1) Edoxaban Tablets (1) Education sessions (1) Educational Program on Air Pollution as a Health Risk Reduction Strategy (1) Educational meetings and visual prompts (1) Educational outreach (1) Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors (1) Effortful Control Camp (1) Eicosapentaenoic acid gastro-resistant capsules (1) Ejaculated semen sample (1) Elective Cancer Surgery (1) Electric pad for human external pain therapy (1) Electrical Impedance Tomography (EIT) (1) Electrocardiogram, telemetry, echocardiogram, laboratory values (1) Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care (1) Electroencephalogram with EKG lead (1) Electronic Health Record Review (1) Electronic Survey questionnaire (1) Electronic survey (1) Elisa-test for IgM and IgG to SARS-CoV-2 (1) Emapalumab (1) Embarrassment message (1) Emergency Laparotomy (1) Emergency Ventilator Splitter (1) Emergency surgery (1) Emotion- and Relationship-Focused Therapeutic Interview (1) Emotional Freedom Technique (1) Emotional Support Plan (1) Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet (1) Emtricitabine/tenofovir disoproxil (1) Enbrel (1) End tidal breath sample (1) Endoscopic intervention (1) Endoscopic management according to standard of care (1) Enhanced Chronic Disease Self-management program (1) Enhanced Go NAPSACC (1) Enhanced hygiene measures (1) Enhanced linkage (1) Enhanced supervised fitness training (1) Enoxaparin 1 mg/kg (1) Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml (1) Enoxaparin Higher Dose (1) Enoxaparin Prefilled Syringe [Lovenox] (1) Enoxaparin Prophylactic Dose (1) Enoxaparin sodium (1) Enoxaparin/Lovenox Intermediate Dose (1) Enriched Survey Feedback (1) Ensifentrine Dose 1 (1) Environmental Decontamination (1) Environmental exposure and clinical features (1) Enzalutamide (1) Enzalutamide Pill (1) EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) (1) Equipment with smartwatch throughout hospital stay on the general ward (1) Ergoferon (1) Escin (1) Esflurbiprofen hydrogel patch 165 mg (EFHP) (1) Esomeprazole 20mg (1) Essential Oil Blend (1) Essential oils (1) Estradiol patch (1) Estrogen Therapy (1) Ethanol with Asprin (1) Etoposide (1) Evaluate HACOR score effectivity in this patients (1) Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer (1) Evaluation of clinical, instrumental and laboratory diagnostics tests (1) Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2) (1) Examinations for the research: (1) Examine the impact of COVID-19 during pregnancy (1) Exebacase (1) Exercise Group (1) Exercise Intervention (1) Exercise Testing and Training (1) Exercise Training Only (1) Exercise and Cognitive Training (1) Exercise brochure (1) Exercise capacity (1) Exercise physiology (1) Exercise program (1) Exercise training (1) Exercise training group (1) Experiences in Close Relationship Scale questionnaire (ECR-S) (1) Experimental 1 (1) Experimental 2 (1) Experimental Group (1) Experimental drug (1) Experimental: Questionnaire without precaution information (1) Experts consensus (1) Expiratory training device (1) Exposed to the novel coronavirus disease 2019 (1) Exposure (not intervention) - SARS-CoV-2 infection (1) Exposure Therapy (1) Exposure to the Dutch measures due to the Covid-19 pandemic. (1) Exposure to the SARS-CoV-2 (1) Exposure to the SARS-CoV-2 and its consequences (1) Exposure: Covid-19 infection (1) Expression of receptors and activating proteases (1) Extended sampling and procedures (1) Extra blood sample (1) Extracorporeal Membrane Oxygenation (1) Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter (1) Extracorporeal left hemicolectomy anastomosis (1) Extracorporeal membrane oxygenation (1) Extravascular Lung Water Index (1) Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol (1) EyeQue Insight (1) F-652 (1) F-FMISO PET/CT Scan (1) FAVICOVIR 200 mg Film Tablet (1) FAVIR 200 MG FT (1) FAVIRA 200 MG Film Tablet (1) FBT (1) FBT+Variety (1) FEIBA (1) FFP2 (1) FITSTART+ PBI (1) FLOW intervention (1) FLT3 Ligand (CDX-301) (1) FMD (1) FNC dummy tablet+Standard of Care (1) FNC+Standard of Care (1) FT516 (1) FTC/TAF (1) Face mask sampling (1) Face-to-face medical visits (1) Facial fractures reduction or osteosynthesis (1) Facial mask (1) Family Nurture Intervention (FNI) (1) FamilyChildCare (provisional name of app) (1) Farmalarm (1) Favipiravir (3200 mg + 1200 mg) (1) Favipiravir (3200 mg + 1200 mg) combined with Azithromycin (1) Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine (1) Favipiravir (3600 mg + 1600 mg) (1) Favipiravir + Currently used therapy (1) Favipiravir + Standard of Care (1) Favipiravir Combined With Tocilizumab (1) Favipiravir and Hydroxychloroquine (1) Favipiravir plus Nitazoxanide (1) Favipiravir tablets (1) Fecal Microbiota Therapy (FMT) (1) Feeling Good Digital App (1) Fenofibrate (1) Fiberoptic Bronchoscopy (FOB) (1) Fibrin generation markers assays (1) Fidaxomicin (1) File Scanning (1) File scanning (1) FilmArray PCR on respiratory samples (1) FilmArray Pneumonia (1) Filtration Test (1) Fingerstick (1) Fingolimod 0.5 mg (1) Fit test (1) Five-days oseltamivir (1) Fixed Anchoring Strategy (1) Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC) (1) Fixed-duration Hydrocortisone (1) Fixed-duration higher dose Hydrocortisone (1) Flexitouch Plus with Cellular Connectivity (FT-CC) (1) Flow controlled ventilation (Evone-ventilator) (1) Flow cytometry (1) Flucelvax (1) Fluoxetine (1) Flurbiprofen 100 mg (1) Fluvirin (1) Fluvoxamine (1) Fluzone High Dose (1) Focus Group Interviews (1) Focused/Targeted Message (1) Folfirinox (1) Folic Acid (1) Follow-up at 14 days (1) Fondapariniux (1) Fondaparinux (1) Food Ads (1) Formulation without Active Drug (1) Fosfomycin disodium (1) Fourth Trimester Mobile Tool (1) Freestyle Libre 14 day CGM system (1) Fremanezumab-Vfrm (1) Froben 100 mg comprimidos revestidos (1) Functional MRI (1) Furosemide Injection Solution for subcutaneous administration (80 mg) (1) Furosemide Injection, USP (1) Fuzheng Huayu Tablet (1) GAD-7 (7-item Generalized Anxiety Disorder) (1) GAD-7 (General Anxiety Disorder) scale (1) GAD-7 General anxiety disorder scale (1) GAMUNEX-C (1) GC4419 (1) GC5131 (1) GENUS device (Active Settings) (1) GENUS device (Sham Settings) (1) GLS-1200 (1) GM-CSF (1) GNX102 (1) GO2 PEEP MOUTHPIECE (1) GPs reports of potential patient safety incidents, non-COVID-19 related (1) GRAd-COV2 (1) GSK3494245 (1) GSK3640254 200 mg (1) GSK3640254 Oral tablet (1) GSK3739937 (1) GSK3882347 (1) GX-19 (1) Gait Retraining (1) Galidesivir (1) Gam-COVID-Vac Lyo (1) Gamification (1) Ganovo+ritonavir+/-Interferon nebulization (1) Garadacimab, Factor XIIa Antagonist Monoclonal Antibody (1) Gargle/Mouthwash (1) Gas exchange measurement (1) Gas exchanges at different PEEP (1) Gastrointestinal endoscopy (1) General Communication Message (1) General Parenting Advice (1) General Public cohort (1) General health education (1) General health through IM Apps (1) Generalized Anxiety Disorder-7 (GAD 7) (1) Generalized Anxiety Disorder-7 (GAD-7) (1) Generic Response Training Control Intervention (1) Gepotidacin (1) Gimsilumab (1) Global Longitudinal Strain (1) Glucose tablets (1) Glycaemic levels (1) Glycine (1) Goal Management Training (GMT) (1) Goal-Oriented Attentional Self-Regulation (GOALS) (1) Graded exercise test (1) Graded exposure therapy (1) Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed (1) Group 2: control group with enoxaparin 40mg/d (1) Group A HCQ (1) Group A: oropharygeal spray and immunostimulant (1) Group B Control (1) Group B: Placebo oropharyngeal spray + Active principle immunostimulant (1) Group C:Active principle oropharyngeal spray + Placebo taken PO (1) Group CBT (1) Group D:Placebo oropharyngeal spray + Placebo taken PO (1) Group Exercise Classes (1) Group Lifestyle Balance (1) Group Lifestyle Balance™ (1) Group Social ABCs (1) Group1 (1) Growth Hormone (1) Growth Mindset (1) Guanfacine hydrochloride (SPD503) (1) Guided online support program (1) Guilt message (1) HADS (1) HADS questionnaire (1) HB-adMSC (1) HCQ & AZ (1) HCQ & AZ vs HCQ+SIR (1) HCQ+AZT (1) HFNO (1) HIIT (intervention) (1) HIT-exercise (1) HLCM051 (1) HLX70 (1) HOME-CoV rule implementation (1) HOPE intervention (1) Halo Oral Spray (1) Halo Placebo (1) Hand sanitizer and hand washing (1) Haptic stimulation (1) Health Care Worker Survey (1) Health Enhancement Program (1) Health Questionnaire (1) Health warning leaflet (1) Health-related quality of life (1) Healthy Minds Program Foundations Training (1) Healthy Weight Program (HW) (1) Healthy lifestyle advise (1) Heated Vest (1) Helmet CPAP (1) Helmet Continuous Positive Airway Pressure (CPAP) (1) Helmet non-invasive ventilation (1) Helmet non-invasive ventilation (NIV) (1) Hemanext One (1) Hemodynamics changes at different PEEP (1) Heparin Infusion (1) Heparin SC (1) Heparin sodium (1) Hepatitis A vaccine (1) Hesperidin and Diosmin mixture (1) Hidroxicloroquina (1) Hidroxicloroquine (1) High Dose of KBP-COVID-19 (1) High Flow Nasal Oxygen (HFNO) (1) High Intensity Interval Training group (1) High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT) (1) High PEEP with end inspiratory pause (1) High PEEP without end inspiratory pause (1) High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule (1) High dose Interferon-beta 1a (1) High dose radiation 100 cGy (1) High flow nasal cannula HFNC (1) High nitrite/NDMA meals (1) High-Concentration Essential Oil (1) High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma (1) High-Titer COVID-19 Convalescent Plasma (HT-CCP) (1) High-flow nasal cannula (1) High-intensity training (1) High-titer Convalescent COVID-19 Plasma (CCP1) (1) Home Health Agency Care (1) Home Pulse Oximetry Monitoring (1) Home Sleep Apnea Testing or In-hospital Polysomnography (1) Home exercise (1) Home exercise program (1) Home sample collection of concerning mole with physician supervision (1) Home visiting (1) Home-based exercise (1) Home-use Test and Follow-up Questionnaire (1) Honey (1) Hormones (1) Hospital admission (1) Hospital anxiety and depression scale (1) Hospitalized Patients for COVID-19 Infection (1) Huaier Granule (1) Human Amniotic Fluid (1) Human Biological samples (1) Human Coach first, then Virtual Assistant (1) Human Cord Tissue Mesenchymal Stromal Cells (hCT-MSCs) (1) Human biological samples (1) Human milk donors (1) Human umbilical cord derived CD362 enriched MSCs (1) Human umbilical cord mesenchymal stem cells + best supportive care (1) Humanistic Care (1) Humor/Salience (1) Hydrogen Oxygen Generator with Nebulizer (1) Hydroxychloroquin with Azithromycin (1) Hydroxychloroquine (placebo) (1) Hydroxychloroquine + Azithromycin (1) Hydroxychloroquine + azithromycin + / - tocilizumab (1) Hydroxychloroquine + lopinavir/ritonavir (1) Hydroxychloroquine + placebo (1) Hydroxychloroquine , Sofosbuvir, daclatasvir (1) Hydroxychloroquine - Daily Dosing (1) Hydroxychloroquine - Daily dosing (1) Hydroxychloroquine Only Product in Oral Dose Form (1) Hydroxychloroquine Oral Product (1) Hydroxychloroquine Pill (1) Hydroxychloroquine Pre-Exposure Prophylaxis (1) Hydroxychloroquine SAR321068 (1) Hydroxychloroquine Sulfate (HCQ) (1) Hydroxychloroquine Sulfate + Azithromycin (1) Hydroxychloroquine Sulfate + Azythromycin (1) Hydroxychloroquine Sulfate 200 milligram (mg) Tab (1) Hydroxychloroquine Sulfate 400 mg twice a day (1) Hydroxychloroquine Sulfate 600 mg once a day (1) Hydroxychloroquine Sulfate 600 mg twice a day (1) Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets (1) Hydroxychloroquine and azithromycin treatment (1) Hydroxychloroquine and azithromycin treatment arm. (1) Hydroxychloroquine as post exposure prophylaxis (1) Hydroxychloroquine combined with Azithromycin (1) Hydroxychloroquine in combination of Azithromycin (1) Hydroxychloroquine plus Nitazoxanide (1) Hydroxychloroquine plus standard preventive measures (1) Hydroxychloroquine sulfate (1) Hydroxychloroquine sulfate &Azithromycin (1) Hydroxychloroquine, Azithromycin (1) Hydroxychloroquine, Clindamycin (1) Hydroxychloroquine, Clindamycin, Primaquine - high dose. (1) Hydroxychloroquine, Clindamycin, Primaquine - low dose. (1) Hydroxychloroquine, Doxycycline (1) Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) (1) Hydroxychloroquine/Azithromycine (1) Hydroxychloroquine/Chloroquine (1) Hydroxycloroquine and Azythromycine (1) Hyperbaric Chamber (1) Hyperbaric Oxygen (1) Hyperbaric Oxygen Therapy (1) Hyperbaric oxygen (1) Hyperbaric oxygen therapy (1) Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device) (1) Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) (1) Hyperimmune plasma (1) Hypertension (1) Hypocaloric, low carbohydrate diet (1) Hypocaloric, moderate low fat diet (1) IC14 (1) IC14, a monoclonal antibody against CD14 (1) ICU Recovery + Physical Therapy (1) ICU treatment (1) ID NOW vs. Accula (1) IER-R (posttraumatic stress) (1) IGV-001 Cell Immunotherapy (1) IIEF-5 questionnaire (1) IMM-101 (1) IN01 vaccine (1) INC424 / Ruxolitinib (1) INM005 (1) INOpulse (1) IO-202 Dose Escalation (1) IO-202 Dose Expansion (1) ION-827359 (1) IP-10 in CDS protocol (1) IPSS questionnaire (1) ISIS 721744 (1) IV Deployment Of cSVF In Sterile Normal Saline IV Solution (1) IV Dexamethasone (1) IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. (1) IVIG (1) IW-3718 (1) Ibudilast (1) Ibuprofen (1) Icatibant (1) Icosapent ethyl (IPE) (1) Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus (1) IgG (1) IgG SARS CoV 2 antibodies (1) IgG SARS CoV2 (1) IgG antibodies immunoassay (1) IgG test (1) IgIV (1) IgM and IgG diagnostic kits to SARS-CoV-2 (1) Iloprost (1) Imaging (1) Imaging by thoracic scanner (1) Imaging of the lungs (1) Imatinib Mesylate (1) Imatinib tablets (1) Immune response study (1) Immunfluorescence (1) Immunofluorescence Imaging (1) Immunofree tablets and Reginmune capsule (1) Immunoglobulin (1) Immunoglobulin of cured patients (1) Immunoglubulins (1) Immunological profiling (1) Immunosuppressive (1) Impact Event Score (1) Impact of COVID-19 questionnaire (1) Impact of Event Scale-Revised (1) Implementation Facilitation (IF) (1) In-Person Default (1) In-person in clinic follow-up visit (1) In-person instruction (1) Inactivated SARS-CoV-2 vaccine (Vero cell) (1) Inactivated convalescent plasma (1) IncobotulinumtoxinA 100 UNT Injection [Xeomin] (1) Increasing Willingness and Uptake of COVID-19 Testing and Vaccination (1) Independent Living Program for Affordable Housing. (1) Individualised Ayurveda (1) Individualized-Chinese herbal medicine (1) Indomethacin (1) Infant Mental Health-Home Visiting (1) Infectious Disease and Cardiology Clinical Consultations (1) Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration (1) Infliximab (1) Information (1) Information and referral condition (1) Information leaflet (1) Information-only intervention (1) Informed consent (1) Infusion IV of Mesenchymal Stem cells (1) Infusion placebo (1) Inhaled Hypertonic ibuprofen (1) Inhaled ILOPROST (1) Inhaled Supplemental Oxygen (1) Inhaled beclomethasone (1) Inhaled budesonide (1) Inhaled budesonide and formoterol (1) Inhaled nitric oxide (iNO) (1) Inhaled nitric oxide gas (1) Inhaled placebo (1) Inhaled sedation (1) Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs (1) Injection into olfactory cleft (1) Inspiratory Muscle Training (1) Inspiratory training device (1) Insulin (1) Insulin regimen (1) Interactive workshops LiPAT intervention group (1) Interferon alfa (1) Interferon-Alpha2B (1) Interferon-Beta (1) Interferon-ß-1a (1) Interferon-β 1a (1) Interferon-β1a (1) Interleukin 6 (IL6) Antagonist (1) Interleukin 6 (IL6) Antagonist and corticosteroids (1) Interleukin assessment in semen (1) Interleukin-1 receptor antagonist (1) Interleukin-6 Gene-174C detection (1) Intermediate dose thromboprophylaxis (1) Intermittent prone positioning instructions (1) Internet-based Cognitive Behavioral Therapy (1) Internet-based guided self-help based on CBT principles (1) Internet-based self-help (1) Internet-based self-help after 3 weeks (1) Internet-connected computer tablet (1) Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic (1) Interpersonal Therapy (1) Intervention App (1) Intervention group CoronaCope (1) Intervention group_rehabilitation program (1) Intervention program (1) Intervention-EDI and health coaching (1) Interview by psychologists (1) Interviews only. (1) Intracorporeal left hemicolectomy anastomosis (1) Intralipid (1) Intramuscular Vaccine (1) Intranasal heparin sodium (porcine) (1) Intraosseous access (1) Intravenous Immune Globulin (1) Intravenous Immunoglobulin (1) Intravenous Infusions of Stem Cells (1) Intravenous access (1) Intravenous drug (1) Intravenous saline injection (Placebo) (1) Intravenous sedation (1) Intubation Box (1) Invasive mechanical ventilation (1) Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours (1) Investigation of smell and taste disorders (1) Ion Mobility Spectrometry (IMS) (1) Iota-Carrageenan (1) Isoflurane Inhalant Product (1) Isoniazid, Rifampicin, Pyrazinamide and Ethambutol (1) Isoprinosine (1) Isoquercetin (IQC-950AN) (1) Isotonic saline (1) Isotonic saline 0.9% (1) Isotretinoin Only Product in Oral Dose Form (1) Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment (1) Itolizumab IV infusion (1) Ivermectin (IVM) (1) Ivermectin + Doxycycline (1) Ivermectin + Doxycycline + Placebo (1) Ivermectin + Placebo (1) Ivermectin 3mg Tab (1) Ivermectin 5 MG/ML (1) Ivermectin 6 MG Oral Tablet (2 tablets) (1) Ivermectin Injectable Solution (1) Ivermectin Tablets (1) Ivermectin nasal (1) Ivermectin oral (1) Ivermectin plus Nitazoxanide (1) Ivermectin wth chloroquine (1) Ixazomib Placebo (1) JNJ-53718678 (1) JNJ-53718678 125 mg (1) JNJ-53718678 2.5 mg/kg (1) JNJ-53718678 250 mg (1) JNJ-53718678 3 mg/kg (1) JNJ-53718678 4.5 mg/kg (1) JNJ-66525433 (1) JS016 (anti-SARS-CoV-2 monoclonal antibody) (1) Janus Kinase Inhibitor (ruxolitinib) (1) KELEA Excellerated Water (1) KIR phenotype evaluation (1) KOH 10 % (1) Kamada Anti-SARS-CoV-2 (1) Kaplan Meier analysis (1) Ketamine (1) Ketamine Hydrochloride (1) Ketamine Injectable Product (1) Ketotifen 1 MG (1) Kevzara sc (1) Knowledge, Attitude, Practice, Awareness, Preference (1) Kundalini Yoga and Anxiety Reduction Training (1) L-citrulline (1) LAU-7b (1) LB1148 (1) LDAEP (1) LEAF-4L6715 (1) LEAF-4L7520 (1) LIIT.CI ACT (1) LIIT.CI CFT (1) LIVE (1) LMWH (1) LRX712 (1) LSALT peptide (1) LY3127804 (1) LY3473329 (1) LYMPHOCYTE MONOCYTE RATIO (1) Laboratory Analyses (1) Laboratory Biomarker Analysis (1) Laboratory tests (1) Lactobaciltus rhamnosus GG (1) Lactobaciltus rhamnosus GG Placebo (1) Lactoferrin (1) Lactoferrin (Apolactoferrin) (1) Lambda 180 mcg S.C (1) Late dexamethazone (1) Late-Dexamethasone (1) Lateral Position (left and right lateral decubitus) (1) Lazertinib (1) Leadership Training (1) Learning running subcuticular sutures on the Gamified Educational Network (1) Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. (1) Let It Out (LIO)-C (1) Leukapheresis (1) Levamisole (1) Levamisole Pill + Budesonide+Formoterol inhaler (1) Levamisole and Isoprinosine (1) Levamisole and isoprinosine (1) Levilimab (1) Lianhua Qingwen (1) Liberase Enzyme (Roche) (1) Licorice extract (1) LifeSignals Biosensor 1AX* (1) Lifestyle App (1) Lifestyle change promotion program (1) Lifestyle intervention (1) Limbix Spark (1) Linagliptin (1) Linagliptin 5 MG (1) Linagliptin tablet (1) Liquid Alpha1-Proteinase Inhibitor (Human) (1) Liquid Model (1) Liquid Peanut Extract (1) Listerine Mouthwash Product (1) Live Long Walk Strong rehabilitation program (1) Liver function tests ,serum ferritin and PCR for COVID-19 . (1) Liver injury (1) Local Bone Autograft (1) Local standard of care (1) Lock-down and social distancing (1) Lopinavir (1) Lopinavir / Ritonavir Pill (1) Lopinavir / Ritonavir plus Ribavirin (1) Lopinavir / ritonavir tablets combined with Xiyanping injection (1) Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride (1) Lopinavir 200Mg/Ritonavir 50Mg FT Reference (1) Lopinavir 200Mg/Ritonavir 50Mg FT Test (1) Lopinavir 200Mg/Ritonavir 50Mg Tab (1) Lopinavir and Ritonavir Tablets (1) Lopinavir and ritonavir (1) Lopinavir-Ritonavir Drug Combination (1) Lopinavir/ Ritonavir (1) Lopinavir/ Ritonavir Oral Tablet (1) Lopinavir/ Ritonavir Placebo (1) Lopinavir/Ritonavir + hydoxychloroquine (1) Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet (1) Lopinavir/Ritonavir 400 mg/100 mg (1) Lopinavir/ritonavir treatment (1) Losmapimod oral tablet (1) Loss Frame and Fear Appeals (1) Lovenox 40 MG in 0.4 mL Prefilled Syringe (1) Low Dose (10 mg) Control (1) Low Dose of KBP-COVID-19 (1) Low Molecular Weight Heparin (1) Low PEEP - FiO2 high (1) Low PEEP - FiO2 low (1) Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule (1) Low dose CT (1) Low dose Interferon-beta 1a (1) Low dose Low molecular weight heparin or Placebo (1) Low dose radiation 35 cGy (1) Low dose radiation therapy (1) Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis (1) Low fat "standard care" control breakfast (1) Low flow ECMO driving by CVVH machine (1) Low nitrite/NDMA meals (1) Low or upper respiratory tract sample (1) Low-Carb High-Fat breakfast (1) Low-Carbohydrate Diet (1) Low-Concentration Essential Oil (1) Low-dose Chest CT (1) Low-dose radiotherapy (1) Lower-dose prophylactic anticoagulation (1) Lucinactant (1) Lung CT (1) Lung CT scan analysis in COVID-19 patients (1) Lung Cancer Screening Decision Tool (1) Lung Function Test (1) Lung Function tests (1) Lung Low Dose Radiation (1) Lung Ultrasound (1) Lung impedance technique (1) Lung ultrasound use in patients hospitalized with COVID (1) M201-A Injection (1) MAGEC Spine Rod (1) MANAGEMENT OF COVID-19 (1) MAS825 (1) MCC IMS (1) MCN (Methylene blue, vitamin C, N-acetyl cysteine) (1) MEDI7219 (1) MELT-100 (1) MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg (1) MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg (1) MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg (1) MFS (1) MGA012 (1) MGC018 (1) MK-5475 (1) MLS Laser (1) MMR vaccine (1) MPT0B640 (1) MR or M-M-R II ® vaccine (1) MR-Pro-ADM (1) MRI (1) MRI (heart, brain, lungs, kidney) (1) MRx-4DP0004 (1) MSB11456 (1) MSC (1) MSC Treatment (1) MSCT (1) MSCs (1) MSCs-derived exosomes (1) MSTT1041A (1) MSTT1041A-matched Placebo (1) MVA-BN-Filo (1) MVA-MERS-S_DF1 - High Dose (1) MVA-MERS-S_DF1 - Low Dose (1) MVC-COV1901 (1) MW33 injection (1) MW33 injection placebo (1) Machine learning model (1) Macrolide administered for 3-5 days (1) Macrolide administered for up to 14 days (1) Magnetic Resonance Imaging (1) Magnetic Resonance Spectroscopy (MRS). (1) Maintenance or reduction of immunosuppression (1) MakAir (1) Male Sexual Health Questionnaire (MSHQ) (1) Maltodextrin (1) Mannitol (1) Manremyc (1) Maraviroc (1) Maraviroc + Currently used therapy (1) Maraviroc 300 mg (1) Maraviroc+Favipiravir+CT (1) Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol) (1) Masimo, LidCO (1) Masked Saline Placebo (1) Maslach Burnout Inventory (MBI) (1) Massive parallel sequencing of host genome (1) Matched Placebo Hydroxychloroquine (1) Matched placebo (1) Matching Placebo (1) Maternal stress (1) Maximal effort test (1) McGrath videolaryngoscope (1) Measles-Mumps-Rubella Vaccine (1) Mechanical Trombectomy (1) Mechanical ventilation with the automated BVM compressor (1) Med-South Weight Loss Intervention (1) Media Intervention (1) Medical Mask (1) Medical Ozone procedure (1) Medical Record Review - Inpatient Treatment (1) Medical records-based recommendation (1) Medical/surgical mask (1) Medically Tailored Meals (1) Medication Review (1) Meditation Therapy (1) Meditation and Anxiety Reduction Training (1) Meditation app usage (1) Mediterranean diet, no caloric restriction (1) Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule (1) Medtronic Interstim II Model 3058 Neurostimulator (1) Mefloquine (1) Mefloquine + azithromycin + / - tocilizumab (1) Melatonin 2mg (1) Melphalan (1) MenACWY (1) MenACWY boost (1) MenACWY single dose (1) MenACWY two dose (1) MenACWY vaccine (1) MenCare+/Bandebereho fathers'/couples' group education (1) Mental Health questionnaire (1) Meplazumab for Injection (1) Merimepodib (1) Mesenchymal Stem Cell (1) Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords (1) Mesenchymal Stromal Cells infusion (1) Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 (1) Mesenchymal cells (1) Mesenchymal stem cell (1) Mesenchymal stem cell therapy (1) Mesenchymal stem cells (1) Mesenchymal stromal cell-based therapy (1) Messaging (1) Metacognitive therapy and work-focused interventions (1) Metformin (1) Metformin XR (1) MethylPREDNISolone 80 Mg/mL Injectable Suspension (1) Methylene Blue 5 MG/ML (1) Methylprednisolone Injectable Product (1) Metoprolol 100 mg (1) Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) (1) Microcrystalline Cellulose, NF (1) Microscopy of defined brain regions on autopsy specimens (1) Midazolam 5 mg (2.5 mL) (1) Midazolam injection (1) Milk of magnesia (1) MindRhythm Harmony (1) Mindful Self-Compassion (1) Mindfullness based cognitive program (1) Mindfulness + Compassion Intervention (MC) (1) Mindfulness Alone (MO) Intervention (1) Mindfulness Based Intervention (1) Mindfulness Rounds (1) Mindfulness based intervention (1) Mindfulness exercises (1) Mindfulness intervention (1) Mindfulness program (1) Mindfulness session(s) (1) Mindfulness training (MT) Connect (1) Mindfulness-Based Cognitive Therapy (1) Mindfulness-based "STOP touching your face" practice (1) Minimal Attention Control Intervention (1) MinnRAP Peer Support Program (1) Minocycline (1) Mobile Enhanced Prevention Support (1) Mobile Mental Health App - 1 (1) Mobile Mental Health App - 10 (1) Mobile Mental Health App - 2 (1) Mobile Mental Health App - 3 (1) Mobile Mental Health App - 4 (1) Mobile Mental Health App - 5 (1) Mobile Mental Health App - 6 (1) Mobile Mental Health App - 7 (1) Mobile Mental Health App - 8 (1) Mobile Mental Health App - 9 (1) Model Building (1) Model validation (1) Moderate-intensity continuous training (1) Modified Rankin score (1) Monalizumab (1) Monitoring Visit - Baseline (1) Monitoring Visit - Week 4 (1) Monitoring Visit - Week 8 (1) Monitoring for aggravation (1) Monitoring physiological data with the Hexoskin smart shirt (1) Montelukast 10 mg (1) Montelukast 10mg (1) Montelukast Oral Granules (1) Montmorrillonite (1) Morning Bright Light Therapy (1) Mother Provides MOM (1) Moxibustion plus Cupping (1) Moxifloxacin or Levofloxacin (1) Mucodentol (1) Multi Modal Balance Training (1) Multi-tasking Training (1) MultiStem (1) Multicapillary column coupled ion mobility spectrometry (1) Multifrequency Bioimpedance Spectroscopy (1) Multiple Doses of Anti-SARS-CoV-2 convalescent plasma (1) Multivitamin (1) Mupirocin (1) Muscle Relaxation Therapy (1) Muscle ultrasound (1) MuscleSound Ultrasound (1) Muse headband with Myndlift app (1) Music Therapy (1) MySafeRx Inspire Flex (1) MySafeRx Inspire Plus (1) N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I (1) N-803 (1) N-95 Respirator (1) N95 Respirator (1) N95 respirator (1) NA (no intervention) (1) NA-831 (1) NA-831 and Atazanavir (1) NA-831and Dexamethasone (1) NBT-NM108 (1) NETosis markers (1) NG Biotech (1) NG test (1) NHANES smell and taste tests (1) NICU Acquires MOM (1) NIO® (Intraosseous access) (1) NIVOLUMAB (1) NK Cells (1) NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells (1) NK-1R antagonist (1) NO gas (1) NO intervention planned due to the observational study design - only a diagnostic testing (1) NO intervention planned due to the observational study design only a diagnostic testing (1) NO-Immunosuppressive (1) NOX66 (1) NP-120 (Ifenprodil) (1) NT-I7 (1) NaCl (1) NaCl 0.9% (1) NaCl Solution (1) Nafamostat Mesylate (1) Naltrexone (1) Naltrexone 380 MG (1) Narrative Exposure Therapy (1) Nasal Dexamethasone (1) Nasal Irrigation (1) Nasal Swab (1) Nasal lavage (1) Naso pharyngeal swab (1) NasoVAX (1) Nasopharyngeal (NP) swab (1) Nasopharyngeal Swab (1) Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR (1) Nasopharyngeal swab and main laboratory (1) Nasopharyngeal swabs (1) Nasopharyngeal, oropharyngeal, or saliva swab (1) Natural Honey (1) Nebulised heparin (1) Nebulised unfractionated heparin (UFH) (1) Nebulized Platelet Lysate (1) Nebulized Sterile Saline (1) Nebulized administration of RLF-100 or Placebo (1) Negative COVID Test Result - Hypothetical Scenario (1) Negative Ion Generator (1) Nemolizumab (1) NestaCell® (1) Neural network diagnosis algorithm (1) Neuromuscular Electrical Stimulation (1) Neuromuscular evaluation (1) Neutral writing control (1) Neutralizing antibodies (1) New QIAstat-Dx fully automatic multiple PCR detection platform (1) New screening strategy (1) Newsfeed function (1) Next generation Sequencing (NGS) analysis (1) Niclosamide (1) Niclosamide suspension (1) Nicotinamide riboside (1) Nigella sativa (1) Nil intervention (1) Nintedanib 150 MG (1) Nintedanib 150 MG [Ofev] (1) Nitazoxanide 500 MG (1) Nitazoxanide 500Mg Oral Tablet (1) Nitazoxanide Tablets (1) Nitazoxanide and atazanavir/ritonavir (1) Nitazoxanide with ivermectin (1) Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation (1) Nitric Oxide delivered via LungFit™ system (1) Nitric Oxide-Continuous and Sessions (1) Nitric Oxide-Releasing Drug (1) Nitric Oxide-Sessions (1) Nivolumab Injection (1) No Intervention - Observational Study (1) No Personal protective equipment (PPE) (1) No Racial Inequality Highlighting (1) No Treatment (1) No intervention (survey study for medical doctors). (1) No intervention - exposure is to COVID-19 (1) No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups (1) No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests (1) No intervention, observational (1) No interventions (1) No interventions planned (1) No interverntion (1) No research related technology based social interactions (1) No special intervention (1) Non Extracorporeal Membrane Oxygenation (1) Non Intervention (1) Non applicable (1) Non interventional study (1) Non invasive visual acuity testing (1) Non-ACEI/ARB (1) Non-Anchoring Strategy Control (1) Non-Heated Vest (1) Non-Interventional (1) Non-Mindfulness intervention (1) Non-contact ECG (1) Non-contact MCE system (1) Non-convalescent Plasma (control plasma) (1) Non-convalescent fresh frozen plasma (Standard plasma) (1) Non-enhanced CT scan of the chest (1) Non-food Ads (1) Non-hospitalization procedures (1) Non-interventional (1) Non-interventional study (1) Non-invasive cardiac imaging (1) Non-invasive red LLLT treatment to chest of patient. (1) Non-invasive ventilatory support (1) None - NA (1) Normal (9%) Saline (1) Normal Saline 0.9% (1) Normal Saline Infusion + standard of care (1) Normal saline 0.9% (1) Normal saline solution (NSS), Placebo - Phase 1 (1) Normal saline solution (NSS), Placebo - Phase 2 (1) Normal saline solution (NSS), Placebo, Day 189 - Phase 2 (1) Normal saline solution (NSS), Placebo, Day 21 - Phase 1 (1) Normal saline solution (NSS), Placebo, Day 21 - Phase 2 (1) Normobaric oxygen therapy (1) Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) (1) Norovirus Bivalent (GI.1 / GII.4) Vaccine(low) (1) Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) (1) Not bravery message (1) Novel laser inferometry test for CORONA virus (1) NuSepin® 0.1 mg (1) NuSepin® 0.2 mg (1) Nudge (1) Nursing care to reduce anxiety, fear and loneliness (1) Nutrition (1) Nutrition Consult and Protein Supplementation (1) Nutrition support (1) Nutritional assessment (1) Nutritional counseling (1) Nutritional education (1) Nutritional support system (NSS) (1) Nuvastatic (1) NİCaS (1) ONC201 (1) OP-101 (1) OT Guided Cognitive Interventions (1) Obesity (1) Observation of Virtual Actions (1) Observation of Virtual Actions (step 4) (1) Observation of behavior and COVID-19 infection will be conducted. (1) Observation of patients with known, suspected, or at risk for COVID-19 infection (1) Observation only (1) Observational (registry) (1) Observational Study (1) Observational cohort study on the natural history of hospitalized SARS-COV-2 patients. (1) Observational measurement of biometric data. No change to health care provided. (1) Observational only (1) Observational study (1) Observational study only (1) Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples (1) Obvio-19 app (1) Octagam (1) Octagam 10% (1) Odd/Even birth year intervention groups (1) Office FU (1) Olaparib Oral Tablet [Lynparza] (1) Olfaction testing (1) Olfactometry (1) Olfactory retraining (1) Omega 3/Nigella Sativa Oil (1) Omega 3/Nigella Sativa Oil/Anise seed capsule (1) Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice (1) Omega 3/Nigella Sativa Oil/Indian Costus (1) Omega 3/Nigella Sativa Oil/Quinine pills (1) Omega-3 Fatty Acid Supplement (1) Omeprazole 20mg (1) Omeprazole 40 mg (1) Omnibiotic AAD (1) On-Line Survey (1) On-line exercise and education (1) On-site exercise and education (1) OnabotulinumtoxinA 100 UNT [Botox] (1) One COVID-19 vaccine candidate (TMV-083) administration - High dose (1) Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop (1) Online Intervention Mental Health COVID-19 (1) Online Questionnaire (1) Online Questionnaires (1) Online Survey about Dietary and Lifestyle Habits (1) Online bibliotherapy programme (1) Online cognitive behavioral therapy (CBT) (1) Online instruction (1) Online support Group (1) Only Standard Treatment (1) Ophthalmologic exam (1) Opt-in Recruitment Email (1) Opt-out Recruitment Email (1) Optical Coherence Tomography (OCT) (1) Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East (1) Oral (1) Oral 25-Hydroxyvitamin D3 (1) Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions (1) Oral fluid swab (1) Oral supplement enriched in antioxidants (1) Oral-B Mouth Sore mouthwash (1) Oropharyngeal Swab (1) Orthopaedic Surgical Procedures (1) Oseltamivir 75mg (1) Other (1) Others(No intervention) (1) Otilimab (1) Outpatient MRI (1) Oxidative Stress ELISA Kit (1) Oxycodone and Midazolam (1) Oxycodone, Paroxetine, and Quetiapine (1) Oxygen Hood (1) Oxygen Therapy (1) Oxygen gas (1) Oxygen supply (1) Oxygen-ozone therapy, probiotic supplementation and Standard of care (1) Oxytocin (1) Ozanimod (1) Ozone auto-hemotherapy (1) P2Et (Caesalpinia spinosa extract) (1) PACE-Life (1) PARTNER-MH (1) PB1046 (1) PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) (1) PCR for COVID-19 (1) PCR, lung ultrasound (1) PD-1 blocking antibody+standard treatment (1) PDS-08 (1) PEAR-008 (1) PEEP trial (1) PEP flute (1) PET-CT of 18F-FDG (1) PET/CT Scan (1) PF-06939999 dose escalation (1) PF-06939999 in combination with docetaxel (1) PF-06939999 monotherapy (1) PF-07104091 + palbociclib (1) PF-07104091 + palbociclib + letrozole (1) PF-07104091 monotherapy (1) PF-07304814 (1) PH-combination therapy (1) PH-monotherapy (1) PH94B (1) PHQ-9 (9-item Patient Health Questionnaire) (1) PHQ-9 (Patient Health Questionnaire) Depression Scale (1) PHQ-9 Depression Scale (1) PHR160 Spray (1) PLACEBO GROUP (1) PLN-74809 (1) PLX-PAD (1) PP-MI Intervention (1) PRO-SERO-COV (1) PROTECTIVE VENTILATION (1) PRV-015 (1) PSC-04 (1) PSG (1) PSQI (1) PSS (Perceived Stress Scale) (1) PT-PCR test for SARS-CoV-2 (1) PT-Pal (1) PTC299 (1) PTI-125, 100 mg tablet (1) PTSD (1) PWV (1) Pacebo: Calcium citrate (1) Pacing + mindfulness (1) Pacritinib (1) Palliative care assessment (1) Pamrevlumab (1) Pandemic control measures (1) Paraclinical examination (1) Paramedic Coaching (1) Parents and Infants Engaged (1) Part 1 - TL-895 (1) Part 2 - Placebo (1) Part 2 - TL-895 (1) Partially HLA-matched SARS-CoVSTs (1) Partner-assisted intervention (1) Passed infection of SARS-CoV-2 (1) Pathogen-specific aAPC (1) Pathways for Parents after Incarceration (1) Patient Characteristics (1) Patient Education (1) Patient Health Questionnaire (PHQ-9) (1) Patient Health Questionnaire-9 (PHQ-9) (1) Patient Navigation Program (1) Patient Status Engine (1) Patient management suffering of coronavirus infection (1) Patient sampling (1) Patient with SAR-CoV-2 infection (1) Patient-centred advice on Telephone Consultation in TB Patients: (1) Patient-only intervention (1) Patients admitted to Intensive Care Unit with SARS-CoV2 (1) Patients received standard of care treatment during hospitalization (1) Patients with the treatment agains COVID19 (1) Pectin (1) Peer Education on Exercise for Recovery (1) Peer Resilience Champion (1) Peginterferon Lambda-1a (1) Peginterferon lambda alfa-1a subcutaneous injection (1) Pegylated Interferon-α2b (1) Pegylated interferon lambda (1) Pembrolizumab (MK-3475) (1) Percutaneous Coronary Revascularization for STEMI (1) Percutaneous Transluminal Angioplasty (PTA) Device (1) Performance of WHEELS-I in promoting DASH/SRD adoption (1) Performing Virtual Actions (1) Performing of lung ultrasound (1) Performing routine care (clinical and paraclinical tests) (1) Peripheral Blood (1) Peripheral blood sampling (1) Personal Exercise Intervention (1) Personal Protective Testing Booth (1) Personal behaviours (1) Personal freedom message (1) Personal protective equipment (1) Personal protective equipment (PPE) (1) Personal protective equipment from biological hazard (1) Personalized Anchoring Strategy (1) Personalized health education (1) Philips Lumify Ultrasound System (1) Phlebotomy (1) Phone Administration of Questionnaires (1) Phone-call screening and management by a medical student/general practitioner tandem (1) Phosphate buffered saline Placebo (1) Photobiomodulation (1) Phsyiotherapy (1) Physical Exam (1) Physical Exercises (1) Physical Therapy (1) Physical Therapy Exercise (1) Physical exercise (1) Physiological saline solution (1) Physiological serum (1) Physiology (1) Physiotherapy - Manual Therapy (1) Piclidenoson (1) Pilot a rapid SARS-CoV-2 testing strategy (1) Pioglitazone (1) Pioglitazone 30 mg (1) Piperacillin-tazobactam (1) Piperacillin/tazobactam (1) Placebo (0.9% normal saline) (1) Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) (1) Placebo (Methylcellulose) capsule (1) Placebo (PB0) (1) Placebo (PBO) (1) Placebo (Plasma-Lyte 148) (1) Placebo (carrier control) (1) Placebo (for Zonisamide) (1) Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) (1) Placebo 0.10 mg + 1.00 mg/kg (1) Placebo 0.20 mg + 2.00 mg/kg (1) Placebo 0.9% NaCl solution (1) Placebo 250 cc 24 hours continuous infusion for 15 days (1) Placebo Atazanavir (1) Placebo Daclatasvir 120 (1) Placebo Daclatasvir 60 mg (1) Placebo EC-18 (1) Placebo Glycerin SLIT (1) Placebo Group (1) Placebo Infusion (1) Placebo LSF (1) Placebo PBMT/sMF (1) Placebo Saline (1) Placebo Sofosbuvir/Daclatasvir 120 (1) Placebo Sofusbuvir + Daclatasvir 60 mg (1) Placebo Starch (1) Placebo Subcutaneous Solution (1) Placebo Tablet (1) Placebo Vaccine (1) Placebo capsules (1) Placebo comparator: DW-NI (1) Placebo comparator: DW-NS (1) Placebo control (non-behavioral infographic) (1) Placebo for Azithromycin (1) Placebo for Hydroxychloroquine (1) Placebo for Risankizumab IV (1) Placebo for Risankizumab SC (1) Placebo for Upadacitinib (1) Placebo inhalation (1) Placebo injection (1) Placebo matching to gepotidacin (1) Placebo mouthwash (water) (1) Placebo of Hydroxychloroquine (1) Placebo of LPV/r Tablets (1) Placebo of excipient(s) will be administered (1) Placebo on a 0- and 14-day schedule (1) Placebo oral (1) Placebo pMDI (1) Placebo plus standard preventive measures (1) Placebo solution (1) Placebo tablet (1) Placebo to Match RDV (1) Placebo videos (1) Placebo- 0.10 mg/kg (1) Placebo- 0.20 mg/kg (1) Placebo- 1.00 mg/kg (1) Placebo- 2.00 mg/kg (1) Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine (1) Placebo/Control (1) Placebo: Emtricitabine/tenofovir disoproxil Placebo (1) Placebo: Hydroxychloroquine (1) Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells (1) Plant Polyphenol (1) Plaquenil 200Mg Tablet (1) Plasma Donation (1) Plasma exchange (1) Plasma expansion with Ringer's Acetate (1) Plasma from COVID-19 convalescent patient (1) Plasma from a volunteer donor (1) Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19 (1) Pleth variability index (1) Plethysmography & DLCO (1) Plitidepsin 1.5 mg/day (1) Plitidepsin 2.0 mg/day (1) Plitidepsin 2.5 mg/day (1) Pneumococcal vaccine (1) Point of care ultrasound (1) Point-of-Care Ultrasonography (POCUS) (1) Point-of-care test for SARS-CoV-2 (1) Polymorphism of the HSD3B1 (1) Polyoxidonium (1) Positive COVID Test Result - Hypothetical Scenario (1) Positive Emotion Skills Course (1) Positive Minds Strong Bodies Enhanced (1) Positive Peer Journaling (PPJ) (1) Positive feedback (1) Post COVID-19 Functional Satus Scale (1) Post Traumatic Stress Disorder questionnaire (PTSD-8) (1) Post-mortem tissue collection (1) Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 (1) Postural Positioning (1) Povidine iodine nasal swabs (1) Povidone-Iodine (PVP-I) (1) Povidone-Iodine 0.4% NI (1) Povidone-Iodine 0.5% (1) Povidone-Iodine 0.5% NI (1) Povidone-Iodine 0.5% NS (1) Povidone-Iodine 0.6% NI (1) Povidone-Iodine 0.6% NS (1) Povidone-Iodine 2% (1) Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP (1) Povidone-iodine (1) Powered Air purifying respirator (1) Pozelimab (1) PrEP (1) Prasugrel Hydrochloride 10 MG Oral Tablet (1) Pravastatin 40 mg (1) Pre-operative breast magnetic resonance imaging (1) Prediction Market (1) Predictive factors for clinical response in patients with COVID-19. (1) Predictors adverse evolution (1) Predictors of health care provide (1) Prednisolone (1) Prednisone tablet (1) Pregnant women under investigation for Coronavirus or diagnosed with COVID-19 (1) Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein (1) Premier Biotech COVID-19 IgG/IgM Rapid test Cassette (1) Presatovir placebo (1) Prescription Opioid Management App (1) Presence of specific anti-SARS-CoV-2 antibodies (1) PreserVision AREDS formulation gel tabs (1) Prevalence of COVID-19 (1) Prevenar 7 and Prevenar 13 (1) Preventive information (1) Previfenon® (1) Primary care (1) Primary care professionals reports of potential patient safety incidents, non-COVID-19 related (1) Pro BNP , Vitamin D (1) Probiorinse (1) Probiotic and LC-PUFA (1) Probiotics (1) Problem-solving and relationship improvement intervention. (1) Progesterone 100 MG (1) Prognostic score (1) Progressive cycling exercise test to exhaustion (1) Project ECHO (1) Project Health (1) Prolastin (1) Prolectin-M; a (1-6)-alpha-D-Mannopyranose class (1) Prolonged Exposure (PE) (1) Promotion of flour (1) Prone (1) Prone Positioning (PP) (1) Prone decubitus (1) Prone position ventilation (1) Prone positioning (PP) (1) Prophylactic/Intermediate Dose Enoxaparin (1) Propofol (1) Propranolol Hydrochloride (1) Proprietary extract of Nerium oleander (1) Prosocial acts (1) Prospective Chart Review (1) Prospective oberservational registry (1) Prospective observation (1) Prospective study across two time-points examining the impact of viral mitigation protocols on mental health (1) Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout (1) Protocolised mechanical ventilation strategy (1) Proton Therapy (1) Prototype BMS-986165 (1) Prototype swab (1) Provision of flour (1) Proxalutamide (1) Psilocybin (1) Psychiatric counseling (1) Psycho-Social Questionnaire (1) Psychoeducation and Safety (1) Psychoeducational intervention (1) Psychological and Behaviour Change Support (1) Psychological and physical rehabilitation based humanistic care (1) Psychological stress and adaptation at work score (PSAS) (1) Psychological treatment (1) Psychosocial stimulation and healthy eating education (1) Public Health England Gold Standard (1) Public space exposure (1) Pulmonary Physiotherapy Techniques (1) Pulmonary Rehabilitation (1) Pulmonary Vascular Permeability Index (1) Pulmonary and Motor Rehabilitation (1) Pulmonary function test (1) Pulmonary function testing (1) Pulmonary function tests (1) Pulmonary ultrasound (1) Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) (1) Pulse CO-Oximetry Hemoglobin measurement transcutaneous (1) Pulse Oximeter (1) Pulse oximetry (1) Pyridostigmine Bromide (1) Pyronaridine-Artesunate (1) Pyronaridine-artesunate (1) Q-NRG Metobolic Cart Device (1) Q16 testing (1) QFR (1) QazCovid-in® - COVID-19 inactivated vaccine (1) QuadraMune(TM) (1) Quadrivalent RIV with 2018-2019 NH H3 strain (1) Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant (1) Quadrivalent RIV with H3 strain 1 (1) Quadrivalent RIV with H3 strain 1 and adjuvant (1) Quadrivalent RIV with H3 strain 2 (1) Quadrivalent RIV with H3 strain 2 and adjuvant (1) Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19) (1) Quality of Life (1) Quality of life promotion (1) Quantitative IgG Test (1) Quantitative analysis of SARS-CoV-2 antibodies (1) Quantitative analysis of anti-SARS-CoV-2-antibodies (1) Quantitative and qualitative assessments of mental health (1) Quantra System (1) Quercetin (1) Quercetin Prophylaxis (1) Quercetin Treatment (1) Questionaire (1) Questionnaire and interview (1) Questionnaire by phone call (1) Questionnaire for evaluation of confinement on deviant sexual fantasies (1) Questionnaire forms (1) Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index (1) Questionnaire with precaution information (1) Questionnaire, phone call (1) Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. (1) Questionnaire-based observational study (1) Questionnaires for specific phobia (1) Questionnaires on psychological quality of life (1) Questionnaires, spirometry (1) Questionnary (1) Quetiapine (1) Quick Defense (1) Quinquina-Stevia/Azythromycin (1) RAAS inhibitor [continued standard of care] (1) RAPA-501-Allo off-the-shelf Therapy of COVID-19 (1) RAPID-3 (1) RBA-2 (1) RBT-9 (90 mg) (1) RDV (1) RECHARGE (1) REGN10933 + REGN10987 (1) REGN10933+REGN10987 (1) REGN3048 (1) REGN3051 (1) RESP301, a Nitric Oxide generating solution (1) RIA-device (Remote Investigation and Assessment) (1) RISE (1) RO6953958 (1) RO7234292 (RG6042) (1) RPH-104 80 mg (1) RS blend (1) RSV LID/ΔM2-2/1030s (1) RSV Mobile Application (1) RSVPreF3 formulation 2 (1) RSVPreF3 formulation 3 (1) RT PCR SARS-CoV-2 (1) RT-PCR Covid-19 (1) RT-PCR SARS-Cov2 (1) RT-PCR and antibody testing (1) RTB101 (1) RTLS data (1) RUC-4 Compound (1) RUTI® vaccine (1) Racial Inequality Highlighted (1) Radiological Detection (1) Radspherin (1) Ramelteon 8mg (1) Ramipril 2.5 MG Oral Capsule (1) Random Donor Plasma (1) Randomized to Delayed Cord Clamping at birth (1) Randomized to Umbilical Cord Milking at birth (1) Ranitidine (1) Rapamycin (1) Rapid Onsite COVID-19 Detection (1) Rapid detection test (1) Rapid diagnostics using Anyplex TMII RV16 Detection (1) Rapid molecular test (1) Rarefaction (1) Rayaldee 30Mcg Extended-Release (ER) Capsule (1) Razuprotafib (1) Razuprotafib Subcutaneous Solution (1) ReWalk 6.0 (1) Reading a Book (1) Real cTBS to the vmPFC (1) Real iTBS to the dlPFC (1) Real-time chat-based support through IM Apps (1) Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) (1) Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid (1) Recombinant Human Interferon α2b Spray (1) Recombinant Interferon Alfa-2b (1) Recombinant S protein SARS vaccine (1) Recombinant human alkaline phosphatase (1) Recombinant human angiotensin-converting enzyme 2 (rhACE2) (1) Recombinant human interferon α1β (1) Recombinant human plasma gelsolin (Rhu-pGSN) (1) Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) (1) Recombinase aided amplification (RAA) assay (1) Reconsolidation of Traumatic Memories (RTM) (1) Reduced Dose Bevacizumab (1) Reference Treatment- BMS-986165-01 (1) Reference: Favipiravir 200 mg (Avigan) (1) Referral card (1) Regadenoson myocardial perfusion imaging stress test (1) Registery Data Collection (1) Regular Inpatient Medical Care (1) Regular messages through Instant Messaging (IM) (1) Rehabilitation (1) Rehabilitation exercise protocol (1) Reinforcement learning message delivery (1) Relamorelin 10 μg (1) Relation between frailty and clinical outcomes in elderly patients with COVID-19. (1) Relaxation (1) Relaxation Breathing (1) Relaxation Therapy (1) Remain COVID Free SSI (1) Remdesivir (RDV) (1) Remote Caregiver Training (1) Remote Cognitive Behavioral Therapy for Insomnia (1) Remote Intensive Group Behavioral Treatment (IGBT) (1) Remote Photoplethysmography (rPPG) vital sign acquisition (1) Remote consultation (1) Remote controlled exercise (1) Remote pulmonary rehabilitation (1) Removal of dead space filter (1) Renin-angiotensin system inhibitors (1) Replenish protein group (1) Reporting of anosmia, ageusia and other clinical symptoms (1) Repository Corticotropin Injection (1) ResCure™ (1) Resilience Program (1) Resolute Onyx (1) Respiratory Exercise Training (1) Respiratory Mechanics (1) Respiratory filter in-line placed with the standard mouthpiece (1) Respiratory mechanics measurement (1) Respiratory physiotherapy (1) Respiratory rehabilitation (1) Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening (1) Response and Attention Training (1) Responsive training with no video feedback (1) Responsive training with video feedback (1) Resveratrol (1) Resveratrol Placebo (1) Retrospective case-control analysis (1) Retrospective data collection (1) Reverse transcription polymerase chain reaction (1) Reverse-transcription polymerase chain reaction (RT-PCR) (1) RhACE2 APN01 (1) Riboflavin Placebo (1) Rifaximin Novel Formulation (1) Rilpivirine Injectable Suspension (RPV LA) (1) Rilpivirine extended release suspension for injection (long-acting) (1) Ringer solution (1) Rintatolimod (1) Risankizumab (1) Risankizumab IV (1) Risankizumab SC (1) Risk factors (1) Risk of MERS infection (1) Risk reduction (1) Ritonavir (1) Ritonavir+Oseltamivir (1) Ritonavir/lopinavir (1) Rituximab (1) Rivaroxaban 2.5 MG (1) Rivaroxaban 2.5 Mg Oral Tablet (1) Rivaroxaban placebo tablets (1) RoActemra iv (1) RoActemra sc (1) Robot Assisted Percutaneous Cardiovascular Intervention (1) Robotic therapy (1) Rosuvastatin (Inhibitor arm) (1) Rosuvastatin (Placebo arm) (1) Rosuvastatin + BAY1817080 (1) Rosuvastatin + BI 1323495 (1) Routine Oral Care and Analgesia (1) Routine care (no SARS-CoVSTs) (1) Routine standard of care (1) Rt PCR (1) Ruconest (1) Ruxolitinib 5 MG (1) Ruxolitinib administration (1) Ruxolitinib plus simvastatin (1) SAB-301 (1) SAMBA II (Diagnostic for the Real World) (1) SAR443122 (1) SARILUMAB (1) SARS-CoV (1) SARS-CoV 2 RNA PCR Semen (1) SARS-CoV 2 RNA PCR Urine (1) SARS-CoV-2 Ab (1) SARS-CoV-2 IgG Antibody Testing Kit (1) SARS-CoV-2 PCR (1) SARS-CoV-2 S1/S2 IgG (1) SARS-CoV-2 Specific T Cells (1) SARS-CoV-2 antibody based IVIG therapy (1) SARS-CoV-2 antibody immunoassays (1) SARS-CoV-2 antibody test (1) SARS-CoV-2 antibody testing (1) SARS-CoV-2 convalescent plasma treatment (1) SARS-CoV-2 non-immune Plasma (1) SARS-CoV-2 plasma (1) SARS-CoV-2 questionnaire survey (1) SARS-CoV-2 rS - Phase 1 (1) SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 (1) SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 (1) SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 (1) SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 (1) SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 (1) SARS-CoV-2 rS/Matrix-M1 Adjuvant (1) SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics (1) SARS-CoV-2 vaccine (inactivated) (1) SARS-CoV-2 vaccine formulation 1 with adjuvant 1 (1) SARS-CoV-2 vaccine formulation 1 with adjuvant 2 (1) SARS-CoV-2 vaccine formulation 2 with adjuvant 1 (1) SARS-CoV-2 vaccine formulation 2 with adjuvant 2 (1) SARS-CoV-2 vaccine formulation 2 without adjuvant (1) SARS-CoV-2 viral composition (1) SARS-CoV-2-test (1) SARS-CoV2 Autoantibody detection (1) SARS-CoV2 Infection (1) SARS-CoV2 serum antibody testing (1) SARS-Cov-2 infection (1) SARSCoV2 Convalescent Plasma (1) SBI-101 (1) SBRT (1) SCB-2019 (1) SCB-2019 with AS03 adjuvant (1) SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant (1) SCD (1) SCH Intervention (1) SCTA01 (1) SECRET questionnaire (1) SEL-212A (1) SEL-212B (1) SF12, EQ-5D-5L and work status standardized quantitative assessments (1) SHG (1) SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) (1) SKILLZ-Girl Enhanced football curriculum (1) SLEDD with a L-MOD (1) SMBI digital app (1) SMS message support (1) SMS messages (1) SMS-based support (1) SNDX-6352 (1) SNG001 (1) SNO (1) SOC (1) SOC + IFX-1 (1) SOC + Intravenous Famotidine (1) SOC plus 15mg/kg EB05 IV (1) SOC plus Placebo IV (1) SOC: Temozolomide (1) SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales (1) SPIN-CHAT Program (1) SPIRIT-in person (1) SPIRIT-remote (1) SSE educational intervention (1) ST-2427 (1) STC-19 score (1) STI-5656 (1) STP + COVID-19 Convalescent Plasma (CP) (1) STP + Standard Plasma (SP) (1) Saline Control (1) Saline Nasal Irrigation (1) Saline Placebo (1) Saline containing 1% Human serum albumin(solution without UC-MSCs) (1) Saline oral/nasal rinse (1) Saline placebo (1) Saline with Baby Shampoo Nasal Irrigation (1) Saline-sodium citrate (SSC) buffer (1) Saliva (1) Saliva and NPS test (1) Saliva specimen (1) Saliva-based testing (1) Sample Collection/Performance Evaluation (A) (1) Sample Collection/Performance Evaluation (B) (1) Sampling (EDTA blood, pharyngeal and nose swabs, bronchoalveolar lavage ,urine) (1) Sampling of tissue (1) Sampling salivary (1) Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] (1) Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] (1) Sarilumab Prefilled Syringe (1) Sarilumab SAR153191 (1) Sars-Cov-2 serology (1) Sars-Cov2 serology (1) Satisfaction evaluation (1) Scanning Chest X-rays and performing AI algorithms on images (1) Schirmer Test I (1) Screening breast magnetic resonance imaging (1) Screening digital breast tomosynthesis (1) Screening digital mammography (1) Screening test for covid ( RT PCR and CT Chest) (1) Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] (1) Sedentary behaviour (1) Self Study (1) Self-Compassion for Chronic Pain Virtual Group Treatment Program (1) Self-Help Therapy (1) Self-System Therapy (1) Self-acupressure (1) Self-administered questionnaires (1) Self-focused acts (1) Self-guided exercises (1) Self-help booklet (1) Self-help guided by a lay provider (1) Self-interest message (1) Self-management booklet (SWitCh: Stay well during COVID-19) (1) Self-prone position recommendation (1) Self-questionnary (1) Selitrectinib (BAY2731954) (1) Semen Qualitative Analysis (1) Semi-directive interview (1) Sensbiosys (1) Sensitivity Intervention (1) Sensitivity and Couples' Intervention (1) SensiumVitals wearable sensor (1) Sequencing (1) Seraph®-100 Microbind® Affinity Blood Filter (1) Serelogy testing, RT PCR (1) Serial seroconversion measurements in hospital employees during the COVID-19 pandemic (1) Serologic SARS-CoV-2 screening (1) Serologic assays for antibodies to SARS-CoV-2 (1) Serologic immunoassays to SARS-CoV-2 antibodies (1) Serologic testing (1) Serological Assay or IgG for SARS-CoV-2 (1) Serological analyses to be lead on a pre-existing biobank (1) Serological screening for IgG and IgM antibodies against COVID-19 (1) Serological test for COVID-19. (1) Serological testing (1) Serological tests will be applied on patients blood sampling (1) Serology (1) Serology Test (1) Serology for Covid-19 (1) Serology test follow-up (1) Serology test for COVID-19 (1) Seroprevalence of SARS-CoV-2 infection in patients with HIV infection (1) Serum SARs COV 2 IGg screening in health care workers (1) Serum test (1) Serum testing (1) Serum tube collection (1) Serum zinc, vitamin d vitamin b12 levels . (1) Setanaxib (1) Sevoflurane inhalant product (1) Sham Attention Training (1) Sham Device Treatment (1) Sham Stimulation (1) Sham cTBS to the vmPFC (1) Sham iTBS to the dlPFC (1) Sham intervention (1) Shared Decision Making (1) Shock-dependent hydrocortisone (1) Sildenafil (1) Sildenafil citrate tablets (1) Silymarin (1) Simha Kriya (1) Simple cognitive task intervention (1) Simplified Geriatric Evaluation (1) Simulation Airway Coaching (1) Simulation of Repurposed Drugs for COVID-19 (1) Simultaneous EGD and colonoscopy (1) Singing for Lung Health group attendance (1) Single fraction whole lung radiotherapy (1) Single high dose vitamin D (1) Sirolimus 1 MG/ML (1) Sirukumab (1) Sitagliptin (1) Six-minute walk test (6MWT) (1) Six-month ARV dispensing (1) Sleep App (1) Sleep Education (1) Sleepio (1) Slef questionnaires fulfilment (1) Small Gift (1) Smartphone application LiPAT (1) Snorkel-based improvised personal protective equipment (1) Social ABCs (1) Social Communication and Emotional Skill Development (SCESD) module (1) Social Distancing Advertisements (1) Social comparison Intervention (1) Social media & news consumption (1) Socialization (1) Sodium Bicarbonate (1) Sodium Chloride 9mg/mL (1) Sodium Nitrite (1) Sodium bicarbonate (1) Sofosbuvir (1) Sofosbuvir + Daclatasvir 120 mg (1) Sofosbuvir 400 MG plus Daclatasvir 200mg (1) Sofosbuvir and Ledipasvir (1) Sofosbuvir plus Ledipasvir (1) Sofosbuvir/Daclatasvir (1) Sofosbuvir/daclatasvir (1) Software Messaging (1) Sofusa DoseConnect (1) Sofusbuvir + Daclastavir 60 mg (1) Solaraze (1) Solcera (1) Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA (1) Spartan COVID-19 System (1) Spartan Cube Point-of Care Covid-19 test (1) Specific anti-SARS-CoV-2 antibodies (1) Specimen Collection (1) Spectrila® (1) Spironolactone 100mg (1) Sputum and blood sampling (1) Sputum collection (1) Sputum sample (1) St. George's Respiratory Questionnaire (SGRQ) (1) Staff Wellbeing Centres (1) Stakeholder of TIP-OA Program (1) Stamaril (live attenuated yellow fever vaccine) (1) Standar medical treatmen (1) Standar of care (1) Standard (specific) therapy for COVID-19 (1) Standard 12-lead ECG, NT-proBNP, echocardiography (1) Standard COVID-19 therapies (1) Standard Care Therapy (1) Standard Dissemination Practice (1) Standard Donor Plasma (1) Standard Dose Bevacizumab (1) Standard Mask (1) Standard Of Care (SOC) (1) Standard Of Care (SOC) + Placebo (1) Standard Plasma (FFP) (1) Standard Public Health measures (1) Standard SII SBCC (1) Standard Therapy (1) Standard Therapy Protocol (STP) (1) Standard Treatment (1) Standard Ventilation Strategy (1) Standard administration of oxygen flow (1) Standard care delivered in the isolation hospitals. (1) Standard care therapy (1) Standard charity resources (1) Standard communication email (1) Standard diagnosis test (1) Standard interface (1) Standard medical care (1) Standard mouthpiece (1) Standard of Care (Intravenous access) (1) Standard of Care (SOC) + ANG-3777 (1) Standard of Care (SOC) and Colchicine+Rosuvastatin (1) Standard of Care (SOC): Radiation Therapy (1) Standard of Care (SoC) (1) Standard of Care Treatment (1) Standard of Care Triple IS (1) Standard of Care thromboprophylaxis (1) Standard of care (Paracetamol) (1) Standard of care (SOC) plus placebo (1) Standard of care for SARS-CoV-2 infection (1) Standard of care management (1) Standard of care therapies (1) Standard of care therapy (1) Standard of care. (1) Standard oxygen therapy (1) Standard protein group (1) Standard screening strategy (1) Standard smoking cessation therapy for TUD plus Chess-based cognitive treatment (1) Standard supportive care (1) Standard therapeutic protocol (1) Standard therapy (1) Standard therapy for AUD (1) Standard therapy for AUD plus Chess-based cognitive treatment (1) Standard therapy for COVID-19 according to the stablished hospital protocols. (1) Standard therapy for TUD (1) Standard therapy of COVID-19 (1) Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation (1) Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection (1) Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation (1) Standard therapy recommended by the Ministry of Health of the Russian Federation. (1) Standard treatment according to the Clinical protocols (1) Standard treatment for COVID-19 (1) Standard-of-care (1) Standard-of-care treatment (1) Standard-titer Convalescent COVID-19 plasma (CCP2) (1) Standardised questionnaires (1) Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) (1) Standards of Care (1) State-trait anxiety inventory scale (1) Statins (Cardiovascular Agents) (1) Stem Cell Educator-Treated Mononuclear Cells Apheresis (1) Stem Cell Product (1) Stereotactic Radiotherapy (1) Sterile Normal Saline for Intravenous Use (1) Sterile Water for Injection (1) Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection (1) Stool collection (1) Stool collection or fecal swab (1) Streptokinase (1) Stress and emotion management (1) Study A (1) Study Arm (1) Study B (1) Study C (1) Study D (1) Study Group (1) Study of immune-mediated mechanisms in patients tested positive for SARS-CoV-2 (1) Suboxone (1) Sudarshan Kriya Yoga (SKY) (1) Sulfonatoporphyrin(TPPS) plus Sunlight exposure. (1) Sulodexide (1) Supine Positioning (1) Supine position (1) Supplement Drink (1) Support treatment (1) Supported Adopted Intervention 1 (1) Supported Adopted Intervention 2 (1) Supported Adopted Intervention 3 (1) Supraflex Cruz 60 Micron (1) Suramin (1) Surge capacity (1) Surgery (1) Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail (1) Surgical Management (1) Surgical Management + Treatment (1) Surgical facial mask (1) Surgical mask (1) Surgical procedures performed under general anesthesia (1) Surveillance card (1) Survey Group (1) Survey administration (1) Survey and Questionnaire (1) Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later (1) Surveys (1) Susceptibility to infection (1) Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors (1) Sustained attention (1) Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST) (1) SyB V-1901 (1) Symptom Survey (1) Symptom and Exposure Surveys (1) Symptomatic drugs (1) Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations) (1) Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA) (1) Symptoms entered into the CovidX application (1) Symptoms questionnare (1) Systemic indirect endovenous ozone therapy (1) T-cell receptor (TCR) repertoire (1) T3 solution for injection (1) T89 (1) TAK-018 (1) TAK-018 Placebo (1) TAK-671 (1) TAK-671 Placebo (1) TAK-906 Maleate (1) TAK-906 Maleate Placebo (1) TAK-981 (1) TAPE-Software (1) TAVR or SAVR (1) TBD Compound 1 (1) TBD Compound 2 (1) TBD Compound 3 (1) TCC-COVID mHealth solution (1) TCM prescriptions (1) TD139 (1) TDCS (1) TDR (1) TEM-tPA (1) TERA Intervention (1) TERN-101 (1) TGplPTH1-34 in fibrin (1) TJ003234 (1) TLRs activation measurement (1) TMS (1) TNKase (1) TOF protocol (1) TRIIM Treatment (1) TRV027 (1) TXA127 (1) TY027 (1) Table Setting Training (1) Tacrolimus (1) Tafenoquine Oral Tablet (1) Take Control (1) Taking biological samples (1) Taking blood samples for analyzing progesterone levels (1) Talabostat Mesylate plus Pembrolizumab (1) Tap water (1) Taste and olfactory function evaluation (1) Taste test (1) Team Intervention (1) Tear Collection (1) Tears swab (1) Technology based social interactions (1) Technology-assisted Index (1) Tele-Pulmonary rehabilitation (1) Tele-Yoga Therapy (1) Tele-delivered psychological intervention (1) Tele-interventions related to diabetes management and mental well-being (1) Tele-medicine platform (1) Tele-yoga therapy (1) Teleconsultation either by phone or by computer consultation (1) Telehealth CBT (1) Telehealth Consultation (1) Telehealth coaching sessions (1) Telehealth monitoring (1) Telehealth phone calls (1) Telemedicine FU (1) Telemedicine follow-up visit (1) Telemedicine to remote outpatient visit in bariatric patient (1) Telephone Coaching (1) Telephone follow-up (1) Telephone interview (1) Telephone survey (1) Telephonic interview during the Italian lockdown. (1) Telephonic medical visit (1) Telerehabilitation-Based (1) Telesimulation (1) Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg (1) Telmisartan 20 mg/amlodipine 2.5 mg . (1) Telmisartan 20 mg/indapamide 1.25 mg (1) Telmisartan 40Mg Oral Tablet (1) Telmisartan 40mg (1) Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care. (1) Temporarily holding the RAAS inhibitor [intervention] (1) Temsirolimus (1) Ten-days oseltamivir (1) Tenecteplase (1) Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE) (1) Test PCR (1) Test for SARS-CoV-2 (1) Test: Favipiravir 200 mg (LOQULAR) (1) Tested for SARS-CoV-2 (regardless of the result) (1) Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals (1) Testing for SARS-CoV-2 (1) Testing of SARS-CoV-2 antibodies (1) Testing procedure for Binding antibodies (1) Tests (1) Tetrandrine (1) Text message (1) Tezacaftor/Ivacaftor + Ivacaftor (1) Thalidomide (1) The CRAFT program (adapted due to COVID-19) (1) The DryShield (1) The MBSR program (adapted due to COVID-19) (1) The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: (1) The PREPARE program (1) The Vie Scope laryngoscope (1) The control group will not receive hydroxychloroquine (1) The demographic, clinical, laboratory, and instrumental data (1) The high-volume evacuator (1) The saliva ejector (1) The standard Macintosh laryngoscope (1) The standard of care (1) The usual treatment (1) Therapeutic Anticoagulation (1) Therapeutic Exercise and Education (1) Therapeutic Plasma Exchange (TPE) (1) Therapeutic Plasma exchange (1) Therapeutic plasma exchange (TPE) (1) Therapist Guided E-Therapy (1) Therapist-guided one-session online exposure therapy according to (Öst, 1989) (1) Therapy Intervention (1) There is no intervention (1) There is no intervention in this study (1) Thermography (1) Thiazide or Thiazide-like diuretics (1) This is an online survey with no intervention. (1) Thoracic CT Scan (1) Thorax CT (1) Thoraxic computed tomography (1) Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 (1) Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) (1) Throat swab and/or nasopharyngeal swab (1) Throat swab sample for measuring current infection with SARS-CoV-2 (1) Thrombin Generation Assay (TGA) (1) Thrombin generation test assay (1) Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) (1) Thromboprophylaxis (1) Thymosin+standard treatment (1) Tigerase® and best available care (1) Tildrakizumab (1) Tinzaparin or unfractionated heparin (1) Tirofiban Injection (1) Tissue plasminogen activator (1) Titanium blood test (1) To assess for development of IgG antibodies against SARS-CoV2 (1) Tociliuzumab (1) Tocilizumab +/- ruxolitinib (stages 2b/3) (1) Tocilizumab 180 MG/ML (1) Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA] (1) Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (1) Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) (1) Tocilizumab Injection [Actemra] (1) Tocilizumab Prefilled Syringe (1) Tocilizumab and Ruxolitinib (Advanced stage 3) (1) Tomeka® (1) Toraymyxin PMX-20R (PMX Cartridge) (1) Toremifene (1) Tracheal intubation and cardiopulmonary resuscitation (1) Tracheostomy with aerosol box in COVID-19 positive patients (1) Tracheotomy (1) Tradipitant (1) Traditional Chinese Medicine Prescription (1) Traditional antirheumatic drugs (1) Training clinicians in basic critical care and the management of severe COVID-19 cases (1) Training for Awareness, Resilience, and Action (TARA) (1) Training of youth, community health assistants and community health workers. (1) Training session adressing information and health literacy (1) Training video on anxiety, fear and loneliness in the COVID-19 environment. (1) Tramadol (1) Tranexamic acid (1) Tranexamic acid tablets (1) Transcranial Electrical Stimulation (1) Transcutaneous Auricular Vagus Nerve Stimulation (1) Transfusion of COVID-19 convalescent plasma (1) Transfusion of SARS-CoV-2 Convalescent Plasma. (1) Transfusion of standard Plasma. (1) Transitional Online Peer Support Group (n=20) (1) Transparent, reusable respirator (1) Transplant patient (1) Transpulmonary pressure measurements (1) Transpulmonary thermodilution (1) Trauma-informed yoga video recording (1) Treadmill electrocardiographic stress test (1) Treamid (1) Treatment (1) Treatment As Usual (1) Treatment and prophylaxis (1) Treatment as usual (1) Treatment as usual vitamin D (1) Treatment for COVID-19 (1) Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days : (1) Treatment with Dexmedetomidine (1) Tremelimumab (1) Trimethoprim Sulfamethoxazole (TMP/SMX) (1) Trivia Training (1) Trust in science message (1) Tuberculin test (1) Two COVID-19 vaccine candidate (TMV-083) administrations - High dose (1) Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose (1) Two dose MenACWY vaccine (1) Two dose MenACWY vaccine 4-12 weeks (1) Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule (1) Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule (1) Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (1) Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 (1) Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule (1) Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule (1) Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 (1) Two doses of placebo at the emergency vaccination schedule (1) Two doses of placebo at the routine vaccination schedule (1) Two doses of placebo at the schedule of day 0, 28(high-dose group) (1) Two doses of placebo at the schedule of day 0, 28(middle-dose group) (1) Tympanic Temperature (1) UB-612 (1) UCMSCs (1) UCPVax + Nivolumab (1) ULTRAPROTECTIVE VENTILATION (1) UNIKINON (Chloroquine phosphate) 200mg tablets (1) UTTR1147A (1) UTTR1147A-matched Placebo (1) Ulinastatin (1) Ultimaster Tansei 80 Micron (1) Ultra Brief Online Mindfulness-based Intervention (1) Ultra-Low-dose radiotherapy (1) Ultrasound lung imaging as part of FAST+ evaluation (1) Ultrasound of the lower limbs (1) Umbilical Cord Lining Stem Cells (ULSC) (1) Umbilical Cord Mesenchymal Stem Cells (1) Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. (1) Umbilical cord Wharton's jelly-derived human (1) Umbilical cord derived mesenchymal stem cells (1) Umifenovir (1) Unavailable COVID Test Result - Hypothetical Scenario (1) Unfractionated Heparin IV (1) Unfractionated heparin SC (1) Unfractionated heparin nebulized (1) Unified Protocol for COVID-19 Parenting Stress (UP-COVID) (1) Uniform random message delivery (1) Universal Screening Arm (1) Unsupervised exercise (1) Unsupervised physical activities (1) Upadacitinib (1) Upadacitinib (ABT-494) (1) Urinary Incontinence (1) Urine Test (1) Urine collection (1) Urine sample (1) Use of Doctorgram Mobile Application (1) Use of Doctorgram Patient Kit (1) Use of Remote Pulse Oximeter (1) Use of mobile application (1) Use of social media during COVID-19 (1) Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures (1) Usual Care Only (1) Usual Care plus Customized Referrals (1) Usual antibiotic treatment (1) Usual care positioning with no instructions (1) V-SARS (1) V/Q SPECT-CT (1) V/Q Vest (1) V591 (1) VC (1) VCPM (1) VESTA respirator (1) VIB4920 (1) VIB7734 (1) VIP4SCI (1) VIR-7831 (1) VITROS Anti-SARS-CoV-2 IgG test (1) VRC-MALMAB0100-00-AB (1) VRC-SRSDNA015-00-VP (1) VXA-CoV2-1 (1) Vaccine (1) Vaginal fluid Covid-19 PCR test (1) Valproate (1) Valsartan (Diovan) (1) Values Clarification and Attitudes Transformation (VCAT) Workshop (1) Vancomycin (1) Vancomycin with Taper/Pulse (1) Vascular surgery (1) Vehicle + Heparin along with best supportive care (1) Vehicle Control (1) Venepuncture (1) VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) (1) Ventil - a gas flow divider (1) Verapamil (1) Veru-111 (1) VibroLUNG (1) Video (1) Video Chat + Basic Feedback (1) Video Chat +Personalized Feedback (1) Video Dance classes (1) Video Default (1) Video Visit (1) Video based aerobic exercise (1) Video based exercise (1) Video-Based (1) Video-Based intervention (1) Videofluoroscopic Swallowing Study (VFSS) (1) Vie Scope laryngoscopy (1) Vielight RX Plus (1) Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic (1) Viral Specific T-cells (VSTs) (1) Virtual ACT Workshop for Emotional Eating (1) Virtual Assistant first, then Human Coach (1) Virtual Care and Remote Automated Monitoring (1) Virtual Care at Home (1) Virtual Group Exercise (1) Virtual Group Intervention (1) Virtual Peer Support Platform (1) Virtual Reality (1) Virtual Reality Behavioral Activation (1) Virtual Reality Goggles (1) Virtual Reality Pain Neuroscience Education (1) Virtual reality therapy first (1) Virtual-Care Cognitive Behavioural Therapy (1) Viruxal Oral and Nasal Spray (1) Vit D (1) VitalConnect Vital Sign Patch (1) Vitamin B12 (1) Vitamin C tablets (1) Vitamin D 1000 IU (1) Vitamin D3 or Placebo (1) Vitamins (1) Viusid and Asbrip (1) VivaDiag™ COVID-19 lgM/IgG Rapid Test (1) ViviGen® Cellular Bone Matrix (1) Volatile Organic Compounds analysis (1) Volunteer of TIP-OA Program (1) Voraxaze (1) WALC-R (1) WFI 5% glucose (1) WFI water nebulization (1) WHO recommendations (waiting condition) (1) WHOQOL-BREF (1) WHOQOL-BREF survey (1) WJ-MSCs (1) WW (1) Wait list time (1) Waiting list (1) Waiting list where participants wait for delayed treatment (1) Waitlist (1) Walk Test (1) Water Without an Elevated Level of KELEA (1) Wearable Activity Trackers, Exercise Prescription and Virtual Care (1) Wearable Medical Device (Empatica E4) (1) Wearing surgical face mask sprayed with hypertonic saline (1) Web + text smoking cessation intervention (1) Web Based Survey (1) Web application users (1) Web-based REDCap survey (1) Web-based psychosocial peer-to-peer support (1) Web-based self-report questionnaires (1) WebEx Physical Activity Program (1) Weekly Assessment (1) Weight Counseling (1) Weight Loss (1) Wellness (1) Wharton's jelly derived Mesenchymal stem cells. (1) White Sender in Acknowledgement (1) White Sender in Informational Videos (1) Whole Exome Sequencing (1) Whole Genome Analysis (1) Whole exome sequencing (1) Withings ScanWatch (1) Without haptic stimulation (1) Woebot Substance Use Disorder (1) Women receiving extra remembering by healthcare (1) Workshops control group LiPAT (1) Wrist-worn feedback physical activity monitor (1) Written Information (1) Written Summary of Rounds (1) XAV-19 (1) XC221 (1) XCEL-UMC-BETA (1) XPro1595 (1) XatJove Anoia Aplication (1) Xiyanping injection (1) YH25448 (1) Yin Hu Qing Wen Granula(low does) (1) YinHu QingWen Decoction (1) YinHu QingWen Decoction(low dose) (1) Yinhu Qingwen Granula (1) Yoga group (1) Zanubrutinib (1) Zaritt Burden Interview (1) Zavegepant (BHV-3500) (1) Zilucoplan® (1) Zinc (Placebo) (1) Zinc Citrate (1) Zinc Gluconate (1) Zinc Picolinate (1) Zinc Picolinate Placebo (1) Zinc Sulfate (1) Zinc gluconate (1) Zithromax Oral Product (1) Zofin (1) Zolpidem + PAP therapy (1) Zonisamide (1) [14C]-GSK3640254 intravenous infusion (1) [14C]-GSK3640254 powder (1) [14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL) (1) [TIMP-2]*[IGFBP-7] (1) a specifically designed self-administered questionnaire (1) a survey (1) acetylsalicylic acid (1) actigraphy (1) acute kidney injury (1) additional blood tubes (1) aerosol box (1) aerosolized DNase (1) after-each-case room disinfection (1) airway management during sedation or general anesthesia (1) all treatment about COVID-2019 (1) allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) (1) allogeneic mesenchymal stem cell (1) alpha one antitrypsin inhalation (1) alveolar recruitment (1) amlodipine 5 mg/indapamide 2.5 mg (1) amoxicillin/clavulanate (1) anti-CD40 antibody (CDX-1140) (1) anti-SARS-CoV-2 human convalescent plasma (1) anti-SARS-CoV-2 plasma (1) antidiabetic treatment (1) antithymocyte globulin (rabbit) (1) appendectomy (1) artus Influenza A/B RT-PCR Test (1) assessment of the sequelae after hospitalization for Sars-COV-2 (1) attendance by ambulance crew (1) auscultation by using traditional stethoscope and electronic stethoscope under full PPE (1) autologous adipose-derived stem cells (1) autopsy (1) avdoralimab (1) azithromycin (1) azoximer bromide (1) bacTRL-Spike (1) behavioral lifestyle intervention (1) belatacept (1) bidirectional oxygenation mouthpiece (1) biochemical analysis (1) biological assays in particular on the lipid metabolism (1) biological samples collection (1) biological samples day of delivery (1) biological samples, questionnaires and interviews (1) biopsies of subcutaneous adipose tissue (1) blastocyst-stage embryo transfer (1) blood sample for seroepidemiological investigation (1) blood sampling for biobank (1) blood test for SARS-COV2 serology (1) bromelain (1) bronchoscopy examination (1) canakinumab (1) captopril 25mg (1) care as usual (1) care modalities (1) carotid-femoral pulse-wave velocity (1) cellulose-containing placebo capsules (1) chest radiography (1) chest x-ray (1) chiropractic team (1) chlorine dioxide 3000 ppm (1) chloroquine (1) cholecalciferol 200,000 IU (1) cholecalciferol 50,000 IU (1) chronic pain team (1) cleavage-stage embryo transfer (1) collection of biological samples (1) collection of swabs (1) community health worker support (1) comparison of sample collection methods (1) complication (1) computerized cognitive training (CCT) (1) congenital malformation (1) conjunctival RT PCR (1) conjunctival swab (1) consultation (1) control (1) convalescent plasma application to SARS-CoV-2 infected patients (1) convalescent plasma from recovered COVID 19 donor (1) conventional management of patients (1) conventional oxygen (1) corticosteroid nasal irrigation (1) covid-19 positive pregnant women (1) current IPAC-UHN PPE (1) daily room disinfection (1) daily syndromic surveillance (1) dapansutrile capsules (1) data record (1) decisions of limitations and stop processing (1) demographic and clinical data obtained from hospital's electronic medical record. (1) diagnostic (1) diagnostic tests for COVID-19 infection (1) dialysis (1) digoxin (1) double gloves (1) draw blood (1) e-Psychotherapy (1) e-ink screen (1) echocardiogram 2D (1) eculizumab (1) efgartigimod IV (1) efgartigimod PH20 SC (1) electrolytes (1) ensoETM device (1) enzalutamide (1) enzalutamide Placebo (1) epidemiological and demographic characteristics (1) evaluation of skin microvascular flow and reactivity (1) everolimus (1) exchange blood transfusion from normal donor (1) exercise brochure (1) exposure (1) fMRI (1) faecal sample collector (1) famotidine (1) favipiravir (1) favipiravir tablets+chloroquine phosphatetablets tablets (1) favorable outcome (1) feces samples (COVI-BIOME ancillary study) (1) fingertip tests for POC assays (1) fsfi survey (1) further processing of health data (1) gammaCore® (Vagus nerve stimulation) (1) gammaCore® Sapphire (non-invasive vagus nerve stimulator) (1) global survey (1) high flow nasal cannula (HFNC) (1) high flow nasal cannula device (1) high-titer anti-Sars-CoV-2 plasma (1) home care monitoring (1) home spirometry (1) hormones (1) hospitalized children with Covid19 (1) human cord tissue mesenchymal stromal cells (1) hydrocortisone (1) hydroxychloroquine + azithromycin (1) hydroxychloroquine in combination with camostat mesylate (1) hydroxychloroquine placebo (1) hydroxychloroquine sulfate 200 MG (1) hyper immunoglobulins containing anti-Corona VS2 immunoglobulin (1) hyperbaric oxygen therapy (HBOT) (1) hyperimmune plasma (1) hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint (1) iAMP test (1) iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System (1) identify SARS-CoV-2 infection by serology (1) imPulse™ Una e-stethoscope (1) imaging, blood tests (1) immunoSEQ Dx (1) impliminting Online Distance Learning (1) in-hospital mortality rate (1) indirect calorimetry (1) inhalable hydroxychloroquine (HCQ) (1) inhaled hydroxychloroquine (1) inhaled type I interferon (1) interleuken 6 level measurment (1) intermediate dose Enoxaparin/ unfractionated heparin (1) intradermal injection of BCG Vaccine (1) intravenous immunoglobulin therapy (1) intubation (1) iota carrageenan (1) ioveraº (1) ioveraº sham (1) it is a survey (1) laboratory biomarkers (1) labs (1) lanadelumab (1) less-frequency hemodialysis (1) leucovorin (1) life questionnaires (1) lifestyle modification (1) liposomal lactoferrin (1) lopinavir/ritonavir (1) lopinavir/ritonavir group (1) lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate (1) lulizumab pegol (1) lung mechanics at different PEEP (1) lung ultrasound (1) lung ultrasound (LUS) (1) mHealth Assessments (1) mMRC (Modified Medical Research Council) Dyspnea Scale (1) mRNA in urine test (1) management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia (1) mavrilimumab (1) measurement of circulating sFlt1 concentration (1) mechanical ventilation (1) mechanical ventilator settings and position (1) media multi-task (1) media package (1) melatonin (1) meplazumab for injection (1) mesenchymal stem cells (1) metenkefalin + tridecactide (1) methylprednisolone (1) methylprednisolone therapy (1) mindfulness, emotion didactics, interpersonal skills, experiential learning (1) miniprobe Alveoflex (1) mobile internet survey on self-test (1) modification of the planned therapeutic management (1) modified IPAC-UHN PPE (1) molecular testing for virus RNA using RT-PCR (1) mometasone furoate nasal spray (1) monthly serologic IgM/G test (1) morning Yoga-based breathing support (1) mortality (1) mouthrinse with bêta-cyclodextrin and citrox (1) mouthrinse without bêta-cyclodextrin and citrox (1) multipeptide cocktail (1) muscle ultrasound (1) mycophenolate mofetil (1) mycophenolate mofetil (MMF) (1) mycophenolic acid (1) nCapp, a cell phone-based auto-diagnosis system (1) nangibotide (1) nasal pharyngeal (NP) swab samples (1) nasopharyngeal Covid 19 RT-PCR (1) nebulised recombinant tissue-Plasminogen Activator (rt-PA) (1) nebulization (1) newborns from covid 19 positive mothers (1) no intervention-mechanistic study (1) no intervention. observational cohort study (1) no interventional study (1) non (1) non applicable (1) non e-cigarette TV commercials (1) non interventional (1) non-RAS blocking antihypertensives (1) non-contact magnetically-controlled capsule endoscopy (1) non-interventional (1) none - observational (1) none, this study is observational (1) nosocomial infection/hospital acquired infection (1) not applicable (observational study) (1) nutritional intervention (1) oSOC (1) observation (1) observation of covid 19 pneumonia (1) olfactory and gustatory tests (1) olfactory device (1) online KKH Sports Singapore Program with Usual Care (1) online mindfulness group (1) online questionnaires (1) online survey (1) oral co-trimoxazole (1) oral polio vaccine + information (1) oropharyngeal swabs (1) oxygen treatment (1) oxyhydrogen (1) pathogen reduced SARS-CoV-2 convalescent plasma (1) patients COVID 19 (1) patients receiving nasal high flow (1) performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection (1) peripheral blood draw (1) phone call (1) photobiomodulation and photodynamic therapy (1) pirfenidone (1) placebo (hartmann plus albumine) (1) placebo capsules (1) placebo for clazakizumab (1) placebo for risankizumab IV (1) placebo rinse (1) placebo+rHuPH20 (1) plasma from convalescent patients with COVID-19 (1) plasma hyperimmune (1) plasma therapy using convalescent plasma with antibody against SARS-CoV-2 (1) poractant alfa (1) positive psychological intervention (1) prayer (1) pre-operative screening (1) pre_dinner Yoga-based breathing support (1) pre_lunch Yoga-based breathing support (1) predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables? (1) prednisolone (1) proper diet (1) prophylactic heparin (1) prophylactic lactoferrin daily (1) psycho-education video (1) psychological and sociological interviews (1) psychological assessment (1) pulmonary anomalies 4 months after documented COVID-19 pneumonia (1) pulmonary ultrasound (1) qRT-PCR and serology (1) quality of life questionnaires (1) quality of live assessment (1) quesionnair (1) questionaire to husband and wife (1) questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality (1) questionnaire and optional interview (1) questionnaire filling (1) quetionnary (1) rapid salivary test (1) rapid serological test (1) reSET-O (1) realtime PCR (1) recombinant human interferon Alpha-1b (1) recovered covid 19 patients plasma (1) rectal swab (1) regular care (1) remdesivir (1) research specific blood sample (1) respiratory function rehabilitation training (1) retrospective metagenomics on clinical samples collected during hospitalization (1) rhDNase I (1) rhPTH(1-84) (1) risankizumab (1) risk factors (1) rosuvastatin (1) saint george respiratory questionnaire (1) saliva collection (1) saliva sample (1) samling of oropharynx and nasopharynx (1) self-administered structured questionnaire (1) serological test (1) serology test (1) sertraline (1) serum chemistry analysis (1) serum inflammatory biomarkers (1) severe covid-19 pneumonia with ET (1) sham TMS (1) smell household Items (1) sodium chloride 0.9% (1) sofosbuvir (1) spirometry (1) standard chemotherapy (1) standard concomitant therapy (1) standard medical treatment (1) standard newborn and infant care (1) standard operating procedures (1) standard procedure (1) standard prophylactic dose Enoxaparin/ unfractionated heparin (1) standard protocol (1) standard treatment (1) standard western medicine treatment (1) standardized Lung Ultrasound (LUS) examination (1) stem cells (1) stress and anxiety questionnaire (1) supportive and symptomatic treatment (1) surveys and questionnaires (1) sweat samples (COVIDOG ancillary study) (1) systemic treatment (1) tacrolimus (1) telehealth applications (1) telephone consult (1) telmisartan 40 mg/amlodipine 5 mg (1) telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg (1) telmisartan 40 mg/indapamide 2.5 mg (1) thalidomide (1) theraputic heparin (1) this study is non- interventional (1) thoracic CT-scan (1) thoracic computed tomography scan (1) thoracic lung ultrasound (1) thromboprofylaxis protocol (1) thromboprophylaxis with low-molecular-weight heparin or fondaparinux (1) thymosin alpha 1 (1) topical steroids and cyclosporin-A (1) tracheostomy (1) transparent sheet (1) trimethoprim/sulfamethoxazole (1) turkish physicians (1) unfractionated heparin (1) urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic (1) use and exposure to disinfectants during the coronavirus pandemic (1) vaccine BCG (1) vaccine candidate MVA-MERS-S (1) vadadustat (1) venipuncture in peripheral vein (1) ventilatory support with oxygen therapy (1) vitamin D (1) vitamin d (1) von Willebrand factor (Recombinant) (1) vv-ECMO (1) washed microbiota transplantation (1) web based survey (1) wedged insole (1) zinc (1) zinc gluconate and ascorbic acid (1) ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF. (1) γ-Globulin (1) Оxygen therapy (1)

