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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug1539 | Hydroxychloroquine Sulfate Tablets Wiki | 0.15 |
drug4019 | pregnant women with laboratory-confirmed 2019-n-CoV Wiki | 0.15 |
drug2134 | NaCl Solution Wiki | 0.10 |
Name (Synonyms) | Correlation | |
---|---|---|
drug2124 | NO intervention planned due to the observational study design only a diagnostic testing Wiki | 0.10 |
drug887 | Convalescent Plasma 1 Unit Wiki | 0.10 |
drug2113 | NETosis markers Wiki | 0.10 |
drug332 | Aviptadil 67μg Wiki | 0.10 |
drug400 | Bariatric procedures Wiki | 0.10 |
drug2989 | Saline containing 1% Human serum albumin(solution without UC-MSCs) Wiki | 0.10 |
drug3414 | Thrombin Generation Assay (TGA) Wiki | 0.10 |
drug774 | Clarithromycin Wiki | 0.10 |
drug1266 | F-652 Wiki | 0.10 |
drug1099 | Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki | 0.10 |
drug962 | Cytokines measurement Wiki | 0.10 |
drug3428 | To assess for development of IgG antibodies against SARS-CoV2 Wiki | 0.10 |
drug3890 | inhalable hydroxychloroquine (HCQ) Wiki | 0.10 |
drug2552 | Placebo on a 0- and 14-day schedule Wiki | 0.10 |
drug178 | Aerosolized 13 cis retinoic acid plus Inhalation Inhaled testosterone Wiki | 0.10 |
drug2496 | Placebo (PB0) Wiki | 0.10 |
drug643 | COVID-19 treatment Wiki | 0.10 |
drug1745 | Ivermectin 3mg Tab Wiki | 0.10 |
drug1615 | IgM and IgG antibodies assay Wiki | 0.10 |
drug2006 | Mental imagery Wiki | 0.10 |
drug1540 | Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki | 0.10 |
drug2882 | RoActemra iv Wiki | 0.10 |
drug357 | BAT2020 Wiki | 0.10 |
drug1098 | Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki | 0.10 |
drug4098 | supportive and symptomatic treatment Wiki | 0.10 |
drug2866 | Review of medical patient file Wiki | 0.10 |
drug1989 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.10 |
drug3972 | nosocomial infection/hospital acquired infection Wiki | 0.10 |
drug1679 | Interferon-ß-1a Wiki | 0.10 |
drug821 | Collection of blood, salivary and nasopharyngeal samples. Wiki | 0.10 |
drug2964 | SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) Wiki | 0.10 |
drug790 | Cliniporator Wiki | 0.10 |
drug679 | CYNK-001 Wiki | 0.10 |
drug1832 | Listerine Mouthwash Product Wiki | 0.10 |
drug1546 | Hydroxychloroquine in combination of Azithromycin Wiki | 0.10 |
drug2695 | Pulmonary and Motor Rehabilitation Wiki | 0.10 |
drug3383 | The standard therapy Wiki | 0.10 |
drug1211 | Equipment with smartwatch throughout hospital stay on the general ward Wiki | 0.10 |
drug2507 | Placebo 0.10 mg + 1.00 mg/kg Wiki | 0.10 |
drug1088 | Drug: GS-5734 - 1.00 mg/kg Wiki | 0.10 |
drug377 | BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki | 0.10 |
drug868 | Contrast-enhanced CMR Wiki | 0.10 |
drug1425 | Health Questionnaire Wiki | 0.10 |
drug3612 | Viral Specific T-cells (VSTs) Wiki | 0.10 |
drug1095 | Drug: NA-831 - 0.20 mg/kg Wiki | 0.10 |
drug1299 | Favipiravir Combined With Tocilizumab Wiki | 0.10 |
drug2606 | Povidine iodine nasal swabs Wiki | 0.10 |
drug891 | Convalescent Plasma as Therapy for Covid-19 patients Wiki | 0.10 |
drug791 | CloSYS mouthwash Wiki | 0.10 |
drug35 | 2019-nCoV IgG/IgM Rapid Test Cassette Wiki | 0.10 |
drug1119 | ELISA and Rapid test to detect antibodies against COVID-19 Wiki | 0.10 |
drug1726 | Investigational Product - ViraCide Wiki | 0.10 |
drug3416 | Thrombomodulin Modified Thrombin Generation Assay (TGA-TM) Wiki | 0.10 |
drug2360 | Oxytocin Wiki | 0.10 |
drug1851 | Lopinavir/ Ritonavir Oral Tablet Wiki | 0.10 |
drug3873 | hydroxychloroquine in combination with camostat mesylate Wiki | 0.10 |
drug2875 | Risk factors Wiki | 0.10 |
drug814 | Coldamaris pro, nasal spray Wiki | 0.10 |
drug2467 | Phone call interview Wiki | 0.10 |
drug1772 | Kevzara sc Wiki | 0.10 |
drug1674 | Interferon alfa Wiki | 0.10 |
drug963 | D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester Wiki | 0.10 |
drug498 | Bolus placebo Wiki | 0.10 |
drug4043 | rNAPc2 Wiki | 0.10 |
drug941 | Covigenix VAX-001 placebo Wiki | 0.10 |
drug684 | Cambridge Validated Viral Detection Method Wiki | 0.10 |
drug1873 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.10 |
drug1454 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.10 |
drug192 | AlloStim Wiki | 0.10 |
drug957 | CytoSorb Wiki | 0.10 |
drug1118 | ELISA Wiki | 0.10 |
drug3905 | labs Wiki | 0.10 |
drug1012 | Degarelix Wiki | 0.10 |
drug3130 | Sofosbuvir Wiki | 0.10 |
drug1067 | Distilled water Wiki | 0.10 |
drug3755 | biological samples collection Wiki | 0.10 |
drug2772 | RT-PCR Covid-19 Wiki | 0.10 |
drug233 | Anluohuaxian Wiki | 0.10 |
drug2375 | PF-07304814 Wiki | 0.10 |
drug1585 | IL-12 plasmid Wiki | 0.10 |
drug1038 | Diagnostic test Covid-19 Wiki | 0.10 |
drug2781 | Radiological Detection Wiki | 0.10 |
drug2883 | RoActemra sc Wiki | 0.10 |
drug1371 | Gargle/Mouthwash Wiki | 0.10 |
drug2667 | Prophylactic/Intermediate Dose Enoxaparin Wiki | 0.10 |
drug2859 | Resting 12 lead ECG Wiki | 0.10 |
drug2639 | Primary exposure is hypoxia (no intervention) Wiki | 0.10 |
drug2567 | Placebo- 1.00 mg/kg Wiki | 0.10 |
drug2117 | NHANES smell and taste tests Wiki | 0.10 |
drug888 | Convalescent Plasma 2 Units Wiki | 0.10 |
drug3573 | VLA2001 Wiki | 0.10 |
drug981 | Daily Vitamin D3 Wiki | 0.10 |
drug3001 | Saliva specimen Wiki | 0.10 |
drug1046 | Dietary supplementation in patients with covid disease admitted to hospital Wiki | 0.10 |
drug2565 | Placebo- 0.10 mg/kg Wiki | 0.10 |
drug3158 | Stabilized hypochlorous acid Wiki | 0.10 |
drug1313 | Fingerstick Wiki | 0.10 |
drug1599 | IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki | 0.10 |
drug534 | Broncho-Vaxom® Wiki | 0.10 |
drug2689 | Public Health England Gold Standard Wiki | 0.10 |
drug2508 | Placebo 0.20 mg + 2.00 mg/kg Wiki | 0.10 |
drug38 | 24 hour Holter ECG Wiki | 0.10 |
drug2506 | Placebo - Starch Powder Soft gels Wiki | 0.10 |
drug2570 | Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine Wiki | 0.10 |
drug942 | Crest Pro-Health Multi-Protection mouthwash Wiki | 0.10 |
drug2509 | Placebo 0.9% NaCl solution Wiki | 0.10 |
drug2728 | Querying the INSEE database Wiki | 0.10 |
drug1236 | Exercise test ECG Wiki | 0.10 |
drug2783 | Raman analysis of saliva, characterization of the Raman database and building of the classification model Wiki | 0.10 |
drug1965 | Massive parallel sequencing of host genome Wiki | 0.10 |
drug2342 | Oral-B Mouth Sore mouthwash Wiki | 0.10 |
drug1436 | Hemopurifier Wiki | 0.10 |
drug2850 | Respiratory infections Wiki | 0.10 |
drug2410 | Partially HLA-matched SARS-CoVSTs Wiki | 0.10 |
drug3313 | TLRs activation measurement Wiki | 0.10 |
drug1282 | Face mask sampling Wiki | 0.10 |
drug1628 | Immunofree tablets and Reginmune capsule Wiki | 0.10 |
drug3488 | TriCor® 145mg tablets Wiki | 0.10 |
drug1094 | Drug: NA-831 - 0.10 mg/kg Wiki | 0.10 |
drug975 | DWJ1248 Wiki | 0.10 |
drug982 | Daily placebo Wiki | 0.10 |
drug1198 | Enoxaparin Prefilled Syringe [Lovenox] Wiki | 0.10 |
drug1257 | Extended sampling and procedures Wiki | 0.10 |
drug722 | Cellular response Wiki | 0.10 |
drug577 | CORVax Wiki | 0.10 |
drug1856 | Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet Wiki | 0.10 |
drug1077 | Dose Finding Phase (MTD) Wiki | 0.10 |
drug940 | Covigenix VAX-001 Wiki | 0.10 |
drug2568 | Placebo- 2.00 mg/kg Wiki | 0.10 |
drug3190 | Standard medical care Wiki | 0.10 |
drug2566 | Placebo- 0.20 mg/kg Wiki | 0.10 |
drug383 | BNT162a1 Wiki | 0.10 |
drug1415 | HFB30132A Wiki | 0.10 |
drug1764 | KIR phenotype evaluation Wiki | 0.10 |
drug347 | Azithromycin 500 milligram (mg) oral Tablet Wiki | 0.10 |
drug387 | BNT162c2 Wiki | 0.10 |
drug3372 | Tetrandrine Wiki | 0.10 |
drug2898 | SAMBA II (Diagnostic for the Real World) Wiki | 0.10 |
drug2887 | Routine care (no SARS-CoVSTs) Wiki | 0.10 |
drug2145 | Nasal Swab Wiki | 0.10 |
drug2453 | Personal Protective Testing Booth Wiki | 0.10 |
drug1619 | Imaging by thoracic scanner Wiki | 0.10 |
drug1643 | Inactivated SARS-CoV-2 vaccine (Vero cell) Wiki | 0.10 |
drug499 | Bolus vitamin D3 Wiki | 0.10 |
drug1857 | Lopinavir/Ritonavir 200 mg/50 mg Film Tablet Wiki | 0.10 |
drug1089 | Drug: GS-5734 - 2.00 mg/kg Wiki | 0.10 |
drug210 | Anakinra Wiki | 0.09 |
drug1292 | Favipiravir Wiki | 0.09 |
drug1455 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.07 |
drug3461 | Tranexamic acid Wiki | 0.07 |
drug519 | Brequinar Wiki | 0.07 |
drug2780 | Radiation therapy Wiki | 0.07 |
drug1300 | Favipiravir Placebo Wiki | 0.07 |
drug638 | COVID-19 survey Wiki | 0.07 |
drug2553 | Placebo on a 0- and 28-day schedule Wiki | 0.07 |
drug3412 | Throat swab Wiki | 0.07 |
drug1195 | Enoxaparin 40 Mg/0.4 mL Injectable Solution Wiki | 0.07 |
drug3955 | nasopharyngeal swab Wiki | 0.07 |
drug1990 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.07 |
drug1874 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 0.07 |
drug977 | Daclatasvir Wiki | 0.07 |
drug3430 | Tocilizumab Wiki | 0.07 |
drug2985 | Saline Wiki | 0.07 |
drug2490 | Placebo Wiki | 0.06 |
drug384 | BNT162b1 Wiki | 0.06 |
drug3979 | observational Wiki | 0.06 |
drug3043 | Selinexor Wiki | 0.06 |
drug1023 | Dexamethasone Wiki | 0.06 |
drug1807 | Lenzilumab Wiki | 0.06 |
drug2771 | RT-PCR Wiki | 0.06 |
drug1116 | EIDD-2801 Wiki | 0.06 |
drug1437 | Heparin Wiki | 0.05 |
drug385 | BNT162b2 Wiki | 0.05 |
drug1193 | Enoxaparin Wiki | 0.05 |
drug367 | BCG vaccine Wiki | 0.05 |
drug2607 | Povidone-Iodine Wiki | 0.05 |
drug2249 | Normal Saline Wiki | 0.05 |
drug3014 | Sargramostim Wiki | 0.05 |
drug3191 | Standard of Care Wiki | 0.05 |
drug1842 | Lopinavir / Ritonavir Wiki | 0.05 |
drug594 | COVID-19 Wiki | 0.05 |
drug3524 | UC-MSCs Wiki | 0.05 |
drug991 | Data collection Wiki | 0.05 |
drug3193 | Standard of Care (SOC) Wiki | 0.05 |
drug3219 | Standard treatment Wiki | 0.04 |
drug2152 | Nasopharyngeal swab Wiki | 0.04 |
drug3697 | Zinc Wiki | 0.04 |
drug2557 | Placebo oral tablet Wiki | 0.04 |
drug3557 | Usual Care Wiki | 0.03 |
drug482 | Blood sample Wiki | 0.03 |
drug1507 | Hydroxychloroquine Wiki | 0.03 |
drug1527 | Hydroxychloroquine Sulfate Wiki | 0.03 |
drug808 | Colchicine Wiki | 0.03 |