    Placebo

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (816)


    Name (Synonyms) Correlation
    drug2194 Nitazoxanide Wiki 0.14
    drug1520 Hydroxychloroquine Wiki 0.12
    drug1802 LY3819253 Wiki 0.11
    Name (Synonyms) Correlation
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    drug176 Ad26.COV2.S Wiki 0.09
    drug2336 Ontamalimab Wiki 0.09
    drug3680 Vitamin Super B-Complex Wiki 0.08
    drug390 BCG vaccine Wiki 0.08
    drug2848 Relamorelin Wiki 0.08
    drug3621 VPM1002 Wiki 0.08
    drug2637 Presatovir Wiki 0.07
    drug389 BCG Vaccine Wiki 0.07
    drug2825 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.07
    drug2855 Remdesivir Wiki 0.07
    drug364 Azithromycin Wiki 0.07
    drug399 BI 474121 Wiki 0.07
    drug978 DWRX2003 Wiki 0.07
    drug3349 TD-0903 Wiki 0.07
    drug2189 Nigella Sativa / Black Cumin Wiki 0.07
    drug1863 Lopinavir-Ritonavir Wiki 0.07
    drug2770 REGN10933+REGN10987 combination therapy Wiki 0.07
    drug1147 Early-Dexamethasone Wiki 0.07
    drug2308 Olokizumab 64 mg Wiki 0.07
    drug1112 Duvelisib Wiki 0.07
    drug2460 Pentoxifylline Wiki 0.07
    drug2095 Moxifloxacin Wiki 0.07
    drug3497 Tofacitinib 10 mg Wiki 0.07
    drug2116 N-Acetyl cysteine Wiki 0.07
    drug3433 Tezepelumab Wiki 0.07
    drug1206 Ensifentrine Wiki 0.07
    drug3486 Tocilizumab (TCZ) Wiki 0.07
    drug1549 Hydroxychloroquine Sulfate Regular dose Wiki 0.07
    drug2414 PUL-042 Inhalation Solution Wiki 0.07
    drug719 Canakinumab Wiki 0.07
    drug381 BAY1817080 Wiki 0.07
    drug1322 Fisetin Wiki 0.07
    drug1375 GSK3640254 Wiki 0.07
    drug2186 Niclosamide Oral Tablet Wiki 0.07
    drug1803 LY3832479 Wiki 0.07
    drug704 CYT107 Wiki 0.07
    drug2796 Radiation therapy Wiki 0.07
    drug1148 Ebselen Wiki 0.07
    drug1548 Hydroxychloroquine Sulfate Loading Dose Wiki 0.07
    drug3562 UC-MSCs Wiki 0.06
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    drug963 DAS181 Wiki 0.06
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    drug717 Camostat Mesilate Wiki 0.05
    drug908 Convalescent plasma Wiki 0.05
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    drug3563 UCMSCs Wiki 0.05
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    drug2027 Mesenchymal stem cells Wiki 0.05
    drug397 BI 1569912 Wiki 0.05
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    drug3617 VIB7734 Wiki 0.05
    drug65 ABTL0812 Wiki 0.05
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    drug3748 Zilucoplan® Wiki 0.05
    drug1527 Hydroxychloroquine + placebo Wiki 0.05
    drug3579 Umbilical cord derived mesenchymal stem cells Wiki 0.05
    drug265 Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients Wiki 0.05
    drug2645 Previfenon® Wiki 0.05
    drug3190 Standar medical treatmen Wiki 0.05
    drug4083 research specific blood sample Wiki 0.05
    drug214 Almitrine Wiki 0.05
    drug3981 muscle ultrasound Wiki 0.05
    drug3533 Treatment as usual vitamin D Wiki 0.05
    drug1551 Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki 0.05
    drug2976 SARS-CoV2 Autoantibody detection Wiki 0.05
    drug4041 placebo+rHuPH20 Wiki 0.05
    drug3651 Video-Based intervention Wiki 0.05
    drug2267 NuSepin® 0.1 mg Wiki 0.05
    drug1686 Interferon beta-1a Wiki 0.05
    drug215 Alteplase 100 MG [Activase] Wiki 0.05
    drug2824 Recombinant Interferon Alfa-2b Wiki 0.05
    drug1272 FAVICOVIR 200 mg Film Tablet Wiki 0.05
    drug412 BM-MSCs Wiki 0.05
    drug74 ACT-20-MSC Wiki 0.05
    drug2418 Pacritinib Wiki 0.05
    drug2331 Online instruction Wiki 0.05
    drug136 AZD5718 Wiki 0.05
    drug2946 SARS-CoV-2 IgG Antibody Testing Kit Wiki 0.05
    drug3946 lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki 0.05
    drug352 Auxora Wiki 0.05
    drug3422 Test for SARS-CoV-2 Wiki 0.05
    drug3698 Wait list time Wiki 0.05
    drug2901 Rintatolimod Wiki 0.05
    drug3714 Weekly Assessment Wiki 0.05
    drug938 Covid-19 presto test Wiki 0.05
    drug112 ASP2390 Wiki 0.05
    drug1337 Fluvoxamine Wiki 0.05
    drug1437 HCQ+AZT Wiki 0.05
    drug964 DAS181 COVID-19 Wiki 0.05
    drug60 A short video intervention Wiki 0.05
    drug3019 STI-5656 Wiki 0.05
    drug395 BGB-DXP593 Wiki 0.05
    drug4081 regular care Wiki 0.05
    drug100 ARCT-021 Dose 2 Wiki 0.05
    drug4136 tacrolimus Wiki 0.05
    drug1830 Levilimab Wiki 0.05
    drug2281 OP-101 Wiki 0.05
    drug299 ArtemiC Wiki 0.05
    drug3620 VITROS Anti-SARS-CoV-2 IgG test Wiki 0.05
    drug492 Biological: mRNA-1273: 50 mcg Wiki 0.05
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    drug1901 Low-dose Chest CT Wiki 0.05
    drug2715 Pyronaridine-Artesunate Wiki 0.05
    drug2829 Recombinant human interferon α1β Wiki 0.05
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    drug3264 Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) Wiki 0.05
    drug1597 INOpulse Wiki 0.05
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    drug3085 Sequencing Wiki 0.05
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    drug3956 mavrilimumab Wiki 0.05
    drug1358 Fuzheng Huayu Tablet Wiki 0.05
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    drug2871 ResCure™ Wiki 0.05
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    drug2771 REGN3048 Wiki 0.05
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    drug1513 Human umbilical cord derived CD362 enriched MSCs Wiki 0.05
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    drug3528 Treamid Wiki 0.05
    drug3062 Self Study Wiki 0.05
    drug3702 Walk Test Wiki 0.05
    drug3900 home care monitoring Wiki 0.05
    drug3005 SOC Wiki 0.05
    drug3708 Web Based Survey Wiki 0.05
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    drug1367 GLS-1200 Wiki 0.05
    drug1766 JNJ-53718678 2.5 mg/kg Wiki 0.05
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    drug3658 Virtual Assistant first, then Human Coach Wiki 0.05
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    drug3778 alpha one antitrypsin inhalation Wiki 0.05
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    Correlated MeSH Terms (224)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.34
    D045169 Severe Acute Respiratory Syndrome NIH 0.27
    D007239 Infection NIH 0.21
    Name (Synonyms) Correlation
    D003141 Communicable Diseases NIH 0.18
    D055371 Acute Lung Injury NIH 0.17
    D011014 Pneumonia NIH 0.16
    D012128 Respiratory Distress Syndrome, Adult NIH 0.15
    D012127 Respiratory Distress Syndrome, Newborn NIH 0.14
    D013577 Syndrome NIH 0.12
    D055370 Lung Injury NIH 0.10
    D008173 Lung Diseases, Obstructive NIH 0.09
    D018357 Respiratory Syncytial Virus Infections NIH 0.08
    D014777 Virus Diseases NIH 0.08
    D059350 Chronic Pain NIH 0.07
    D012859 Sjogren's Syndrome NIH 0.07
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.07
    D011658 Pulmonary Fibrosis NIH 0.07
    D012141 Respiratory Tract Infections NIH 0.07
    D000505 Alopecia NIH 0.07
    D000690 Amyotrophic Lateral Sclerosis NIH 0.07
    D014552 Urinary Tract Infections NIH 0.07
    D009136 Muscular Dystrophies NIH 0.07
    D000755 Anemia, Sickle Cell NIH 0.07
    D003092 Colitis NIH 0.07
    D003093 Colitis, Ulcerative NIH 0.07
    D016472 Motor Neuron Disease NIH 0.07
    D011024 Pneumonia, Viral NIH 0.07
    D008231 Lymphopenia NIH 0.06
    D018589 Gastroparesis NIH 0.06
    D000437 Alcoholism NIH 0.06
    D014456 Ulcer NIH 0.06
    D014947 Wounds and Injuries NIH 0.06
    D007249 Inflammation NIH 0.06
    D018450 Disease Progression NIH 0.05
    D012640 Seizures NIH 0.05
    D003139 Common Cold NIH 0.05
    D003327 Coronary Disease NIH 0.05
    D003324 Coronary Artery Disease NIH 0.05
    D004194 Disease NIH 0.05
    D005355 Fibrosis NIH 0.05
    D012598 Scoliosi NIH 0.05
    D058186 Acute Kidney Injury NIH 0.05
    D008171 Lung Diseases, NIH 0.05
    D020141 Hemostatic Disorders NIH 0.05
    D001778 Blood Coagulation Disorders NIH 0.05
    D001168 Arthritis NIH 0.05
    D019973 Alcohol-Related Disorders NIH 0.05
    D055623 Keratosis, Actinic NIH 0.05
    D001835 Body Weight NIH 0.05
    D029481 Bronchitis, Chronic NIH 0.05
    D000071074 Neonatal Sepsis NIH 0.05
    D000070627 Chronic Traumatic Encephalopathy NIH 0.05
    D015775 Fractures, Stress NIH 0.05
    D002446 Celiac Disease NIH 0.05
    D001997 Bronchopulmonary Dysplasia NIH 0.05
    D001991 Bronchitis NIH 0.05
    D001982 Bronchial Diseases NIH 0.05
    D008595 Menorrhagia NIH 0.05
    D017565 Sarcoidosis, Pulmonary NIH 0.05
    D006929 Hyperaldosteronism NIH 0.05
    D001249 Asthma NIH 0.05
    D001248 Asthenopia NIH 0.05
    D002547 Cerebral Palsy NIH 0.05
    D009164 Mycobacterium Infections NIH 0.05
    D011470 Prostatic Hyperplasia NIH 0.05
    D009128 Muscle Spasticity NIH 0.05
    D020388 Muscular Dystrophy, Duchenne NIH 0.05
    D054559 Hyperphosphatemia NIH 0.05
    D012817 Signs and Symptoms, Digestive NIH 0.05
    D003015 Clostridium Infections NIH 0.05
    D006969 Hypersensitivity, Immediate NIH 0.05
    D006965 Hyperplasia NIH 0.05
    D025241 Spondylarthritis NIH 0.05
    D004314 Down Syndrome NIH 0.05
    D001289 Attention Deficit Disorder with Hyperactivity NIH 0.05
    D003928 Diabetic Nephropathies NIH 0.05
    D016470 Bacteremia NIH 0.05
    D000067292 Alcohol Drinking in College NIH 0.05
    D012130 Respiratory Hypersensitivity NIH 0.05
    D011645 Puerperal Infection NIH 0.05
    D007642 Keratosis NIH 0.05
    D066087 Perinatal Death NIH 0.05
    D003248 Constipation NIH 0.05
    D003244 Consciousness Disorders NIH 0.05
    D005879 Tourette Syndrome NIH 0.05
    D008168 Pulmonary NIH 0.05
    D018410 Pneumonia, Bacterial NIH 0.05
    D004696 Endocarditis NIH 0.05
    D003371 Cough NIH 0.05
    D003331 Coronary Artery NIH 0.05
    D065626 Non-alcoholic Fatty Liver Disease NIH 0.05
    D000309 Adrenal Insufficiency NIH 0.05
    D007008 Hypokalemia NIH 0.05
    D007011 Hypoparathyroidism NIH 0.05
    D023921 Coronary Stenosis NIH 0.05
    D007896 Leishmaniasis NIH 0.05
    D005234 Fatty Liver NIH 0.05
    D060050 Angina, Stable NIH 0.05
    D063130 Maternal Death NIH 0.05
    D001724 Birth Weight NIH 0.05
    D003424 Crohn Disease NIH 0.04
    D001008 Anxiety Disorders NIH 0.04
    D001172 Arthritis, Rheumatoid NIH 0.04
    D007674 Kidney Diseases NIH 0.04
    D001327 Autoimmune Diseases NIH 0.04
    D000428 Alcohol Drinking NIH 0.04
    D013313 Stress Disorders, Post-Traumatic NIH 0.04
    D009103 Multiple Sclerosis NIH 0.04
    D018805 Sepsis NIH 0.04
    D007511 Ischemia NIH 0.04
    D008180 Lupus Erythematosus, Systemic NIH 0.04
    D015658 HIV Infections NIH 0.04
    D040921 Stress Disorders, Traumatic NIH 0.03
    D009203 Myocardial Ischemia NIH 0.03
    D000857 Olfaction Disorders NIH 0.03
    D009771 Obsessive-Compulsive Disorder NIH 0.03
    D001010 Anxiety, Separation NIH 0.03
    D065886 Neurodevelopmental Disorders NIH 0.03
    D012507 Sarcoidosis NIH 0.03
    D000070642 Brain Injuries, Traumatic NIH 0.03
    D013122 Spinal Diseases NIH 0.03
    D013180 Sprains and Strains NIH 0.03
    D001167 Arteritis NIH 0.03
    D006948 Hyperkinesis NIH 0.03
    D000075902 Clinical Deterioration NIH 0.03
    D051436 Renal Insufficiency, Chronic NIH 0.03
    D000072861 Phobia, Social NIH 0.03
    D010149 Pain, Postoperative NIH 0.03
    D009155 Mutism NIH 0.03
    D000787 Angina Pectoris NIH 0.03
    D000799 Angioedema NIH 0.03
    D053201 Urinary Bladder, Overactive NIH 0.03
    D050197 Atherosclerosis NIH 0.03
    D015004 Yellow Fever NIH 0.03
    D000013 Congenital Abnormalities NIH 0.03
    D009220 Myositis NIH 0.03
    D015179 Colorectal Neoplasms NIH 0.03
    D020529 Multiple Sclerosis, Relapsing-Remitting NIH 0.03
    D016491 Peripheral Vascular Diseases NIH 0.03
    D003193 Compulsive Personality Disorder NIH 0.03
    D058345 Asymptomatic Infections NIH 0.03
    D000208 Acute Disease NIH 0.03
    D005909 Glioblastoma NIH 0.03
    D014808 Vitamin D Deficiency NIH 0.03
    D054179 Angioedemas, Hereditary NIH 0.03
    D000068376 Compassion Fatigue NIH 0.03
    D000379 Agoraphobia NIH 0.03
    D000370 Ageusia NIH 0.03
    D054990 Idiopathic Pulmonary Fibrosis NIH 0.03
    D008268 Macular Degeneration NIH 0.03
    D019896 Alpha 1-Antitrypsin Deficiency NIH 0.03
    D014115 Toxemia NIH 0.03
    D001714 Bipolar Disorder NIH 0.03
    D012140 Respiratory Tract Diseases NIH 0.03
    D019966 Substance-Related Disorders NIH 0.03
    D001930 Brain Injuries, NIH 0.03
    D006331 Heart Diseases NIH 0.03
    D003920 Diabetes Mellitus, NIH 0.03
    D058729 Peripheral Arterial Disease NIH 0.03
    D005334 Fever NIH 0.03
    D011251 Pregnancy Complications, Infectious NIH 0.03
    D012559 Schizophrenia NIH 0.03
    D009080 Mucocutaneous Lymph Node Syndrome NIH 0.03
    D001987 Bronchiectasis NIH 0.03
    D053120 Respiratory Aspiration NIH 0.03
    D058070 Asymptomatic Diseases NIH 0.03
    D004408 Dysgeusia NIH 0.03
    D002658 Developmental Disabilities NIH 0.03
    D003924 Diabetes Mellitus, Type 2 NIH 0.03
    D018184 Paramyxoviridae Infections NIH 0.03
    D000072657 ST Elevation Myocardial Infarction NIH 0.03
    D016584 Panic Disorder NIH 0.03
    D000257 Adenoviridae Infections NIH 0.03
    D060825 Cognitive Dysfunction NIH 0.03
    D000067073 Psychological Trauma NIH 0.03
    D004715 Endometriosis NIH 0.03
    D005221 Fatigue NIH 0.03
    D015535 Arthritis, Psoriatic NIH 0.03
    D011111 Polymyalgia Rheumatica NIH 0.03
    D013700 Giant Cell Arteritis NIH 0.03
    D047928 Premature Birth NIH 0.03
    D000077062 Burnout, Psychological NIH 0.03
    D012120 Respiration Disorders NIH 0.02
    D005356 Fibromyalgia NIH 0.02
    D003643 Death, NIH 0.02
    D011236 Prediabetic State NIH 0.02
    D000544 Alzheimer Disease NIH 0.02
    D007251 Influenza, Human NIH 0.02
    D001927 Brain Diseases NIH 0.02
    D004211 Disseminated Intravascular Coagulation NIH 0.02
    D014652 Vascular Diseases NIH 0.02
    D003110 Colonic Neoplasms NIH 0.02
    D008103 Liver Cirrhosis, NIH 0.02
    D006470 Hemorrhage NIH 0.02
    D010003 Osteoarthritis, NIH 0.02
    D006967 Hypersensitivity, NIH 0.02
    D002659 Child Development Disorders, Pervasive NIH 0.02
    D009461 Neurologic Manifestations NIH 0.02
    D003333 Coronaviridae Infections NIH 0.02
    D006973 Hypertension NIH 0.02
    D013927 Thrombosis NIH 0.02
    D007153 Immunologic Deficiency Syndromes NIH 0.02
    D007154 Immune System Diseases NIH 0.02
    D002055 Burnout, Professional NIH 0.02
    D001523 Mental Disorders NIH 0.02
    D013315 Stress, Psychological NIH 0.02
    D000066553 Problem Behavior NIH 0.02
    D003704 Dementia NIH 0.02
    D003863 Depression, NIH 0.02
    D011665 Pulmonary Valve Insufficiency NIH 0.02
    D010300 Parkinsonian NIH 0.02
    D015212 Inflammatory Bowel Diseases NIH 0.02
    D016638 Critical Illness NIH 0.02
    D004417 Dyspnea NIH 0.02
    D001321 Autistic Disorder NIH 0.02
    D009205 Myocarditis NIH 0.02
    D007238 Infarction NIH 0.01
    D003922 Diabetes Mellitus, Type 1 NIH 0.01
    D053717 Pneumonia, Ventilator-Associated NIH 0.01
    D000067877 Autism Spectrum Disorder NIH 0.01
    D003866 Depressive Disorder NIH 0.01
    D000860 Hypoxia NIH 0.01
    D002318 Cardiovascular Diseases NIH 0.01
    D009369 Neoplasms, NIH 0.01

    Correlated HPO Terms (91)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.16
    HP:0006536 Pulmonary obstruction HPO 0.07
    HP:0002583 Colitis HPO 0.07
    Name (Synonyms) Correlation
    HP:0002206 Pulmonary fibrosis HPO 0.07
    HP:0002293 Alopecia of scalp HPO 0.07
    HP:0100279 Ulcerative colitis HPO 0.07
    HP:0011947 Respiratory tract infection HPO 0.06
    HP:0001888 Lymphopenia HPO 0.06
    HP:0002578 Gastroparesis HPO 0.06
    HP:0001677 Coronary artery atherosclerosis HPO 0.06
    HP:0001928 Abnormality of coagulation HPO 0.05
    HP:0012387 Bronchitis HPO 0.05
    HP:0002905 Hyperphosphatemia HPO 0.05
    HP:0003811 Neonatal death HPO 0.05
    HP:0006802 Abnormal anterior horn cell morphology HPO 0.05
    HP:0002900 Hypokalemia HPO 0.05
    HP:0005145 Coronary artery stenosis HPO 0.05
    HP:0003560 Muscular dystrophy HPO 0.05
    HP:0000846 Adrenal insufficiency HPO 0.05
    HP:0001257 Spasticity HPO 0.05
    HP:0002960 Autoimmunity HPO 0.05
    HP:0012532 Chronic pain HPO 0.05
    HP:0008711 Benign prostatic hyperplasia HPO 0.05
    HP:0100584 Endocarditis HPO 0.05
    HP:0002099 Asthma HPO 0.05
    HP:0000132 Menorrhagia HPO 0.05
    HP:0002608 Celiac disease HPO 0.05
    HP:0000829 Hypoparathyroidism HPO 0.05
    HP:0007018 Attention deficit hyperactivity disorder HPO 0.05
    HP:0000077 Abnormality of the kidney HPO 0.05
    HP:0100614 Myositis HPO 0.05
    HP:0004469 Chronic bronchitis HPO 0.05
    HP:0007354 Amyotrophic lateral sclerosis HPO 0.05
    HP:0040187 Neonatal sepsis HPO 0.05
    HP:0001397 Hepatic steatosis HPO 0.05
    HP:0000859 Hyperaldosteronism HPO 0.05
    HP:0006510 Chronic pulmonary obstruction HPO 0.05
    HP:0100280 Crohn's disease HPO 0.04
    HP:0001919 Acute kidney injury HPO 0.04
    HP:0002088 Abnormal lung morphology HPO 0.04
    HP:0002725 Systemic lupus erythematosus HPO 0.04
    HP:0001369 Arthritis HPO 0.04
    HP:0100806 Sepsis HPO 0.04
    HP:0012622 Chronic kidney disease HPO 0.04
    HP:0001658 Myocardial infarction HPO 0.04
    HP:0002487 Hyperkinetic movements HPO 0.03
    HP:0012174 Glioblastoma multiforme HPO 0.03
    HP:0001370 Rheumatoid arthritis HPO 0.03
    HP:0001681 Angina pectoris HPO 0.03
    HP:0100754 Mania HPO 0.03
    HP:0100834 Neoplasm of the large intestine HPO 0.03
    HP:0002300 Mutism HPO 0.03
    HP:0012089 Arteritis HPO 0.03
    HP:0100665 Angioedema HPO 0.03
    HP:0000756 Agoraphobia HPO 0.03
    HP:0002621 Atherosclerosis HPO 0.03
    HP:0001268 Mental deterioration HPO 0.03
    HP:0012378 Fatigue HPO 0.03
    HP:0030127 Endometriosis HPO 0.03
    HP:0000722 Obsessive-compulsive behavior HPO 0.03
    HP:0001250 Seizure HPO 0.03
    HP:0003003 Colon cancer HPO 0.03
    HP:0001945 Fever HPO 0.03
    HP:0002110 Bronchiectasis HPO 0.03
    HP:0100753 Schizophrenia HPO 0.03
    HP:0000458 Anosmia HPO 0.02
    HP:0002758 Osteoarthritis HPO 0.02
    HP:0005521 Disseminated intravascular coagulation HPO 0.02
    HP:0002511 Alzheimer disease HPO 0.02
    HP:0001298 Encephalopathy HPO 0.02
    HP:0001395 Hepatic fibrosis HPO 0.02
    HP:0000819 Diabetes mellitus HPO 0.02
    HP:0012393 Allergy HPO 0.02
    HP:0004950 Peripheral arterial stenosis HPO 0.02
    HP:0002721 Immunodeficiency HPO 0.02
    HP:0002037 Inflammation of the large intestine HPO 0.02
    HP:0100651 Type I diabetes mellitus HPO 0.02
    HP:0000708 Behavioral abnormality HPO 0.02
    HP:0100512 Low levels of vitamin D HPO 0.02
    HP:0000726 Dementia HPO 0.02
    HP:0010444 Pulmonary insufficiency HPO 0.02
    HP:0012819 Myocarditis HPO 0.02
    HP:0002098 Respiratory distress HPO 0.02
    HP:0000717 Autism HPO 0.02
    HP:0005978 Type II diabetes mellitus HPO 0.01
    HP:0000729 Autistic behavior HPO 0.01
    HP:0000822 Hypertension HPO 0.01
    HP:0000716 Depressivity HPO 0.01
    HP:0012418 Hypoxemia HPO 0.01
    HP:0002664 Neoplasm HPO 0.01
    HP:0001626 Abnormality of the cardiovascular system HPO 0.01

    Clinical Trials

    Navigate: Correlations   HPO

    There are 462 clinical trials


    1 Phase I, Double-Blinded, Placebo-Controlled Dosage Escalation Study of the Safety and Immunogenicity of Adjuvanted and Non-Adjuvanted Inactivated SARS Coronavirus (SARS-CoV) Vaccine Administered by the Intramuscular Route

    Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory (breathing) system. The purpose of this study is to evaluate the safety and protective (immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An adjuvant is a substance that may be added to a vaccine to improve the immune response so that less of the vaccine may need to be given. Study participants will include 72 volunteers, ages 18-40, living in the Houston, Texas area. The study will take place at Baylor College of Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to look like the study vaccine but contains no medication) given 1 month apart. Participants will fill out a memory aid (diary) to document daily temperature and illness signs and symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples will be collected. Participants will be in the study for up to 211 days, including screening.

    NCT00533741
    Conditions
    1. Coronavirus (SARS-CoV)
    Interventions
    1. Drug: Aluminum hydroxide
    2. Drug: Placebo
    3. Biological: SARS-CoV
    MeSH:Coronavirus Infections

    Primary Outcomes

    Measure: Frequency and description of serious adverse events (SAEs).

    Time: 5 months after receipt of the booster dose of vaccine.

    Measure: Frequency of significant increases in serum antibody to CoV S protein in Enzyme Linked Immunosorbent Assay (ELISA) and in neutralization tests, and increases in Geometric Mean Titers (GMT)s in sera.

    Time: Screening, 1 and 5 months after the booster dose of vaccine.

    Measure: Frequency and severity of solicited injection site and systemic signs and symptoms and unsolicited adverse events (AE) / SAEs.

    Time: 1 month after receipt of the first and second doses of vaccine.

    Secondary Outcomes

    Measure: Frequency of significant serum antibody increases and increases in Geometric Mean Titers (GMT)s, as measured in neutralizing antibody tests and an ELISA against SARS-CoV S protein.

    Time: Collected just before the first vaccination and at 1 month (just before booster).
    2 Efficacy of Ingesting Gaia Herb's Quick Defense Product in Reducing Acute Respiratory Illness Symptomatology in Women: a 12-Week, Double Blind, Placebo-Controlled Randomized Trial

    The primary objective of this study is to evaluate the effectiveness of ingesting an alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately following each onset of acute respiratory illness (ARI) symptomatology during a 12-week period in the winter and early spring in women. Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period will experience reduced ARI symptomatology, both acutely during each ARI episode and collectively over the entire 12-week study period.

    NCT02003651
    Conditions
    1. Acute Respiratory Infections
    Interventions
    1. Dietary Supplement: Quick Defense
    2. Dietary Supplement: Placebo
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess common cold illness severity and symptoms (see attached questionnaire). Subjects will fill in the one-page WURSS-24 at the end of each day during the 12-week monitoring period. This 12-week period will cover the winter and early spring period of 2014. From the responses recorded during the 84-day study, an ARI severity score will be calculated by summing the daily ARI global severity score (0=not sick, 1=very mild ARI to 7=severe). The ARI symptom score for the 84-day period will be calculated by summing all 10 symptom scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). In similar fashion, the ARI function ability score for the 84-day period will be calculated by summing all 9 function scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). Separate scores will be calculated comparing groups for each illness episode recorded by the subjects.

    Measure: Common cold symptoms

    Time: 12-weeks
    3 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

    The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

    NCT02254408
    Conditions
    1. Respiratory Syncytial Virus
    Interventions
    1. Drug: Presatovir
    2. Drug: Placebo
    MeSH:Infection

    Primary Outcomes

    Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

    Measure: Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9

    Time: Baseline; Day 9

    Description: A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: Primary RSV lower respiratory tract infection (LRTI) Secondary bacterial LRTI LRTI due to unusual pathogens Lower respiratory tract complication of unknown etiology

    Measure: Percentage of Participants Who Developed a Lower Respiratory Tract Complication

    Time: Up to Day 28

    Secondary Outcomes

    Description: Participants were considered to have an event if either condition is met: Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or; Participant dies prior to or on Day 28

    Measure: Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality

    Time: Up to Day 28
    4 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

    The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

    NCT02254421
    Conditions
    1. Respiratory Syncytial Virus Infection
    Interventions
    1. Drug: Presatovir
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

    Primary Outcomes

    Description: The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.

    Measure: Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9

    Time: Baseline to Day 9

    Secondary Outcomes

    Measure: Number of Supplemental O2-Free Days Through Day 28

    Time: Up to Day 28

    Measure: Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28

    Time: Up to Day 28

    Measure: Percentage of All-Cause Mortality Among Participants Through Day 28

    Time: Up to Day 28
    5 A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients

    The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.

    NCT02351180
    Conditions
    1. Lung Transplant Infection
    Interventions
    1. Drug: Inhaled beclomethasone
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Virus Diseases

    Primary Outcomes

    Measure: Freedom from new or progressive chronic lung allograft dysfunction

    Time: 180 days

    Measure: Death

    Time: 180 days

    Secondary Outcomes

    Measure: Respiratory virus symptom score

    Time: 7 days

    Measure: Acute rejection

    Time: 180 days

    Measure: Lymphocytic bronchiolitis

    Time: 180 days

    Measure: Donor-specific antibodies

    Time: 180 days

    Measure: Chronic lung allograft dysfunction

    Time: 365 days
    6 Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia

    Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy. A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia. Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.

    NCT02517489
    Conditions
    1. Community Acquired Pneumonia
    Interventions
    1. Drug: Hydrocortisone
    2. Drug: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Measure: Day 28 all causes mortality

    Time: at day 28

    Description: For the sub-group of patients included with COVID19, failure is defined as death or need of respiratory support (mechanical ventilation or high-flow oxygen therapy);

    Measure: Day 21 failure

    Time: at day 21

    Secondary Outcomes

    Measure: In patients non-invasively ventilated at inclusion, proportion of patients needing endotracheal intubation

    Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

    Measure: In patients non-ventilated at inclusion, proportion of patients requiring non-invasive ventilation

    Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

    Measure: In patients non-ventilated at inclusion, proportion of patients needing endotracheal intubation

    Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

    Measure: Day 28 ventilator-free-days

    Time: between 0 and day 28

    Measure: Number of patients with vasopressor therapy initiation from inclusion to day 28

    Time: between 0 and day 28

    Measure: Day 28 vasopressor-free-days

    Time: between 0 and day 28

    Measure: ICU and/or intermediate care unit LOS

    Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

    Measure: All-causes mortality at day 90

    Time: at day 90

    Measure: SF-36 Health Survey at day 90

    Time: at day 90

    Measure: Biomarkers: procalcitonin at baseline, day 3 and day 7

    Time: at inclusion, day 3 and day 7

    Measure: Biomarkers: C-reactive protein at baseline, day 3 and day 7

    Time: at inclusion, day 3 and day 7

    Measure: Biomarkers: plasmatic concentration of pro-inflammatory cytokines (IL-6, IL-20, IL-22, IL-22BP, HBD2, TNF) at baseline, day 3 and day 7

    Time: at inclusion, day 3 and day 7

    Measure: P/F ratio measured daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28

    Time: measured daily from baseline to day 7, at the end of treatment i.e 14 days after the start of treatment, at the end of ICU-stay (for a maximum of 28 days) and/or day 28

    Measure: SOFA calculated daily from baseline to day 7, at the end of treatment, at the end of ICU-stay and/or day 28

    Time: calculated daily from baseline to day 7, at the end of treatment (i.e 14 days after the start of treatment), at the end of ICU-stay (for a maximum of 28 days) and/or day 28

    Measure: Proportion of patients experiencing secondary infection during their ICU-stay

    Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

    Measure: Proportion of patients experiencing gastrointestinal bleeding during their ICU-stay

    Time: Participants will be followed for the duration of hospital stay, for a maximum of 28 days

    Measure: Daily amount of insulin administered to the patient from day 1 to day 7

    Time: Patients will be followed from day 1 to day 7

    Measure: Weight-gain at baseline and day 7

    Time: Patients will be followed at baseline and day 7

    Other Outcomes

    Description: Sub-group of patients included with COVID19

    Measure: P/F ratio measured daily from Day1 to Day7, at Day 14 and at Day 21 and/or at the end of ICU-stay

    Time: from day 1 to day 7, at day 14 and day 21 and/or at the end of ICU-stay

    Description: Sub-group of patients included with COVID19

    Measure: Proportion of patients needing endotracheal intubation

    Time: at day 21

    Description: Sub-group of patients included with COVID19

    Measure: Proportion of patients experiencing secondary infection during their ICU-stay

    Time: From baseline to day 21
    7 Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Induced Rhinovirus Upper Respiratory Tract Infection in Healthy Volunteers. A Double-blind, Randomized, Placebo-controlled Study

    This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.

    NCT02522949
    Conditions
    1. Common Cold
    Interventions
    1. Device: ColdZyme® mouth spray
    2. Device: Placebo
    MeSH:Common Cold

    Primary Outcomes

    Description: Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo

    Measure: Reduction in viral load in the URT

    Time: 7 days

    Secondary Outcomes

    Description: Reduction of number of days having a total symptom severity score of 6 or higher using a 5-graded Jackson scale, in relation to placebo.

    Measure: Prevention of symptomatic URTI (Upper Respiratory Tract Infection)

    Time: 11 days

    Description: Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab).

    Measure: Prevention of asymptomatic URTI.

    Time: 11 days

    Description: The number of days with cold is defined as the sum of all days with a total score of ≥ 6 according to the modified method of Jackson.

    Measure: Fewer days with symptomatic URTI

    Time: 11 days

    Description: The number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline.

    Measure: Fewer days with asymptomatic URTI.

    Time: 11 days

    Description: Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha).