drug2192 | Nitazoxanide Wiki | 0.03 |
drug3628 | Vitamin C Wiki | 0.03 |
drug899 | Convalescent plasma Wiki | 0.02 |
drug2215 | No intervention Wiki | 0.02 |
drug3199 | Standard of care Wiki | 0.02 |
drug884 | Convalescent Plasma Wiki | 0.02 |
drug341 | Azithromycin Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D012327 | RNA Virus Infections NIH | 0.26 |
D003333 | Coronaviridae Infections NIH | 0.19 |
D003141 | Communicable Diseases NIH | 0.18 |
Name (Synonyms) | Correlation | |
---|---|---|
D007239 | Infection NIH | 0.17 |
D012141 | Respiratory Tract Infections NIH | 0.16 |
D030341 | Nidovirales Infections NIH | 0.15 |
D018352 | Coronavirus Infections NIH | 0.15 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.12 |
D044342 | Malnutrition NIH | 0.10 |
D015817 | Eye Infections NIH | 0.10 |
D001424 | Bacterial Infections NIH | 0.10 |
D018357 | Respiratory Syncytial Virus Infections NIH | 0.10 |
D010608 | Pharyngeal Diseases NIH | 0.10 |
D006562 | Herpes Zoster NIH | 0.10 |
D006560 | Herpes Labialis NIH | 0.10 |
D055501 | Macrophage Activation Syndrome NIH | 0.10 |
D009059 | Mouth Diseases NIH | 0.07 |
D003139 | Common Cold NIH | 0.07 |
D009410 | Nerve Degeneration NIH | 0.07 |
D003231 | Conjunctivitis NIH | 0.07 |
D000208 | Acute Disease NIH | 0.07 |
D012140 | Respiratory Tract Diseases NIH | 0.06 |
D009767 | Obesity, Morbid NIH | 0.06 |
D000370 | Ageusia NIH | 0.06 |
D058070 | Asymptomatic Diseases NIH | 0.05 |
D003327 | Coronary Disease NIH | 0.05 |
D007154 | Immune System Diseases NIH | 0.05 |
D004211 | Disseminated Intravascular Coagulation NIH | 0.05 |
D009422 | Nervous System Diseases NIH | 0.05 |
D003428 | Cross Infection NIH | 0.05 |
D009765 | Obesity NIH | 0.04 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.04 |
D006331 | Heart Diseases NIH | 0.04 |
D008231 | Lymphopenia NIH | 0.04 |
D011014 | Pneumonia NIH | 0.04 |
D008173 | Lung Diseases, Obstructive NIH | 0.04 |
D014808 | Vitamin D Deficiency NIH | 0.03 |
D020246 | Venous Thrombosis NIH | 0.03 |
D007251 | Influenza, Human NIH | 0.03 |
D020141 | Hemostatic Disorders NIH | 0.03 |
D001778 | Blood Coagulation Disorders NIH | 0.03 |
D016638 | Critical Illness NIH | 0.03 |
D000857 | Olfaction Disorders NIH | 0.02 |
D011024 | Pneumonia, Viral NIH | 0.02 |
D018450 | Disease Progression NIH | 0.02 |
D008171 | Lung Diseases, NIH | 0.02 |
D013927 | Thrombosis NIH | 0.02 |
D007249 | Inflammation NIH | 0.02 |
D055370 | Lung Injury NIH | 0.02 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
D004630 | Emergencies NIH | 0.02 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
D013577 | Syndrome NIH | 0.01 |
D055371 | Acute Lung Injury NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0011947 | Respiratory tract infection HPO | 0.16 |
HP:0004395 | Malnutrition HPO | 0.10 |
HP:0000224 | Hypogeusia HPO | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000509 | Conjunctivitis HPO | 0.07 |
HP:0002180 | Neurodegeneration HPO | 0.07 |
HP:0005521 | Disseminated intravascular coagulation HPO | 0.05 |
HP:0001513 | Obesity HPO | 0.05 |
HP:0006510 | Chronic pulmonary obstruction HPO | 0.04 |
HP:0001888 | Lymphopenia HPO | 0.04 |
HP:0006536 | Pulmonary obstruction HPO | 0.04 |
HP:0100512 | Low levels of vitamin D HPO | 0.03 |
HP:0002090 | Pneumonia HPO | 0.03 |
HP:0002625 | Deep venous thrombosis HPO | 0.03 |
HP:0001928 | Abnormality of coagulation HPO | 0.03 |
HP:0000458 | Anosmia HPO | 0.02 |
HP:0002088 | Abnormal lung morphology HPO | 0.02 |
Navigate: Correlations HPO
There are 91 clinical trials
The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.
Description: Death event
Measure: Survival rate Time: 12 weeksDescription: inflammatory indicator
Measure: body temperature Time: 2 weeksBackground: - Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development. Objectives: - To collect samples and data from individuals who have been exposed to or have contracted viral infections. Eligibility: - Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases. - Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate. Design: - Participants will be pre-screened to determine if they meet the eligibility criteria for the trial. - If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies. - Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing. - Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection. - Treatment is not offered under this study.
Description: January 2031
Measure: Sample collection, analysis of immune function, or review of tissue bx or clinical rpts from outside labs in designated pop. w/ viral, suspected, or recovered from a viral infection or a close contact of people w/or suspected to have a viral inf... Time: open-endedCOVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. No specific anti-viral treatment exists. The mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Cellular therapy, using mesenchymal stem cells has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. This clinical trial is to inspect the safety and efficiency of mesenchymal stem cells (MSCs) therapy for severe COVID-19.
Description: Evaluation of Pneumonia Improvement
Measure: Change in lesion proportion (%) of full lung volume from baseline to day 28. Time: Day 28Description: Evaluation of Pneumonia Improvement
Measure: Change in lesion proportion (%) of full lung volume from baseline to day 10 and 90 Time: Day 10, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Change in consolidation lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90. Time: Day 10, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Change in ground-glass lesion proportion (%) of full lung volume from baseline to day 10, 28 and 90. Time: Day 10, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Pulmonary fibrosis - related morphological features in CT scan at day 90 a. cord-like shadow b. honeycomb-like shadows c. interlobular septal thickening d. intralobular interstitial thickening e. pleural thickening Time: Day 90Description: Evaluation of Pneumonia Improvement
Measure: Lung densitometry: Change in total voxel 'weight' in lesion area voxel 'weight'=voxel density (in HU) × voxel volume (in voxel) Time: Day 10, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Lung densitometry: volumes histogram of lung density distribution (<-750, -750~-300, -300~50, >50) at day 10, 28 and 90. Time: Day 10, Day 28, Day 90Description: Clinical improvement defined as a one-point deduction from baseline in a 6 ordinal scale: Not hospitalized; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Time to clinical improvement in 28 days. Time: Day 28Description: Evaluation of Pneumonia Improvement
Measure: Oxygenation index( PaO2/FiO2) Time: Day 6, Day 10, Day 28Description: Evaluation of Pneumonia Improvement
Measure: Duration of oxygen therapy(days) Time: Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Blood oxygen saturation Time: Day 6, Day 10, Day 28Description: Evaluation of Pneumonia Improvement
Measure: 6-minute walk test Time: Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Maximum vital capacity (VCmax) Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement
Measure: Diffusing Capacity (DLCO) Time: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90Description: Evaluation of Pneumonia Improvement No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.
Measure: mMRC (Modified Medical Research Council) dyspnea scale Time: Day 28, Day 90Description: Marker of Immunological function
Measure: Changes of absolute lymphocyte counts and subsets from baseline to day 6, 10, 28 and 90. Time: Day 6, Day 10, Day 28, Day 90Description: Marker of Immunological function
Measure: Changes of cytokine/chemokine levels from baseline to day 6, 10, 28 and 90. Time: Day 6, Day 10, Day 28, Day 90Description: Safety endpoints
Measure: Adverse events Time: Day 0 through Day 90Description: Safety endpoints
Measure: Serious adverse events Time: Day 0 through Day 90Description: Safety endpoints
Measure: All-cause mortality Time: Day 0 through Day 90Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported. The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2. Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals. The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals. Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.
Description: The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.
Measure: nosocomial infection Time: At inclusionThe study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.
Description: Death event
Measure: Survival rate Time: 12 weeksDescription: inflammatory indicator
Measure: body temperature Time: 2 weeksThe purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.
Description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 3 monthsThe Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.
Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission
Measure: Maternal and perinatal outcomes Time: during gestation and at the time of delivery of the babyIn the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.
Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples
Measure: Rate of decline in SARS-CoV-2 viral load Time: Baseline (at randomization) and at 96 hoursDescription: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.
Measure: Change in National Early Warning Score score Time: Baseline (at randomization) and at 96 hoursDescription: Transfer from regular ward to intensive care unit during index admission
Measure: Admission to intensive care unit Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality during index admission
Measure: In-hospital mortality Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Measure: Duration of hospital admission Time: During index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality assessed at 30 and 90 days
Measure: Mortality at 30 and 90 days Time: At follow-up 30 and 90 daysDescription: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities
Measure: Clinical status Time: 14 days after randomizationDescription: Change in C-reactive protein concentrations from randomization to 96 hours after randomization
Measure: Change in C-reactive protein concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in alanine aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in aspartate aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in bilirubin concentrations from randomization to 96 hours after randomization
Measure: Change in bilirubin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization
Measure: Change in estimated glomerular filtration rate Time: Baseline (at randomization) and at 96 hoursDescription: Change in cardiac troponin concentrations from randomization to 96 hours after randomization
Measure: Change in cardiac troponin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization
Measure: Change in natriuretic peptide concentrations Time: Baseline (at randomization) and at 96 hoursThe Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.
Description: different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission
Measure: Maternal and perinatal outcomes Time: at the time of deliveryThis study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Measure: Categorization of hospitalization status Time: 14 daysDescription: Delta PaO2 measured in arterial puncture
Measure: Change in patient's oxygen partial pressure Time: 4 daysDescription: Delta PaCO2 measured in arterial puncture
Measure: Change in patient's carbondioxid partial pressure Time: 4 daysDescription: pH measured in arterial puncture
Measure: Level of pH in blood Time: 4 daysCoronavirus disease 2019 (COVID-19) is caused by the newly discovered coronavirus, SARS-CoV-2. The median time from onset of symptoms of COVID-19 to development of acute respiratory distress syndrome (ARDS) has been reported as short as 9 days. No effective prophylactic or post-exposure therapy is currently available. According to data from the Danish Health Authority (www.sst.dk/corona), as of March 21st, 2020, there were 1326 patients infected with the disease in Denmark, more than 250 are admitted to a hospital, and >50 of them have required intensive care. Nearly 350.000 cases and 15.000 deaths have been reported globally. These numbers are likely to markedly increase during the coming weeks, challenging the capacity of health systems worldwide. In patients infected with SARS-CoV-2, it has been described that disease severity and outcomes are related to the characteristics of the immune response. Interleukin (IL)-6 and other components of the inflammatory cascade contribute to host defense against infections. However, exaggerated synthesis of IL-6 can lead to an acute severe systemic inflammatory response known as 'cytokine storm'. In the pathogenesis of SARS-CoV-2 pneumonia, a study found that a cytokine storm involving a considerable release of proinflammatory cytokines occurred, including IL-6, IL-12, and tumor necrosis factor α (TNF-α). Studies on the Middle East respiratory syndrome caused by another coronavirus (MERS-CoV), indicate that cytokine genes of IL-6, IL-1β, and IL-8 can be markedly upregulated. Similarly, patients with SARS-CoV-2 pneumonia admitted to an intensive care unit had higher plasma levels of cytokines including IL-6, IL-2, IL-7, IL-10, granulocyte-colony stimulating factor (G-CSF), interferon-γ-inducible protein (IP10), monocyte chemoattractant protein (MCP1), macrophage inflammatory protein 1 alpha (MIP1A), and TNF-α. These findings indicate that the magnitude and characteristics of the cytokine response is related to the severity and prognosis of patients with SARS-CoV-2 pneumonia. It has been suggested that IL-6 blockade may constitute a novel therapeutic strategy for other types of cytokine storm, such as the systemic inflammatory response syndrome including sepsis, macrophage activation syndrome and hemophagocytic lymphohistiocytosis. Remarkable beneficial effects of IL-6 blockade therapy using a IL-6 receptor inhibitor has been described in patients with severe SARS-CoV-2 pneumonia in a retrospective case series from China. Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi). IL-6 receptor inhibitors are currently licensed for several autoimmune disorders and are considered well tolerated and safe in general. The most common side effects reported are upper respiratory tract infections, headache, hypertension, and abnormal liver function tests. The most serious side effects are serious infections, complications of diverticulitis, and hypersensitivity reactions. it is hypothesized that IL-6 might play a key role in the cytokine storm associated with serious adverse outcomes in patients infected with SARS-CoV-2 pneumonia, and that blockade of IL-6 would be suitable therapeutic target for these patients. The study will investigate the effect of different types of IL-6 inhibition versus no adjuvant treatment compared to standard of care in patients with severe SARS-CoV-2 pneumonia. Primary objective: To compare the effect of either one of three IL-6 inhibitor administrations, relative to the standard of care, on time to independence from supplementary oxygen therapy, measured in days from baseline to day 28, in patients with severe SARS-CoV-2 pneumonia.