    Measure: Lower level of proinflammatory proteins

    Time: 11 days

    Measure: Lower daily total symptom score

    Time: 11 days

    Measure: Lower daily score of individual symptoms

    Time: 11 days
    8 A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

    The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

    NCT02534350
    Conditions
    1. Respiratory Syncytial Virus (RSV)
    Interventions
    1. Drug: Presatovir
    2. Drug: Placebo
    MeSH:Infection Virus Diseases

    Primary Outcomes

    Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set

    Time: Up to 7 days

    Measure: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median

    Time: Up to 7 days

    Secondary Outcomes

    Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

    Measure: Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7

    Time: Up to 7 days

    Description: FEV1 is defined as forced expiratory volume in the first second.

    Measure: Percent Change From Study Baseline in FEV1% Predicted Value

    Time: Baseline; Day 28
    9 MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial

    This is a placebo-controlled clinical trial to assess the efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.

    NCT02845843
    Conditions
    1. Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
    Interventions
    1. Drug: Combination of Lopinavir /Ritonavir and Interferon beta-1b
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Measure: 90-day mortality

    Time: 90-day

    Secondary Outcomes

    Measure: Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors)

    Time: 28 days

    Measure: RT-PCR cycle threshold value in the lower respiratory samples

    Time: At randomization and every 3 days afterwards, until 2 consecutive samples are negative or reaching a maximum of 90 days

    Measure: Sequential organ failure assessment (SOFA) scores

    Time: Days 0, 3, 7, 14, 21 and 28

    Measure: ICU-free days

    Time: Number of days in which patients are not being cared for in the ICU during the first 28 days after enrollment

    Measure: Length of stay in hospital

    Time: Up to one year from enrollment

    Measure: Number of Patients with Adverse drug reactions related to the treatment

    Time: From enrollment to 28 day

    Measure: Karnofsky Performance Scale

    Time: 90-day

    Measure: ICU mortality

    Time: Up to one year from enrollment

    Measure: Hospital mortality

    Time: Up to one year from enrollment

    Measure: 28-day mortality

    Time: 28-day
    10 CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

    This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood vessel problems.

    NCT02915198
    Conditions
    1. Prediabetic State
    2. Atherosclerosis
    3. Metformin
    Interventions
    1. Drug: Metformin XR
    2. Drug: Placebo
    MeSH:Atherosclerosis Prediabetic State
    HPO:Atherosclerosis Type IV atherosclerotic lesion

    Primary Outcomes

    Description: The primary outcome measure is the time to first occurrence of death, non-fatal myocardial infarction or stroke, hospitalization for unstable angina with objective evidence of acute myocardial ischemia, or coronary revascularization driven by acute or progressive symptoms.

    Measure: Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization

    Time: through study completion, an average of 4.5 years

    Secondary Outcomes

    Description: Time to first occurrence of death, myocardial infarction, or stroke Time to first occurrence of a primary endpoint event, peripheral arterial disease event, or hospitalization for congestive heart failure Cumulative incidence of all components of the primary endpoint, including recurrent or multiple events in the same participant Cumulative incidence and time to first occurrence of each component of the primary outcome measure, peripheral arterial disease events, and hospitalization for congestive heart failure

    Measure: Time in days to Cardiovascular Outcomes

    Time: through study completion, an average of 4.5 years

    Description: Time to new or recurrent diagnosis of a malignancy or death from a malignancy

    Measure: Time in days to Oncologic Outcome

    Time: through study completion, an average of 4.5 years

    Description: Time to new diagnosis of type 2 diabetes (ADA criteria)

    Measure: Time in days to Diabetes Outcome

    Time: through study completion, an average of 4.5 years
    11 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Ad5FGF-4 in Patients With Refractory Angina Due to Myocardial Ischemia

    The purpose of this study is to determine whether a single intracoronary infusion of an adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4 (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life. Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT) duration. Long-term safety of Ad5FGF-4 will also be assessed.

    NCT02928094
    Conditions
    1. Angina, Stable
    Interventions
    1. Biological: Ad5FGF-4
    2. Biological: Placebo
    MeSH:Angina Pectoris Myocardial Ischemia Coronary Artery Disease Angina, Stable Ischemia
    HPO:Angina pectoris Coronary artery atherosclerosis Myocardial infarction

    Primary Outcomes

    Description: Modified Bruce Protocol with exercise duration limited by angina or angina equivalent

    Measure: Change in Exercise Tolerance Test (ETT) duration

    Time: Baseline and Month 6

    Secondary Outcomes

    Description: Canadian Cardiovascular Society (CCS) angina classification

    Measure: Change in patient functional status (CCS class)

    Time: Baseline and Month 6

    Description: Average weekly angina episodes

    Measure: Change in weekly angina frequency

    Time: Baseline and Month 6

    Description: Average weekly nitroglycerin usage

    Measure: Change in weekly nitroglycerin usage

    Time: Baseline and Month 6

    Description: Seattle Angina Questionnaire

    Measure: Change in quality of life

    Time: Baseline and Month 6

    Description: Adverse events and clinical laboratory testing

    Measure: Safety of Ad5FGF-4

    Time: Through Month 6

    Description: Occurrence of clinically significant events

    Measure: Long-term safety of Ad5FGF-4

    Time: Through Month 60
    12 CSP #2004 - Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)

    The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.

    NCT03005379
    Conditions
    1. Clostridium Difficile Infection
    Interventions
    1. Drug: Fecal Microbiota Therapy (FMT)
    2. Drug: Placebo
    MeSH:Clostridium Infections

    Primary Outcomes

    Description: The primary outcome is recurrent CDI (definite or probable) or death within 56 days of randomization. Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS Laboratory confirmation of C. difficile from a stool specimen. Probable recurrence is defined as the same clinical manifestations as above, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).

    Measure: Recurrent CDI (definite or probable) or death

    Time: Within 56 days of randomization

    Secondary Outcomes

    Description: The incidence of recurrent CDI (definite or possible) or death within 6 months of randomization.

    Measure: Recurrent CDI (definite or possible), or death

    Time: Within 6 months of randomization

    Description: The investigators will use a brief assessment of both overall and gastrointestinal health status, using a previously validated instrument.

    Measure: Quality of Life

    Time: 56 days from randomization

    Description: The number of CDI recurrences within 6 months for a patient is the count of separate CDI recurrences from randomization to 6 months after randomization.

    Measure: Number of CDI recurrences

    Time: Within 6 months of randomization

    Description: This is similar to probable recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test and PCR, not episodes that are not tested or are uninterpretable.

    Measure: Diarrhea that is negative for C. difficile by EIA toxin test and PCR

    Time: Within 56 days of randomization

    Description: An assessment for non-diarrheal manifestations of CDI such as abdominal pain, urgency, and fecal incontinence will be performed.

    Measure: Multiple related symptoms

    Time: Within 6 months of randomization

    Description: The incidence of definite recurrent CDI within 56 days of randomization. Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days Other clinical symptoms including ileus, toxic mega colon, or colectomy PLUS Laboratory confirmation of C. difficile from a stool specimen.

    Measure: Definite recurrent CDI

    Time: Within 56 days of randomization

    Description: The incidence of probable recurrent CDI within 56 days of randomization. Possible recurrence is defined as the same clinical manifestations as definite recurrent CDI, but WITHOUT laboratory confirmation of C. difficile (stool test not sent, negative result, or uninterpretable result).

    Measure: Possible recurrent CDI

    Time: Within 56 days of randomization

    Description: The incidence of death within 56 days of randomization.

    Measure: Death

    Time: Within 56 days of randomization

    Description: This is similar to possible recurrent CDI, but includes only episodes of diarrhea that test negative for C. difficile by EIA toxin test, not episodes that are not tested or are uninterpretable.

    Measure: Diarrhea that is negative for C. difficile by EIA toxin testing but positive by PCR

    Time: Within 56 days of randomization

    Other Outcomes

    Description: Safety outcomes to be collected include: Serious adverse events, with a focus on SAEs involving hospitalization (new or prolonged), and all-cause mortality Adverse events which may be related to FMT treatment. This includes adverse events which Site Investigators consider related/possibly related to the study treatment and all adverse events which occur within 14 days of study treatment (since an aggregate analysis of events temporally linked to treatment could show a causal relationship when compared to placebo) Infectious transmissions which are plausibly linked to FMT treatment. Development of new conditions theoretically linked to alterations in gut microbiota.

    Measure: Adverse and Serious Adverse Events

    Time: Within 6 months of randomization
    13 A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

    This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

    NCT03006068
    Conditions
    1. Ulcerative Colitis (UC)
    Interventions
    1. Drug: Upadacitinib (ABT-494)
    2. Drug: Placebo
    MeSH:Colitis Colitis, Ulcerative Ulcer
    HPO:Colitis Ulcerative colitis

    Primary Outcomes

    Description: Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.

    Measure: Assessing Treatment-Emergent Adverse Events

    Time: Up to 288 Weeks
    14 International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

    The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.

    NCT03039621
    Conditions
    1. Acute Respiratory Viral Infections
    Interventions
    1. Drug: Ergoferon
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Virus Diseases

    Primary Outcomes

    Description: Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

    Measure: Time to Alleviation of All ARVI Symptoms.

    Time: 14 days of observation.

    Secondary Outcomes

    Description: Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).

    Measure: Time to Normalization of Body Temperature.

    Time: 14 days of observation.

    Description: Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.

    Measure: Time to Alleviation of Flu-like Nonspecific Symptoms.

    Time: 14 days of observation.

    Description: Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.

    Measure: Time to Alleviation of Respiratory Symptoms.

    Time: 14 days of observation.

    Description: Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

    Measure: Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.

    Time: On days 2-6 of the observation period.

    Description: Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.

    Measure: ARVI Severity.

    Time: On days 2-6 of the observation period.

    Description: Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).

    Measure: Percentage of Recovered Patients.

    Time: On days 2-6 of the observation period.

    Description: Based on patient diary data. The number of intakes of prescribed antipyretics.

    Measure: Rates of Antipyretics Use Per Patient.

    Time: On days 1- 5 of the treatment period.

    Description: Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).

    Measure: Percentage of Patients With Worsening of Illness.

    Time: 14 days of observation peiod.
    15 A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis

    This is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.

    NCT03126760
    Conditions
    1. Relapsing, Remitting Multiple Sclerosis
    Interventions
    1. Drug: Repository Corticotropin Injection
    2. Drug: Placebo
    MeSH:Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis

    Primary Outcomes

    Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

    Measure: Response rate on Expanded Disability Status Scale (EDSS) at Day 42

    Time: Day 42

    Description: Data for AE and SAE will be presented.

    Measure: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time: Up to Day 42

    Description: Data will be summarized for each visit.

    Measure: Change from Baseline in diastolic/systolic blood pressures

    Time: Baseline and Up to Day 42

    Measure: Change from Baseline in respiratory rate

    Time: Baseline and Up to Day 42

    Measure: Change from Baseline in heart rate

    Time: Baseline and Up to Day 42

    Measure: Change from Baseline in body temperature

    Time: Baseline and Up to Day 42

    Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - Hematology

    Time: Baseline and Up to Day 42

    Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - blood chemistry

    Time: Baseline and Up to Day 42

    Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities -urinalysis

    Time: Baseline and Up to Day 42

    Secondary Outcomes

    Description: The MSIS-29 measures the physical (20 items) and psychological (9 items) impact of MS from the participant's perspective. This validated questionnaire will result in a total score between 29 and 145 and can provide separate scores for physical and psychological impact. The MSIS-29 will be completed by the participant at all required times points during the study except on Study Day 14 when the MSIS-29 will be administered via telephone by a call center trained in the administration of the MSIS-29 or captured via a web portal.

    Measure: The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs)

    Time: Days 7, 14, 21 and 42

    Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.

    Measure: The response rates on EDSS and 90% CIs on Day 7 and Day 21

    Time: Days 7 and 21

    Description: The CGI-I was developed for use in clinical research to provide a brief overview of the change in a participant's global function compared to baseline and regardless of study drug treatment. It requires a rating from 1 (very much improved) to 7 (very much worse).

    Measure: Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs

    Time: Days 7, 21 and 42
    16 A Staged Study Incorporating a Phase 1b, Multicenter, Unmasked, Dose Escalation Evaluation of Safety and Tolerability and a Phase 2, Multicenter, Unmasked, Randomized, Parallel Group, Controlled, Proof of Concept Investigation of Efficacy and Safety of ASP7317 for Atrophy Secondary to Age-related Macular Degeneration

    This study is for adults 50 years or older who are losing their clear, sharp central vision. Central vision is needed to be able to read and drive a car. They have been diagnosed with dry age-related macular degeneration (called dry AMD). The macula is the part of the eye that allows one to see fine detail. AMD causes cells in the macula to die (atrophy). This study is looking at a new treatment for slowing or reversing dry AMD, called ASP7317. ASP7317 is a specially created type of cells derived from stem cells. ASP7317 cells are injected into the macula of the eye. Immunosuppressive medicines (called IMT) are also taken around the time of injection of the cells to prevent the body from rejecting them. The study is divided into 3 stages. Stage 1 looks at the safety of ASP7317 at different dose levels. Researchers want to learn which of 3 different dose levels of ASP7317 work without causing unwanted effects. The doses are low, medium and high numbers of cells. IMT medicines will also be taken by mouth (oral) for 13 weeks around the time of the injection of ASP7317. In Stage 2, the participants are selected by chance (randomization) to be in the ASP7317 treatment group or to be in the control group (no treatment). What was learned about the dose of ASP7317 in stage 1 will be used to determine the appropriate dose(s) in this stage. In those who receive ASP7317, oral IMT medicines will also be taken for 13 weeks. 26 weeks after ASP3717 is injected, the best corrected visual acuity will be compared between participants who received ASP7317 and in those who did not (control group). Visual acuity is a test to find out what the smallest letters are that one can read on a standard chart. This test will be masked. Masked means the study opticians who measure one's visual acuity don't know whether the participant received ASP7317 or not. In Stage 3, participants in the untreated control group from stage 2 will have the option to receive treatment with ASP7317. They must have been in the study for 26 weeks and still meet the requirements for treatment.

    NCT03178149
    Conditions
    1. Age-Related Macular Degeneration
    Interventions
    1. Drug: ASP7317
    2. Other: Placebo
    3. Drug: tacrolimus
    4. Drug: mycophenolate mofetil (MMF)
    MeSH:Macular Degeneration

    Primary Outcomes

    Description: Best corrected visual acuity (BCVA) will be measured by an assessor certified to use the early treatment of diabetic retinopathy study (ETDRS) method. The BCVA score (in letter units) will be reported.

    Measure: PoC only: Change from baseline in BCVA score, measured by ETDRS method at week 26

    Time: Baseline and Week 26

    Description: Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). Adverse event collection will begin upon the participant signing the informed consent.

    Measure: Safety as assessed by Incidence, frequency and severity of adverse events (AEs)

    Time: Up to 60 Months

    Description: An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (hospitalization for treatment/observation/examination caused by AE is to be considered as serious); or other medically important events.

    Measure: Safety as assessed by Incidence, frequency and severity of Serious adverse events (SAEs)

    Time: Up to 60 Months

    Description: ATIMP events which may represent a significant hazard to the trial's participant population, and thus require expedited reporting, including but not limited to the following example ATIMPs: ectopic or proliferative cell growth (RPE or non-RPE) with adverse clinical Consequence; any new diagnosis of an immune-mediated disorder; any new cancer, irrespective of prior history; unexpected, clinically significant AEs possibly related to the cell transplant procedure, IMT or ASP7317 (e.g., graft failure or rejection).

    Measure: Safety as assessed by Incidence, frequency and severity of advanced therapy investigational medicinal product (ATIMP) events

    Time: Up to 60 Months

    Description: Evidence of graft failure or rejection will be assessed by BCVA, slit lamp examination, dilated indirect ophthalmoscopy, fundus photographs, spectral domain-optical coherence tomography (SD-OCT) and fluorescein angiography (FA), when performed.

    Measure: Number of Participants with graft failure or rejection

    Time: Up to 60 Months

    Description: Evidence of graft failure or rejection will be assessed by BCVA, slit lamp examination, dilated indirect ophthalmoscopy, fundus photographs, spectral domain-optical coherence tomography (SD-OCT) and fluorescein angiography (FA), when performed.

    Measure: Incidence of graft failure or rejection

    Time: Up to 60 Months

    Description: Immediate notification (within 24 hours of becoming aware) to the sponsor is required for any evidence of graft failure or rejection. AEs which are assessed as being evidence of graft failure or rejection will be summarized in additional AE tables, including time to onset relative to the start of adjunct study medication.

    Measure: Time of onset of ASP7317 to graft failure or rejection

    Time: Up to 60 Months

    Description: An abnormality identified during a medical test will be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of adjunct study medications; age-related eye disease studies (AREDS) lens grade increase from baseline by ≥ 1 grade; the abnormality or test value is clinically significant; visual acuity loss of ≥ 10 letters due to graft failure or rejection.

    Measure: Number of clinically significant objective test results in laboratory tests

    Time: Up to 26 Weeks

    Description: Clinically significant changes in blood pressure will be reported as moderate or severe.

    Measure: Number of clinically significant objective test results in blood pressure

    Time: Up to 12 Weeks

    Description: Clinically significant changes in AC cells grade will be reported with a grade ranging from 0 to 4+ (0 = good and 4+ = not good), on a scale from <1 to >50, with cells in field as the indicator (0 = <1 cells in the field and 4+ = >50 cells in the field).

    Measure: Number of clinically significant objective test results in anterior chamber (AC) cells grade

    Time: Up to 26 Weeks

    Description: Clinically significant changes in flare grade will be reported with a grade ranging from 0 to 4+ and defined as follows: none (grade 0), faint (grade 1), moderate (iris and lens details clear, grade 2), marked (iris and lens details hazy, grade 3), and intense (fibrin or plastic aqueous, grade 4).

    Measure: Number of clinically significant objective test results in AC flare grade

    Time: Up to 26 Weeks

    Description: Clinically significant changes in vitreous haze grade will be reported with a grade ranging from 0 to 4+ and defined as follows: clear (grade 0), opacities without obstruction of retinal details (grade 1), few opacities resulting in the mild burning of posterior details of optic nerve and retinal vessels (grade 2), optic nerve head and retinal vessels significantly blurred but still visible (grade 3), dense opacity obscuring optic nerve head (grade 4).

    Measure: Number of clinically significant objective test results in vitreous haze grade

    Time: Up to 26 Weeks

    Description: Intraocular pressure in both eyes will be measured by tonometry. Intraocular pressure should be measured after biomicroscopic examination and before pupil dilation approximately the same time of day, when possible.

    Measure: Number of clinically significant objective test results in intraocular pressure (IOP) in each eye

    Time: Up to 60 Months

    Secondary Outcomes

    Description: BCVA will be measured by an assessor certified to use the ETDRS method. The BCVA score (in letter units) will be reported.

    Measure: PoC only: Change from baseline in BCVA score, average of assessments from weeks 4 to 26

    Time: Baseline and up to Week 26

    Description: BCVA will be measured by an assessor certified to use the ETDRS method.

    Measure: PoC only: Participant response, defined as a confirmed ≥ 10-letter (0.2 logMAR) improvement in BCVA, at week 26

    Time: Week 26

    Description: The index quadrant is defined as the macular quadrant (superior, temporal, inferior or nasal) where ASP7317 is injected or, for the untreated control group, this is the macular quadrant recommended for ASP7317 injection by the subject selection committee (SSC).

    Measure: PoC only: Change from baseline in mean retinal sensitivity of all test points in the index quadrant at week 26

    Time: Baseline and Week 26

    Description: DDAF will be assessed by Fundus Autofluorescence Photography (FAF). The image reading center will review the FAF images for area of DDAF and pattern of hyper autofluorescence around the DDAF.

    Measure: PoC only: Change from baseline in (square root) area of definite decreased autofluorescence (DDAF) in the index quadrant at week 26

    Time: Baseline and Week 26

    Description: The FRII is a 7-item questionnaire that evaluates the effect of geographic atrophy on a patient's ability to independently perform reading activities.

    Measure: Change from baseline in the Functional Reading Independence Index (FRII) at week 26

    Time: Baseline and Week 26

    Description: The IVI-VLV questionnaire (28 questions) will be used to assess activities of daily living, mobility, safety and emotional well-being. This questionnaire measures perceived restriction of participation associated with daily living activities.

    Measure: Change from baseline in the Impact of Vision Impairment - Very Low Vision questionnaire (IVI-VLV) at week 26

    Time: Baseline and Week 26
    17 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

    The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

    NCT03259308
    Conditions
    1. Ulcerative Colitis
    Interventions
    1. Drug: Ontamalimab
    2. Drug: Placebo
    MeSH:Colitis Colitis, Ulcerative Ulcer
    HPO:Colitis Ulcerative colitis

    Primary Outcomes

    Description: Remission is defined as a composite score of patient-reported symptoms using daily ediary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.

    Measure: Number of Participants With Remission at Week 12

    Time: Week 12

    Secondary Outcomes

    Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.

    Measure: Number of Participants With Endoscopic Remission at Week 12

    Time: Week 12

    Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.

    Measure: Number of Participants With Clinical Remission at Week 4, 8, 12

    Time: Week 4, 8, 12

    Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.

    Measure: Number of Participants With Clinical Response (Composite) at Week 12

    Time: Week 12

    Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.

    Measure: Number of Participants With Mucosal Healing at Week 12

    Time: Week 12

    Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and PGA) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).

    Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12

    Time: Week 12

    Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).

    Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12

    Time: Week 12

    Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Here participants with partial Mayo score <= 2 with no individual subscore >1 at the Week 4, 8, and 12 will be assessed.

    Measure: Number of Participants With Partial Mayo Score Less than or Equal to (<=) 2 with no Individual Subscore Greater than (>) 1 at Week 4, 8, 12

    Time: Week 4, 8, 12

    Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.

    Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0

    Time: Week 12

    Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.

    Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12

    Time: Week 4, 8, 12

    Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.

    Measure: Number of Participants With Deep Remission at Week 12

    Time: Week 12

    Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.

    Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.

    Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12

    Time: Baseline, Week 8, 12

    Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

    Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12

    Time: Baseline, Week 12

    Description: Incidence of hospitalizations during the entire study period will be assessed.

    Measure: Incidence of Hospitalizations

    Time: From start of study up to follow up (Week 29)

    Description: Incidence of total inpatient days during the entire study period will be assessed.

    Measure: Incidence of Total Inpatient Days

    Time: From start of study up to follow up (Week 29)
    18 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

    The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

    NCT03259334
    Conditions
    1. Ulcerative Colitis
    Interventions
    1. Drug: Ontamalimab
    2. Other: Placebo
    MeSH:Colitis Colitis, Ulcerative Ulcer
    HPO:Colitis Ulcerative colitis

    Primary Outcomes

    Description: Remission is defined as a composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency subscore of 0 or 1 with at least a 1-point change from baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability). The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); Physician global assessment (PGA: 0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.

    Measure: Number of Participants With Remission at Week 12

    Time: Week 12

    Secondary Outcomes

    Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.

    Measure: Number of Participants With Endoscopic Remission at Week 12

    Time: Week 12

    Description: Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from baseline in stool frequency subscore, and rectal bleeding subscore of 0. The stool frequency subscore and rectal bleeding subscore range from 0 to 3 with higher scores indicating more severe disease.

    Measure: Number of Participants With Clinical Remission at Week 4, 8, 12

    Time: Week 4, 8, 12

    Description: Clinical response (composite) is defined as a decrease from baseline in the composite score of participant-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1. The Mayo score is a measure of UC disease activity. It ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease The subscores are Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3). The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.

    Measure: Number of Participants With Clinical Response (Composite) at Week 12

    Time: Week 12

    Description: Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.

    Measure: Number of Participants With Mucosal Healing at Week 12

    Time: Week 12

    Description: Remission is defined as a total mayo score of less than or equal to <=2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1, at the Week 12. The total mayo score ranges from 0 to 12 points and consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).

    Measure: Number of Participants With Remission Based on Total Mayo Score at Week 12

    Time: Week 12

    Description: Clinical response (Mayo) is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding >=1 point or an absolute subscore for rectal bleeding <=1. The total mayo score ranges from 0 to 12 points and consists of the following 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); Findings of endoscopy (0-3); PGA (0-3).

    Measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12

    Time: Week 12

    Description: The partial mayo score ranges from 0 to 9 points and consists of the following 3 subscores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score does not include the endoscopy subscore. Number of participants with partial mayo score <=2 with no individual subscore >1 at the Week 4, 8, 12 will be assessed.

    Measure: Number of Participants With Partial Mayo Score Less than or Equal (<=) 2 with no individual subscore Greater than (>) 1 at Week 4, 8, 12

    Time: Week 4, 8, 12

    Description: Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability). The centrally read endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Here number of participants with endoscopic remission at week 12 with a subscore of 0 will be assessed.

    Measure: Number of Participants with Endoscopic Remission at Week 12 With Endoscopic Subscore of 0

    Time: Week 12

    Description: Clinical remission with both rectal bleeding and stool frequency subscores of 0 at week 4, 8, 12 will be assessed. The stool frequency subscore and rectal bleeding subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points.

    Measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Subscores of 0 at Week 4, 8, 12

    Time: Week 4, 8, 12

    Description: Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.. The stool frequency subscore, rectal bleeding subscore and endoscopic subscore of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. The composite score is a recommended measure consisting of the Mayo score without the PGA subscore and ranges from 0 to 9 points. Geboes score grading system, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher geboes score indicates more severe disease.

    Measure: Number of Participants With Deep Remission at Week 12

    Time: Week 12

    Description: Participants will be asked to record the abdominal pain worst severity using 0-10 numeric rating scale, with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Abdominal Pain Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the diarrhea frequency (enter number of loose or watery bowel movements) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Diarrhea Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the urgency frequency (enter number of bowel movements with urgency) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Urgency Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the stool frequency (enter number of bowel movements passed) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Absolute Stool Frequency Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: Participants will be asked to record the rectal bleeding severity and frequency (enter number of bowel movements with blood) as experienced over the previous 24 hours, in the e-diary.

    Measure: Change From Baseline in Absolute Rectal Bleeding Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: The total sign/symptom score (average of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) ranges from 0 to 10 with higher scores indicating higher severity.

    Measure: Change From Baseline Total Sign/Symptom Score Based on Participant e-Diary at Week 12

    Time: Baseline, Week 12

    Description: The IBDQ is a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.

    Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 8, 12

    Time: Baseline, Week 8, 12

    Description: The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

    Measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores and Individual Domain Scores) at Week 12

    Time: Baseline, Week 12

    Description: Incidence of hospitalizations during the entire study period will be assessed.

    Measure: Incidence of Hospitalizations

    Time: From start of study up to follow up (Week 29)

    Description: Incidence of total inpatient days during the entire study period will be assessed.

    Measure: Incidence of Total Inpatient Days

    Time: From start of study up to follow up (Week 29)
    19 A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

    This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

    NCT03285308
    Conditions
    1. Gastroparesis
    2. Diabetes Mellitus
    Interventions
    1. Drug: Relamorelin
    2. Drug: Placebo
    MeSH:Gastroparesis
    HPO:Gastroparesis

    Primary Outcomes

    Description: Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.

    Measure: To compare the efficacy of relamorelin with placebo in participants with respect to their diabetic gastroparesis symptoms during the 12 weeks of treatment

    Time: Baseline, 12 Weeks

    Description: Vomiting episodes will be patient-recorded daily using an electronic diary.

    Measure: Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment

    Time: 12 Weeks

    Secondary Outcomes

    Description: A Nausea Responder is defined as an improvement of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.

    Measure: Percentage of Patients Meeting the Nausea Responder Criterion

    Time: Baseline to Week 12

    Description: An Abdominal Pain Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Abdominal Pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.

    Measure: Percentage of Patients Meeting the Abdominal Pain Responder Criterion

    Time: Baseline to Week 12

    Description: A Bloating Responder is defined as an improvement of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.

    Measure: Percentage of Patients Meeting the Bloating Responder Criterion

    Time: Baseline to Week 12

    Description: A Postprandial Fullness Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites

    Measure: Percentage of Patients Meeting the Postprandial Fullness Responder Criterion

    Time: Baseline to Week 12

    Description: The number of patients who experienced one or more TEAE during the 12 week treatment period.

    Measure: Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)

    Time: Baseline to Week 12
    20 A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

    This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.

    NCT03301090
    Conditions
    1. Corona Virus Infection
    Interventions
    1. Other: Placebo
    2. Biological: REGN3048
    3. Biological: REGN3051
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Changes from baseline in abbreviated physical examination

    Time: Days 1-2

    Measure: Changes from baseline in clinical safety laboratory values

    Time: From Day 2 up to Day 121

    Measure: Changes from baseline in Electrocardiogram (ECG) parameters

    Time: 15 mins after infusion

    Measure: Changes from baseline in Electrocardiogram (ECG) parameters

    Time: 24 hrs after infusion

    Measure: Changes from baseline in symptom-directed physical examination

    Time: From Day 1 up to Day 121

    Measure: Changes from baseline in vital signs

    Time: From Day 1 up to Day 121

    Measure: The incidence of Adverse Events

    Time: From Day 1 up to Day 121

    Measure: The incidence of treatment-emergent Serious Adverse Events

    Time: From Day 1 up to Day 121

    Measure: The severity of Adverse Events assessed by toxicity grading criteria

    Time: From Day 1 up to Day 121

    Measure: The severity of treatment-emergent Serious Adverse Events assessed by toxicity grading criteria

    Time: From Day 1 up to Day 121

    Measure: The type of treatment-emergent Serious Adverse Events

    Time: From Day 1 up to Day 121

    Secondary Outcomes

    Measure: AUC for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: AUC for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: AUC(0-infinity) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: AUC(0-infinity) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: CL for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: CL for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: CMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: CMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: K(e) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: K(e) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: t(1/2) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: t(1/2) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays

    Time: Day 121

    Measure: The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays

    Time: Day 57

    Measure: TMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: TMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: V(ss) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121

    Measure: V(ss) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)

    Time: From Day 1 up to Day 121
    21 Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease: The GPAD-3 Study

    Peripheral artery disease (PAD) is a disease in which plaque builds up in the arteries that carry blood to the head, organs, and limbs. PAD usually occurs in the arteries in the legs, but can affect any arteries. Over time, plaque can harden and narrow the arteries which limits the flow of oxygen-rich blood to organs and other parts of the body. Blocked blood flow to the arteries can cause pain and numbness. The pain is usually worse with exercise and gets better with rest. PAD can raise the risk of getting an infection which could lead to tissue death and amputation. This study is investigating whether granulocyte-macrophage colony stimulating factor (GM-CSF) improves symptoms and blood flow in people with PAD. GM-CSF is a drug that is used to stimulate the bone marrow to release stem cells. Participants in the study will be randomly selected to receive GM-CSF or a placebo. After a four-week screening phase, participants will receive injections of GM-CSF or a placebo three times a week for three-weeks. Three months later, participants will again receive injections of GM-CSF or placebo three times a week for three-weeks. At six months, the study team will follow up to see if the group that received GM-CSF had more improvement than the group that received placebo.

    NCT03304821
    Conditions
    1. Peripheral Artery Disease (PAD)
    Interventions
    1. Drug: GM-CSF
    2. Drug: Placebo
    MeSH:Peripheral Arterial Disease Peripheral Vascular Diseases
    HPO:Peripheral arterial stenosis

    Primary Outcomes

    Description: Participants will be walk up and down a 100-foot hallway for 6 minutes to cover the maximum distance possible. The distance, measured in feet, completed after 6 minutes will be recorded.

    Measure: Change in 6-minute walk distance

    Time: Baseline, Month 3, Month 6, Month 9

    Secondary Outcomes

    Description: Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes. The peak walking time (PWT) is the time until exercise is terminated because of severe claudication. Exercise testing will be performed twice and longest time will be used as the PWT for that study visit.

    Measure: Change in Peak Walking Time (PWT)

    Time: Baseline, Month 3, Month 6, Month 9

    Description: The Walking Impairment Questionnaire (WIQ) domain of walking distance asks respondents to rate how difficult it is to walk around home, as well as distances of 50, 150, 300, 600, 900 and 1500 feet. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 28 with higher scores indicating increased ability to walk further distances.

    Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Distance Score

    Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

    Description: The Walking Impairment Questionnaire (WIQ) domain of walking speed asks respondents to rate how difficult it is to walk the distance of one block slowly, at an average speed, quickly, and running/jogging. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 16 with higher scores indicating increased ability to walk fast.

    Measure: Change in Walking Impairment Questionnaire (WIQ): Walking Speed Score

    Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

    Description: The Walking Impairment Questionnaire (WIQ) domain of stair climbing asks respondents to rate how difficult it is to climb 1, 2, and 3 flights of stairs. Possible responses are: not hard (4), slightly difficult (3), somewhat difficult (2), very difficult (1), and unable to do (0). Total raw scores range from 0 to 12 with higher scores indicating better ability to climb stairs.

    Measure: Change in Walking Impairment Questionnaire (WIQ): Stair Climbing Score

    Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

    Description: 36-item Short-Form Health Survey (SF-36) consists of eight scaled scores for the domains of: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Study participants respond to questions relating to their health and activity level by selecting from a variety of Likert scale and yes/no response options. Each scale is directly transformed into a 0-100 scale and lower scores indicate more disability (a score of 0 equates to maximum disability while a score of 100 indicates no disability).

    Measure: Change in 36-item Short-Form Health Survey (SF-36) Score

    Time: Baseline, Month 3, Month 6, Month 9, Follow-up Years 1, 2, and 3

    Description: Claudication onset time (COT) during the treadmill exercise will be recorded along with the peak walking time (PWT). The claudication onset time (COT) is the duration of exercise until onset of the participant's typical claudication. This is differentiated from the peak walking time (PWT) which is the time until exercise is terminated because of severe claudication. Graded treadmill exercise testing will be performed using the Gardner protocol where the treadmill speed is kept at 2 mph and the grade starts at 0 and inclines by 2% every two minutes.

    Measure: Change in Claudication Onset Time (COT)

    Time: Baseline, Month 3, Month 6, Month 9

    Description: To obtain the ankle-brachial index (ABI), bilateral upper and lower extremity blood pressure cuffs are inflated about 30 millimeters of mercury (mmHg) above the systolic pressure. Doppler flow signals are used to detect the reappearing perfusion while reducing the cuff pressure. The results is expressed as a segmental/arm pressure ratio (ABI index). The highest pressure of the two arms will be used for calculating the ABI. The average ratio is about 1.0+/-0.10; an index of 0.90 or lower is considered abnormal. In patients with calcific, non-compressible arteries (certain diabetics) where ABI measurements are unreliable, a toe/ arm pressure index ratio will be performed, with a 2.5 cm cuff used on the great or second toes. A toe/arm index less than 0.65 is considered abnormal.

    Measure: Change in Ankle-Brachial Index (ABI)

    Time: Baseline, Month 3, Month 6, Month 9

    Description: Foot transcutaneous oxygen tension (TcPO2) is a noninvasive way to measure peripheral arterial disease. TcPO2 is obtained with a monitor before exercise after the patients have been standing for three minutes and is monitored throughout exercise. Values are recorded at initial claudication distance, absolute claudication distance, and after recovery from exercise. A commonly used cut point is 60 millimeters of mercury (mmHg), with values below this indicating the presence of peripheral arterial disease.

    Measure: Change in Foot Transcutaneous Oxygen Tension (TcPO2)

    Time: Baseline, Month 3, Month 6, Month 9
    22 A Phase 4, Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Pulmonary Sarcoidosis

    The purpose of this study is to find out if Acthar Gel is safe and effective to treat pulmonary sarcoidosis. Participants will be randomly assigned (like flipping a coin) to receive a shot under their skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their assigned shot twice a week for 24 weeks. All participants who complete the 24-week treatment period will be eligible to receive Acthar Gel for 24 more weeks, even if they were originally in the placebo group.

    NCT03320070
    Conditions
    1. Sarcoidosis, Pulmonary
    Interventions
    1. Drug: Acthar Gel
    2. Drug: Placebo
    MeSH:Sarcoidosis, Pulmonary Sarcoidosis

    Primary Outcomes

    Description: Based on absolute change of percent predicted, FVC is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], or Worse (-1) [≤ -5% absolute change]

    Measure: Number of Participants in each Category of Assessment based on Forced Vital Capacity, a Pulmonary Function Test Parameter

    Time: 24 weeks

    Description: Based on absolute change of percent predicted, FVC is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], or Worse (-1) [≤ -5% absolute change]

    Measure: Number of Participants in each Category of Assessment based on Forced Vital Capacity, a Pulmonary Function Test Parameter

    Time: 48 weeks

    Description: Based on absolute change of percent predicted, DLCO is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], Worse (-1) [≤ -5% absolute change]

    Measure: Number of Participants in each Category of Assessment based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter

    Time: 24 weeks

    Description: Based on absolute change of percent predicted, DLCO is evaluated to determine if the condition is: Improved (+1) [≥ 5% absolute change] Unchanged (0) [>- 5% to < 5% absolute change], Worse (-1) [≤ -5% absolute change]

    Measure: Number of Participants in each Category of Assessment based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter

    Time: 48 weeks

    Description: HRCT imaging will be evaluated by the investigator/radiology and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1).

    Measure: Number of Participants in each Category of Assessment based on High Resolution Computer Tomography (HRCT)

    Time: 24 weeks

    Description: HRCT imaging will be evaluated by the investigator/radiology and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1).

    Measure: Number of Participants in each Category of Assessment based on High Resolution Computer Tomography (HRCT)

    Time: 48 weeks

    Description: King's Sarcoidosis Questionnaire (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≥ 4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≤ -4 points

    Measure: Number of participants in each Category of Assessment based on the King's Sarcoidosis Questionnaire (General Health), a Quality of Life Parameter

    Time: 24 weeks

    Description: King's Sarcoidosis Questionnaire (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≥ 4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≤ -4 points

    Measure: Number of participants in each Category of Assessment based on the King's Sarcoidosis Questionnaire (General Health), a Quality of Life Parameter

    Time: 48 weeks

    Description: The FAS is a 10-item checklist for participants to indicate the level of their fatigue. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≤ -4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≥ 4 points

    Measure: Number of participants in each Category of Assessment based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter

    Time: 24 weeks

    Description: The FAS is a 10-item checklist for participants to indicate the level of their fatigue. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale is evaluated to determine if the condition is: Improved (+1) based on a change of ≤ -4 points Unchanged (0) based on a change of >- 4 to < 4 points Worse (-1) based on a change of ≥ 4 points

    Measure: Number of participants in each Category of Assessment based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter

    Time: 48 weeks

    Description: Corticosteroids are typically the first-line when treatment of sarcoidosis is required. Concerns of significant corticosteroid toxicity results in efforts to taper as early as possible. Participants are evaluated at each visit following randomization, and an algorithm is used to taper them off prednisone using incremental doses of 40, 30, 20, 10, 7.5, 5, 2.5 and 0 mg. When the clinical status is: Improvement, they go down by one level First stable visit without toxicity, they continue the same dose Second stable visit without toxicity, the go down by one level Stable visit with toxicity, their toxicity is treated and they may go down by one level Worsening, they go up by one or two levels, but do not exceed 40 mg/day

    Measure: Number of Participants Receiving each Dose of Prednisone

    Time: 24 weeks

    Description: Corticosteroids are typically the first-line when treatment of sarcoidosis is required. Concerns of significant corticosteroid toxicity results in efforts to taper as early as possible. Participants are evaluated at each visit following randomization, and an algorithm is used to taper them off prednisone using incremental doses of 40, 30, 20, 10, 7.5, 5, 2.5 and 0 mg. When the clinical status is: Improvement, they go down by one level First stable visit without toxicity, they continue the same dose Second stable visit without toxicity, the go down by one level Stable visit with toxicity, their toxicity is treated and they may go down by one level Worsening, they go up by one or two levels, but do not exceed 40 mg/day

    Measure: Number of Participants Receiving each Dose of Prednisone

    Time: 48 weeks
    23 A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]

    The purpose of this study is to evaluate whether adding an investigational medication called recombinant human parathyroid hormone (rhPTH[1-84]) to standard hypoparathyroidism therapy (oral calcium and active vitamin D tablets) may result in superior improvements in symptoms of hypoparathyroidism assessed by hypoparathyroidism symptom diary (HPT-SD) symptom scale compared with standard therapy.

    NCT03324880
    Conditions
    1. Hypoparathyroidism
    Interventions
    1. Biological: rhPTH(1-84)
    2. Biological: Placebo
    MeSH:Hypoparathyroidism
    HPO:Hypoparathyroidism

    Primary Outcomes

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. For symptom subscale score, the average score of the symptom items 1-7 will be calculated.

    Measure: Change From Baseline in Hypoparathyroidism Symptom Diary (HPT-SD) Symptom Subscale Score at Week 26

    Time: Baseline, Week 26

    Secondary Outcomes

    Description: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire contains 13 fatigue-related questions. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. High scores represent less fatigue.

    Measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26

    Time: Baseline, Week 26

    Description: The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in PCS derived from SF-36v2 at Week 26 will be reported.

    Measure: Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26

    Time: Baseline, Week 26

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. For Impact subscale, the average score of the impact items 10-13 will be calculated.

    Measure: Change From Baseline in Hypoparathyroidism Symptom Diary (HPT-SD) Impact Subscale Score at Week 26

    Time: Baseline, Week 26

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2.

    Measure: Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HPT-SD) Impact Items Score at Week 26

    Time: Baseline, Week 26

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2.

    Measure: Change From Baseline in Hypoparathyroidism Symptom Diary (HPT-SD) Symptom Item Anxiety (item 8) Score at Week 26

    Time: Baseline, Week 26

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2.

    Measure: Change From Baseline in Hypoparathyroidism Symptom Diary (HPT-SD) Symptom Item Sadness or Depression (Item 9) Score at Week 26

    Time: Baseline, Week 26

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. The change in individual symptom item scores will be reported.

    Measure: Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HPT-SD) Symptom Items Score at Week 26

    Time: Baseline, Week 26

    Description: Response is defined as a 30% reduction in HPT-SD symptom subscale score from baseline. The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. For symptom subscale score, the average score of the symptom items 1-7 will be calculated.

    Measure: Number of Participants With Response at Week 26

    Time: Baseline to Week 26

    Description: The HPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness and depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. The Most Bothersome Symptom Score will be analyzed.

    Measure: Change From Baseline in the Most Bothersome Symptom Score at Week 26

    Time: Baseline, Week 26

    Description: The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) assessment is a 37-item instrument. Each item will be scored from 0=Not at all to 4=Very much.

    Measure: Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Score at Week 26

    Time: Baseline, Week 26

    Description: The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in the score of individual domains of SF-36v2 at Week 26 will be reported.

    Measure: Change From Baseline in Individual Domains of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26

    Time: Baseline, Week 26

    Description: The SF-36 is a validated instruments that question participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in the MCS of SF-36v2 at Week 26 will be reported.