Description: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: baselineDescription: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: peak during hospitalisation, up to 28 daysDescription: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: 14 daysDescription: Measured from standard blood test
Measure: C-reactive protein (CRP) level Time: 28 daysDescription: Measured as occurrence of any serious adverse events
Measure: Number of participants with serious adverse events Time: During treatment, up to 28 daysResearchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.
Description: Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients
Measure: ICU and hospital mortality of COVID-19 patients Time: 7 daysDescription: Secondary outcome will be to measure 30 days mortality from Hospital discharge
Measure: 30 days mortality Time: 30 daysCOVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.
Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard
Measure: SAMBA COVID-19 POC PCR Test Time: 28 daysDescription: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale
Measure: Patient acceptability Time: 28 daysDescription: Time to positive IgM/IgG test positivity
Measure: Immune Response Positivity Time: 40 daysBased on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.
Description: Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)
Measure: Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee Time: 3 weeksDescription: Maximal concentration of high-sensitivity cardiac troponin
Measure: Maximal concentration of cardiac troponin Time: 10 daysCoronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death. Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR. It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors. It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.
Description: Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19
Measure: Coinfections Time: during ICU stay, up to 28 daysDescription: it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance)
Measure: Respiratory dysfunction requiring mechanical ventilation Time: during ICU stay, up to 28 daysDescription: 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).
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: during ICU stay, up to 28 daysDescription: APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%.
Measure: SAPS II score Time: at admissionDescription: The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained
Measure: Disseminated Intravascular Coagulation (DIC) score Time: during ICU stay, up to 28 daysDescription: measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality.
Measure: Short Form 36 Time: at 9 months +/- 3 months after ICU stayDescription: The scale allows to detect anxiety and depression using 14 items rated from 0-3. Measuring the long-term impact of confirmed COVID-19 infection
Measure: Hospital anxiety and depression scale (HADS) Time: at 9 months +/- 3 months after ICU stayDescription: 22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection
Measure: Impact of Event Scale - revised (IES-R) Time: at 9 months +/- 3 months after ICU stayDescription: Question the stressful experience or event, followed by 20 multiple-choice questions. Measuring the long-term impact of confirmed COVID-19 infection
Measure: Post-traumatic stress disorder Checklist version DSM-5 (PSL-5) Time: at 9 months +/- 3 months after ICU stayDescription: The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection
Measure: Modified Medical Research Council (MMRC) Dyspnea Scale Time: at 9 months +/- 3 months after ICU stayDescription: Evolution of viral clearance in nasal and depp PCR during ICU
Measure: Viral clearance Time: through study completion, an average of 28 daysThe coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.
Description: From blood samples: protein levels, whole genome sequence, transcriptomic analysis data. From upper respiratory samples: protein levels, virus transcriptomic analysis data. From stool: microbiota analysis data. From urine: protein level.
Measure: COVID-19 desease description Time: Inclusion visit (Day 1)Description: From blood samples: protein levels.
Measure: COVID-19 desease description Time: Day 30 to 90To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
Description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
Measure: Viral nucleic acid test negative conversion rate Time: 5 monthsDescription: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
Measure: Clinical cure rate Time: 5 monthsTo evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
Description: Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Measure: Changes in high-resolution computer tomography of the lung Time: 3 monthsDescription: St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.
Measure: Changes in the scores of the St. George's Hospital Respiratory Questionnaire Time: 3 monthsDescription: mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.
Measure: Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores Time: 3 monthsDescription: Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
Measure: Changes in vital capacity of the lung Time: 3 monthsBackground: Aim: To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design, participants and interventions: Prospective, randomized, parallel group, double-blinded, placebo controlled, study. including 440 participants who will be randomised to 2 treatment arms: hydroxychloroquine or placebo. Outcome variables: symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR, viral load during SARS-CoV-2 infection, seroconversion during the study period, incidence of any acute respiratory infection, days of sick leave. Statistical considerations: No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers. Thus, sample size calculations in the proposed trial are based on the investigators' best estimates for several parameters. In accordance to the effect of oseltamivir against symptomatic influenza, we assumed an approximate effectiveness of approximately 60% (HR of 0.4) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464969/) as realistic. As a prophylactic intervention with HCQ, which may have side effects and for which supply shortage can be expected, was judged justifiable only if its effectiveness is high, we based our sample size consideration on a HR of 0.3. To estimate the probability of an event in both the experimental and the control group, very little data is available. In a Dutch point-prevalence study 0-10% of health-care workers were infected depending on the healthcare institution, depending on the hospital. This point-prevalence study was performed between 6 and 9 March, when the reported number of cases in the Netherlands was 33 and 77, respectively, according to the RIVM (https://www.rivm.nl/nieuws/resultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus). Additionally, in an a report published in the Lancet, 20% of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext). Several media reports indicate that this proportion is similar across various healthcare institutions and countries (https://www.nytimes.com/2020/03/24/world/europe/coronavirus-europe-covid-19.html) and (https://www.aljazeera.com/news/2020/03/spain-tightens-restrictions-week-lockdown-begins-2003 30191539568.html). As the proposed study will be performed in a high-risk setting, we assumed an event (i.e. PCR positivity) probability of 10% in the control group and 3% in the experimental arm after the maximum study period. In summary, a sample size of 210 participants per arm is necessary to detect a HR of 0.3 with a power of 80.3% with an alpha-error of 0.05. To account for drop-outs and asymptomatic, undetected infection at inclusion or past infection with existing immunity, an additional 10 participants will randomized per treatment arm. The overall study population is therefore 440 participants. Statistical analysis will be based on two populations: A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline. And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80% of all doses of study medication.
Arriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.
Description: children admitted to pediatric emergencies for respiratory signs Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs Respiratory asymptomatic children admitted to pediatric emergencies
Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients Time: at the end an average 28 daysDescription: the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency
Measure: Contact frequency Time: At inclusionOur aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.
Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8
Measure: Change of baseline total sequential organ failure assessment (SOFA) score Time: Visit study day 8Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8
Measure: Improvement of lung involvement measurements Time: Visit study day 8Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8
Measure: Increase of pO2/FiO2 ratio Time: Visit Study Day 8Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of sequential organ failure assessment (SOFA) score Time: Day 28Description: Mortality on day 28
Measure: Rate of Mortality Time: Day 28Description: Mortality on day 90
Measure: Rate of Mortality Time: Day 90Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Cytokine stimulation Time: Screening, Day 4Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Gene expression Time: Screening, Day 4Description: Change of serum/plasma proteins between days 0 and 4
Measure: Serum/plasma proteins Time: Screening, Day 4Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation
Measure: Classification of the immune function Time: ScreeningThere is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting. In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources. This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.
Description: Secondary aggravation is defined as : a re-hospitalization or aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death
Measure: Rate of secondary aggravation Time: an average at 30 days (- 2 days +3 days) of admission to the emergency departmentDescription: the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.
Measure: Change of standart biological parameters Time: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency departmentThe COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.
Description: Analysis of all-cause death in relation with clinical patient profile
Measure: Death rate Time: Through study completion, an average of 4 weeksDescription: Correlation between clinical patient profile and transfer need to intensive care unit
Measure: Transfer to intensive care unit Time: Through study completion, an average of 4 weeksDescription: Type of ventilation procedures needed during the hospitalization (Orotracheal intubation for mechanical ventilation or Non-invasive ventilation or 29/5000 high flow oxygen therapy - Optiflow) in relation with clinical patient profile
Measure: Ventilation analysis Time: Through study completion, an average of 4 weeksDescription: Description of clinical and biological patient profile leading to a worse prognosis
Measure: Construction of a predictive score for COVID-19 severe form Time: Through study completion, an average of 4 weeksSummary of the study Study population: A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD) Potential output and analysis: - Extent of age-specific infection and antibody formation - Cumulative incidence of infection - Rate of asymptomatic infection - Relationship with socioeconomics, lifestyle and risk factors (comorbidities) Study design: Prospective, longitudinal, stratified by age and gender Duration of study: Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months) Information to be obtained from participants: - serum samples for information on SARS-CoV2 infection and antibody formation - data on clinical symptoms
Description: Antibody Titres IgG and IgM
Measure: Prevalence of SARS-CoV-2 antibody titres Time: 5 weeksDescription: Re-Calculation including incidence of the general population
Measure: Prevalence of SARS-CoV-2 antibody titres after 3 Months Time: 4 MonthsCoronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.
Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry
Measure: Fibrosis Time: 12 monthsDescription: Decreased functional capacity on ergospirometers
Measure: Ergospirometers Time: 12 monthesThe purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
Measure: Safety of in-hospital thromboprophylaxis Time: Day 30Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).
Measure: Median twice-daily enoxaparin dose Time: 4 hours post initial doseDescription: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalizedDescription: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.
Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE Time: Day 30Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).
Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support Time: Day 30The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.
Description: The primary objective of the study will be evaluated by the proportion of patients contaminating the air 1 meter from their face. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR.
Measure: Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. Time: within 48 hours of the confirmation of SARS-Cov-2 infection documented by RT-PCRInflammation and abnormalities in laboratory coagulation tests are inseparably tied. For example, coagulation abnormalities are nearly universal in septic patients. Coagulation disorders have also been reported in many patients with severe courses of Coronavirus disease 2019 (Covid-19). But it is difficult to assess these changes. Global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. But other tests are available. Thrombin generation assay (TGA) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. But also in conventional TGA the protein C system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. Therefore the investigators add recombinant human thrombomodulin to a conventional TGA. Thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.
Description: nM;
Measure: ETP (AUC) without rhThrombomodulin (rhTM) Time: 6 monthsDescription: nM;
Measure: ETP (AUC) with rhThrombomodulin (rhTM) Time: 6 monthsDescription: Ratio of endogenous thrombin potential (ETP) with rhTM to ETP without rhTM
Measure: ETP-ratio Time: 6 monthsDescription: Comparison of ETP-ratios from ICU patients and ETP-ratios from citrated plasma samples from healthy donors
Measure: ETP-Normalisation Time: 6 monthsIn the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.
Description: The primary study endpoint is the ratio of patients who will develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered achieving the primary endpoint.
Measure: The ratio of patients who will develop serious respiratory failure (SRF) Time: Visit study day 14Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment Time: Visit study day 14Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of SOFA score in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of peripheral mononuclear blood cells' (PBMCs) functionality of enrolled subjects will be compared between days 1 and 7
Measure: Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7
Measure: Change of plasma inflammatory mediators levels between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Mortality on day 30
Measure: Rate of Mortality Time: Visit study day 30Description: Mortality on day 90
Measure: Rate of Mortality Time: Visit study day 90Description: Transcriptional, proteomic and metabolomic change will be compared between days 1 and 7
Measure: Change of gene expression between days 1 nad 7 Time: days 1 and 7This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 6 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 6 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 6 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 6 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 6 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 6 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysPurpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Description: Presence or absence of IgG antibodies to SARS-CoV2
Measure: Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. Time: at enrollmentDescription: swab for presence of SARS-CoV-2 virus
Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. Time: at enrollmentProphylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.
Description: assessed by positive polymerase chain reaction (PCR) from routine nasal swabs (performed every 28 days)
Measure: Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections Time: 12 weeks after initiation of therapyDescription: defined as combined endpoint of hospitalization rate or death
Measure: Number of severe COVID-19 cases Time: 12 weeks after initiation of therapyDescription: grading as outlined by the world health organization (WHO)
Measure: Severity of COVID-19 cases Time: 12 weeks after initiation of therapyDescription: significant clinical and laboratory abnormalities according to CTCAE criteria
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 12 weeks after initiation of therapyDescription: other than COVID-19
Measure: Number of viral and bacterial infections Time: 12 weeks after initiation of therapyDescription: Development of azithromycin-resistant bacterial strains as assessed by nasal swabs test
Measure: Number of participants with azithromycin-resistant bacterial strains in nasal swabs test Time: 12 weeks after initiation of therapySevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.
Description: Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples
Measure: Proportion of conjunctival samples tested positive for SARS-CoV-2 Time: 1 yearDescription: Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR
Measure: Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples Time: 1 yearDescription: Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR
Measure: Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples Time: 1 yearDescription: Number of patients developed COVID-19 divided by the number of the study population
Measure: Rate of development of COVID-19 in the study patient population Time: 1 yearDescription: Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19
Measure: Positive conjunctival sample rate in patient developed COVID-19 Time: 1 yearThis is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
Description: Time it takes to identify eligible donors whom are willing to donate
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measure: Plasma Donor Time: Measured in days for 365 daysDescription: Time from consent to infusion
Measure: Plasma Recipient Time: Measured evey 24 hours up to 30 daysDescription: Survival
Measure: Plasma Recipient Time: Measured in days with 30 day from discharge follow-upDescription: Time until plasma is donated
Measure: Plasma Donor Time: Measured every 24 hours up to 1 yearDescription: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Morbidity reduction
Measure: Plasma Recipient Time: Day 1, 2, 3, 4, 7, and 30 dayDescription: Reduced Length of Stay in hospital
Measure: Plasma Recipient Time: Measured every 24 hours until patient discharged from hospital up to 1 yearDescription: Reduced Length of Stay on Advance Respiratory Support
Measure: Plasma Recipient Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 yearThe overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.
The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children. Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children
Description: measure by two rt-PCR COVID-19 tests regardless the serological status of the child
Measure: evaluation of the prevalence of positive real-time-polymerase chain reaction (rt-PCR) in school children during the pandemic period in Nice Time: at 42 daysDescription: measure by two serological COVID-19 test (IgG and/or IgM)
Measure: evaluation of the serological prevalence of the Covid-19 infection Time: at inclusion and at 42 daysDescription: measure by two serological COVID-19 test (IgG and/or IgM)
Measure: evaluation of the COVID-19 reinfection among seropositive children at the inclusion time Time: at inclusion and at 42 daysDescription: positivity of rt-PCR test for other viruses (adenovirus, metapneumovirus, picornavirus, respiratory syncytial virus, influenza et parainfluenza and other coronavirus strains)
Measure: evaluation of the prevalence of positive rt-PCR of other respiratory viruses (including others coronavirus) Time: at 42 daysDescription: measure of level of the two inflammation biomarkers (IFIT1 interferon and CCL8)
Measure: comparison of inflammatory response level between different coronavirus strains Time: at 42 daysDescription: measure of the medico-social relative risk associated with rt-PCR COVID-19 test positivity among : school level, gender, school type, day care facilities before 11th May, number of siblings, housing type, number of bedrooms, precariousness level, by score EPICES ( (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'examens de santé, means Assessment of precariousness and health inequalities in health examination centers). Questionnaire of EPICES counts 11 items, the answer to each question is assigned a coefficient, the sum of the 11 answers gives the score EPICES. The score is continuous, it varies from 0 (lack of precariousness) to 100 (maximum precariousness).
Measure: Estimation of medico-social risk factors associated with COVID-19 infection Time: at 42 daysThe trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.
Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administrationDescription: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administrationDescription: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationCOVID-19 DISEASE Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus, severe acute respiratory syndrome from COVID-19, that was first recognized in Wuhan, China, in December 2019. While most people with COVID-19 develop mild or uncomplicated illness, approximately 14% develop severe disease requiring hospitalization and oxygen support and 5% require admission to an intensive care unit. In severe cases, COVID-19 can be complicated by acute respiratory disease syndrome (ARDS) requiring prolonged mechanical ventilation, sepsis and septic shock, multiorgan failure, including acute kidney, liver and cardiac injury. ARDS REHABILITATION Critically ill people who undergo prolonged mechanical ventilation often develop weakness, with severe symmetrical weakness of and deconditioning of the proximal musculature and of the respiratory muscles (critical illness neuropathy/myopathy).These individuals also develop significant functional impairment and reduced health-related quality of life (HRQL) up to 2 and 5 years after discharge. ARDS survivors may complain of depression, anxiety, memory disturbances, and difficulty with concentration often unchanged at 2 and 5 years. Less than half of all ARDS survivors return to work within the first year following discharge, two-thirds at two years, and more than 70% at five years. Early physiotherapy (PT) of people with ARDS has recently been suggested as a complementary therapeutic tool to improve early and late outcomes. The aims of PT programs should be to reduce complications of immobilization and ventilator-dependency, to improve residual function, to prevent new hospitalisations, and to improve health status and HRQL. Physiotherapy in critical patients is claimed also to prevent and contribute to treat respiratory complications such as secretion retention, atelectasis, and pneumonia. Early mobilization and maintenance of muscle strength may reduce the risk of difficult weaning, limited mobility, and ventilator dependency. Lastly, pulmonary rehabilitation in ICU in mechanically ventilated subjects may reduce length of stay in ICU up to 4.5 day, shorten mechanical ventilation of 2.3 days and weaning by 1.7 days. The aim of this study is to investigate how early pulmonary and motor rehabilitation impacts on length of hospital admission (ICU and acute ward) and early and late outcomes inpatients that develop ARDS due to COVID-19.
Description: days of ICU stay
Measure: Length of ICU stay Time: up to 60 daysDescription: days of hospital stay
Measure: Length of hospital stay Time: up to 90 daysELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.
Description: Time until participant reports well
Measure: Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'. Time: Maximum of 14 daysDescription: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)
Measure: Severity of all symptoms Time: 1-14 days or until the participant reports that they are wellDescription: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)
Measure: The length of time for individual symptoms to resolve Time: 1-14 days or until the participant reports that they are wellDescription: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)
Measure: Severity of individual symptoms Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants and frequency of contacts
Measure: Contacting healthcare (NHS 24, OOH, GP) Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants and frequency of contacts
Measure: Participants needing GP appointments Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants
Measure: Participants attending hospital Time: 1-14 days or until the participant reports that they are wellDescription: Number of days
Measure: Length of stay in hospital if admitted Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants
Measure: Number of participants reporting over the counter medication use Time: 1-14 days or until the participant reports that they are wellDescription: Number of people within participant's household who develop symptoms
Measure: Reduction in transmission to household contacts Time: 1-14 days or until the participant reports that they are wellDescription: Number of participants in intervention arm reporting side effects
Measure: Number of participants reporting side effects of nasal irrigation Time: 1-14 days or until the participant reports that they are wellDescription: Participants asked if they have experienced common side effects or other and to rate the severity on a 7 point scale of 'Did not have this side effect' to 'severe'
Measure: Types and severity of side effects reported Time: 1-14 days or until the participant reports that they are wellDescription: Estimated cost requested when participant states over the counter medication used
Measure: Cost of over the counter medication used Time: 1-14 days or until the participant reports that they are wellIntroduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects. Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim To describe: - Mortality 28 days after randomization - Time to mechanical ventilation during the study - Duration of dependency on oxygen supply - Length of stay - Temporal trend of clinical improvement (7-category ordinal scale) - Safety analysis
Description: Proportion of cases who during 14 days exhibit one of the following conditions (the most severe): respiratory failure that requires mechanical ventilation organ failure that requires intensive care monitoring and treatment death
Measure: Proportion of cases who during 14 exhibit one of the following conditions Time: 14 daysDescription: Mortality 28 days after randomization
Measure: Mortality 28 days after randomization Time: 28 daysBackground. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:
Description: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 1 MonthDescription: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 3 MonthsDescription: Usual weight at baseline vs weight before confinement (gk)
Measure: Weight changes during confinement Time: 8 weeksDescription: number and type of nutritional supplements from baseline
Measure: prescription of nutritional supplements and observance Time: 3 monthsCOVID-19 has adversely affected the healthcare system across the world. The world was not prepared for global outbreak of infectious diseases. The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is enabling researchers worldwide to acquire a large amount of clinical data regarding coronavirus disease (COVID-19). The COVID-19 infection severely affects the respiratory system in the critical cases and results in mortalities. The affected people experience a dry cough, fever, breathing problems, diarrhea, muscle pain, and sore throat. Besides that, some of the evidence from Italy, South Korea, China, and Spain suggest that the COVID-19 cases also lose their senses of smell and taste resulting in alterations in those patients. The objective of this proposed study is to determine whether COVID-19 cases have Olfactory and gustatory dysfunctions as a hallmark indicator and can be used as diagnostic tools for the isolation of suspected people. Investigators are presenting a prospective proportional case-control study that is conducted to investigate the COVID-19 cases with anosmia and /or Ageusia in a university hospital in Riyadh, Saudi Arabia. The sample size of this case series would be 250 cases of suspected COVID-19 patients. The cases included in the study are analyzed prospectively to determine if the cases had a history of anosmia and /or Ageusia, and then tested for the alteration of these senses through a panel of standardized odors/taste strips. That is looked at statistically allowing us to confirm the proposed effectiveness of these tests as a diagnostic tool.