    Measure: Change From Baseline in Mental Component Summary (MCS) Score of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26

    Time: Baseline, Week 26

    Description: The WPAI:Hypoparathyroidism will be used to assess how hypoparathyroidism affects partcipants' ability to work and perform regular activities. Concepts that the WPAI:Hypoparathyroidism measures include time missed from work and impairment of work and other regular activities due to specific health problems. The change from baseline in the questionnaire response will be reported.

    Measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Hypoparathyroidism (WPAI:Hypoparathyroidism) Score at Week 26

    Time: Baseline, Week 26

    Description: The PGI-S is a verbal rating scale asks the respondent to best describe how their symptoms severity. Response options are no symptoms, mild, moderate, severe and very severe. Mean change in scores of PGI-S at Week 26 will be reported.

    Measure: Change From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Severity (PGI-S) at Week 26

    Time: Baseline, Week 26

    Description: The PGI-C is verbal rating scale asks the respondent to best describe change in symptoms compared to the beginning of study. Response options are very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. Mean change in scores of PGI-C at Week 26 will be reported.

    Measure: Change From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Change (PGI-C) at Week 26

    Time: Baseline, Week 26

    Description: The neurocognitive test battery will include tests evaluating the frontal-executive domain, which encompasses functions attributable to the prefrontal cortex and its connections to the basal ganglia (mostly striatum). The tests will include the CogState (CS) Brief Battery (including the Detection: speed [range from 2.001 to 6; lower scores (LS) indicate improvement (IMP)], Identification: speed [range from 2.001 to 6; LS indicate IMP], One Card Learning: accuracy [range from 0 to 1.5708; higher scores (HS) indicate IMP], One Back: speed [range from 2.001 to 6; LS indicate IMP]), CS Groton Maze Learning Test: total errors (range from 0 to infinity; LS indicate IMP), CS International Shopping List Task (ISLT): number of correct responses (range from 0 to infinity; HS indicate IMP), and CS ISLT -Delayed Recall:number of correct responses (range from 0 to infinity; HS indicate IMP). Change in in-clinic neurocognitive assessment scores at Week 24 will be reported.

    Measure: Change From Baseline in In-Clinic Neurocognitive Assessment Scores at Week 24

    Time: Baseline, Week 24

    Description: The neurocognitive test battery will include tests evaluating the frontal-executive domain, which encompasses functions attributable to the prefrontal cortex and its connections to the basal ganglia (mostly striatum). The tests will include the CogState (CS) Brief Battery (including the Detection: speed [range from 2.001 to 6; lower scores (LS) indicate improvement (IMP)], Identification: speed [range from 2.001 to 6; LS indicate IMP], One Card Learning: accuracy [range from 0 to 1.5708; higher scores (HS) indicate IMP], One Back: speed [range from 2.001 to 6; LS indicate IMP]), CS Groton Maze Learning Test: total errors (range from 0 to infinity; LS indicate IMP), CS International Shopping List Task (ISLT): number of correct responses (range from 0 to infinity; HS indicate IMP), and CS ISLT -Delayed Recall:number of correct responses (range from 0 to infinity; HS indicate IMP). Changes in at-home neurocognitive assessment scores (CS Brief Battery) at Week 24 will be reported.

    Measure: Change From Baseline in At-Home Neurocognitive Assessment Scores at Week 24

    Time: Baseline, Week 24

    Description: Change in 24-hour urine calcium excretion at Week 26 will be reported.

    Measure: Change From Baseline in 24-hour Urine Calcium Excretion at Week 26

    Time: Baseline, Week 26

    Description: Change in serum phosphate level at Week 26 will be reported.

    Measure: Change From Baseline in Serum Phosphate Level at Week 26

    Time: Baseline, Week 26

    Description: Changes in doses of active vitamin D and calcium supplements at Week 26 will be reported.

    Measure: Change From Baseline in Doses of Active Vitamin D and Calcium Supplements at Week 26

    Time: Baseline, Week 26

    Description: Number of participants with albumin-corrected serum calcium between 1.875 millimoles per liter (mmol/L) (7.5 milligram per decilitre [mg/dL]) and upper limit of normal (ULN) for the central laboratory normal range at Week 26 will be reported.

    Measure: Number of Participants With Albumin-corrected Serum Calcium Control at Week 26

    Time: Week 26

    Description: Number of participants achieving composite criteria of the following: albumin-corrected serum calcium between 1.875 mmol/L (7.5 mg/dL) and the ULN for the central laboratory normal range, dose of active vitamin D decreased by 50% and at least a 50% reduction from the baseline oral calcium supplement dose at Week 26 will be reported.

    Measure: Number of Participants who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Vitamin D Dose and Oral Calcium Supplement Dose at Week 26

    Time: Baseline to Week 26

    Description: Bone turnover markers includes serum bone-specific alkaline phosphatase, procollagen amino-terminal peptide, C-terminal telopeptide of type 1 collagen, and osteocalcin.

    Measure: Change From Baseline in Bone Turnover Markers at Week 26

    Time: Baseline, Week 26

    Description: An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs that started or worsened on or after the date and time of the first dose of investigational product.

    Measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time: From start of study drug administration up to Week 30
    24 A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI7219 in Healthy Subjects, Including Assessment of the Impact of Changes to the Oral Formulation and Determination of Intravenous Pharmacokinetics

    This is a 6-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy subjects. Parts A, B, C & E are the single-dose parts of the study. Parts D & F are the multiple ascending dose (MAD) parts of the study. The starting dose and formulation for Parts D & F will be selected from data emerging from Parts A, B and E. Enrollment of approximately 198 subjects is anticipated.

    NCT03362593
    Conditions
    1. Healthy Volunteers
    Interventions
    1. Drug: MEDI7219
    2. Drug: Placebo
    3. Drug: Formulation without Active Drug

    Primary Outcomes

    Description: Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

    Measure: Number of subjects with Adverse Events as a measure of safety and tolerability of MEDI7219

    Time: Baseline to last follow up visit (Parts A and C - Day 28) (Part D & F Day 63) and (Parts B and E 28 days post last dose)

    Secondary Outcomes

    Description: PK parameters will be calculated from the plasma concentration versus time data for Cmax (maximum observed concentration)

    Measure: Pharmacokinetics of MEDI7219: Cmax

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

    Description: PK parameters will be calculated from the plasma concentration versus time data for Tmax (time to maximum observed concentration)

    Measure: Pharmacokinetics of MEDI7219: Tmax

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit, Parts F cohort 2 ONLY: Pre-dose and 8 hours post-dose

    Description: PK parameters will be calculated from the plasma concentration versus time data for T1/2 (terminal half-life)

    Measure: Pharmacokinetics of MEDI7219: t1/2

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

    Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-inf) [area under the curve (AUC) extrapolated to infinity]

    Measure: Pharmacokinetics of MEDI7219: AUC (0-inf)

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

    Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-last) [area under the curve (AUC) from time 0 to last measurable concentration]

    Measure: Pharmacokinetics of MEDI7219: AUC(0-last)

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

    Description: PK parameters will be calculated from the plasma concentration versus time data for (AUC 0-24) [area under the curve (AUC) from time 0 to 24 hours post dose]

    Measure: Pharmacokinetics of MEDI7219: AUC(0-24h)

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

    Description: PK parameters will be calculated from the plasma concentration versus time data for AUC%extrapolated [The percentage of AUC(0-inf) accounted for by extrapolation]

    Measure: Pharmacokinetics of MEDI7219: AUC (%extrap)

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)

    Description: PK parameters will be calculated from the plasma concentration versus time data for Lambda-z [Slope of the regression line passing through the apparent elimination phase in a concentration vs time plot]

    Measure: Pharmacokinetics of MEDI7219: Lambda-z

    Time: Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)

    Description: PK parameters will be calculated from the plasma concentration for CL/F (apparent clearance)

    Measure: Pharmacokinetics of MEDI7219: CL/F

    Time: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)

    Description: PK parameters will be calculated from the plasma concentration for Vz/F (volume of distribution)

    Measure: Pharmacokinetics of MEDI7219: Vz/F

    Time: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Pre-dose to Day 63/EOS visit (Parts D & F)

    Description: PK parameters will be calculated from the plasma concentration for Frel (relative bioavailability)

    Measure: Pharmacokinetics of MEDI7219: Frel

    Time: Pre-dose to 144 hours post-dose (Parts B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)

    Description: PK parameters will be calculated from the plasma concentration for Vd (volume of distribution)

    Measure: Pharmacokinetics of MEDI7219: Vd

    Time: Pre-dose to 144 hours (Part C)

    Description: PK parameters will be calculated from the plasma concentration for F (absolute bioavailability)

    Measure: Pharmacokinetics of MEDI7219: F

    Time: Pre-dose to 144 hours (Part C )

    Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-tau) [area under the curve (AUC) for a dosing interval]

    Measure: Pharmacokinetics of MEDI7219: AUC (0-tau)

    Time: Pre-dose to Day 63/EOS visit (Parts D & F)

    Description: Presence of Anti-drug antibody to MEDI7219

    Measure: Immunogenicity

    Time: Day -1 to Day 28/EOS Visit (Parts A and C); Day -1 to Day 63/EOS Visit (Parts D & F); Day -1 to 28 days post last dose of final period/EOS Visit (Parts B and E)

    Description: PK parameters will be calculated from the plasma concentration versus time data for Cmax (maximum observed concentration)

    Measure: Pharmacokinetics of Formulation Component: Cmax

    Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)

    Description: PK parameters will be calculated from the plasma concentration versus time data for Tmax (time to maximum observed concentration)

    Measure: Pharmacokinetics of Formulation Component: Tmax

    Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)

    Description: PK parameters will be calculated from the plasma concentration versus time data for T1/2 (terminal half-life)

    Measure: Pharmacokinetics of Formulation Component: T(1/2)

    Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)

    Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-inf) [area under the curve (AUC) extrapolated to infinity]

    Measure: Pharmacokinetics of Formulation Component: AUC (0-inf)

    Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)

    Description: PK parameters will be calculated from the plasma concentration versus time data for AUC (0-last) [area under the curve (AUC) from time 0 to last measurable concentration]

    Measure: Pharmacokinetics of Formulation Component: AUC (0-last)

    Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)

    Description: PK parameters will be calculated from the plasma concentration versus time data for (AUC 0-24) [area under the curve (AUC) from time 0 to 8 hours post dose]

    Measure: Pharmacokinetics of Formulation Component: AUC (0-8h)

    Time: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)

    Description: PK parameters will be calculated from the plasma concentration from CL (apparent clearance)

    Measure: Pharmacokinetics of MEDI7219: CL

    Time: Pre-dose to 144 hours post-dose (Part C)
    25 A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

    A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

    NCT03383146
    Conditions
    1. Gastroparesis
    2. Diabetes Mellitus
    Interventions
    1. Drug: Relamorelin
    2. Drug: Placebo
    MeSH:Gastroparesis
    HPO:Gastroparesis

    Primary Outcomes

    Description: Participants will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score using an electronic diary

    Measure: Change from Baseline to Week 12 in the weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)

    Time: Baseline to Week 12

    Description: Participants will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score using an electronic diary

    Measure: Change from Baseline to Week 52 in weekly average DGSSS

    Time: Baseline to Week 52

    Description: Incidence of AEs

    Measure: Number of participants with adverse events (AEs)

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS clinical laboratory values during the 52 week treatment period

    Measure: Number of clinically significant (CS) clinical laboratory values

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS vital sign values during the 52 week treatment period

    Measure: Vital sign values (heart rate, blood pressure, respiratory rate, and temperature)

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS ECG values during the 52 week treatment period

    Measure: Electrocardiogram (ECG) Heart Rate

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS ECG values during the 52 week treatment period

    Measure: ECG PR Interval

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS ECG values during the 52 week treatment period

    Measure: ECG QRS Interval

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS ECG values during the 52 week treatment period

    Measure: ECG QT Interval

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS ECG values during the 52 week treatment period

    Measure: ECG QTc Interval

    Time: Baseline to Week 52

    Description: The number of participants who experienced CS HbA1c levels during the 52 week treatment period

    Measure: Change from Baseline in hemoglobin A1c (HbA1c) levels

    Time: Baseline to Week 52

    Description: The number of participants who experienced anti-relamorelin antibodies during the 52 week treatment period

    Measure: Change from Baseline in anti-relamorelin antibodies

    Time: Baseline to Week 52
    26 A Randomized, 24-week Parallel-group Placebo-controlled Multicenter (Phase 2) Study of Anthocyanins in People at Risk for Dementia

    The aim of this project is to study the safety and efficacy of anthocyanins in improving key dementia-related mechanisms and cognitive functioning in older people at risk for dementia. Secondary analyses will include a variety of biological measures, including biochemistry, imaging and cardiovascular measures.

    NCT03419039
    Conditions
    1. Dementia
    2. Inflammation
    3. Mild Cognitive Impairment
    4. Coronary Artery Disease
    Interventions
    1. Dietary Supplement: Anthocyanins
    2. Dietary Supplement: Placebo
    MeSH:Dementia Coronary Artery Coronary Artery Disease Inflammation Cognitive Dysfunction
    HPO:Cognitive impairment Coronary artery atherosclerosis Dementia Mental deterioration

    Primary Outcomes

    Description: A composite measure from the CogTrack battery

    Measure: Quality of episodic memory.

    Time: Baseline to 24 weeks

    Secondary Outcomes

    Description: CogTrack evaluates attentional intensity index, sustained intensity index, cognitive reaction time, attentional fluctuation index, quality of working memory, quality of episodic memory and speed of memory retrieval.

    Measure: Secondary endpoints from CogTrack

    Time: Baseline to 24 weeks

    Description: Lipid profile, fatty acids, cytokines ( among others: IL-1, IL-2, IL-6, TNF-a), plasma antoxidant status and vitamins (lipid peroxidation markers, vitamins E, C, A, total plasma antioxidant capacity, glutathion)., carinthine, blood glucose, HbA1c, anthocyanins and metabolites, mapping of a-beta degradation products.

    Measure: Blood outcome analysis

    Time: Baseline to 24 weeks

    Description: Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).

    Measure: Cardiovascular parameters

    Time: Baseline to 24 weeks

    Description: Microbiota

    Measure: Fecal analysis

    Time: Baseline to 24 weeks

    Description: kyrinin

    Measure: Urine analysis

    Time: Baseline to 24 weeks

    Description: anthocyanin metabolites

    Measure: CSF measurements

    Time: Baseline to 24 weeks

    Description: Diagnosing and follow-up of cerebrovascular disease

    Measure: MR-imaging/CT

    Time: Baseline to 24 weeks
    27 A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

    This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

    NCT03426345
    Conditions
    1. Gastroparesis
    2. Diabetes Mellitus
    Interventions
    1. Drug: Relamorelin
    2. Drug: Placebo
    MeSH:Gastroparesis
    HPO:Gastroparesis

    Primary Outcomes

    Description: Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.

    Measure: To compare the efficacy of relamorelin with placebo in participants with respect to their diabetic gastroparesis symptoms during the 12 weeks of treatment

    Time: Baseline to Week 12

    Description: Vomiting episodes will be patient-recorded daily using an electronic diary.

    Measure: Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment

    Time: Baseline to Week 12

    Secondary Outcomes

    Description: A Nausea Responder is defined as an improvement of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.

    Measure: Percentage of Patients Meeting the Nausea Responder Criterion

    Time: Baseline to Week 12

    Description: An Abdominal Pain Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Abdominal Pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal pain, and 10 meaning the worst possible abdominal pain.

    Measure: Percentage of Patients Meeting the Abdominal Pain Responder Criterion

    Time: Baseline to Week 12

    Description: A Bloating Responder is defined as an improvement of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.

    Measure: Percentage of Patients Meeting the Bloating Responder Criterion

    Time: Baseline to Week 12

    Description: A Postprandial Fullness Responder is defined as an improvement of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.

    Measure: Percentage of Patients Meeting the Postprandial Fullness Responder Criterion

    Time: Baseline to Week 12

    Description: The number of patients who experienced one or more TEAE during the 12 week treatment period.

    Measure: Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)

    Time: Baseline to Week 12
    28 Noradrenergic Biomarkers in PTSD: Precision Medicine & Mechanisms

    Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. There are a variety of treatment options for PTSD, including psychotherapy (talk therapy) options, as well as medications, such as the drug prazosin. Each of the treatment options available is effective at significantly reducing the symptoms of PTSD in some, but not all, individuals with PTSD. However, investigators are not yet able to predict in advance who is likely to respond to which of the available treatments. Neither are the investigators able to explain what changes in the brain after exposure to a traumatic stressors, and why it results in persistent symptoms of PTSD for some people, but not for others. In this study, the investigators are testing two things: First, is testing whether two simple, easy tests of how an individual's blood pressure changes with standing and how an individual's eye reacts to a pulse of light may be able to predict whether that person is likely to respond to the medication prazosin for PTSD. Second, is testing whether those who have been exposed to a traumatic stress show differences in how their body regulates the response to the stress-signal noradrenaline.

    NCT03539614
    Conditions
    1. Posttraumatic Stress Disorder
    Interventions
    1. Drug: Prazosin
    2. Drug: Placebo
    MeSH:Stress Disorders, Post-Traumatic

    Primary Outcomes

    Description: The PTSD Checklist for DSM 5 is a self-reported rating scale where an individual rates the severity of each symptom of PTSD on a likert scale. The ratings on individual items are summed to create a total score, which ranges from 0 to 80, with higher scores indicating more symptoms. The relationship between changes in participants' total PCL scores at different time points and prazosin exposure - and whether this relationship is moderated by baseline biomarker values - will be analyzed using a linear mixed effects model.

    Measure: Change in total PTSD Checklist for DSM 5 (PCL5) score

    Time: The PCL5 total score is assessed at baseline, during each stage of the study, and at the endpoint of the study. Thus, measurements will be scheduled to occur at the following time points, relative to the baseline visit: 0, 4, 8, 9-12, 16, and 20 weeks
    29 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)

    The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

    NCT03559517
    Conditions
    1. Crohn's Disease
    Interventions
    1. Biological: Ontamalimab
    2. Other: Placebo
    MeSH:Crohn Disease
    HPO:Crohn's disease

    Primary Outcomes

    Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

    Measure: Number of Participants With Clinical Remission at Week 16

    Time: Week 16

    Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.

    Measure: Number of Participants With Endoscopic Response at Week 16

    Time: Week 16

    Secondary Outcomes

    Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.

    Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16

    Time: Week 16

    Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.

    Measure: Number of Participants With Enhanced Endoscopic Response at Week 16

    Time: Week 16

    Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

    Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16

    Time: Week 16

    Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.

    Measure: Number of Participants With Clinical Response at Week 16

    Time: Week 16

    Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).

    Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16

    Time: Week 16

    Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.

    Measure: Number of Participants With Complete Endoscopic Healing at Week 16

    Time: Week 16

    Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.

    Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16

    Time: Week 16

    Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.

    Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16

    Time: Week 16

    Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

    Measure: Number of Participants With Clinical Remission Over Time

    Time: Baseline up to Week 16

    Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).

    Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16

    Time: Baseline, Week 16

    Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.

    Measure: Number of Participants With Endoscopic Healing at Week 16

    Time: Week 16

    Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life

    Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score

    Time: Baseline, Week 8, Week 12, up to Week 16, or early termination

    Description: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

    Measure: Change From Baseline in Short Form (SF)-36 at Week 16

    Time: Baseline, Week 16

    Description: Incidence of all cause hospitalizations will be assessed.

    Measure: Incidence of Hospitalizations

    Time: Baseline up to Week 32

    Description: Incidence of total inpatient days will be assessed.

    Measure: Incidence of Total Inpatient Days

    Time: Baseline up to Week 32

    Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.

    Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries

    Time: Baseline up to Week 32
    30 A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)

    The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

    NCT03566823
    Conditions
    1. Crohn's Disease
    Interventions
    1. Biological: Ontamalimab
    2. Other: Placebo
    MeSH:Crohn Disease
    HPO:Crohn's disease

    Primary Outcomes

    Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11 point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

    Measure: Number of Participants With Clinical Remission at Week 16

    Time: Week 16

    Description: Endoscopic response is measured by a decrease from baseline in simple endoscopic score for Crohn's disease (SES-CD) (ranging from 0 to 56, with higher values indicating more severe disease). Number of participants with endoscopic response will be reported.

    Measure: Number of Participants With Endoscopic Response at Week 16

    Time: Week 16

    Secondary Outcomes

    Description: Clinical remission is defined by Crohn's Disease Activity Index CDAI score. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical remission as measured by CDAI will be reported.

    Measure: Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) at Week 16

    Time: Week 16

    Description: Enhanced endoscopic response is measured by a decrease from baseline in SES-CD (range from 0 to 56, with higher values indicating more severe disease). Number of participants with enhanced endoscopic response will be reported.

    Measure: Number of Participants With Enhanced Endoscopic Response at Week 16

    Time: Week 16

    Description: Clinical remission is determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

    Measure: Number of Participants With Clinical Remission by 2-item Patient Reported Outcome (PRO) at Week 16

    Time: Week 16

    Description: Clinical response as per 2-item PRO score is to meet at least 1 of the 2 criteria over the 7 most recent days: 1. A decrease in the average daily abdominal pain based on 11-point NRS ranging 0 (No pain) to 10 (Worst imaginable pain), with stool frequency of type 6/7 (very soft/liquid stools) either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission, that is based on the average daily stool frequency of type 6/7 as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]). 2. A decrease from baseline in the average daily stool frequency of type 6/7 as per the BSFS, with the average daily worst abdominal pain either: a) not worsening from baseline and/or b) meeting the criteria for clinical remission (based on average daily abdominal pain using a 11-point NRS). Number of participants with clinical response will be reported.

    Measure: Number of Participants With Clinical Response at Week 16

    Time: Week 16

    Description: Number of participants with both clinical remission by 2-item PRO as determined by meeting the criteria for clinical remission using the 2-item PRO subscores of average worst daily abdominal pain (based on the 4-point scale ranging from 0 = none to 3 = severe) and average daily stool frequency of type 6/7 (very soft stools/liquid stools) as per the BSFS (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days and endoscopic response, as measured by a decrease in SES-CD (range from 0 to 56, with higher values indicating more severe disease).

    Measure: Number of Participants With Clinical Remission and Endoscopic Response at Week 16

    Time: Week 16

    Description: Complete endoscopic healing at Week 16 as measured by SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) will be assessed. Number of participants with complete endoscopic healing will be reported.

    Measure: Number of Participants With Complete Endoscopic Healing at Week 16

    Time: Week 16

    Description: Clinical response as measured by at least a 100-point reduction in the CDAI from baseline (CDAI-100 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -100 at Week 16 will be reported.

    Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -100 at Week 16

    Time: Week 16

    Description: Clinical response as measured by at least a 70-point reduction in the CDAI from baseline (CDAI-70 response) will be assessed. CDAI is used to assess CD which range from 0-149 points: Asymptomatic remission, 150-220 points: Mild to moderate active CD, 221-450 points: Moderate to severe active CD, >451 points: Severely active to fulminant disease. Number of participants with clinical response CDAI -70 at Week 16 will be reported.

    Measure: Number of Participants With Clinical Response as Measured by Crohn's Disease Activity Index (CDAI) -70 at Week 16

    Time: Week 16

    Description: Clinical remission is determined by meeting the criteria for remission using the 2-item patient reported outcome (PRO) subscores of average worst daily abdominal pain (based on 11-point numeric rating scale [NRS] ranging from 0 [No pain] to 10 [Worst imaginable pain]) and average daily stool frequency of type 6/7 as per the Bristol Stool Form Scale (BSFS) (ranging from type 1 [separate hard lumps-like stools] to type 7 [entirely liquid stools]) over the 7 most recent days. Number of participants with clinical remission will be reported.

    Measure: Number of Participants With Clinical Remission Over Time

    Time: Baseline up to Week 16

    Description: Patient-reported CD clinical signs and symptom data will be collected using a daily e-diary. Participants record abdominal pain severity (numeric rating scale [NRS]), very soft stool/liquid stool frequency (as shown by BSFS [ranging from type 1 {separate hard lumps-like stools} to type 7 {entirely liquid stools}] type 6/7), total stool frequency, rectal bleeding frequency, rectal urgency frequency, nausea severity (none to severe), vomiting frequency, incontinence frequency, abdominal pain used in CDAI and general wellbeing (generally well to terrible).

    Measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 16

    Time: Baseline, Week 16

    Description: Endoscopic healing at Week 16 measured as SES-CD (ranging from 0 to 56, with higher values indicating more severe disease) individual variables (Size of Ulcers, Ulcerated surface, Affected surface and Presence of Narrowing) will be assessed as well. Number of participants with endoscopic healing will be reported.

    Measure: Number of Participants With Endoscopic Healing at Week 16

    Time: Week 16

    Description: The IBDQ consists of 32 items grouped into 4 domains scored as bowel (10 to 70), systemic (5 to 35), emotional (12 to 84), and social function (5 to 35). The total score ranges from 32 to 224. For each domain and the total score, a higher score indicates better health-related quality of life

    Measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score

    Time: Baseline, Week 8, Week 12, up to Week 16, or early termination

    Description: The Short form-36 health survey is used to assess HRQL. It consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role- emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

    Measure: Change From Baseline in Short Form (SF)-36 at Week 16

    Time: Baseline, Week 16

    Description: Incidence of all cause hospitalizations will be assessed.

    Measure: Incidence of Hospitalizations

    Time: Baseline up to Week 32

    Description: Incidence of total inpatient days will be assessed.

    Measure: Incidence of Total Inpatient Days

    Time: Baseline up to Week 32

    Description: Incidence of Crohn's disease-related surgeries and other surgical procedures.

    Measure: Incidence of Crohn's Disease (CD)-related and Other Surgeries

    Time: Baseline up to Week 32
    31 CSP #2008 - Pentoxifylline in Diabetic Kidney Disease

    Pentoxifylline (PTX) is a medication that has been on the market since 1984 for use in disease in the blood vessels of the legs. There is some preliminary information that it may protect the kidneys from damage due to diabetes and other diseases. "Pentoxifylline in Diabetic Kidney Disease" is a study to bee conducted in 40 VA hospitals across the nation to determine definitively whether or not PTX can prevent worsening of kidney disease and delay death in patients with diabetic kidney disease.

    NCT03625648
    Conditions
    1. Diabetic Kidney Disease
    Interventions
    1. Drug: Pentoxifylline
    2. Drug: Placebo
    MeSH:Kidney Diseases Diabetic Nephropathies
    HPO:Abnormality of the kidney Nephropathy

    Primary Outcomes

    Description: ESRD will be defined as need for chronic dialysis or renal transplantation.

    Measure: Time to ESRD or death

    Time: 5 to 9 years

    Secondary Outcomes

    Description: Quality of life as measured by the Kidney Disease Quality of Life Short Form (KDQoL-SF)

    Measure: Quality of life (KDQoL-SF)

    Time: 5 to 9 years

    Description: Time until doubling of serum creatinine

    Measure: Time until doubling of serum creatinine

    Time: 5 to 9 years

    Description: The risk of a CHF hospitalization will be based on the participant-time data, specifically, the number of events per years.

    Measure: Incidence of congestive heart failure hospitalization (CHF)

    Time: 5 to 9 years

    Description: The risk of a MACE event will be based on participant-time data, specifically, the number of events per participant years.

    Measure: Incidence of a three-point MACE

    Time: 5 to 9 years

    Description: The risk of a PVD event will be based on participant-time data, specifically, the number of events per participant years.

    Measure: Incidence of a peripheral vascular disease (PVD)

    Time: 5 to 9 years

    Description: Percentage of participants with 50% reduction in UACR from baseline

    Measure: Percentage of participants with 50% reduction in UACR from baseline

    Time: 5 to 9 years

    Description: Rate of change in eGFR per year during the study period.

    Measure: Rate of change in eGFR per year during the study period

    Time: 5 to 9 years
    32 Targeting Inflammation and Alloimmunity in Heart Transplant Recipients With Tocilizumab (RTB-004)

    The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

    NCT03644667
    Conditions
    1. Heart Transplant
    Interventions
    1. Biological: tocilizumab
    2. Biological: Placebo
    3. Drug: Standard of Care Triple IS

    Primary Outcomes

    Description: This outcome is defined by a composite 1 year post-transplant endpoint of: detection of de novo donor-specific antibodies (dnDSA) (Core Laboratory), acute cellular rejection (ACR) ≥ ISHLT 2R rejection (Core Laboratory), antibody mediated rejection (AMR) ≥ ISHLT AMR 1 (Core Laboratory), hemodynamic compromise rejection in the absence of a biopsy or histological rejection, death, or re-transplantation.

    Measure: Proportion of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation - By Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Secondary Outcomes

    Description: A comparison by treatment group of the incidence of freedom from development of de novo donor-specific antibodies (dnDSA). dnDSA is a newly developed alloantibody that is against the donor organ.

    Measure: Freedom of Detection of de Novo Donor-Specific Antibodies (dnDSA) - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: A comparison by treatment group of the incidence of freedom from development of acute cellular rejection ≥2R (Reference: International Society of Heart and Lung Transplantation [ISHLT] acute cellular rejection-grade 2R or greater severity).

    Measure: Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Rejection - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: A comparison by treatment group of the incidence of freedom from development of antibody-mediated rejection defined as ISHLT grade AMR 1 or greater severity.

    Measure: Freedom from Antibody Mediated Rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1 - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: A comparison by treatment group of the incidence of freedom from development of hemodynamic compromise (HDC). Hemodynamic compromise is defined by: - Need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m^2 or a 25% decrease from baseline, in addition to one of the following: ejection fraction of <40% or a 20% decrease from baseline, and the need for inotropic agents OR fractional shortening of <20% or a 25% decrease from baseline, and the need for inotropic agents.

    Measure: Freedom from Hemodynamic Compromise Rejection in the Absence of a Biopsy or Histological Rejection - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: A comparison by treatment group of the incidence of freedom from development of episode of rejection requiring treatment. Reference: Acute cellular rejection as defined by the 2004 International Society of Heart and Lung Transplantation (ISHLT) grading scale.

    Measure: Freedom from Any-Treated Rejection - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: A comparison by treatment group of the incidence of freedom from acute cellular rejection (ACR) ≥ ISHLT 2R rejection. Reference: 2004 International Society of Heart and Lung Transplantation [ISHLT [ grading scale).

    Measure: Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Per Patient - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: Time from transplant, free of antibody mediated rejection, defined as ISHLT grade AMR 1 or greater will be compared between the treatment groups. Hemodynamic compromise is defined as the need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m2 or a 25% decrease from baseline in addition to one of the following: Ejection fraction of <40% or a 20% decrease from baseline, and the need for inotropic agents Fractional shortening of <20% or a 25% decrease from baseline, and the need for inotropic agents

    Measure: Freedom from Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)]

    Description: Time from transplant, free of antibody mediated rejection, defined as ISHLT grade AMR 1 or greater will be compared between the treatment groups

    Measure: Freedom from Hemodynamic Compromise Rejection in the Absence of a Biopsy or Histological Rejection Per Participant - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: Incidence of all-cause mortality will be compared between the treatment groups.

    Measure: Occurrence of Death - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: Incidence of participant(s) being re-listed for transplant will be compared between the treatment groups.

    Measure: Occurrence of Re-Listed for Transplantation - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)

    Description: Incidence of participant(s) re-transplantation will be compared between the treatment groups.

    Measure: Occurrence of Re-Transplantation - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)]

    Description: The frequency of events will be compared between the treatment groups.

    Measure: Number of Acute Cellular Rejection (≥ International Society of Heart and Lung Transplantation (ISHLT) 2R) Per Patient - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)]

    Description: The frequency of events will be compared between the treatment groups.

    Measure: Number of Antibody Mediated Rejection (AMR) (≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1) Per Participant - by Treatment Group

    Time: 12 months post-transplantation

    Description: The frequency of events will be compared between the treatment groups.

    Measure: Number of Rejection Episodes Associated with Hemodynamic Compromise (HDC) Per Participant - by Treatment Group

    Time: From transplant through 12 months post transplant surgery (12 months)]

    Description: Per protocol, per clinical research site standard of care.

    Measure: Change in Intravascular Ultrasound (IVUS) Measurements From Baseline to 1 Year Post-Transplant- by Treatment Group

    Time: Baseline (4 to 8 weeks post-transplant), 1 year post-transplant

    Description: In accordance with the International Society of Heart and Lung Transplantation (ISHLT) Cardiac Allograft Vasculopathy (CAV) angiographic grading scale.

    Measure: Angiographic Evidence of Cardiac Allograft Vasculopathy (CAV) - by Treatment Group

    Time: 12 months post-transplantation

    Description: Incidence of participant loss to follow up will be compared between the treatment groups.

    Measure: Participant Loss to follow up - by Treatment Group

    Time: 12 months post-transplantation

    Description: The frequency of serious infections requiring intravenous antimicrobial therapy and need for hospitalization will be compared between treatment groups.

    Measure: Occurrence of Serious Infections Requiring Intravenous Antimicrobial Therapy and Need for Hospitalization - by Treatment Group

    Time: Through 24 months post transplant surgery

    Description: The incidence of tuberculosis will be compared between treatment groups.

    Measure: Incidence of Tuberculosis - by Treatment Group

    Time: Through 24 months post transplant surgery

    Description: The incidence of CMV infection will be compared between treatment groups.

    Measure: Incidence of Cytomegalovirus (CMV) Infection - by Treatment Group

    Time: Through 24 months post transplant surgery

    Description: The incidence of PTLD will be compared between treatment groups.

    Measure: Incidence of Post-Transplant Lymphoproliferative Disease (PTLD) - by Treatment Group

    Time: Through 24 months post transplant surgery

    Description: The number of participants who discontinue study drug, per protocol, will be compared between treatment groups.

    Measure: Tolerability (Discontinuation of Study Drug) of Tocilizumab (TCZ) - by Treatment Group

    Time: Through 24 months post transplant surgery
    33 A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection

    The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).

    NCT03656510
    Conditions
    1. Respiratory Syncytial Virus Infections
    Interventions
    1. Drug: JNJ-53718678
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Virus Diseases Respiratory Syncytial Virus Infections

    Primary Outcomes

    Description: RSV viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by the RSV viral load as measured by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay of nasal swabs.

    Measure: Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

    Time: Baseline through Day 5

    Secondary Outcomes

    Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in the mid-turbinate nasal swab specimens.

    Measure: RSV Viral Load and Change from Baseline Over Time

    Time: Baseline through Day 21

    Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.

    Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

    Time: Baseline through Days 3, 8 and 14

    Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

    Measure: Time to Undetectable RSV Viral Load

    Time: Up to 21 days

    Description: Proportion of participants with undetectable RSV viral load will be reported.

    Measure: Proportion of Participants with Undetectable RSV Viral Load at each timepoint

    Time: Up to 21 days

    Description: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

    Measure: Duration of Signs and Symptoms of RSV Disease Assessed by the Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS)

    Time: Up to 21 days

    Description: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

    Measure: Severity of RSV Disease Assessed by PRESORS

    Time: Up to 21 days

    Description: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

    Measure: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

    Time: Baseline up to 21 days

    Description: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

    Measure: Change from Baseline in Clinician PRESORS Scores

    Time: Baseline up to 21 days

    Description: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

    Measure: Time to Resolution of RSV Symptoms

    Time: Up to 21 days

    Description: Time to improvement based on general questions on overall health will be reported.

    Measure: Time to Improvement on Overall Health

    Time: Up to 21 days

    Description: Proportion of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

    Measure: Proportion of Participants with Improvement or Worsening of RSV Disease

    Time: Up to 21 days

    Description: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

    Measure: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

    Time: Up to 21 days

    Description: Proportion of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

    Measure: Proportion of Participants with Vital Sign Abnormalities

    Time: Up to 28 days

    Description: Proportion of participants with abnormal body temperature will be reported.

    Measure: Proportion of Participants with Abnormal Body Temperature as Measured by the Parent(s)/Caregiver(s)

    Time: Up to 28 days

    Description: Proportion of participants who require (re)hospitalization during treatment and follow-up will be reported.

    Measure: Proportion of Participants who Require (re)Hospitalization During Treatment and Follow-up

    Time: Up to 21 days

    Description: Time return to age-adjusted normal values for vital signs (heart rate, respiratory rate, and/or blood oxygen) for participants with risk factors for severe RSV Disease will be recorded.

    Measure: Time Return to Age-Adjusted Normal Values for vital signs (Heart Rate, Respiratory Rate, and/or Blood Oxygen) for Participants with Risk Factors for Severe RSV Disease

    Time: Up to 21 days

    Description: Time to discharge (from initial admission and from initiation of treatment) will be recorded for Cohort 1 only.

    Measure: Cohort 1: Time to Discharge

    Time: Up to 21 days

    Description: Proportion of participants who require to be admitted to the ICU will be reported for Cohort 1 only.

    Measure: Cohort 1: Proportion of Participants who Require to be Admitted to Intensive Care Unit (ICU)

    Time: Up to 21 days

    Description: In the event that a participant requires ICU, admission, the duration of need for ICU stay will be reported for Cohort 1 only.

    Measure: Cohort 1: Duration of ICU Stay

    Time: Up to 21 days

    Description: Proportion of participants who require supplemental oxygen will be reported for Cohort 1 only.

    Measure: Cohort 1: Proportion Participants who Require Supplemental Oxygen

    Time: Up to 21 days

    Description: Duration of the oxygen supplementation in participants requiring will be reported for Cohort 1 only.

    Measure: Cohort 1: Duration of Supplemental Oxygen

    Time: Up to 21 days

    Description: Proportion of participants who require non-invasive ventilator support (for example [e.g], continuous positive airway pressure) status will be reported for Cohort 1 only.

    Measure: Cohort 1: Proportion of Participants who Require Non-invasive Ventilator Support

    Time: Up to 21 days

    Description: Proportion of participants who require invasive ventilator support (e.g, endotracheal-mechanical ventilation) will be reported for Cohort 1 only.

    Measure: Cohort 1: Proportion of Participants who Require Invasive Mechanical Ventilation Support

    Time: Up to 21 days

    Description: Duration of non-invasive ventilator support (e.g, continuous positive airway pressure) to deliver oxygen will be measured for Cohort 1 only.

    Measure: Cohort 1: Duration of Non-invasive Ventilator Support

    Time: Up to 21 days

    Description: Duration of invasive ventilator support (e.g, endotracheal-mechanical ventilation) to deliver oxygen will be measured for Cohort 1 only.

    Measure: Cohort 1: Duration of Invasive Ventilator Support

    Time: Up to 21 days

    Description: Proportion of participants who need (defined by <50% of normal oral intake) hydration and/or feeding by IV administration or nasogastric tube will be reported for Cohort 1 only.

    Measure: Cohort 1: Proportion of Participants who Need Hydration and/or Feeding by Intravenously (IV) Administration or Nasogastric Tube

    Time: Up to 21 days

    Description: Time to clinical stability is defined as the time from initiation of study treatment until the time at which the following criteria are met: Time to return to age-adjusted normal values for otherwise healthy and pre-RSV infection status for participants with risk factor for severe RSV disease (heart rate, respiratory rate, blood oxygen level), no more oxygen supplementation or otherwise healthy participants and with risk factor(s) for severe RSV disease and no more intravenously (IV)/nasogastric tube feeding/hydration) in otherwise healthy participants or return to pre-RSV status of IV/nasogastric tube feeding/hydration in participants with risk factor for severe RSV disease for Cohort 1 only.

    Measure: Cohort 1: Time to Clinical Stability with Clinical Stability Evaluated by the Investigator

    Time: Up to 21 days

    Description: Time from initiation of study treatment until SpO2 >=92 percentage (%) and SpO2 >= 95% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms will be reported for Cohort 1 only.

    Measure: Cohort 1: Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) >= 92% and SpO2 >= 95% on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms

    Time: Up to 21 days

    Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measure: Percentage of Participants with Adverse Events

    Time: Up to 28 days

    Description: Percentage of participants with abnormal laboratory (serum chemistry, hematology and urinalysis) findings will be reported.

    Measure: Percentage of Participants with Abnormal Laboratory Findings

    Time: Up to 28 days

    Description: Percentage of participants with abnormal ECGs findings will be reported.

    Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

    Time: Up to 21 days

    Description: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

    Measure: Plasma Concentrations of JNJ-53718678

    Time: Days 1 and 3

    Description: Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures) will be reported.

    Measure: Medical Resource Utilization

    Time: Up to 28 days

    Description: Acceptability and palatability of the JNJ-53718678 formulation will be assessed through a questionnaire asking about the child's reaction when given the medicine, completed by parent(s)/caregiver(s) after last dosing.

    Measure: Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)

    Time: Day 8

    Description: Number of participants with changes in the RSV F-gene compared with baseline sequences will be assessed by sequencing of the viral genome.

    Measure: Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences

    Time: Up to 21 days
    34 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)

    A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.

    NCT03688074
    Conditions
    1. Asthma
    2. Bronchial Diseases
    3. Respiratory Tract Diseases
    4. Lung Diseases, Obstructive
    5. Lung Diseases
    6. Respiratory Hypersensitivity
    7. Hypersensitivity, Immediate
    8. Hypersensitivity
    9. Immune System Diseases
    Interventions
    1. Biological: Tezepelumab
    2. Other: Placebo
    MeSH:Asthma Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Immune System Diseases Hypersensitivity, Immediate Inflammation
    HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction

    Primary Outcomes

    Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

    Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

    Secondary Outcomes

    Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

    Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

    Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

    Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

    Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

    Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
    35 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

    This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

    NCT03808922
    Conditions
    1. Lower Respiratory Tract Infection
    2. Parainfluenza
    3. Immunocompromised
    4. COVID-19
    Interventions
    1. Drug: DAS181
    2. Drug: Placebo
    3. Drug: DAS181 COVID-19
    4. Drug: DAS181 OL
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Paramyxoviridae Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Removal of all oxygen support (with stable SpO2)

    Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

    Time: by Day 28

    Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

    Time: Day 14

    Secondary Outcomes

    Measure: All-cause mortality rate (main study)

    Time: at Day 28

    Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

    Time: by Day 21

    Measure: Time (in days) to RTRA (main study)

    Time: Days 10, 14, 21, 28

    Measure: Percent of subjects who achieve clinical stability (main study)

    Time: by Day 28

    Measure: Percent of subjects discharged (without mortality and hospice) (main study)

    Time: by Days 14, 21, 28 and 35

    Measure: Time (in days) to first hospital discharge (without hospice) (main study)

    Time: through Day 35

    Measure: Total number of inpatient days (main study)

    Time: up to Day 35

    Measure: Baseline SAD-RV infection-related mortality rate (main study)

    Time: at Day 28

    Measure: Baseline SAD-RV infection-related mortality rate (main study)

    Time: at Day 35

    Measure: All-cause mortality rate (main study)

    Time: at Day 35

    Measure: Change in pulmonary function (FEV1% predicted) (main study)

    Time: Day 1, Day 7, Day 14, Day 28

    Measure: Time to improved COVID19 clinical status (Sub-study)

    Time: Day 5, Day 10, Day 21, Day 28

    Measure: Time to RTRA

    Time: Day 10, Day 14, Day 21, Day 28

    Measure: Time to Clinical stability

    Time: Day 14, Day 21, Day 28

    Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

    Time: Day 5, Day 10, Day 14, Day 21, Day 28

    Measure: Time to Clinical deterioration

    Time: Day 5, Day 10, Day 14, Day 21, Day 28

    Measure: Time to Discharge from hospital (without readmission before Day 28).

    Time: Day 14, Day 21, Day 28

    Measure: Time to Death (all causes)

    Time: Day 14, Day 21, Day 28
    36 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury

    This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A. , approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits.The study enrollment is discontinued early due to the impact of COVID-19 on enrollment.

    NCT03821402
    Conditions
    1. Upper Limb Spasticity
    Interventions
    1. Biological: DAXI for injection dose LOW DOSE
    2. Biological: DAXI for injection dose MEDIUM DOSE
    3. Biological: DAXI for injection Dose HIGH DOSE
    4. Other: Placebo
    MeSH:Muscle Spasticity
    HPO:Spasticity

    Primary Outcomes

    Description: Mean change from baseline in muscle tone measured with the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG) of the elbow, wrist, OR finger flexors at Week 6. Score range: 0 (Normal tone, no in tone) to 4 (Affected part{s} rigid in flexion or extension)

    Measure: Change from Baseline from suprahypertonic muscle group (SMG) score

    Time: Week 6

    Description: Mean score on of the the Physician Global Impression of Change (PGIC) at Week 6. Score range: -4 (Markedly worse) to +4 (Markedly improved).

    Measure: Change from Baseline Physician Global Impression of Change (PGIC) score

    Time: Week 6

    Secondary Outcomes

    Description: Proportion of subjects who improve by a full point on the Modified Ashworth Scale (MAS) in the suprahypertonic muscle group (SMG). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)

    Measure: Muscle tone improvement

    Time: Weeks 6 and 12

    Description: Proportion of subjects with improvement (score ≥ 1) on the Physician Global Impression of Change (PGIC). Score range: 0 (Normal tone, no increase in tone) to 4 (Affected part{s} rigid in flexion or extension)

    Measure: Physician Global Impression of Change (PGIC) improvement

    Time: Weeks 6 and 12

    Description: Change in functional impairment as measured by the Disability Assessment Scale (DAS) for the principal treatment target (PTT). Score range: 0 (No disability) to 3 (Severe disability - normal activities limited).

    Measure: Disability Assessment Scale (DAS) functional impairment

    Time: Weeks 6 and 12

    Description: Duration of effect

    Measure: Duration of effect

    Time: Up to 36 weeks

    Description: Number of subjects with potential Botulinum Toxin type A distant spread of toxin adverse events, and number of subjects who develop neutralizing antibodies to Botulinum Toxin Type A will be assessed.

    Measure: Safety and immunogenicity assessment

    Time: Up to 36 weeks
    37 Promotion of Maternal Gut Microbiota and Psychological Stimulation on Child Cognitive Development at 6 Months of Age

    Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota colonization. The discovery of the gut microbiota-brain axis suggested that there is a reciprocal influence between the brain and the gut through a constant communication. This bi-directional axis enables signals to be transferred from brain to influence sensory, motor, and secretory modalities of the GI tract, also permits signal from the gut to influence brain function. The establishment of intestinal microbiota during early neurodevelopmental period suggests the colonization and maturation of gut microbiota may influence brain development. Several studies have shown there is an association between shifts in the gut microbiota composition in children with neurodevelopmental disorders. This study aims to investigate how maternal probiotic + LC-PUFA supported with government program supplements, healthy eating, and psychosocial stimulation could affect fetal brain development and later child brain functions and cognitive development. Intervention would be delivered to pregnant women for 9 months, starting at the end of second trimester of gestational period.

    NCT03851120
    Conditions
    1. Maternal Exposure
    2. Health Behavior
    3. Infant Development
    Interventions
    1. Dietary Supplement: Probiotic and LC-PUFA
    2. Dietary Supplement: Placebo
    3. Behavioral: Psychosocial stimulation and healthy eating education

    Primary Outcomes

    Description: measured in parenchymal and cortical regions

    Measure: Total brain volume

    Time: 1 year

    Description: Myelination index

    Measure: Fetal brain development

    Time: 1 year

    Description: Looking time (s) as a response to stimuli differentiation at 4 months of age

    Measure: Child cognitive and brain function at 4 months of age

    Time: 1 year

    Description: BSID-III

    Measure: Child cognitive at 6 months of age

    Time: 1 month

    Description: BERA

    Measure: Brain function at 6 months of age

    Time: 1 month

    Secondary Outcomes

    Description: Edinburgh Postnatal Depression Scale (EPDS)

    Measure: Mother depression scale

    Time: 1 year

    Description: Visual acuity

    Measure: Cognitive development and brain function at 4-months of age

    Time: 1 year

    Description: Baby weighing scale

    Measure: Birth weight

    Time: 1 month

    Description: Change in weight-for-age z-score

    Measure: Child's Growth

    Time: 6 months

    Description: Change in Length-for-age z-score

    Measure: Child's linear growth

    Time: 6 months

    Description: Change in Head-circumference-for-age

    Measure: Head circumference

    Time: 6 months

    Description: Change in weight-for-length z score

    Measure: Child nutritional status

    Time: 6 months

    Description: Maternal involvement using HOME inventory questionnaires

    Measure: Quality of interaction with parents

    Time: 1 year

    Description: Zinc, iron, folate blood level

    Measure: Maternal micronutrient status

    Time: 1 year

    Description: Blood glucose

    Measure: Gestational diabetes

    Time: 1 year

    Description: Diagnosed by doctor

    Measure: Pre-eclampsia

    Time: 1 year

    Description: Gestational age

    Measure: Preterm birth

    Time: 1 year

    Description: actual dietary intake, dietary pattern and quality

    Measure: Mother's dietary quality

    Time: 1 year

    Description: Microbiota composition by S16rRNA analysis

    Measure: Fecal microbiota composition

    Time: 1 year
    38 A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

    The primary objective of this Phase II exploratory trial is to provide Proof of Concept (PoC) data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive Computerized Cognitive Training (CCT).

    NCT03859973
    Conditions
    1. Schizophrenia
    Interventions
    1. Drug: BI 425809
    2. Drug: Placebo
    MeSH:Schizophrenia
    HPO:Schizophrenia

    Primary Outcomes

    Measure: Change from baseline in neurocognitive function as measured by the neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

    Time: Up to 12 weeks

    Secondary Outcomes

    Measure: Change from baseline in cognitive function as measured by the overall MCCB composite score (including social cognition)

    Time: Up to 12 weeks

    Description: Schizophrenia Cognition Rating Scale (SCoRS)

    Measure: Change from baseline in the effect of cognitive deficit on day-to-day functioning as measured by SCoRS total score

    Time: Up to 12 weeks

    Description: Positive and Negative Syndrome Scale (PANSS)

    Measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

    Time: Up to 12 weeks

    Measure: Percentage of patients with (S)AEs

    Time: Up to 12 weeks
    39 Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

    Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

    NCT03871491
    Conditions
    1. Maternal Death
    2. Maternal Infections Affecting Fetus or Newborn
    3. Neonatal SEPSIS
    4. Maternal Sepsis During Labor
    5. Neonatal Death
    6. Postpartum Sepsis
    Interventions
    1. Drug: Azithromycin
    2. Drug: Placebo
    MeSH:Infection Sepsis Toxemia Neonatal Sepsis Pregnancy Complications, Infectious Puerperal Infection Perinatal Death Maternal Death Death
    HPO:Neonatal death Neonatal sepsis Sepsis

    Primary Outcomes

    Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

    Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.

    Time: within 6 weeks (42 days)

    Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

    Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group

    Time: 4 weeks (28 days) post-delivery

    Secondary Outcomes

    Description: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.

    Measure: Incidence of chorioamnionitis

    Time: prior to delivery

    Description: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.

    Measure: Incidence of endometritis

    Time: within 42 days post-delivery

    Description: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).

    Measure: Incidence of other infections

    Time: within 42 days post-delivery

    Description: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.

    Measure: Incidence of use of subsequent maternal antibiotic therapy

    Time: after randomization to 42 days post-delivery

    Description: Time from drug administration until initial discharge after delivery (time may vary by site).

    Measure: Maternal initial hospital length of stay

    Time: within 42 days post-delivery

    Description: Maternal readmissions within 42 days of delivery

    Measure: Incidence of maternal readmissions

    Time: within 42 days post-delivery

    Description: Maternal admission to special care units

    Measure: Incidence of maternal admission to special care units

    Time: within 42 days post-delivery

    Description: Maternal unscheduled visit for care

    Measure: Incidence of maternal unscheduled visit for care

    Time: within 42 days post-delivery

    Description: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.

    Measure: Incidence of maternal GI symptoms

    Time: within 42 days post-delivery

    Description: Maternal death due to sepsis using the Global Network algorithm for cause of death

    Measure: Incidence of maternal death due to sepsis

    Time: within 42 days post-delivery

    Description: Incidence of other neonatal infections.

    Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection)

    Time: within 42 days post-delivery

    Description: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).

    Measure: Neonatal initial hospital length of stay

    Time: within 28 days of delivery

    Description: Neonatal readmissions within 42 days of delivery

    Measure: Incidence of neonatal readmissions

    Time: within 42 days of delivery

    Description: Neonatal admission to special care units

    Measure: Incidence of neonatal admission to special care units

    Time: within 28 days of delivery

    Description: Neonatal unscheduled visit for care

    Measure: Incidence of neonatal unscheduled visit for care

    Time: within 42 days post-delivery

    Description: Neonatal death due to sepsis using the Global Network algorithm for causes of death

    Measure: Incidence of neonatal death due to sepsis

    Time: within 28 days of delivery

    Description: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.

    Measure: Incidence of pyloric stenosis within 42 days of delivery

    Time: within 42 days of delivery
    40 A Phase 1b Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Pharmacokinetics, and Anti-viral Effects of Galidesivir Administered Via Intravenous Infusion to Subjects With Yellow Fever or COVID-19

    This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics, safety and antiviral activity of galidesivir in subjects with yellow fever (YF) or COVID-19.

    NCT03891420
    Conditions
    1. COVID-19
    2. Yellow Fever
    Interventions
    1. Drug: Galidesivir
    2. Drug: Placebo
    MeSH:Yellow Fever Fever
    HPO:Fever

    Primary Outcomes

    Measure: number of subjects with treatment emergent adverse events and serious adverse events

    Time: absolute number through the end of the study, approximately 56 days

    Measure: number of subjects with change in laboratory parameters

    Time: absolute number and change from baseline through the end of the study, approximately 56 days

    Measure: exposure of galidesivir as measured by plasma concentrations

    Time: 24 hours post dose on Day 1 through 12 hours post dose on Day 7

    Secondary Outcomes

    Measure: yellow fever virus (YFV) titer (Group A)

    Time: change in YFV titer from baseline through Day 21

    Measure: antiviral effect on SARS-CoV-2 in the respiratory tract - COVID-19 (Group B)

    Time: change in SARS-CoV-2 from baseline through Day 21

    Measure: changes in clinical status using 8-point ordinal scale in COVID-19 (Group B)

    Time: through Day 21

    Measure: changes from baseline and time to improvement using NEWS in COVID-19 (Group B)

    Time: through Day21

    Measure: mortality

    Time: mortality at Day 56
    41 A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants

    This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).

    NCT03943056
    Conditions
    1. Healthy Volunteer
    Interventions
    1. Drug: BIIB091
    2. Drug: Placebo

    Primary Outcomes

    Description: An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.

    Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts

    Secondary Outcomes

    Measure: Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)

    Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

    Measure: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)

    Time: Baseline and multiple timepoints up to Day 3

    Measure: Maximum Observed Concentration (Cmax)

    Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts

    Measure: Time to Reach Maximum Observed Concentration (Tmax)

    Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts

    Measure: Elimination Half-Life (t½)

    Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

    Measure: Apparent Total Body Clearance (CL/F)

    Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

    Measure: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)

    Time: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts

    Measure: Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu)

    Time: Baseline and multiple timepoints up to Day 3

    Measure: Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu)

    Time: Baseline and multiple timepoints up to Day 3

    Measure: Renal clearance (CLr)

    Time: Baseline and multiple timepoints up to Day 3

    Measure: Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau)

    Time: Baseline and multiple timepoints up to Day 16

    Measure: Accumulation Ratio (R)

    Time: Baseline and multiple timepoints up to Day 16

    Measure: Trough concentration (Ctrough)

    Time: Baseline and multiple timepoints up to Day 16
    42 A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

    Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.

    NCT03969212
    Conditions
    1. Influenza
    Interventions
    1. Drug: Baloxavir Marboxil
    2. Drug: Placebo
    MeSH:Influenza, Human

    Primary Outcomes

    Description: Defined as the percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the index patient (IP) in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.

    Measure: Virological Transmission by Day 5

    Time: Baseline to Day 5 (5 days)

    Secondary Outcomes

    Description: Defined as the percentage of HHCs who become PCR+ for Influenza by Day 5 post IP randomization and develop Influenza symptoms at any time during the study. HHCs ≥12 years old were defined symptomatic if (1) Presence of temperature ≥38.0 Celsius and one respiratory symptom (cough, sore throat, nasal congestion) or (2) Presence of one respiratory symptom and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years old were defined symptomatic if presence of temperature ≥38.0 Celsius and cough, nasal congestion, or rhinorrhea. Note: For HHCs of any age, respiratory or general systemic symptoms had to be either (1) new, or (2) worsened versus baseline with baseline symptoms due to a pre-existing comorbidity. HHCs must have their virus subtype match that of the IP.

    Measure: Symptomatic Transmission by Day 5

    Time: Baseline to Day 5 (5 days)

    Description: Defined as the percentage of households with at least one HHC who meets the primary endpoint.

    Measure: Virological Transmission at the Household Level by Day 5

    Time: Baseline to Day 5 (5 days)

    Description: Defined as the percentage of households with at least one HHC who meets the "Symptomatic transmission by Day 5 endpoint.

    Measure: Symptomatic Transmission at the Household Level by Day 5

    Time: Baseline to Day 5 (5 days)

    Description: Defined as the percentage of HHCs who become PCR+ for Influenza by Day 9 post IP randomization. HHCs must have their virus subtype match that of the IP, and include: (1) all HHC meeting primary endpoint, AND (2) all HHC cases detected after Day 5 Visit meeting the following criteria: (2a) included HHC case is in a household where another HHC has already met the primary endpoint, OR (2b) included HHC case is PCR (+) for influenza bearing treatment-emergent amino acid substitutions in the PA protein that have been associated with reduced susceptibility to baloxavir marboxil.

    Measure: Virological Transmission by Day 9

    Time: Baseline to Day 9 (9 days)

    Description: Defined as the percentage of HHCs who meet the "Virological transmission by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.

    Measure: Symptomatic Transmission by Day 9

    Time: Baseline to Day 9 (9 Days)

    Description: Defined as the percentage of HHCs who become PCR (+) for influenza (confirmed at central laboratory) by Day 9.

    Measure: Any Virological Infection by Day 9

    Time: Baseline to Day 9 (9 Days)

    Description: Defined as the percentage of households with at least one HHC who meets the "Any virological infection by Day 9" endpoint.

    Measure: Any Virological Infection at the Household Level by Day 9

    Time: Baseline to Day 9 (9 Days)

    Description: Defined as the percentage of HHCs who meet the "Any virological infection by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.

    Measure: Any Symptomatic Infection by Day 9

    Time: Baseline to Day 9 (9 Days)

    Description: Defined as the percentage of households with at least one HHC who meets the "Any symptomatic infection by Day 9" endpoint.

    Measure: Any Symptomatic Infection at the Household Level by Day 9

    Time: Baseline to Day 9 (9 Days)

    Measure: Percentage of IPs With Adverse Events (AEs)

    Time: Baseline to Day 9 (≥12 years old) and Day 21 (<12 years old)

    Description: The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. An increase in the VAS score of 7 points or greater was defined as the threshold for a meaningful improvement.

    Measure: Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L; Appendix 3) questionnaire at Day 3 and Day 9 Visits (IPs only)

    Time: Baseline, Day 3 and Day 9

    Description: The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment.

    Measure: Change From Baseline in Work Productivity and Activity Impairment According to Work Productivity and Activity Impairment (WPAI) plus Classroom Impairement Questions Score (IPs only)

    Time: Baseline and Day 9
    43 Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

    The main objectives are: - Part I: To investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy male subjects following oral administration of single rising doses. - Part II: The relative bioavailability of BI 706321 after administration of tablets and capsules under fasted conditions will be compared with each other and the effect of food on the tablet bioavailability will be investigated.

    NCT03971695
    Conditions
    1. Healthy
    Interventions
    1. Drug: BI 706321
    2. Drug: Placebo

    Primary Outcomes

    Measure: Part I: Safety and tolerability of BI 706321 is the percentage of subjects with drug-related adverse events

    Time: Up to 22 Days

    Measure: Part II: AUC0-tz (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point)

    Time: Up to 22 Days

    Measure: Part II: Cmax (maximum measured concentration of BI 706321 in plasma)

    Time: Up to 22 Days

    Secondary Outcomes

    Measure: Part I: AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity)

    Time: Up to 22 Days

    Measure: Part I: Cmax (maximum measured concentration of BI 706321 in plasma)

    Time: Up to 22 Days

    Measure: Part I: tmax (time from dosing to the maximum measured concentration of BI 706321 in plasma)

    Time: Up to 22 Days

    Measure: Part II: AUC0-∞ (area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity)

    Time: Up to 22 Days
    44 A Pilot Study to Evaluate the Gastrointestinal Response to Increasing Doses of a Resistant Starch Blend in Healthy Subjects

    This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.

    NCT03983772
    Conditions
    1. Quality of Life
    2. Health, Subjective
    Interventions
    1. Dietary Supplement: RS blend
    2. Other: Placebo

    Primary Outcomes

    Description: Concentration of total short-chain fatty acids, including valerate, isovalerate and isobutyrate, and individually-reported n-butyrate concentration as well as propionate and acetate % will be reported by Genova Diagnostics Report

    Measure: Change in Concentration of short-chain fatty acids from baseline to each product intervention

    Time: Baseline (2 week period) compared to each product completion period of 2 weeks

    Secondary Outcomes

    Description: Fecal frequency (time in hours between stools) will be evaluated for each time period and compared between baseline (2 week period) and product intervention period (each 2 week period)

    Measure: Change in fecal frequency (hours between stools) from baseline at each intervention

    Time: Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

    Description: Response pattern score on PROMIS Scale v1.0 - GI Diarrhea will be compared between baseline and each intervention period

    Measure: Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Diarrhea 6a)

    Time: Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

    Description: Response pattern score on PROMIS Scale v1.0 - GI Constipation will be compared between baseline and each intervention period

    Measure: Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Constipation)

    Time: Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)

    Description: Response pattern score on PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016 will be compared between baseline and each intervention period

    Measure: Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016)

    Time: Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination)
    45 A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

    NCT04039113
    Conditions
    1. Chronic Obstructive Pulmonary Disease (COPD)
    Interventions
    1. Biological: Tezepelumab
    2. Other: Placebo
    MeSH:Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive
    HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    Description: The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.

    Measure: Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo)

    Time: Over 52 Weeks

    Secondary Outcomes

    Description: Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio

    Measure: Time to first moderate or severe COPD exacerbation

    Time: By Week 52

    Description: Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio

    Measure: Proportion with at least one moderate/severe COPD exacerbation

    Time: Over 52 Weeks

    Description: The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.

    Measure: Severe COPD exacerbation rate ratio (tezepelumab vs. placebo)

    Time: Over 52 Weeks

    Description: Difference in change from baseline in pre-BD forced expiratory volume in 1 second (FEV1) in tezepelumab arm as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.

    Measure: Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

    Time: Baseline, Week 52

    Description: Proportion of subjects achieving a decrease of 4 units or more in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 52, i.e. minimum clinically important difference (MCID). Outcome measure: odds ratio

    Measure: Change in respiratory health status/health-related quality of life

    Time: Baseline, Week 52

    Description: Difference (tezepelumab vs. placebo) in SGRQ from baseline at Week 52. SGRQ is a 50-item patient reported outcome questionnaire. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0% indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. Decrease of 4 units is associated with a minimum clinically important difference (MCID).

    Measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Time: Baseline, Week 52

    Description: Difference (tezepelumab vs. placebo) in COPD assessment tool (CAT) from baseline at Week 52. CAT is an 8-item patient reported outcome questionnaire developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. The score ranges from 0 to 40, with higher scores indicating greater COPD impact on health status.

    Measure: Change from baseline in the COPD Assessment Test (CAT) Total Score

    Time: Baseline, Week 52

    Description: Serum trough concentration of tezepelumab

    Measure: Evaluate pharmacokinetics of tezepelumab

    Time: Weeks 0, 4, 12, 24, 36, 52, 64

    Description: Incidence of anti-drug antibodies (ADA)

    Measure: Evaluate immunogenicity of tezepelumab

    Time: Over 52 weeks
    46 A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

    The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

    NCT04056611
    Conditions
    1. Respiratory Syncytial Virus Infections
    Interventions
    1. Drug: JNJ-53718678 250 mg
    2. Drug: Placebo
    3. Drug: JNJ-53718678 125 mg
    MeSH:Infection Virus Diseases Respiratory Syncytial Virus Infections

    Primary Outcomes

    Description: The proportion of participants who develop RSV LRTI through Visit Day 28 per the Endpoint Adjudication Committee (EAC) assessment will be reported.

    Measure: Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

    Time: Up to Day 28

    Secondary Outcomes

    Description: The proportion of participants who develop RSV-associated LRTC through Visit Day 28 per the EAC's assessment will be reported.

    Measure: Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC)

    Time: Up to Day 28

    Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

    Measure: Number of Participants with Adverse Events (AEs)

    Time: Up to 49 days

    Description: Percentage of participants with abnormal clinical laboratory findings will be reported.

    Measure: Percentage of Participants with Abnormal Clinical Laboratory Findings

    Time: Up to 49 days

    Description: Percentage of participants with abnormal ECGs findings will be reported.

    Measure: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

    Time: Up to 49 days

    Description: Percentage of participants with abnormal vital signs findings will be reported.

    Measure: Percentage of Participants with Abnormal Vital Signs Findings

    Time: Up to 49 days

    Description: The proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

    Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

    Time: Up to 49 days

    Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, (all-cause mortality) will be reported.

    Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality)

    Time: Up to 49 days

    Description: Proportion of participants progressing to death (all-cause mortality), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

    Measure: Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

    Time: Up to 49 days

    Description: Proportion of participants progressing to death (all-cause mortality) will be reported.

    Measure: Proportion of Participants Progressing to Death (All-cause Mortality)

    Time: Up to 1 year

    Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

    Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment

    Time: Up to 49 days

    Description: Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) will be reported.

    Measure: Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)

    Time: Up to 49 days

    Description: Number of supplemental O2 free days will be reported.

    Measure: Number of Supplemental Oxygen (O2) Free Days Through Day 28

    Time: Through Day 28

    Description: Incidence of supplemental oxygen requirement in participants will be reported.

    Measure: Incidence of Supplemental Oxygen Requirement

    Time: Up to 28 days

    Description: Duration of supplemental oxygen requirement in participants will be reported.

    Measure: Duration of Supplemental Oxygen

    Time: Up to 28 days

    Description: Change from baseline in respiratory rate as measured by the investigator during scheduled visits will be reported.

    Measure: Change from Baseline in Respiratory Rate

    Time: Baseline up to 49 days

    Description: Change from baseline in heart rate as measured by the investigator during scheduled visits will be reported.

    Measure: Change from Baseline in Heart Rate

    Time: Baseline up to 49 days

    Description: Change from baseline in SpO2 as measured by the investigator during scheduled visits will be reported.

    Measure: Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2)

    Time: Baseline up to 49 days

    Description: Change from baseline in body temperature as measured by the investigator during scheduled visits will be reported.

    Measure: Change from Baseline in Body Temperature

    Time: Baseline up to 49 days

    Description: Proportion of participants hospitalized (of participants who were not hospitalized at baseline) will be reported.

    Measure: Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline)

    Time: Up to 1 year

    Description: Proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) will be reported.

    Measure: Proportion of Participants Re-hospitalized

    Time: Up to 1 year

    Description: Total length of hospital stay (time in hospital from first dosing) will be reported.

    Measure: Total Length of Hospital Stay

    Time: Up to 49 days

    Description: Total time in the ICU (time in ICU from first dosing) will be reported.

    Measure: Total Time in the Intensive Care Unit (ICU)

    Time: Up to 49 days

    Description: Incidence of Grade 3 and Grade 4 AEs will be assessed by system organ class where Grade 3: Severe and Grade 4: Life-threatening.

    Measure: Incidence of Grade 3 and Grade 4 Adverse Events (AEs)

    Time: Up to 49 days

    Description: Incidence of respiratory AEs will be reported.

    Measure: Incidence of Respiratory AEs

    Time: Up to 49 days

    Description: Incidence of thoracic-related AEs will be reported.

    Measure: Incidence of Thoracic-related AEs

    Time: Up to 49 days

    Description: Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.

    Measure: Incidence of Antibiotic use in Participants who Develop and in Those who do not Develop RSV LRTI or RSV-Associated LRTC per the EAC's Assessment

    Time: Up to 49 days

    Description: Time to resolution of symptoms, assessed through an instrument for participant-reported symptoms (RiiQ Symptom Scale) will be reported.

    Measure: Time to Resolution of Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale

    Time: Up to 49 days

    Description: Change from baseline in severity of symptoms reported by participants in the RiiQ symptom scale through Day 28 will be reported.

    Measure: Change from Baseline in Severity of Symptoms Reported by Participants in the RiiQ Symptom Scale Through Day 28

    Time: Baseline up to Day 28

    Description: Time to resolution of respiratory illness, through the PGI-S Scale, will be reported.

    Measure: Time to Resolution of Respiratory Illness as Assessed by Patient Global Impression of Severity (PGI-S) Scale

    Time: Up to 49 days

    Description: Change from baseline in PGI-H scale through Day 28 will be reported.

    Measure: Change from Baseline in Patient Global Impression of Health (PGI-H) Scale Through Day 28

    Time: Baseline up to Day 28

    Description: Change from baseline in PGI-C scale through Day 28 will be reported.

    Measure: Change from Baseline in Patient Global Impression of Change (PGI-C) Scale Through Day 28

    Time: Baseline up to Day 28

    Description: AUC (0-24h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose.

    Measure: Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-53718678

    Time: Up to 24 hours postdose (on Days 1 and 8)

    Description: Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.

    Measure: Trough Plasma Concentration (Ctrough) of JNJ-53718678

    Time: Predose on Days 1 and 8

    Description: Cmax is defined as the maximum observed plasma concentration of JNJ-53718678 in the dosing interval.

    Measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678

    Time: Day 1

    Description: The potential association of plasma concentration-time data of JNJ-53718678 with antiviral activity (RSV viral kinetics) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

    Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Antiviral Activity

    Time: Up to 49 days

    Description: The potential association of plasma concentration-time data of JNJ-53718678 with selected safety (including AEs and laboratory abnormalities) parameters will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

    Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Safety Parameters

    Time: Up to 49 days

    Description: The potential association of plasma concentration-time data of JNJ-53718678 with clinical outcomes (proportion of participants developing LRTI) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.

    Measure: Association of Plasma Concentration-time Data of JNJ-53718678 and Clinical Outcomes

    Time: Up to 49 days

    Description: RSV viral load and change from baseline over time will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in the mid-turbinate nasal swab specimens.

    Measure: RSV Viral Load and Change from Baseline Over Time

    Time: Baseline up to Day 28

    Description: RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.

    Measure: RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 8, 11, 15, 22 and 28

    Time: Baseline up to Days 8, 11, 15, 22 and 28

    Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

    Measure: Time to Undetectable RSV Viral Load

    Time: Up to 49 days

    Description: Proportion of participants with undetectable RSV viral load at each time point throughout the study will be reported.

    Measure: Proportion of Participants with Undetectable RSV Viral Load at Each Timepoint

    Time: Up to 49 days

    Description: Change from baseline for the HRQOL assessment as assessed through the EQ-5D-5L through Day 28 will be reported.

    Measure: Change from Baseline for the Health-related Quality of Life (HRQOL) as Assessed by 5-level EuroQol 5-Dimension (EQ-5D-5L) Through Day 28

    Time: Baseline up to Day 28

    Description: Change from baseline for the HRQOL assessment as assessed through RiiQ impact scales through Day 28 will be reported.

    Measure: Change from Baseline for the HRQOL as Assessed by RiiQ Impact Scales Through Day 28

    Time: Baseline up to Day 28

    Description: Change from baseline in the RSV F gene sequence will be reported.

    Measure: Change from Baseline in the RSV F Gene Sequence

    Time: Baseline up to 49 days
    47 A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

    The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.

    NCT04068792
    Conditions
    1. Respiratory Syncytial Viruses
    Interventions
    1. Other: RSV Mobile Application
    2. Drug: Placebo
    3. Drug: JNJ-53718678 2.5 mg/kg
    4. Drug: JNJ-53718678 3 mg/kg
    5. Drug: JNJ-53718678 4.5 mg/kg
    MeSH:Virus Diseases

    Primary Outcomes

    Description: Respiratory Syncytial Virus (RSV) viral load AUC will be determined from immediately prior to first dose of study drug through Day 5. The RSV viral load is measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.

    Measure: Part 2: RSV Viral Load Area Under Curve (AUC) from Immediately Prior to First Dose of Study Drug Through Day 5

    Time: On the day of diagnosis (Baseline) through Day 5 of interventional stage

    Secondary Outcomes

    Description: Total Respiratory Symptom Score over time will be captured by RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV positive participants that do not enter in the interventional stage.

    Measure: Part 1: Total Respiratory Symptom Score Over Time

    Time: Up to 21 Days of observational stage

    Description: Clinician PRESORS scores will be reported for hospitalized RSV positive participants. Clinician PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

    Measure: Part 1: Change from Baseline in Clinician Pediatric RSV Electronic Severity and Outcome Rating Scale (PRESORS) Scores

    Time: On the day of RSV diagnosis (Baseline) up to Discharge post-diagnosis (21 Days) of observational stage

    Description: RSV Viral load during pre-diagnostic phase will be determined based on measurements of RSV viral load in nasal secretions by a qRT-PCR assay in mid-turbinate nasal swab specimens.

    Measure: Part 1: RSV Viral Load

    Time: Pre-diagnostic phase: Within 24hrs of Observation Day 1

    Description: RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage) will be measured by real-time qRT-PCR assay in the mid-turbinate nasal swab specimens.

    Measure: Part 1: RSV Viral Load Kinetics from Day 1 to Day 8

    Time: On the day of diagnosis (Baseline) through Day 8 of observational stage

    Description: Change from baseline in Parent(s)/Caregiver(s) PRESORS scores (worsening or improvement) will be reported.

    Measure: Part 1: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores Over Time

    Time: On the day of diagnosis (Baseline) up to 21 Days of the observational stage

    Description: RSV viral load and change from baseline over time will be measured by qRT-PCR assay in mid-turbinate nasal swab specimens.

    Measure: Part 2: RSV Viral Load and Change from Baseline Over Time

    Time: On the day of diagnosis (Baseline) through Day 21 of interventional stage

    Description: RSV viral load AUC will be determined by qRT-PCR assay in mid-turbinate nasal swab specimens.

    Measure: Part 2: RSV Viral Load Area Under the curve (AUC) from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14

    Time: On the day of diagnosis (Baseline) through Days 3, 8 and 14 of interventional stage

    Description: Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.

    Measure: Part 2: Time to Undetectable RSV Viral Load

    Time: Up to 21 days of interventional stage

    Description: Percentage of participants with undetectable RSV viral load will be reported.

    Measure: Part 2: Percentage of Participants with Undetectable RSV Viral Load at each timepoint

    Time: Up to 21 days of interventional stage

    Description: Duration of signs and symptoms of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

    Measure: Part 2: Duration of Signs and Symptoms of RSV Disease Assessed by the PRESORS

    Time: Up to 21 days of interventional stage

    Description: Severity of RSV disease will be assessed by PRESORS. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues).

    Measure: Part 2: Severity of RSV Disease Assessed by PRESORS

    Time: Up to 21 days of interventional stage

    Description: Change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) daily by parent/caregiver.

    Measure: Part 2: Change from Baseline in Parent(s)/Caregiver(s) PRESORS Scores

    Time: On the day of diagnosis (Baseline) up to 21 days of interventional stage

    Description: Change from baseline in clinician PRESORS scores (worsening or improvement) will be reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease (fever, cough, sputum, wheezing, difficulty breathing, nasal congestion, and feeding issues) by clinician.

    Measure: Part 2: Change from Baseline in Clinician PRESORS Scores

    Time: On the day of diagnosis (Baseline) up to 21 days of interventional stage

    Description: Time to resolution (that is, to none or mild) of RSV symptoms will be recorded.

    Measure: Part 2: Time to Resolution of RSV Symptoms

    Time: Up to 21 days of interventional stage

    Description: Time to improvement based on general questions on overall health will be reported.

    Measure: Part 2: Time to Improvement on Overall Health

    Time: Up to 21 days of interventional stage

    Description: Percentage of participants with improvement or worsening of RSV disease based on general questions on overall health will be reported.

    Measure: Part 2: Percentage of Participants with Improvement or Worsening of RSV Disease

    Time: Up to 21 days of interventional stage

    Description: Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) will be recorded.

    Measure: Part 2: Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)

    Time: Up to 21 days of interventional stage

    Description: Percentage of participants with vital signs (heart rate, respiratory rate, body temperature and peripheral capillary oxygen saturation [SpO2]) abnormalities will be reported.

    Measure: Part 2: Percentage of Participants with Vital Sign Abnormalities

    Time: Up to 28 days of interventional stage

    Description: Percentage of participants who require (re)hospitalization during treatment and follow-up will be reported.

    Measure: Part 2: Percentage of Participants who Require (re)Hospitalization During Treatment and Follow-up

    Time: Up to 28 days of interventional stage

    Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measure: Part 2: Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time: Up to 28 days of interventional stage

    Description: Percentage of participants with abnormal laboratory findings (hematology, biochemistry, urinalysis) will be reported.

    Measure: Part 2: Percentage of Participants with Abnormal Laboratory Findings

    Time: Up to 28 days of interventional stage

    Description: Percentage of participants with abnormal ECGs findings will be reported.

    Measure: Part 2: Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings

    Time: Up to 28 days of interventional stage

    Description: Plasma Concentrations of JNJ-53718678 will be evaluated and determined by population pharmacokinetics (popPK) modelling.

    Measure: Part 2: Plasma Concentrations of JNJ-53718678

    Time: Day 1 and Day 3 of interventional stage
    48 A Phase 4, Multicenter, 2-part Study Composed of a 1-Year Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation Followed by a 1-Year Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents Aged 6 to 17 Years With Attention-deficit/Hyperactivity Disorder

    This interventional multicenter dose-optimization Phase IV PASS conducted in Europe and the USA evaluates the comparative long-term safety and efficacy of SPD503 in children and adolescents aged 6 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) for whom stimulants are not suitable, not tolerated, or shown to be ineffective. The study will be conducted in two parts: Study Part A (randomized, double-blinded, parallel-group, placebo- and active comparator-controlled, 3-treatment arm safety and efficacy evaluation of SPD503) and Study Part B (open label SPD503 treatment).

    NCT04085172
    Conditions
    1. Attention Deficit Hyperactivity Disorder (ADHD)
    Interventions
    1. Drug: Guanfacine hydrochloride (SPD503)
    2. Drug: Atomoxetine hydrochloride
    3. Other: Placebo
    MeSH:Hyperkinesis Attention Deficit Disorder with Hyperactivity
    HPO:Attention deficit hyperactivity disorder Hyperactivity Hyperkinetic movements

    Primary Outcomes

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 10 in both Part A and Part B of the study.

    Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 10

    Time: Baseline, Week 10

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 18 in Part A of the study.

    Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 18

    Time: Baseline, Week 18

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. The RTI task of CANTAB involves elements of decision-making and attention as measured by choice accuracy as well as motor responses, by measuring motor and mental response speeds, and assesses movement time, reaction time, response accuracy, and impulsivity. This outcome measure will be assessed at Week 49 in both Part A and Part B of the study.

    Measure: Change from Baseline in the Reaction Time (RTI) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) at Week 49

    Time: Baseline, Week 49

    Secondary Outcomes

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Cognitive domain, sustained attention will be measured by the CANTAB RVP task. RVP measures the ability to sustain attention over time and is a sensitive measure of frontal-parietal function. In this task, single digits appear in a pseudo--random order at a rate of 100 digits per minute in a box at the center of the screen. Participants are to detect a 3-digit target sequence (e.g. 2-4-6) and respond by pressing a button at the bottom of the screen when the final number of the sequence appears on the screen.

    Measure: Change from Baseline in the Rapid Visual Information Processing (RVP) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

    Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments, SWM is a component of cognitive executive function which is measured by SWM task of CANTAB between the errors. The ability to retain spatial information and manipulate remembered items in working memory will be measured with the SWM task of CANTAB which is self-ordered and assesses the individual's ability to strategize heuristically. The test is a sensitive measure of frontal lobe and executive dysfunction.

    Measure: Change from Baseline in the Spatial Working Memory (SWM) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

    Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments.Response control or inhibition cognitive domain will be measured by the CANTAB SST. SST measure response inhibition. The participant must respond to an arrow stimulus by touching either of 2 choices depending on the direction the arrow points. If an audio tone is present, the participant is not to respond.

    Measure: Change from Baseline in the Stop Signal Task (SST) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

    Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

    Description: The neurocognitive function effects of SPD503 on adolescents and children diagnosed with ADHD will be evaluated using the CANTAB cognitive assessments. Recognition memory of cognition domain will be measured by the CANTAB DMS task. DMS measures both simultaneous matching and short-term visual memory. The participant is shown a complex visual pattern (the sample) and after a brief delay, 4 similar patterns. The participant must identify the pattern that matches the sample.

    Measure: Change from Baseline in the Delayed Matching to Sample (DMS) Task of the Cambridge Automated Neuropsychological Test Battery (CANTAB) in Both Part A and Part B at Specified Time Points

    Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

    Description: Sexual maturation will be measured by Tanner stage. The stage of puberty or sexual maturation will be evaluated for each participant according to Tanner staging. The Tanner stage for genitals (male, stages I-V), breasts (females, stages I-V), and pubic hair (both sexes, stages I-V) will be documented at the specified times.

    Measure: Tanner Stage in Both Part A and Part B at Specified Time Points

    Time: Part A: Baseline, Week 10, Week 18, Week 49 Part B: Baseline, Week 10, Week 49

    Description: Physical examinations will include height and weight. Growth will be measured by weight, height, and BMI. Body mass index is a measure of body fat based on height and weight. Vital signs will be assessed based on blood pressure, pulse rate, respiratory rate and body temperature in both Part A and Part B. The HR, PR interval, QRS interval, and QT interval will be measured from all ECGs and the QTcB and QTcF assessed at specified time points in both Part A and Part B of the study.

    Measure: Number of participants with clinically significant changes in Vital signs, ECG, Physical Examination

    Time: From start of study drug administration up to follow up (week 52)

    Description: Psychiatric symptoms will be measured by the Brief Psychiatric Rating Scale for Children (BPRS-C) total score. The 21 items of the clinician-rated BPRS-C are grouped into the following 7 scales: depression, anxiety, psychomotor excitation, behavior problems, withdrawal retardation, thinking disturbance, and organicity. Each item of the 21 items is clinician-graded using the following 7-point severity Likert-scale from 0 to 6 (not present=0; very mild=1; mild=2; moderate=3; moderately severe=4; severe=5; extremely severe=6. BPRS-C will be assessed at specified time points in both Part A and Part B.

    Measure: Brief Psychiatric Rating Scale for Children (BPRS-C)

    Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

    Description: The C-SSRS is a structured tool to assess suicidal ideation and behavior. A maximum of 19 items will be completed as follows: 7 items are required, a potential 10 additional items will be completed upon a positive response to a required item, and 2 items completed if suicide or suicide-like behavior is observed during the interview. The C-SSRS uses dichotomous scales (i e, yes or no), Likert scales, and text or narrative to further describe thoughts or behaviors. C-SSRS Score will be assessed at specified time points in both Part A and Part B.

    Measure: Columbia- Suicide Severity Rating Scale (CSSRS)

    Time: Baseline (from start of study drug administration) to Week 52

    Description: UKU rating scale was developed for clinicians to assess side effects of psychopharmacological medications based on interviews and other relevant source information. UKU items relevant to the established safety profile of SPD503 such as Increased Duration of Sleep, Asthenia or Lassitude or lncreased Fatigability, Sleepiness or Sedation, and Orthostatic Dizziness. UKU rating scale will be assessed at specified time points in both Part A and Part B.

    Measure: Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale

    Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52 Part B: Baseline, Week 10, Week 23, Week 36, Week 49, Week 50, Week 51 and Week 52

    Description: Sedative effects will be measured by participant ratings on the Pediatric Daytime Sleepiness Scale (PDSS). The PDSS is a self-reported assessment of daytime sleepiness in children aged 11 to 15 years. PDSS questionnaire was designed to be easy to administer, score, and interpret. Sleepiness-related questions are based on previous research of situations that can be sensitive to sleep loss in this age group. The 8 questions are scored on Likert-scale from 0 to 4 (never=0; seldom=1; sometimes=2; frequently=3; always=4). The total score on the PDSS can range from 0 (never sleepy) to 32 (always sleepy). PDSS will be assessed at specified time points in both Part A and Part B.

    Measure: Pediatric Daytime Sleepiness Scale (PDSS)

    Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

    Description: The ADHD-RS-5 (DuPaul et al., 2016) is used widely by mental health, educational, and medical practitioners in screening, diagnosis, and treatment evaluation to determine the frequency and severity of ADHD symptoms and impairments in children and adolescents. Attention-deficit/hyperactivity disorder symptoms is measured by the investigator-administered ADHD Rating Scale-5 (ADHD-RS-5) total score and hyperactivity/impulsivity and inattentiveness symptoms as subscale scores. The ADHD-RS-5 is based on the diagnostic criteria for ADHD as described in the DSM-5 and consists of 2 symptom subscales, inattention and hyperactivity-impulsivity, each with 9 items and a total scale of 18 items. Each item in the subscale is scored with a value ranging from 0 (no symptoms) to 3 (severe symptoms). The total score can range from 0 to 54. ADHD-RS-5 Total Score and Subscales wiil be assessed at specified time points in both Part A and Part B.

    Measure: ADHD Rating Scale-5 (ADHD-RS-5) Total Score and Subscales

    Time: Part A: Baseline, Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

    Description: Global clinical measurement of ADHD improvement as measured by Clinical Global Impression-Improvement (CGI-I) using the Clinical Global Impression-Severity (CGI-S) to establish baseline. The CGI scale will be used to evaluate the severity of mental illness over time. The CGI-S will be administered to assess the severity of mental illness at baseline. The CGI-S is scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-I is also scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I will be measured at specified time points in both Part A and Part B.

    Measure: Clinical Global Impression-Improvement (CGI-I)

    Time: Part A: Week 1, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Week 10, Week 23, Week 36 and Week 49

    Description: The Parent Report Form of the Child Health and Illness Profile - Child Edition (CHIP-CE:PRF) will be administered to provide information on self-esteem and school functioning in pediatric participants diagnosed with ADHD. The 5 domains and 12 subdomains covered in the 76 items comprising the CHIP-CE:PRF. Satisfaction: with health (7 items) and self (4 items); Comfort: physical (9 items) and emotional symptoms (9 items) and activity restrictions (4 items) due to illness; Resilience: behaviors and family involvement (8 items) in activities likely to enhance health, Social problem-solving (5 items),Physical activity (6 items); Risk avoidance: behaviors that if not avoided are likely to pose risks to health: Individual risk avoidance (4 items), Threats to achievement (10 items); Achievement: developmentally appropriate role functioning in school and with peers: Academic performance (5 items), Peer relations (5 items). CHIP-CE: PRF will be assessed in both Part A and Part B.

    Measure: Child Health and Illness Profile - Child Edition: Parent Report Form (CHIP-CE:PRF)

    Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49

    Description: School performance will be measured by teacher ratings of academic skills using the APRS at specified time points in both Part A and Part B. The APRS is a reliable rating scale that has been shown to be valid in assessing teacher perceptions of the quality of a student's academic competency. The scale includes 19 items that are directed toward work performance in various participant areas; academic success, behavioral control in academic situations, and attention to assignments. Teachers mark responses in a Likert-scale format from 1 (never or poor) to 5 (very often or excellent). From the APRS, a total score and the following 3 subscale scores are calculated: academic success, impulse control, and academic productivity.

    Measure: Academic Performance Rating Scale (APRS)

    Time: Part A: Baseline, Week 10, Week 18, Week 23, Week 36 and Week 49 Part B: Baseline, Week 10, Week 23, Week 36 and Week 49
    49 A Randomized, Placebo-controlled, Subject and Investigator Blinded Study Investigating the Safety, Tolerability and Preliminary Efficacy of 8-week Treatment With Intra-articular LRX712 to Regenerate Articular Cartilage in Patients With Mild/Moderate Knee Osteoarthritis

    This study will explore the preliminary efficacy of multiple intra-articular injections of LRX712 by evaluating the ability of the drug to restore structural integrity of articular cartilage. Efficacy will be evaluated in the context of the systemic safety and local tolerability of the investigational drug.

    NCT04097379
    Conditions
    1. Osteoarthritis (OA)
    Interventions
    1. Drug: LRX712
    2. Drug: Placebo
    MeSH:Osteoarthritis
    HPO:Osteoarthritis

    Primary Outcomes

    Description: Efficacy of multiple intra-articular injections of LRX712 in regenerating cartilage as measured with 7T MRI

    Measure: Changes in articular cartilage [23Na] content from baseline compared to placebo at week 28

    Time: Baseline and Week 28

    Secondary Outcomes

    Description: Efficacy of multiple intra-articular injections of LRX712 measured with 7T MRI

    Measure: Changes in articular cartilage [23Na] content from baseline compared to placebo at Week 16 and 52

    Time: Baseline, Week 16 and 52

    Description: Efficacy of multiple intra-articular injections of LRX712 measured with 7T MRI

    Measure: Changes from baseline in cartilage morphometrics (volume and thickness) in the medial femoral condyle at Week 16, 28 and 52

    Time: Baseline, Week 16, 28 and 52

    Description: The observed time to reach max (Tmax) plasma concentration following drug administration

    Measure: Time to Reach the Maximum Plasma Concentration (Tmax)

    Time: Pre-dose to 28 weeks

    Description: The observed maximum (Cmax) plasma concentration following drug administration

    Measure: Maximum Observed Plasma Concentration (Cmax)

    Time: Pre-dose to 28 weeks

    Description: The observed minimum (Cmin) plasma concentration following drug administration

    Measure: Minimum Observed Plasma Concentration (Cmin)

    Time: Pre-dose to 28 weeks

    Description: The observed synovial concentration following drug administration

    Measure: Concentration in synovial fluid

    Time: Day 1; week 4; week 8
    50 Improving Everyday Functioning in Adults Aged 70 and Over Using a Multivitamin Supplement

    Investigation of the chronic effect of 12 week multivitamin supplementation on markers of everyday function in adults aged 70 and over.

    NCT04112732
    Conditions
    1. Aging
    2. Stress
    Interventions
    1. Dietary Supplement: Multivitamin
    2. Other: Placebo

    Primary Outcomes

    Description: An overall outcome measure which is a composite measure made up of four personal well-being questions used in the Measuring National Well-being programme plus one additional question. These five questions are: Overall, how satisfied are you with your life nowadays? Overall, to what extent do you feel the things you do in your life are worthwhile? Overall, how happy did you feel yesterday? Overall, how anxious did you feel yesterday? Overall, how well did you feel yesterday?

    Measure: Overall Well-Being (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Secondary Outcomes

    Description: Systolic and Diastolic blood pressure measured via Portapres a non-invasive, continuous beat-to-beat blood pressure monitoring system.

    Measure: Cardiovascular reactivity- Blood pressure (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Beats per minute, measured via Portapres a non-invasive, continuous beat-to-beat blood pressure monitoring system.

    Measure: Cardiovascular reactivity- Heart rate (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: C-Reactive Protein (CRP)

    Measure: Immune/inflammatory response (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Secretory Immunoglobulin-A (s-IgA)

    Measure: Immune/inflammatory response(change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: The Kingston Caregiver Stress Scale.This tool is designed to assess levels of perceived stress associated with caregiving in informal carers. The scale comprises three sections that assess levels of stress in relation to care-related feelings; family matters; and financial stresses. Higher scores indicate higher levels of stress

    Measure: Self-Reported Stress (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: The Perceived Stress Scale (PSS), The PSS is a 10-item scale which measures the extent to which participants perceive their lives to be overwhelming, uncontrollable and unpredictable.Scale responses range from 0 (never) to 4 (very often) and items are summed to yield a total score. Higher scores indicate greater perceived levels of stress, experienced over the previous month

    Measure: Self-Reported Stress (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Cohen Hoberman Inventory of Physical Symptoms.The CHIPS was designed as a measure of perceived burden due to the experience of a range of physical symptoms. The scale comprises a list of 33 common everyday symptoms (e.g. 'acne', 'diarrhoea', 'heart pounding or racing') and asks respondents 'how much that problem has bothered or distressed you during the past two weeks including today'. Items are scored for 1-5, then summed across all items. Higher scores indicate worse health

    Measure: General health(change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: SF-20. The survey measures health across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score. Raw scores are transformed to fit the 0% to 100% interval as described in the original publication (note that for question #1 on general health, an initial transformation is performed as follows: 1 = 5, 2 = 4.36, 3 = 3.43, 4 = 1.99, 5 = 1). Reversal of scoring is completed as necessary such that the highest score always represents the best possible score. The exception to this scoring pattern is the pain score, for which 0% represents the best possible score and 100% the worst possible score,

    Measure: General health (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Instrumental Activities of Daily Living Scale. is an appropriate instrument to assess independent living skills.There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.

    Measure: Daily functioning and care behaviours (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Hospital Anxiety and Depression Scale, this is a 14 item scales, with scale responsed rangin from 0 to 5. Scores are summed to produce separate scores for anxiety and depression. Higher scores indicate more frequent feelings of anxiety and depressive symptoms. Scores between 0 and 7 are considered normal. Scores between 8 and 10 are indicative of borderline mood disorder and scores > 11 indicates probable mood disorder

    Measure: Mood trait measures (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Profile of Moods States (POMS). This comprises 37 items with response ranging from 'not at all' to 'extremely'. Scores from the POMS-SF are used to derive a total score for 'mood disturbance', as well as subscores for the domains of 'tension', 'depressed', 'anger', 'vigour', 'fatigue' and 'concentration'. A total score disturbance score can also be calculated by adding the scores from the first five of these global scores and subtracting 'vigour

    Measure: Mood trait measures (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: State-Trait Anxiety Inventory (STAI) The STAI is a widely used instrument consisting of two subscales assessing 'State' and 'Trait' anxiety respectively. Each subscale contains 20 statements (e.g. 'I am calm') each with a 4-point Likert scale, giving a range of potential scores from 20 to 80. Participants rate how much they feel like each statement at the time of making the response (State subscale), and how much they generally feel like each statement (Trait subscale). Higher scores indicate greater anxiety.

    Measure: Acute measures of subjective state in responses to a stressor (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: NASA-Task Load Index. The NASA-TLX comprises a set of six scales anchored with 'Low' and 'High' at the extreme points. Three of the scales reflect the demand placed upon the respondent by the task (Mental Demand, Physical Demand, Temporal Demand), whereas three reflect the interaction between the respondent and the task (Effort, Perceived Performance, Frustration).

    Measure: Acute measures of subjective state in responses to a stressor (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Task performance on the Multi-Tasking Framework (MTF),

    Measure: Cognitive function (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Prospective and Retrospective memory Questionnaire, The PRMQ is a 16 item scale that quantifies memory failures for everyday tasks over two subscales: prospective memory (e.g., do you forget appointments if you are not prompted by someone else or by a reminder such as a calendar or diary?) and retrospective memory (e.g., do you fail to do something you were supposed to do a few minutes later even though it's there in front of you, like take a pill or turn off the kettle?). Scale responses range from 1 (never) to 5 (very often), and higher scores indicate poorer everyday memory.

    Measure: Cognitive function (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: A covert measure of prospective memory, whereby participants will be asked to remember to return a reminder slip with their 'participant number' written on, which will be posted out before testing visits.

    Measure: Cognitive function (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Pittsburgh Sleep Quality Index. The PSQI assesses seven factors - subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction - via questions regarding sleep timings and zero to three-point scales in which participants rate whether they have experienced a number of issues (e.g. 'During the past week, how often have you had trouble sleeping because you have had bad dreams?') from 'not during the past week' to '3 or more times in the past week'. A global sleep score is created by totalling the seven subfactor scores, with higher scores indicating poorer sleep quality.

    Measure: Sleep quality (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Yale Physical Activity Scale, The YPAS is an interviewer-administered questionnaire developed to assess physical activity in older adults. The YPAS is divided into two sections: in the first section, there is a comprehensive physical work, exercise, and recreational activities checklist to assess time spent in these types of activities during a typical week in the past month. The second section contains questions to quickly assess an individual's participation in five activity dimensions: vigorous activity, leisurely walking, moving on feet, standing, and sitting. Responses on the YPAS allow eight summary indices to be calculated: total time spent per week in all physical activities, weekly energy expenditure in kcal per week, five individual indices for the activity dimensions, and an activity dimension summary index

    Measure: Mobility (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Falls Efficacy Scale, measures of "fear of falling" or, more properly, "concerns about falling.To calculate the FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges from a minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

    Measure: Mobility (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Timed up and Go Test, length of time in seconds it takes participants to stand form a chair, walk 3 metres, turn around and sit back down in chair.

    Measure: Mobility(change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Grip Strength. 3 trials on non dominant hand. Measured in kg.

    Measure: Mobility (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Balance tests. Measured to see if participants can hold 3 stances for 10s. If they can they are awarded 1 point, if not 0 points.

    Measure: Mobility(change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Lubben Social Network Scale, This measure uses 6 questions: 3 key questions evaluate the size of 3 different aspects of social network that are attributable to family ties and a parallel set attributable to friendship ties. Each LSNS-6 question is scored on a 0 to 5 scale. The total score is an equally weighted sum of these 6 questions, with scores ranging from 0 to 30.

    Measure: Social network size (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Convoy Method. • Respondents are presented with a set of three concentric circles, with the word 'You' contained within a smaller circle in the middle. Respondents are asked to think about "people who are important in your life right now, but who are not equally close". Respondents are then asked to think about "people to whom you feel so close it is hard to imagine life without them"; these people are entered into the innermost circle. For the next circle respondents are asked to consider "people to whom you may not feel quite that close but who are still very important to you". Finally, in the outer circle respondents are asked to place "People whom you haven't already mentioned but who are close enough and important enough in your life that they are part of your personal network". The numbers of people within each network are counted and can be used to represent support networks in each of the categories and / or summed to produce an index of total social network size

    Measure: Social network size (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: The De Jong Gierveld Loneliness Scale,This tool can be used to provide a single index of loneliness in addition to indices of 'Emotional Loneliness' and 'Social Loneliness' . To score the answers to the scale, the neutral and positive answers are scored as "1" on the negatively worded questions and On the positively worded items, the neutral and negative answers are scored as "1"

    Measure: Loneliness (change from baseline)

    Time: Measured at baseline and then following chronic (12 weeks) treatment

    Description: Blood biomarkers taken to assess impact of nutritional status, this will measure vitmain B12, ferritin and folate.

    Measure: Nutrition Status

    Time: Measured at baseline and then following chronic (12 weeks) treatment
    51 A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects

    The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

    NCT04119440
    Conditions
    1. MERS (Middle East Respiratory Syndrome)
    Interventions
    1. Biological: MVA-MERS-S_DF1 - Low Dose
    2. Biological: MVA-MERS-S_DF1 - High Dose
    3. Other: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.

    Measure: Frequency of adverse events associated with MVA-MERS-S_DF-1.

    Time: day 1, 14, 29, 42, 56, 84, 168, 336, 364

    Measure: Frequency and severity of local injection site reactogenicity signs and symptoms

    Time: day 1, 14, 29, 42, 84, 336

    Secondary Outcomes

    Description: Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory

    Measure: Immunogenicity

    Time: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)
    52 A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

    The purpose of this study is to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

    NCT04126213
    Conditions
    1. Respiratory Syncytial Virus Infections
    Interventions
    1. Biological: RSVPreF3 formulation 2
    2. Biological: RSVPreF3 formulation 3
    3. Drug: Placebo
    MeSH:Respiratory Syncytial Virus Infections

    Primary Outcomes

    Description: An AE is any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Solicited administration site events are: pain, redness and swelling.

    Measure: Percentage of maternal subjects reporting solicited administration site events

    Time: From Day 1 to day 7

    Description: Solicited systemic events are: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.

    Measure: Percentage of maternal subjects reporting solicited systemic events

    Time: From Day 1 to day 7

    Description: The hematological assays are: Complete Blood Count (CBC) with differential and platelet count. The biochemical assays are: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), creatinine and blood urea nitrogen.

    Measure: Percentage of maternal subjects with hematological and biochemical laboratory abnormality at baseline

    Time: At baseline (Day -15)

    Description: The hematological assays are: Complete Blood Count (CBC) with differential and platelet count. The biochemical assays are: alanine amino-transferase Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), creatinine and blood urea nitrogen.

    Measure: Percentage of maternal subjects with hematological and biochemical laboratory abnormality at Day 8

    Time: At Day 8 (visit 2)

    Description: An unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.

    Measure: Percentage of maternal subjects with unsolicited adverse events (AEs)

    Time: From Day 1 to Day 30

    Description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy).

    Measure: Percentage of maternal subjects with at least one serious adverse event (SAE)

    Time: From Day 1 to Day 43 post-delivery

    Description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measure: Percentage of maternal subjects with AEs leading to study withdrawal

    Time: From Day 1 to Day 43 post-delivery

    Description: An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

    Measure: Percentage of maternal subjects with at least one medically attended AE (MAE)

    Time: From Day 1 to Day 43 post-delivery

    Description: Pregnancy outcomes include live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth (antepartum or intrapartum) with no congenital anomalies, foetal death/still birth (antepartum or intrapartum) with congenital anomalies, elective/therapeutic termination with no congenital anomalies and elective/therapeutic termination with congenital anomalies.

    Measure: Percentage of maternal subjects with pregnancy outcomes

    Time: From Day 1 to Day 43 post-delivery

    Description: Pregnancy-related AESIs include maternal death, hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, caesarean scar pregnancy, uterine rupture), postpartum hemorrhage, foetal growth restriction, gestational diabetes mellitus, non-reassuring foetal status, pathways to preterm birth (premature preterm rupture of membranes, preterm labor, provider-initiated preterm birth), chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy, acute fatty liver of pregnancy), maternal sepsis.

    Measure: Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs)

    Time: From Day 1 to Day 43 post-delivery

    Description: Neonatal AESIs, reported up to 6 weeks after birth, include small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally or prenatally diagnosed), congenital anomalies (major external structural defects, internal structural defects, functional defects), neonatal death (in a preterm live birth or in a term live birth), neonatal infections (blood stream infections, meningitis, respiratory infection), respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia.

    Measure: Percentage of infant subjects with neonatal AESIs

    Time: From birth to Day 43 post-birth

    Description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

    Measure: Percentage of infant subjects with at least one SAE

    Time: From birth to Day 43 post-birth

    Description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measure: Percentage of infant subjects with AEs leading to study withdrawal

    Time: From birth to Day 43 post-birth

    Description: A MAE is an AE that needs medical supervision.

    Measure: Percentage of infant subjects with at least one MAE

    Time: From birth to Day 43 post-birth

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentration is expressed in ELISA units per milliliter (ELU/mL). The assay is performed for each group and for each age category (18 -<35 years; ≥ 35 years; overall)

    Measure: RSVPreF3 Immunoglobulin G (IgG)-specific antibody concentration in terms of Geometric Mean Concentrations (GMCs) at Day 1, before vaccination for each group and by age category

    Time: At Day 1 (before vaccination)

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The assay is performed for each group and for each age category (18 -<35 years; ≥ 35 years; overall)

    Measure: RSVPreF3 IgG antibody GMCs at Day 31

    Time: At Day 31

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The assay is performed for each group and for each age category (18 -<35 years; ≥ 35 years; overall)

    Measure: RSVPreF3 IgG antibody GMCs at delivery

    Time: At delivery(Visit 5)

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The assay is performed for each group and for each age category (18 -<35 years; ≥ 35 years; overall)

    Measure: RSV-A neutralizing antibody Geometric Mean Titers (GMTs) at Day 1, before vaccination

    Time: At Day 1 (before vaccination)

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The assay is performed for each group and for each age category (18 -<35 years; ≥ 35 years; overall)

    Measure: RSV-A neutralizing antibody GMTs at Day 31

    Time: At Day 31

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The assay is performed for each group and for each age category (18 -<35 years; ≥ 35 years; overall)

    Measure: RSV-A neutralizing antibody GMTs at delivery

    Time: At delivery (Visit 5)

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The antibodies are measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample can be obtained).

    Measure: RSVPreF3 IgG antibody GMCs in infants born to maternal subjects

    Time: At birth (Visit Day 1 for infants)

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The antibodies are measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample can be obtained).

    Measure: RSV-A neutralizing antibody GMTs in infants born to maternal subjects

    Time: At birth (Visit Day 1 for infants)

    Description: The placental transfer ratio is determined between cord blood or an infant blood sample collected within 3 days after birth (if no cord blood sample can be obtained) and maternal RSVPreF3 IgG-specific antibody concentrations. Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA.

    Measure: Geometric Mean Ratio between cord blood and maternal RSVPreF3 IgG-specific antibody concentrations

    Time: At delivery (visit 5 for maternal subjects) or birth (visit Day 1 for infants)

    Secondary Outcomes

    Description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy).

    Measure: Percentage of maternal subjects with at least one SAE

    Time: From Day 1 to Day 181 post-delivery

    Description: An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

    Measure: Percentage of maternal subjects with at least one MAE

    Time: From Day 1 to Day 181 post-delivery

    Description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measure: Percentage of maternal subjects with at least one AE leading to study withdrawal

    Time: From Day 1 to Day 181 post-delivery

    Description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

    Measure: Percentage of infant subjects with at least one SAE from birth through 6 months after birth

    Time: From birth to Day 181 post-birth

    Description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measure: Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 6 months after birth

    Time: From birth to Day 181 post-birth

    Description: An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

    Measure: Percentage of infant subjects with at least one MAE from birth through 6 months after birth

    Time: From birth to Day 181 post-birth

    Description: An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

    Measure: Percentage of infant subjects with at least one SAE from birth through 1 year after birth

    Time: From birth to Month 12 post-birth

    Description: An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measure: Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 1 year after birth

    Time: From birth to Month 12 post-birth

    Description: A MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

    Measure: Percentage of infant subjects with at least one MAE from birth through 1 year after birth

    Time: From birth to Month 12 post-birth

    Description: A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.

    Measure: Percentage of maternal subjects with at least one RSV-associated Medically Attended RSV-associated Respiratory Tract Illnesses (MA-RTI)

    Time: From delivery (visit 5) to Day 181 post-delivery

    Description: An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) < 95% or respiratory rate increase and a confirmed RSV infection.

    Measure: Percentage of infant subjects with at least one RSV-associated LRTI

    Time: From birth (Visit at Day 1) to Day 181 post-birth

    Description: A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 93 % or lower chest wall in-drawing and a confirmed RSV infection.

    Measure: Percentage of infant subjects with at least one RSV-associated severe LRTI

    Time: From birth (Visit Day 1) to Day 181 post-birth

    Description: A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 90 % or inability to feed or failure to respond / unconscious and a confirmed RSV infection.

    Measure: Percentage of infant subjects with at least one RSV-associated very severe LRTI

    Time: From birth (Visit Day 1) to Day 181 post-birth

    Description: An RSV-associated hospitalization is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.

    Measure: Percentage of infant subjects with at least one RSV-associated hospitalisation

    Time: From birth (Visit Day 1) to Day 181 post-birth

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.

    Measure: RSVPreF3 IgG antibody GMCs in maternal subjects, at day 43

    Time: At Day 43 post-delivery

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.

    Measure: RSV-A neutralizing antibody GMTs in maternal subjects, at day 43

    Time: At Day 43 post-delivery

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay.

    Measure: RSV-B neutralizing antibody GMTs in maternal subjects at Day 1

    Time: At Day 1 (before vaccination)

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-B neutralizing antibody GMTs in maternal subjects at Day 31

    Time: At Day 31

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-B neutralizing antibody GMTs in maternal subjects at delivery

    Time: At delivery (Visit 5)

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-B neutralizing antibody GMTs in maternal subjects at Day 43 post-delivery

    Time: At Day 43 post-delivery

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.

    Measure: RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth

    Time: At Day 43 after birth

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.

    Measure: RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth

    Time: At Day 121 after birth

    Description: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.

    Measure: RSVPreF3 IgG antibody concentration at Day 181 after birth

    Time: At Day 181 after birth

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-A neutralizing antibody GMTs at Day 43 after birth

    Time: At Day 43 after birth

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-A neutralizing antibody GMTs at Day 121 after birth

    Time: At Day 121 after birth

    Description: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-A neutralizing antibody GMTs at Day 181 after birth

    Time: At Day 181 after birth

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU. The antibodies are measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample can be obtained).

    Measure: RSV-B neutralizing antibody GMTs at birth

    Time: At birth (Visit at Day 1)

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-B neutralizing antibody GMTs at Day 43 after birth

    Time: At Day 43 after birth

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-B neutralizing antibody GMTs at Day 121 after birth

    Time: At Day 121 after birth

    Description: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.

    Measure: RSV-B neutralizing antibody GMTs at Day 181 after birth

    Time: At Day 181 after birth
    53 A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)

    The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

    NCT04129164
    Conditions
    1. Sjögren's Syndrome
    Interventions
    1. Drug: VIB4920
    2. Drug: Placebo
    MeSH:Sjogren's Syndrome Syndrome

    Primary Outcomes

    Measure: Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1

    Time: Baseline (Day 1) and Day 169

    Measure: Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2

    Time: Baseline (Day 1) and Day 169

    Secondary Outcomes

    Measure: Change From Baseline in ESSPRI at Day 169 in Population 1

    Time: Baseline (Day 1) and Day 169

    Measure: Percentage of Participants achieving ESSDAI [3] and ESSDAI [4] response in Population 1

    Time: Baseline (Day 1) to Day 169

    Measure: Percentage of Participants achieving ESSPRI response in Population 2

    Time: Baseline (Day 1) to Day 169

    Measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2

    Time: Baseline (Day 1) and Day 169

    Measure: Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2

    Time: Baseline (Day 1) and Day 169

    Measure: Patient's Global Impression of Severity at Day 169 in Populations 1 and 2

    Time: Day 169

    Measure: Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Populations 1 and 2

    Time: From Baseline (Day 1) up to Day 365

    Measure: Number of participants With Adverse Events of Special Interest (AESIs) in Populations 1 and 2

    Time: From Baseline (Day 1) up to Day 365

    Measure: Number of Participants With Abnormal Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) Reported as TEAEs in Populations 1 and 2

    Time: From Baseline (Day 1) up to Day 365

    Measure: Plasma Concentration of VIB4920

    Time: Day 1 to Day 365

    Measure: Percentage of Participants With Positive Antibody Titer to VIB4920 in Populations 1 and 2

    Time: Day 1 to Day 365
    54 Investigator- and Subject-blinded, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy Trial of CFZ533 in Pediatric and Young Adult Subjects With New Onset Type 1 Diabetes (T1DM)

    The study is a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.

    NCT04129528
    Conditions
    1. Type 1 Diabetes Mellitus
    Interventions
    1. Drug: CFZ533
    2. Other: Placebo
    MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
    HPO:Diabetes mellitus Type I diabetes mellitus

    Primary Outcomes

    Description: To evaluate safety and tolerability of CFZ533 in new onset T1DM.

    Measure: Proportion of subjects with adverse events (AE)/serious adverse events (SAE) in treatment groups.

    Time: at 16 months

    Description: To evaluate the treatment effect of CFZ533 on pancreatic beta cell function.

    Measure: Stimulated C-peptide AUC by mixed meal tolerance test (MMTT).

    Time: at 12 months

    Secondary Outcomes

    Description: To evaluate the pharmacokinetics (PK) of CFZ533.

    Measure: Free CFZ533 plasma concentration.

    Time: at day 1

    Description: To evaluate the pharmacokinetics (PK) of CFZ533.

    Measure: Free CFZ533 plasma concentration.

    Time: at 1 week

    Description: To evaluate the pharmacokinetics (PK) of CFZ533.

    Measure: Free CFZ533 plasma concentration.

    Time: at 12 months

    Description: To evaluate the treatment effect of CFZ533 on full or partial remission.

    Measure: Proportion of subjects with full or partial remission.

    Time: at 12 months

    Description: To evaluate durability of effects of CFZ533 on pancreatic beta cell function.

    Measure: Stimulated C-peptide AUC by MMTT.

    Time: at 3 years
    55 A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single Dose of Exebacase in Patients Receiving Standard-of-Care Antibiotics for the Treatment of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Right-Sided Infective Endocarditis

    The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S. aureus) bloodstream infections (BSI), including right-sided infective endocarditis (IE). Patients will be randomized to receive a single intravenous dose of exebacase or placebo. Patients will receive SoCA selected by the investigators based on the protocol. Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to SoCA to treat S. aureus BSI including IE.

    NCT04160468
    Conditions
    1. Staphylococcus Aureus Bacteremia
    2. Staphylococcus Aureus Endocarditis
    Interventions
    1. Drug: Exebacase
    2. Drug: Placebo
    MeSH:Bacteremia Endocarditis
    HPO:Endocarditis

    Primary Outcomes

    Measure: Clinical responder rate at Day 14 in the methicillin-resistant Staphylococcus aureus (MRSA) population

    Time: Day 14

    Description: TEAEs will be summarized by treatment group.

    Measure: Treatment-emergent adverse events (TEAEs) through Day 60

    Time: Through Day 60

    Secondary Outcomes

    Measure: Clinical responder rate at Day 14 in all S. aureus patients

    Time: Day 14

    Measure: 30-day survival in the MRSA population

    Time: Through Day 30

    Measure: Clinical responder rate at Day 60 in the MRSA population

    Time: Day 60

    Measure: Clinical responder rate at Day 60 in all S. aureus patients

    Time: Day 60

    Measure: Clinical responder rate at Day 60 in right-sided IE patients (all S. aureus and MRSA populations)

    Time: Day 60
    56 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

    This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

    NCT04183192
    Conditions
    1. Healthy Subjects
    2. Pharmacokinetics
    3. Pharmacodynamics
    Interventions
    1. Biological: Mepolizumab
    2. Biological: Mepolizumab
    3. Biological: Mepolizumab
    4. Biological: Mepolizumab
    5. Biological: Reslizumab
    6. Biological: Reslizumab
    7. Biological: Reslizumab
    8. Biological: Reslizumab
    9. Biological: Placebo

    Primary Outcomes

    Description: 1. The values and variability of standard pharmacodynamic metrics (AUEC and maximal difference at a single time-point) for eosinophils at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab

    Measure: Area under effect curve and maximum change from baseline for eosinophils for mepolizumab and reslizumab

    Time: 63 or 123 days, depending on treatment arm

    Secondary Outcomes

    Description: 1. The values and variability of pharmacokinetic characteristics (Cmax and area under the curve of free drug concentration) at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab.

    Measure: Maximum concentration and area under the curve for mepolizumab and reslizumab

    Time: 63 or 123 days, depending on treatment arm

    Description: 2. Parameters (Emax, and EC50) calculated by the model after combining data from low, intermediate low, intermediate high, and high doses of mepolizumab or reslizumab with placebo data.

    Measure: Pharmacodynamic model parameters for mepolizumab and reslizumab

    Time: 63 or 123 days, depending on treatment arm
    57 An Electrophysiological Predictor of SSRI Response in Veterans With PTSD

    This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 3.25 years, until at least 94 participants complete the 17 week study.

    NCT04183205
    Conditions
    1. Posttraumatic Stress Disorder
    Interventions
    1. Diagnostic Test: LDAEP
    2. Drug: Placebo
    3. Drug: sertraline
    MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

    Primary Outcomes

    Description: The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80.

    Measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change

    Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

    Secondary Outcomes

    Description: The QIDS-SR will be used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.

    Measure: Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) Change

    Time: Administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

    Description: The HAM-D is the most widely used clinician-administered scale for assessing severity of depression symptoms. The 6-item unidimensional core Melancholia subscale of the HAM-D will be used as the primary depression outcome variable.

    Measure: Hamilton Depression Rating Scale (HAM-D) Change

    Time: Administered at weeks 0, 2, 6 and 14

    Description: DASS-21 is a 21-item measure that assesses the severity of a range of symptoms common to depression, anxiety, and stress. The total score can be used as a measure of general distress or depression, anxiety, and stress subscales can be scored separately.

    Measure: Depression Anxiety Stress Scales (DASS-21) Change

    Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

    Description: The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD. Participants will rate how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). The PCL-5 will be anchored to participants' worst traumatic event. In addition to the administration of these measures during the four assessment sessions, the PCL-5 will also be administered bi-weekly at each psychiatrist check-in visit.

    Measure: PTSD Checklist for DSM-5 (PCL-5) Change

    Time: Administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

    Description: The PANAS consists of two, 10-item mood scales that measure positive (e.g., 'enthusiastic') and negative (e.g., 'upset') affect separately.

    Measure: The Positive and Negative Affect Schedule (PANAS) Change

    Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

    Description: SCL-90-R measures the following nine primary psychiatric symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The Global Severity Index (GSI) is the average rating given to all 90 items and provides a measure of general psychopathology.

    Measure: Symptom Checklist (SCL-90-R) Change

    Time: Administered at screening session 1, and weeks 0, 2, 6, and 14
    58 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A

    This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

    NCT04183491
    Conditions
    1. Healthy Subjects
    2. Pharmacokinetics
    3. Pharmacodynamics
    Interventions
    1. Biological: Interferon beta-1a
    2. Biological: Interferon beta-1a
    3. Biological: Interferon beta-1a
    4. Biological: Peginterferon beta-1a
    5. Biological: Peginterferon beta-1a
    6. Biological: Peginterferon beta-1a
    7. Biological: Placebo

    Primary Outcomes

    Description: The values and variability of standard pharmacodynamic (PD) metrics (AUEC and maximal difference at a single time-point) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a

    Measure: Area under effect curve (AUEC) and maximum change from baseline for neopterin for interferon beta-1a and peginterferon beta-1a

    Time: 7 or 14 days, depending on treatment arm

    Secondary Outcomes

    Description: 2. The values and variability of pharmacokinetic characteristics (Cmax and AUC of free drug concentration) at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a

    Measure: Maximum concentration (Cmax) and area under the curve (AUC) for interferon beta-1a and peginterferon beta-1a

    Time: 7 or 14 days, depending on treatment arm

    Description: 1. The values and variability of standard PD metrics (AUEC and maximal difference at a single time-point) for MxA at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a

    Measure: Area under effect curve and maximum change from baseline for Myxovirus-resistance protein A (MxA) for interferon beta-1a and peginterferon beta-1a

    Time: 7 or 14 days, depending on treatment arm

    Description: 3. Parameters (Emax [maximum effect], and EC50 [half maximal effect concentration]) calculated by the model after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data

    Measure: Pharmacodynamic model parameters for interferon beta-1a and peginterferon beta-1a

    Time: 7 or 14 days, depending on treatment arm
    59 A Randomized, Double Blind, Placebo-Controlled Phase 1b Study With Open-Label Extension to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Patients With Duchenne Muscular Dystrophy (DMD)

    The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367.

    NCT04184882
    Conditions
    1. Duchenne Muscular Dystrophy (DMD)
    Interventions
    1. Drug: ASP0367
    2. Drug: Placebo
    MeSH:Muscular Dystrophies Muscular Dystrophy, Duchenne
    HPO:Muscular dystrophy

    Primary Outcomes

    Description: An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE observed after starting administration of the investigational product (IP) to 14 days after the last dose of IP for the double blind part or moving to the open-label extension part, whichever comes first. An IP-related TEAE is defined as any TEAE with a causal relationship of "yes" by the investigator.

    Measure: Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant vital sign values.

    Measure: Number of participants with vital sign abnormalities and/or AEs

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant body weight.

    Measure: Number of participants with body weight change abnormalities and/or AEs

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant 12-ECG values.

    Measure: Number of participants with electrocardiogram (ECG) abnormalities

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant echocardiography values.

    Measure: Number of participants with echocardiography abnormalities and/or AEs

    Time: Up to Week 28

    Description: Number of participants with potentially clinically significant laboratory values.

    Measure: Number of participants with laboratory value abnormalities and/or AEs

    Time: Up to Week 28

    Description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 6 items for suicidal behavior (1. Actual attempt, 2. Interrupted attempt, 3. Aborted attempt, 4. Preparatory acts or behavior, 5. Suicidal Behavior 6. Completed suicide,) will be reported.

    Measure: Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time: Baseline and up to Week 28

    Description: The Digit span test is a subtest of Wechsler Intelligence Scale for children (WISC). This test comprises 3 parts on the fifth edition (WISC-V). Digit Span Forward requires the subject to repeat numbers in the same order as presented by the interviewer. Digit Span Backward requires the subject to repeat the numbers in the reverse order of that presented by the interviewer. Digit Span Sequencing requires the subject to sequentially order the numbers presented by the interviewer. Scores of this test are based on each raw score and total raw score.

    Measure: Change from baseline in digit span test

    Time: Baseline and up to Week 24

    Secondary Outcomes

    Description: AUCtau will be recorded from the PK plasma samples collected.

    Measure: Pharmacokinetics (PK) of ASP0367 in plasma: AUC from the time of dosing to the start of next dosing interval (AUCtau)

    Time: Up to Week 2

    Description: Cmax will be recorded from the PK plasma samples collected.

    Measure: PK of ASP0367 in plasma: maximum concentration (Cmax)

    Time: Up to Week 2

    Description: Whole blood cell samples will be collected to measure percent change in target gene expressions.

    Measure: Pharmacodynamics (PD) of ASP0367: Percent change from baseline in peroxisome proliferator-activated receptor (PPAR) delta target genes expression levels in blood

    Time: Baseline and up to Week 4

    Description: Serum samples will be collected to record myostatin/follistatin ratio.

    Measure: PD of ASP0367: Percent change from baseline in serum myostatin/follistatin ratio

    Time: Baseline and up to Week 12

    Description: The PUL Assessment v2.0 includes a total of 23 upper limb test items, with the first entry item A used to define the starting functional level. The remaining 22 items are subdivided into 3 major dimension levels as following; shoulder level (6 items, maximum score of 12), elbow level (9 items, maximum score of 17) and distal level dimension (7 items, maximum score of 13). Positive change in scores indicates an improvement.

    Measure: Change from baseline in Performance of Upper Limb Module (PUL) (v2.0) assessment score

    Time: Baseline and up to Week 12

    Description: PedsQL Multidimensional Fatigue Scale comprises the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items). A 5-point response scale in each item is utilized (0 never a problem; 1 almost never a problem; 2 sometimes a problem; 3 often a problem; 4 almost always a problem). Negative change in scores indicates an improvement. This scale is based on the subject's age and will be assessed by both subject and parent or legal guardian.

    Measure: Change from baseline on Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale

    Time: Baseline and up to Week 12

    Description: The 2-minute walk test (2MWT) is a measurement of endurance that assesses walking distance over 2 minutes. Only ambulatory subjects conduct the 2MWT in this study.

    Measure: Change from baseline in distance walked in 2 minutes assessed in meters

    Time: Baseline and up to Week 12

    Description: The a6MCT has been developed as a submaximal endurance test for both legs (leg-cycling) and arms (arm-cranking) for children who are expected to lose their walking ability in the near future or are wheel chair dependent. Only arm-cranking will be applied to this study.

    Measure: Percent change from baseline in the assisted 6 minute cycling test (a6MCT) maximal attained revolutions

    Time: Baseline and up to Week 12

    Description: The a6MCT has been developed as a submaximal endurance test for both legs (leg-cycling) and arms (arm-cranking) for children who are expected to lose their walking ability in the near future or are wheel chair dependent. Only arm-cranking will be applied to this study.

    Measure: Change from baseline in the a6MCT maximal attained revolutions

    Time: Baseline and up to Week 12

    Description: The fat fraction by MRS will be assessed for the vastus lateralis (VL) and soleus (SOL) muscles.

    Measure: Change from baseline in fat fraction by magnetic resonance spectroscopy (MRS)

    Time: Baseline, Week 12 and Week 24
    60 A Phase 1 Multiple Ascending Intradermal Dose Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites

    The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM). This study will also evaluate the effect of multiple ascending intradermal doses of ASP2390 on HDM-specific immunoglobulin G subclass 4 (IgG4) levels in adult male and female participants allergic to HDM.

    NCT04184895
    Conditions
    1. Allergic to House Dust Mites
    Interventions
    1. Biological: ASP2390
    2. Biological: Placebo

    Primary Outcomes

    Description: AEs will be coded using medical dictionary for regulatory activities(MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product whether or not considered related to the medicinal product. Confirmed and suspected SARS-CoV-2 infection and COVID-19 will be recorded as an AE. An AE is considered serious if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.

    Measure: Number of participants with Adverse Events (AEs)

    Time: Up to 5 years

    Description: Number of participants with potentially clinically significant laboratory values.

    Measure: Number of participants with laboratory value abnormalities and/or AEs

    Time: Up to week 63

    Description: Number of participants with potentially clinically significant vital sign values.

    Measure: Number of participants with vital sign abnormalities and/or AEs

    Time: Up to week 63

    Description: Routine 12-lead ECGs will be taken after the participant has been resting in the supine position for at least 5 minutes. Routine 12-lead ECGs will be taken in triplicate.

    Measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs

    Time: Up to week 63

    Description: Subcutaneous immunotherapy systemic reaction events will be graded using the World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. Each grade is based on organ system involved and severity. Organ systems are defined as cutaneous, conjunctival, upper respiratory, lower respiratory, gastrointestinal, cardiovascular and other. A reaction from a single organ system such as cutaneous, conjunctival or upper respiratory, but not asthma, gastrointestinal, or cardiovascular is classified as a grade 1. Symptom(s)/sign(s) from more than 1 organ system or asthma, gastrointestinal, or cardiovascular are classified as grades 2 or 3. Respiratory failure or hypotension with or without loss of consciousness define grade 4 and death grade 5. The grade is determined by the physician's clinical judgement.

    Measure: Number of participants with subcutaneous immunotherapy systemic reaction events

    Time: Up to week 11

    Description: Participants will be asked to record local reactogenicity (pain, tenderness, erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).

    Measure: Number of participants with specific local reactogenicity events

    Time: Up to week 12

    Description: Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).

    Measure: Number of participants with specific systemic reactogenicity events

    Time: Up to week 12

    Secondary Outcomes

    Description: The house dust mite (HDM) allergen-specific IgG4 immunological response for all participants will be presented for each treatment by visit using descriptive statistics.

    Measure: Change from baseline in immunological response to ASP2390 as assessed by HDM allergen-specific IgG4 levels

    Time: Baseline and up to week 24
    61 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab

    This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

    NCT04189484
    Conditions
    1. Healthy Subjects
    2. Pharmacokinetics
    3. Pharmacodynamics
    Interventions
    1. Biological: Evolocumab
    2. Biological: Evolocumab
    3. Biological: Evolocumab
    4. Biological: Evolocumab
    5. Biological: Alirocumab
    6. Biological: Alirocumab
    7. Biological: Alirocumab
    8. Biological: Alirocumab
    9. Biological: Placebo

    Primary Outcomes

    Description: The values and variability of AUEC for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

    Measure: Area under effect curve (AUEC) for LDL-C for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Description: The values and variability of maximum change from baseline for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

    Measure: Maximum change from baseline for LDL-C for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Secondary Outcomes

    Description: The values and variability of AUEC for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

    Measure: AUEC for Apolipoprotein B (ApoB) for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Description: The values and variability of maximal difference at a single time-point for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

    Measure: Maximum change from baseline for apoB for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Description: The values and variability of Cmax at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

    Measure: Maximum concentration (Cmax) for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Description: The values and variability of AUC at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

    Measure: Area under the curve (AUC) for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Description: Model parameters (Emax) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

    Measure: Pharmacodynamic model parameters (maximum effect [Emax]) for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm

    Description: Model parameters (EC50) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

    Measure: Pharmacodynamic model parameters (half maximum effect concentration [EC50]) for evolocumab and alirocumab

    Time: 42, 56, or 84 days, depending on treatment arm
    62 A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 Administered as Oral Solution and Tablets to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Bioavailability Comparison of BI 474121 as Tablet Versus Oral Solution and Tablet With and Without Food (BA Part)

    The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.

    NCT04194645
    Conditions
    1. Healthy
    Interventions
    1. Drug: BI 474121
    2. Drug: Placebo

    Primary Outcomes

    Measure: Percentage of subjects with drug-related adverse events (Single-rising dose (SRD) part)

    Time: Up to 15 days

    Measure: BA part: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    Time: Up to 96 hours

    Measure: BA part: Cmax (maximum measured concentration of the analyte in plasma)

    Time: Up to 96 hours

    Secondary Outcomes

    Measure: SRD part: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

    Time: Up to 96 hours

    Measure: SRD part: Cmax (maximum measured concentration of the analyte in plasma)

    Time: Up to 96 hours

    Measure: BA part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time: Up to 96 hours
    63 A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) and Acquired Angioedema (AAE) Due to C1-INH Deficiency

    The purpose of this study is to evaluate the safety and efficacy of repeated subcutaneous (SC) administrations of lanadelumab in preventing angioedema attacks in adolescents and adults with non-histaminergic angioedema with normal C1-INH and in adults with acquired angioedema (AAE) due to C1-INH deficiency.

    NCT04206605
    Conditions
    1. Angioedema
    Interventions
    1. Drug: Lanadelumab
    2. Other: Placebo
    MeSH:Angioedema Angioedemas, Hereditary
    HPO:Angioedema

    Primary Outcomes

    Description: An angioedema attack is defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 will be assessed.

    Measure: Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182

    Time: Day 0 through Day 182

    Secondary Outcomes

    Description: Number of participants achieving attack-free status during the treatment period of day 0 through day 182 will be assessed.

    Measure: Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182

    Time: Day 0 through Day 182

    Description: Moderate attack is defined as grade 2 (some assistance may be needed, no or minimal medical intervention/therapy required), Severe attack is defined as grade 3 (some assistance usually required, medical intervention/therapy required, hospitalizations possible). Number of investigator-confirmed moderate or severe angioedema attacks during the treatment period of day 0 through day 182 will be assessed.

    Measure: Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182

    Time: Day 0 Through Day 182

    Description: Number of investigator-confirmed angioedema attacks during the presumed steady state period of day 70 through day 182 will be assessed.

    Measure: Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182

    Time: Day 70 through Day 182

    Description: Number of participants achieving attack-free status during the presumed steady state period of day 70 through day 182 will be assessed.

    Measure: Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182

    Time: Day 70 through Day 182

    Description: Number of investigator-confirmed moderate or severe angioedema attacks during the presumed steady state period of day 70 through day 182 will be assessed.

    Measure: Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182

    Time: Day 70 through Day 182

    Description: Number of participants with maximum attack severity during the presumed steady state period of day 70 through day 182 will be assessed.

    Measure: Number of Participants with Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182

    Time: Day 70 through Day 182

    Description: Number of participants with maximum attack severity during treatment period of day 0 through day 182 will be assessed.

    Measure: Number of Participants with Maximum Attack Severity During Treatment Period of Day 0 Through Day 182

    Time: Day 0 through Day 182

    Description: The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 0 through Day 182 will be calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 0 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 0 through Day 182.

    Measure: Time to First Angioedema Attack After Day 0 Through Day 182

    Time: Day 0 Through Day 182

    Description: The time to the first angioedema attack (days) after Day 0 for the efficacy evaluation period of Day 70 through Day 182 will be calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 70 through Day 182) to the date and time of the first in angioedema attack after the first dose for the efficacy evaluation period of Day 70 through Day 182.

    Measure: Time to First Angioedema Attack After Day 70 Through Day 182

    Time: Day 70 through Day 182

    Description: Efficacy evaluation period will consist of two periods: Day 0 (after study drug administration) through Day 182 (the end of treatment period), presumed steady-state period from Day 70 through Day 182. Run in period will be 4 weeks and may be extended up to 8 weeks to determine their baseline attack rate. The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period will be expressed as a monthly (28 days) angioedema attack rate. Number of participants achieving at least 50 percent (%), 70%, 90% and 100% reduction in the investigator-confirmed normalized number of attacks per 4 weeks during each of the efficacy evaluation periods relative to the observation period NNA will be assessed.

    Measure: Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) per 4 Weeks during each of the Efficacy Evaluation Periods Relative to the Observation Period NNA

    Time: Day 0 Through Day 182

    Description: The normalized number of investigator-confirmed angioedema attacks (NNA) during each efficacy evaluation period will be expressed as a monthly (28 days) angioedema attack rate. Number of participants achieving normalized number of attacks < 1.0 per 4 weeks during each of the efficacy evaluation periods will be assessed.

    Measure: Number of Participants Achieving Normalized Number of Attacks (NNA) Less than (<)1.0 per 4 weeks During Each of the Efficacy Evaluation Periods

    Time: Day 0 Through Day 182, Day 70 through Day 182

    Description: A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product (IP) or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. AESI will include hypersensitivity reactions, events of disordered coagulation such as bleeding AESI, hypercoagulable AESI. Number of participants with TEAEs including AESI and SAE will be assessed.

    Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)

    Time: From start of the study up to follow up (Day 196)

    Description: Plasma Concentrations of lanadelumab will be assessed.

    Measure: Plasma Concentrations of Lanadelumab

    Time: Day 0, 4, 28, 56, 84, 112, 140, 168 and 182

    Description: Plasma Kallikrein activity will be measured by biomarker cleaved high molecular weight kininogen (cHMWK ) level to assess pharmacodynamics of lanadelumab.

    Measure: Plasma Kallikrein (pKal) Activity

    Time: Day 0, 4, 28, 56, 84, 112, 140, 168 and 182

    Description: Number of participants with neutralizing or non-neutralizing antidrug antibodies in plasma will be assessed.

    Measure: Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma

    Time: Day 0, 28, 56, 84, 112, 140, 168 and 182

    Description: The AE-QoL questionnaire is a self-administered validated instrument to assess health related (HR)QoL among participants with recurrent angioedema. The AE-QoL consists of 17 disease-specific quality-of-life items, to produce a total AEQoL score and 4 domain scores (functioning, fatigue/mood, fear/shame, and nutrition) and each of the 17 items has a five point response scale ranging from 1 (Never) to 5 (Very Often).

    Measure: Change in Total Angioedema Quality of life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182

    Time: Day 0 through Day 182
    64 Single-Centre, Randomised, Double-Blind, 3-Period Cross-Over Study to Investigate Effects on QTcF Interval of Verinurad ER 24 mg or IR 40 mg in Combination With Allopurinol 300 mg, Compared to Matching Placebos In Healthy Volunteers

    This study will be conducted to investigate the safety of verinurad in healthy volunteers in combination with allopurinol 300 mg, compared with placebo in particular its effect on electrocardiogram (ECG), with focus on the QT/QTc interval

    NCT04256629
    Conditions
    1. Healthy Volunteers (Intended Indication: Chronic Kidney Disease)
    Interventions
    1. Drug: Verinurad
    2. Drug: Placebo
    3. Drug: Allopurinol
    MeSH:Kidney Diseases Renal Insufficiency, Chronic
    HPO:Abnormality of the kidney Chronic kidney disease Nephropathy

    Primary Outcomes

    Description: To assess the effect of a single dose of verinurad given as either a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supra-therapeutic exposure), both in combination with allopurinol 300 mg, on the QTcF interval compared to placebo using a concentration-QTcF interval analysis

    Measure: Maximum observed plasma concentration (Cmax)

    Time: Visit 2,3,4:- Day 1: Pre-dose, 0.5,1,1.5,2, 3, 4, 5, 6, 7, 8 and 12 hours post-dose; Day 2: 24 and 36 hours post-dose; Day 3: 48 hours post-dose

    Description: To assess the effect of a single dose of verinurad given as either a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supra-therapeutic exposure), both in combination with allopurinol 300 mg, on the QTcF interval compared to placebo using a concentration-QTcF interval analysis

    Measure: Baseline-corrected and placebo-adjusted QTcF interval (ΔΔQTcF)

    Time: Screening; Visit 2,3,4:- Day -1, 1,2, 3; Follow up visit (7 to 10 days after the last dose)

    Secondary Outcomes

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation(supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected heart rate (ΔHR)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted heart rate (ΔΔHR)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected RR interval (ΔRR interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted RR interval (ΔΔRR interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected PR interval (ΔPR interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted PR interval (ΔΔPR interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted QRS interval (ΔQRS interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted QRS interval (ΔΔQRS interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected QT interval (ΔQT interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted QT interval (ΔΔQT interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected QTcF interval (ΔQTcF interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To investigate the effect of verinurad given either as a 24 mg ER8 formulation (therapeutic exposure) or a 40 mg IR formulation (supratherapeutic exposure), both in combination with allopurinol 300 mg

    Measure: Baseline-corrected and placebo-adjusted QTcF interval (ΔΔQTcF interval)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To assess the pharmacokinetics (PK) of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Area under plasma concentration-time curve from zero to infinity (AUC)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects.

    Measure: Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC0-t)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Maximum observed plasma concentration (Cmax)

    Time: Visit 2,3, and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Time to reach maximum observed plasma concentration (tmax)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Time delay between drug administration and the first observed concentration in plasma (tlag)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Time of last quantifiable plasma concentration (tlast)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Apparent total body clearance of drug from plasma after extravascular administration (parent drug only) [CL/F]

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Apparent volume of distribution during the terminal phase after extravascular administration (parent drug only) [Vz/F]

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Apparent volume of distribution at steady state (Vss/F)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess the PK of verinurad and its metabolites (M1 and M8) and allopurinol and its metabolite (oxypurinol) in healthy subjects

    Measure: Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)

    Time: Visit 2, 3 and 4:- Day 1: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 12 h post-dose; Day 2: 24 and 36 h post-dose; Day 3: 48 h post-dose

    Description: To assess clinical chemistry/hematology/urinalysis as a variable of safety and tolerability of verinurad and allopurinol

    Measure: Number of subjects with abnormal haematology, clinical chemistry and urinalysis

    Time: Screening; Visit 2,3 and 4:- Day -1, Day 3: 48 h post-dose, Follow up period

    Description: To assess vital signs as a variable of safety and tolerability of verinurad and allopurinol

    Measure: Number of subjects with abnormal blood pressure and pulse rate

    Time: Screening; Visit 2,3 and 4:- Day -1, Day 1: pre-dose, 1 and 6 h post-dose; Day 2: 24 h post-dose; Day 3: 48 h post-dose, Follow up visit
    65 MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial

    The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.

    NCT04267926
    Conditions
    1. Multiple Sclerosis
    2. Fatigue
    Interventions
    1. Drug: 20 mg MitoQ
    2. Drug: Placebo
    3. Drug: 40mg of MitoQ
    MeSH:Multiple Sclerosis Sclerosis Fatigue
    HPO:Fatigue

    Primary Outcomes

    Description: MFIS is a self -reported fatigue survey. Scale 0 - 84

    Measure: Modified Fatigue Inventory Scale (MFIS)

    Time: 12 weeks

    Secondary Outcomes

    Description: SDMT measures cognitive function. Scale 0-110

    Measure: Symbol Digit Modalities Test (SDMT)

    Time: 12 weeks

    Description: EDSS measures neurological function. Scale 0-10

    Measure: Expanded Disability Status Scale (EDSS)

    Time: 12 weeks

    Description: BDI is a self-reported questionnaire measuring depression. Scale 0-21

    Measure: Beck's Depression Inventory (BDI)

    Time: 12 weeks
    66 Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19

    The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.

    NCT04273646
    Conditions
    1. 2019 Novel Coronavirus Pneumonia
    2. COVID-19
    Interventions
    1. Biological: UC-MSCs
    2. Drug: Placebo
    MeSH:Coronavirus Infections Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Evaluation of Pneumonia Improvement

    Measure: Pneumonia severity index

    Time: From Baseline (0W) to 12 week after treatment

    Description: Evaluation of Pneumonia Improvement

    Measure: Oxygenation index (PaO2/FiO2)

    Time: From Baseline (0W) to 12 week after treatment

    Secondary Outcomes

    Description: Incidence of acute and chronic treatment-related adverse events in patients with novel coronavirus severe pneumonia receiving UC-MSCs infusion as assessed.

    Measure: Side effects in the UC-MSCs treatment group

    Time: From Baseline (0W) to 96 week after treatment

    Description: Marker for efficacy of treatment

    Measure: 28-days survival

    Time: Day 28

    Description: Markers of organ function(Score each criterion on a scale of 0 to 4, and the higher the score, the worse the prognosis.)

    Measure: Sequential organ failure assessment

    Time: Day 28

    Description: Markers of Infection

    Measure: C-reactive protein

    Time: From Baseline (0W) to 12 week after treatment

    Description: Markers of Infection

    Measure: Procalcitonin

    Time: From Baseline (0W) to 12 week after treatment

    Description: Marker of Immunological function

    Measure: Lymphocyte count

    Time: From Baseline (0W) to 12 week after treatment

    Description: Marker of Immunological function

    Measure: CD3+, CD4+ and CD8+ T celll count

    Time: From Baseline (0W) to 12 week after treatment

    Description: Marker of Immunological function

    Measure: CD4+/CD8+ratio

    Time: From Baseline (0W) to 12 week after treatment
    67 The Efficacy of Treating Pulmonary Fibrosis and Pulmonary Function Injury in COVID-19 With the Fuzheng Huayu Tablets: a Multicenter Randomized Controlled Trial

    According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.

    NCT04279197
    Conditions
    1. Pulmonary Fibrosis Due to COVID-19
    Interventions
    1. Drug: Fuzheng Huayu Tablet
    2. Drug: Vitamin C tablets
    3. Other: Placebo
    4. Other: respiratory function rehabilitation training
    MeSH:Pulmonary Fibrosis Fibrosis
    HPO:Pulmonary fibrosis

    Primary Outcomes

    Description: Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.

    Measure: The improvement proportion of pulmonary fibrosis

    Time: Week 24

    Secondary Outcomes

    Description: Evaluation of Lung Function Improvement

    Measure: Blood oxygen saturation

    Time: Week 24

    Description: Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19

    Measure: Clinical symptom score

    Time: Week 24

    Description: This scale can reflect the quality of life of patients to some extent.

    Measure: Quality of Life-BREF (QOL-BREF)

    Time: Week 24

    Description: This scale can reflect the quality of life of patients to some extent.

    Measure: Patient Health Questionnaire-9(PHQ-9)

    Time: Week 24

    Description: This scale can reflect the quality of life of patients to some extent.

    Measure: Generalized anxiety disorder-7(GAD-7)

    Time: Week 24

    Description: Evaluation of Lung Function Improvement

    Measure: The 6-minute walk distance

    Time: Week 24
    68 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

    This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

    NCT04280705
    Conditions
    1. COVID-19
    Interventions
    1. Other: Placebo
    2. Drug: Remdesivir

    Primary Outcomes

    Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.

    Measure: Time to Recovery

    Time: Day 1 through Day 29

    Secondary Outcomes

    Description: Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Alanine Transaminase (ALT)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Aspartate Transaminase (AST)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Creatinine

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Glucose

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Hemoglobin

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Platelets

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Prothrombin Time (PT)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Total Bilirubin

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in White Blood Cell Count (WBC)

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Neutrophils

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Lymphocytes

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Monocytes

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Basophils

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

    Measure: Change From Baseline in Eosinophils

    Time: Days 1, 3, 5, 8, 11, 15 and 29

    Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.

    Measure: Change in National Early Warning Score (NEWS) From Baseline

    Time: Days 1, 3, 5, 8, 11, 15, 22, and 29

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1

    Time: Day 1

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3

    Time: Day 3

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5

    Time: Day 5

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8

    Time: Day 8

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11

    Time: Day 11

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15

    Time: Day 15

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22

    Time: Day 22

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.

    Measure: Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29

    Time: Day 29

    Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

    Measure: Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)

    Time: Day 1 through Day 29

    Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

    Measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)

    Time: Day 1 through Day 29

    Description: Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.

    Measure: Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics

    Time: Day 1 through Day 10

    Description: Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

    Measure: Duration of Hospitalization

    Time: Day 1 through Day 29

    Description: Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

    Measure: Duration of New Non-invasive Ventilation or High Flow Oxygen Use

    Time: Day 1 through Day 29

    Description: Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die .

    Measure: Duration of New Oxygen Use

    Time: Day 1 through Day 29

    Description: Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

    Measure: Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

    Time: Day 1 through Day 29

    Description: New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.

    Measure: Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use

    Time: Day 1 through Day 29

    Description: The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline

    Measure: Percentage of Participants Requiring New Oxygen Use

    Time: Day 1 through Day 29

    Description: The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline

    Measure: Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

    Time: Day 1 through Day 29

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.

    Measure: Mean Change in the Ordinal Scale

    Time: Day 1, 3, 5, 8, 11, 15, 22, and 29

    Description: The mortality rate was determined as the proportion of participants who died by study Day 15.

    Measure: 14-day Participant Mortality

    Time: Day 1 through Day 15

    Description: The mortality rate was determined as the proportion of participants who died by study Day 29.

    Measure: 29-day Participant Mortality

    Time: Day 1 through Day 29

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant

    Measure: Time to an Improvement by at Least One Category Using an Ordinal Scale

    Time: Day 1 through Day 29

    Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant

    Measure: Time to an Improvement of at Least Two Categories Using an Ordinal Scale

    Time: Day 1 through Day 29

    Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.

    Measure: Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First

    Time: Day 1 through Day 29
    69 Human Umbilical Cord Mesenchymal Stem Cells Treatment for Pneumonia Patients Infected by 2019 Novel Coronavirus

    The 2019 novel coronavirus pneumonia outbroken in Wuhan, China, which spread quickly to 26 countries worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, there is no effective treatment in clinical practice. The present clinical trial is to explore the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for novel coronavirus pneumonia patients.

    NCT04293692
    Conditions
    1. COVID-19
    Interventions
    1. Biological: UC-MSCs
    2. Other: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Evaluation of Pneumonia change

    Measure: Size of lesion area by chest imaging

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Evaluation of Pneumonia change

    Measure: Blood oxygen saturation

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Secondary Outcomes

    Description: Marker for efficacy of treatment

    Measure: Rate of mortality within 28-days

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: 0-4 score, the higher the score is, the poor of the prognosis will be.

    Measure: Sequential organ failure assessment

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Number of participants with treatment-related adverse events

    Measure: Side effects in the UC-MSCs treatment group

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Markers of the heart function

    Measure: Electrocardiogram, the changes of ST-T interval mostly

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Markers of infection

    Measure: Concentration of C-reactive protein C-reactive protein, immunoglobulin

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Marker of Immunology and inflammation

    Measure: CD4+ and CD8+ T cells count

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Marker of Immunology and inflammation

    Measure: Concentration of the blood cytokine (IL-1β, IL-6, IL-8,IL-10,TNF-α)

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

    Description: Markers of the heart function

    Measure: Concentration of the myocardial enzymes

    Time: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8
    70 A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

    This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.

    NCT04298060
    Conditions
    1. Influenza Infection
    2. SAD-RV Infection and COVID-19
    Interventions
    1. Drug: DAS181
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Influenza, Human

    Primary Outcomes

    Description: Percent of subjects who have returned to room air

    Measure: Percent of subjects who have returned to room air

    Time: 7 days

    Description: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

    Measure: Percent change of subjects return to baseline oxygen requirement

    Time: 7 days
    71 Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)

    The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other staff working in a facility where there are cases of either proven, or suspected, COVID-19, who can be followed reliably for 5 months. 40,000 participants will be recruited and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.

    NCT04303507
    Conditions
    1. COVID19
    2. Coronavirus
    3. Acute Respiratory Illnesses
    Interventions
    1. Drug: Chloroquine or Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Description: Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups

    Measure: Number of symptomatic COVID-19 infections

    Time: Approximately 90 days

    Secondary Outcomes

    Description: Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.

    Measure: Symptoms severity of COVID-19

    Time: Approximately 90 days

    Description: Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.

    Measure: Number of asymptomatic cases of COVID-19

    Time: Approximately 90 days

    Description: Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

    Measure: Number of symptomatic acute respiratory illnesses

    Time: Approximately 90 days

    Description: Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.

    Measure: Severity of symptomatic acute respiratory illnesses

    Time: Approximately 90 days

    Other Outcomes

    Description: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.

    Measure: Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.

    Time: Approximately 90 days

    Description: Number of days lost to work in relation to the treatment arm

    Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic.

    Time: Approximately 90 days

    Description: The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.

    Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs

    Time: Approximately 90 days

    Description: The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.

    Measure: Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L)

    Time: Approximately 90 days
    72 Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

    Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

    NCT04308668
    Conditions
    1. Corona Virus Infection
    2. Acute Respiratory Distress Syndrome
    3. SARS-CoV Infection
    4. Coronavirus
    5. Coronavirus Infections
    Interventions
    1. Drug: Hydroxychloroquine
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    Description: Number of participants at 14 days post enrollment with active COVID19 disease.

    Measure: Incidence of COVID19 Disease among those who are asymptomatic at baseline

    Time: 14 days

    Description: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

    Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline

    Time: 14 days

    Secondary Outcomes

    Description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

    Measure: Incidence of Hospitalization

    Time: 14 days

    Description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

    Measure: Incidence of Death

    Time: 90 days

    Description: Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.

    Measure: Incidence of Confirmed SARS-CoV-2 Detection

    Time: 14 days

    Description: Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.

    Measure: Incidence of Symptoms Compatible with COVID19 (possible disease)

    Time: 90 days

    Description: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

    Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal

    Time: 14 days

    Description: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

    Measure: Overall symptom severity at 5 and 14 days

    Time: 5 and 14 days

    Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

    Measure: Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry

    Time: 14 days
    73 Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

    This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).

    NCT04311177
    Conditions
    1. Corona Virus Infection
    2. Acute Respiratory Distress Syndrome
    3. SARS-CoV Infection
    Interventions
    1. Drug: Losartan
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    Description: Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.

    Measure: Hospital Admission

    Time: 15 days

    Secondary Outcomes

    Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

    Measure: Change in PROMIS Dyspnea Functional Limitations

    Time: baseline, 10 days

    Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

    Measure: Change in PROMIS Dyspnea Severity

    Time: baseline, 10 days

    Description: Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.

    Measure: Daily Maximum Temperature

    Time: 10 days

    Description: Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.

    Measure: Emergency Department/Clinic Presentations

    Time: 28 days

    Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

    Measure: Disease Severity Rating Day 7

    Time: 7 days

    Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

    Measure: Disease Severity Rating Day 15

    Time: 15 days

    Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

    Measure: Disease Severity Rating Day 28

    Time: 28 days

    Description: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

    Measure: Viral Load by Oropharyngeal Swab Day 9

    Time: 9 days

    Description: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

    Measure: Viral Load by Oropharyngeal Swab Day 15

    Time: 15 days

    Description: Outcome reported as the mean number of days participants in each arm did not require ventilator use.

    Measure: Ventilator-Free Days

    Time: 28 days

    Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use.

    Measure: Therapeutic Oxygen-Free Days

    Time: 28 days

    Description: Outcome reported as the percent of participants in each arm who require hospital admission by day 15 following randomization.

    Measure: Need for Hospital Admission at 15 Days

    Time: 15 days

    Description: Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.

    Measure: Need for Oxygen Therapy at 15 Days

    Time: 15 days
    74 Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

    This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.

    NCT04312009
    Conditions
    1. Corona Virus Infection
    2. Acute Respiratory Distress Syndrome
    3. SARS-CoV Infection
    Interventions
    1. Drug: Losartan
    2. Other: Placebo
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

    Primary Outcomes

    Description: Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.

    Measure: Difference in Estimated (PEEP adjusted) P/F Ratio at 7 days

    Time: 7 days

    Secondary Outcomes

    Description: Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.

    Measure: Daily Hypotensive Episodes

    Time: 10 days

    Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

    Measure: Hypotension Requiring Vasopressors

    Time: 10 days

    Description: Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.

    Measure: Acute Kidney Injury

    Time: 10 days

    Description: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.

    Measure: Sequential Organ Failure Assessment (SOFA) Total Score

    Time: 10 days

    Description: Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.

    Measure: Oxygen Saturation / Fractional Inhaled Oxygen (F/S)

    Time: 10 days

    Description: Outcome reported as the number of participants who have expired at 28 days post enrollment.

    Measure: 28-Day Mortality

    Time: 28 days

    Description: Outcome reported as the number of participants who have expired at 90 days post enrollment.

    Measure: 90-Day Mortality

    Time: 90 days

    Description: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

    Measure: ICU Admission

    Time: 10 days

    Description: Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.

    Measure: Number of Ventilator-Free Days

    Time: 10 days

    Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.

    Measure: Number of Therapeutic Oxygen-Free Days

    Time: 10 days

    Description: Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

    Measure: Number of Vasopressor-Free Days

    Time: 10 days

    Description: Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.

    Measure: Length of ICU Stay

    Time: 10 days

    Description: Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.

    Measure: Length of Hospital Stay

    Time: 10 days

    Description: Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.

    Measure: Incidence of Respiratory Failure

    Time: 10 days

    Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

    Measure: Change in PROMIS Dyspnea Functional Limitations

    Time: 10 days

    Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

    Measure: Change in PROMIS Dyspnea Severity

    Time: 10 days

    Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

    Measure: Disease Severity Rating

    Time: 10 days

    Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

    Measure: Viral Load by Nasopharyngeal Swab Day 9

    Time: 9 days

    Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

    Measure: Viral Load by Nasopharyngeal Swab Day 15

    Time: 15 days

    Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

    Measure: Viral Load by Blood Day 9

    Time: 9 days

    Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

    Measure: Viral Load by Blood Day 15

    Time: 15 days
    75 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

    Adults who have tested positive for SARS-CoV-2 infection and who do not require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome

    NCT04312997
    Conditions
    1. COVID-19
    Interventions
    1. Drug: PUL-042 Inhalation Solution
    2. Drug: Placebo
    MeSH:Infection Respiratory Aspiration

    Primary Outcomes

    Description: To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection and, 2) who do not require supplemental oxygen (Ordinal Scale for Clinical Improvement 3 or less) at the time of enrollment. The primary endpoint is the difference in the proportion of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

    Measure: Severity of COVID-19

    Time: 28 days

    Secondary Outcomes

    Description: SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy

    Measure: SARS-CoV-2 infection

    Time: 28 days

    Description: To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement. The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

    Measure: Severity of COVID-19 over 14 days

    Time: 14 days

    Description: To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score. The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening.

    Measure: Severity of COVID-19 symptoms

    Time: 28 days

    Description: The requirement for ICU admission within 28 days from the start of the experimental therapy.

    Measure: ICU admission

    Time: 28 days

    Description: The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.

    Measure: Mechanical Ventilation

    Time: 28 days

    Description: All cause mortality at 28 days from the start of experimental therapy

    Measure: Mortality

    Time: 28 days
    76 A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

    Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.

    NCT04313023
    Conditions
    1. COVID-19
    Interventions
    1. Drug: PUL-042 Inhalation Solution
    2. Drug: Placebo
    MeSH:Infection Disease Progression

    Primary Outcomes

    Description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.

    Measure: Severity of COVID-19

    Time: 28 days

    Secondary Outcomes

    Description: Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

    Measure: Incidence of SARS-CoV-2 infection

    Time: 28 days

    Description: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit

    Measure: Incidence of SARS-CoV-2 infection

    Time: 14 days

    Description: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.

    Measure: Severity of COVID-19

    Time: 14 days

    Description: The requirement for ICU admission within 28 days from the start of experimental therapy.

    Measure: ICU admission

    Time: 28 days

    Description: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.

    Measure: Mechanical ventilation

    Time: 28 days

    Description: All cause mortality at 28 days from the start of experimental therapy.

    Measure: Mortality

    Time: 28 days
    77 An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19

    Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 regardless of disease severity strata. Phase 3 Cohort 1: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with critical COVID-19 receiving mechanical ventilation at baseline. Phase 3 Cohort 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with COVID-19 receiving mechanical ventilation at baseline.

    NCT04315298
    Conditions
    1. COVID-19
    Interventions
    1. Drug: Sarilumab
    2. Drug: Placebo

    Primary Outcomes

    Description: Phase 2

    Measure: Percent change in C-reactive protein (CRP) levels in patients with serum IL-6 level greater than the upper limit of normal

    Time: Day 4

    Description: Phase 3 Cohort 1 7-point Ordinal Scale: Death; Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized

    Measure: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with critical COVID-19 receiving mechanical ventilation at baseline

    Time: Up to day 22

    Description: Phase 3 Cohort 2

    Measure: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale in patients with COVID-19 receiving mechanical ventilation at baseline

    Time: Up to day 22

    Secondary Outcomes

    Description: Phase 2

    Measure: Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical patients with serum IL-6 levels greater than the upper limit of normal

    Time: Up to day 29

    Description: Phase 2

    Measure: Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale reporting in severe or critical patients with all IL-6 levels

    Time: Up to day 29

    Description: Phase 2 Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary) Documented fever defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary)

    Measure: Time to resolution of fever for at least 48 hours without antipyretics in patients with documented fever

    Time: Up to day 29

    Description: Phase 2 Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)

    Measure: Time to resolution of fever for at least 48 hours without antipyretics by clinical severity

    Time: Up to day 29

    Description: Phase 2 Defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary)

    Measure: Time to resolution of fever for at least 48 hours without antipyretics by baseline IL-6 levels

    Time: Up to day 29

    Description: Phase 2 Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to improvement in oxygenation for at least 48 hours

    Time: Up to day 29

    Description: Phase 2 Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to improvement in oxygenation for at least 48 hours by clinical severity

    Time: Up to day 29

    Description: Phase 2 Defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to improvement in oxygenation for at least 48 hours by baseline IL-6 levels

    Time: Up to day 29

    Description: Phase 2 Resolution of fever defined as postbaseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary) Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2

    Measure: Time to resolution of fever and improvement in oxygenation for at least 48 hours

    Time: Up to day 29

    Description: Phase 2

    Measure: Mean change in the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 2

    Measure: Percentage of patients in each clinical status category using the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 2 NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)

    Measure: Time to discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours

    Time: Up to day 29

    Description: Phase 2

    Measure: Change from baseline in NEWS2 scoring system

    Time: Up to day 29

    Description: Phase 2 Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)

    Measure: Number of days with fever

    Time: Up to day 29

    Description: Phase 2

    Measure: Proportion of patients alive, off oxygen

    Time: At day 29

    Description: Phase 2

    Measure: Number of days of resting respiratory rate >24 breaths/min

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of days with hypoxemia

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of days of supplemental oxygen use

    Time: Up to day 29

    Description: Phase 2

    Measure: Time to saturation ≥94% on room air

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of ventilator free days in the first 28 days

    Time: Baseline to day 29

    Description: Phase 2

    Measure: Number of patients requiring initiation of mechanical ventilation

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of patients requiring non-invasive ventilation

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of patients requiring the use of high flow nasal cannula

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of patients admitted into an intensive care unit (ICU)

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of days of hospitalization among survivors

    Time: Up to day 29

    Description: Phase 2

    Measure: Number of deaths due to any cause

    Time: Up to day 60

    Description: Phase 3

    Measure: Proportion of patients with at least 1-point improvement in clinical status using the 7-point ordinal scale

    Time: Up to day 22

    Description: Phase 3 Defined as discharged, or alive without supplemental oxygen use or at pre-COVID oxygen use

    Measure: Proportion of patients who recover

    Time: Up to day 22

    Description: Phase 3

    Measure: Proportion of deaths

    Time: Through day 29

    Description: Phase 3

    Measure: Proportion of patients alive not receiving mechanical ventilation

    Time: At day 22

    Description: Phase 3

    Measure: Proportion of patients alive not requiring extracorporeal membrane oxygenation (ECMO)

    Time: At day 22

    Description: Phase 3

    Measure: Proportion of patients with a 2-point improvement in clinical status on the 7-point ordinal scale

    Time: Up to day 22

    Description: Phase 3

    Measure: Time to at least 1-point improvement in clinical status assessment on the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 3

    Measure: Time to at least 2-point improvement in clinical status assessment on the 7-point ordinal scale

    Time: Up to day 29

    Description: Phase 3

    Measure: Proportion of patients receiving mechanical ventilation

    Time: Up to day 22

    Description: Phase 3

    Measure: Proportion of patients receiving ECMO

    Time: Up to day 22

    Description: Phase 3

    Measure: Proportion of patients discharged and alive

    Time: At day 22

    Description: Phase 3 Defined as discharged or alive without supplemental oxygen use or at pre-COVID oxygen use

    Measure: Time to recovery

    Time: Up to day 29

    Description: Phase 3

    Measure: Proportion of deaths

    Time: Through day 60

    Description: Phase 3

    Measure: Time to death due to any cause

    Time: Through day 60

    Description: Phase 3

    Measure: Number of ventilator free days

    Time: Up to day 29

    Description: Phase 3

    Measure: Number of days of hospitalization among survivors

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with serious adverse events

    Time: Up to Day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with Grade 4 neutropenia (ANC <500/mm3)

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with Grade 4 neutropenia (ANC <500/mm3)

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with hypersensitivity reactions

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with infusion reactions

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: Proportion of patients with gastrointestinal perforation

    Time: Up to day 29

    Description: Phase 2 and Phase 3

    Measure: White blood cell count

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Hemoglobin levels

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Platelet count

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Creatinine levels

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Total bilirubin level

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Alanine aminotransferase (ALT) level

    Time: Up to day 29 if still hospitalized

    Description: Phase 2 and Phase 3

    Measure: Aspartate aminotransferase (AST) level

    Time: Up to day 29 if still hospitalized
    78 Exploratory Clinical Study to Assess the Efficacy of NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia

    This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.

    NCT04315987
    Conditions
    1. COVI
    2. COVID-19 Pneumonia
    Interventions
    1. Biological: NestaCell®
    2. Biological: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Ordinal scale (WHO ordinal scale that measures illness severity over time)

    Measure: Change in Clinical Condition

    Time: 10 days

    Secondary Outcomes

    Description: Evaluation of Pneumonia change

    Measure: Rate of mortality within 10-days

    Time: 10 days

    Description: Evaluation of Pneumonia change

    Measure: Change of Clinical symptoms - respiratory rate

    Time: 10 days

    Description: oxygen saturation

    Measure: Hypoxia

    Time: 10 days

    Description: oxygen saturation

    Measure: PaO2 / FiO2 ratio

    Time: 10 days

    Description: Marker of Immunological function

    Measure: CD4+ and CD8+ T cell count

    Time: Days 1, 2, 4, 6 and 8.

    Description: PaO2 / FiO2 ratio

    Measure: Changes of blood oxygen

    Time: 10 days

    Description: Number of participants with treatment-related adverse events

    Measure: Side effects in the treatment group

    Time: 10 days

    Description: Complete blood count, ALT, AST, GGT, CK, CKmB and creatinine

    Measure: Complete blood count, cardiac, hepatic and renal profiles;

    Time: Days 1, 2, 4, 6 and 8.
    79 A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment

    The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe and critical COVID 19. Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 270 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

    NCT04317040
    Conditions
    1. Covid19
    Interventions
    1. Drug: CD24Fc
    2. Drug: Placebo

    Primary Outcomes

    Description: Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 2, 3, or 4" to "scale 5 or higher" based on NIAID ordinal scales.

    Measure: Improvement of COVID-19 disease status

    Time: 29 days

    Secondary Outcomes

    Description: Proportion of patients who died or had respiratory failure, defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high flow oxygen devices, at Day 29

    Measure: Proportion of patients who died or had respiratory failure.

    Time: 29 days

    Description: Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation, or ESMO, or death, or from NIAID scale 2 to death.

    Measure: Disease progression of COVID-19

    Time: 29 days

    Description: All cause of death

    Measure: All cause of death

    Time: 15 days and 29 days

    Description: Proportion of clinical relapse, as defined by rate of return to oxygen support for more than 1 day within 29 days from randomization after initial recovery

    Measure: Proportion of clinical relapse

    Time: 29 days

    Description: Conversion rate of clinical status on days 8 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

    Measure: Conversion rate of clinical status at Day 8

    Time: 8 days

    Description: Conversion rate of clinical status on days 15 (proportion of subjects who changed from NIAID ordinal "scale 3 or 4" to "scale 5 or higher")

    Measure: Conversion rate of clinical status at Day 15

    Time: 15 days

    Description: The discharge time, calculated after the randomization.

    Measure: Hospital discharge time

    Time: 29 days

    Description: Duration of mechanical ventilation (IMV, NIV) (days)

    Measure: Duration of mechanical ventilation

    Time: 29 days

    Description: Duration of pressors (days)

    Measure: Duration of pressors

    Time: 29 days

    Description: Duration of extracorporeal membrane oxygenation (days)

    Measure: Duration of ECMO

    Time: 29 days

    Description: Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days)

    Measure: Duration of high flow oxygen therapy

    Time: 29 days

    Description: Changes of absolute lymphocyte count in peripheral blood

    Measure: Absolute lymphocyte count

    Time: 29 days

    Description: The changes of plasma concentration of D-dimers

    Measure: Change of D-dimers

    Time: 15 and 29 days
    80 Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

    This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150. During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored. The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy. Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.

    NCT04319900
    Conditions
    1. Novel Coronavirus Pnuemonia
    Interventions
    1. Drug: favipiravir tablets+chloroquine phosphatetablets tablets
    2. Drug: Favipiravir tablets
    3. Drug: Placebo
    MeSH:Coronavirus Infections Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Description: Time of improvement or recovery of respiratory symptoms

    Measure: Time of Improvement or recovery of respiratory symptoms

    Time: 10 days during the intervention period

    Description: Number of days from positive to negative for test of swab or sputum virus nucleic acid

    Measure: Number of days virus nucleic acid shedding

    Time: 10 days during the intervention period

    Description: Frequency of improvement or recovery of respiratory symptoms

    Measure: Frequency of Improvement or recovery of respiratory symptoms

    Time: 10 days during the intervention period

    Secondary Outcomes

    Description: Duration of fever after recruitment

    Measure: Duration of fever

    Time: 10 days during the intervention period

    Description: Disease is defined as severe if it meets any of the following criteria: 1.Respiratory rate ≥30/min; 2. Oxygen saturation ≤93%; 3. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) ≤300 mmHg (1 mmHg=0.133 kPa)

    Measure: Frequencies of progression to severe illness

    Time: 10 days during the intervention period

    Description: Time of improvement of pulmonary imaging

    Measure: Time of improvement of pulmonary imaging

    Time: 10 days during the intervention period

    Description: Peripheral blood c-reactive protein concentration

    Measure: Peripheral blood c-reactive protein concentration

    Time: day-1,3,7,14 after the intervention period

    Description: Absolute value of peripheral blood lymphocytes

    Measure: Absolute value of peripheral blood lymphocytes

    Time: day-1,3,7,14 after the intervention period

    Description: percentage of peripheral blood lymphocytes

    Measure: percentage of peripheral blood lymphocytes

    Time: day-1,3,7,14 after the intervention period
    81 A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

    This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

    NCT04320615
    Conditions
    1. COVID-19 Pneumonia
    Interventions
    1. Drug: Tocilizumab (TCZ)
    2. Drug: Placebo
    MeSH:Pneumonia
    HPO:Pneumonia

    Primary Outcomes

    Measure: Clinical Status Assessed Using a 7-Category Ordinal Scale

    Time: Day 28

    Secondary Outcomes

    Measure: Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of Time: Up to 60 days

    Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status

    Time: Up to 60 days

    Measure: Incidence of Mechanical Ventilation

    Time: Up to 60 days

    Measure: Ventilator-Free Days to Day 28

    Time: Up to Day 28

    Measure: Incidence of Intensive Care Unit (ICU) Stay

    Time: Up to 60 days

    Measure: Duration of ICU Stay

    Time: Up to 60 days

    Measure: Time to Clinical Failure

    Time: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days). If already in ICU on ventilation, failure = a one-category worsening on the ordinal scale, withdrawal, or death

    Measure: Mortality Rate

    Time: Days 7, 14, 21, 28, and 60

    Measure: Time to Hospital Discharge

    Time: Up to 60 days

    Measure: Time to Recovery

    Time: Up to 60 days

    Measure: Duration of Time on Supplemental Oxygen

    Time: Up to 60 days

    Measure: Percentage of Participants with Adverse Events

    Time: Up to 60 days

    Measure: COVID-19 (SARS-CoV-2) Viral Load Over Time

    Time: Up to 60 days

    Measure: Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity

    Time: Up to 60 days

    Measure: Proportion of Participants with Post-Treatment Infection

    Time: Up to 60 days

    Measure: Serum Concentration of IL-6

    Time: Up to 60 days

    Measure: Serum Concentration of sIL-6R

    Time: Up to 60 days

    Measure: Serum Concentration of Ferritin

    Time: Up to 60 days

    Measure: Serum Concentration of C-Reactive Protein (CRP)

    Time: Up to 60 days

    Measure: Serum Concentration of TCZ

    Time: Up to 60 days
    82 Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

    A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated. Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening. The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

    NCT04325893
    Conditions
    1. Coronavirus
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Coronavirus Infections

    Primary Outcomes

    Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.

    Time: Day 14

    Secondary Outcomes

    Measure: Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.

    Time: Day 28

    Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

    Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 14

    Time: Day 14

    Description: WHO Ordinal Scale for Clinical Improvement ranges from 0 to 8, higher score meaning poorer outcome

    Measure: Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.

    Time: Day 28

    Measure: Number of all-cause mortality at day 14

    Time: Day 14

    Measure: Number of all-cause mortality at day 28

    Time: Day 28

    Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 5

    Time: Day 5

    Measure: Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10

    Time: Day 10

    Measure: The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.

    Time: Day 28

    Measure: Number of all-cause mortality at day 28 in patients aged 75 and older

    Time: day 28

    Measure: Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older

    Time: day 28

    Measure: Rate of severe adverse events at day 28

    Time: day 28

    Measure: Number of all-cause mortality at day 14 in patients aged 75 and older

    Time: day 14
    83 ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

    This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

    NCT04326426
    Conditions
    1. Coronavirus Infection
    Interventions
    1. Drug: Tradipitant
    2. Drug: Placebo
    MeSH:Infection Co Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

    Time: 14 days or discharge

    Secondary Outcomes

    Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

    Time: 14 days or discharge

    Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

    Time: 14 days or discharge

    Measure: In-hospital mortality

    Time: 14 days or discharge

    Measure: Mean change in NEWS2 score from baseline

    Time: 14 days or discharge

    Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

    Time: 14 days or discharge

    Measure: Reduction from baseline of NRS for cough

    Time: 14 days or discharge

    Measure: Reduction from baseline of NRS for nausea

    Time: 14 days or discharge

    Measure: Time to normalization of fever for at least 48 hours

    Time: 14 days or discharge

    Measure: Time to improvement in oxygenation for at least 48 hours

    Time: 14 days or discharge
    84 An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

    Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19 Secondary Objectives: - Evaluate the 28-day survival rate - Evaluate the clinical efficacy of sarilumab compared to the