Description: to how extent alteration of smell and taste senses is related to covid19 status
Measure: correlation of anosmia and ageusia to covid19 positive patients Time: from 1/06/2020 to 31/12/2020Description: to determine the range of sense affection ranging from total loss to mild form
Measure: objective assessment of severity of smell and taste senses alterations in covid19 patients Time: from 1/06/2020 to 31/12/2020Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.
Description: This is defined on day 8 (End of Treatment - EOT). Patients with upper respiratory tract infection by SARS-CoV-2 meet the study primary endpoint if they were not admitted to hospital or their symptoms did not progress to lower respiratory tract infection. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) Time: Day 1 to Day 8Description: This is defined on day 8 (EOT visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the primary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline Time: Day 1 to Day 8Description: Evaluation of need of hospitalization, SARS-CoV-2 infection progression from upper to lower respiratory tract infection, between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of two parameters with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Respiratory score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: Comparison of the score of respiratory symptoms with historical comparators from Hellenic Sepsis Study Group Database Time: Day 1 to Day 8Description: Comparison of clinical data (need of hospitalization, the infection progression of SARS-CoV-2 from upper to lower respiratory tract infections) in enrolled patients between baseline and study visit day 4 Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint.
Measure: Clinical outcome negative for two parameters(hospital admission/disease progression) on day 4 Time: Day 4Description: This is defined on day 4 (5th visit). Patients with lower respiratory tract infection by SARS-CoV-2 meet the secondary endpoint if they present at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain. Patients who develop by day 4 severe respiratory failure do not meet the study secondary endpoint. Score ranges from 0 (no symptoms) to 9 (worst for all symptoms).
Measure: At least 50% change of the score of respiratory symptoms from the baseline on day 4 Time: Day 4Description: Evaluation of range of enrolled patients who develop severe respiratory failure between baseline and day 14 (TOC VISIT). Severe respiratory failure is defined by presence of all of the following pO2/FiO2 less than 150 Need for mechanical or non-mechanical ventilation (CPAP)
Measure: Range of development of severe respiratory failure Time: Day 1 to Day 14Description: Evaluation of hospital readmission until day 14 (TOC VISIT) from enrollment defined as either need of re-hospitalization for discharged patients or any need for hospitalization of out-patients.
Measure: Range of hospital readmission until day 14 Time: Day 1 to Day 14Description: Comparison of Real Time - Polymerase Chain Reaction (RT-PCR) results for SARS-CoV-2 viral load in rhinopharyngeal samples of enrolled patients at days 1, 4 and 8
Measure: Change of viral load in respiratory secretions from baseline on day 8 Time: Day 1 to Day 8Description: Change of cytokine production of monocytes in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; monocytes will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of TNFα. This will be analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of function of monocytes at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th1 cells in enrolled patients with upper/lower respiratory tract infection at days 1 and 8 (EOT) visit; Th1 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IFNγ. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th1 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of cytokine production of Th2 cells in enrolled patients with lower respiratory tract infection at days 1 and 8 (EOT) visit; Th2 cells will be stimulated for 24 hours with SARS-CoV-2 purified antigens for the production of IL6. This will be analyzed separately for patients with upper and with lower respiratory tract infection.
Measure: Change of function of Th2 cells at days 1 and 8 Time: Day 1 to Day 8Description: Change of the serum levels of interleukin-6 (IL-6) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-6 (IL-6) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of interleukin-8 (IL-8) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum interleukin-8 (IL-8) cytokine levels between days 1 and 8 Time: Day 1 to day 8Description: Change of the serum levels of human beta defensin-2 (hBD-2) of enrolled patients between day 1 and day 8 (EOT VISIT); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of serum human beta defensin-2 (hBD-2) between days 1 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-6 (IL-6) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of cytokine levels interleukin-6 (IL-6) at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Change of rhinopharynx levels of interleukin-1 (IL-1) of enrolled patients between day 1, day 4 and day8 (EOT visit); this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of interleukin-1 (IL-1) cytokine levels at the rhinopharynx between days 1,4 and 8 Time: Day 1 to day 8Description: Comparison of the Interleukin-10/Tumor Necrosis Factor α (IL-10/TNFα) ratio in enrolled patients at days 1 and 8; this is also analyzed separately for patients with upper and with lower respiratory tract infection
Measure: Change of the IL-10/TNFα ratio between days 1 and 8 Time: Day 1 to Day 8SARS-CoV-2 transmission is frequently occurring in hospital settings, with numerous reported cases of nosocomial transmission highlighting the vulnerability of healthcare workers. If products proved to be efficacious against COVID-19, why are so many HCW getting COVID-19? Is it related to experience? Is it generated by the exhaustive job? Is there any degree of relationship to stress? These questions are still without fully correct answers. Achieving global benefits for HCW is still waiting.
Description: To assess the prevalence of surface contamination with COVID-19 from personal protective equipment (PPE) worn by medical doctors, immediately after evaluating sick patients
Measure: Asses surface contamination personel protective equipment Time: 2 monthsDescription: Quantify the amount of COVID-19 in the PPE doctor´s in contact with infected patients.
Measure: Virus charge cuantification Time: 2 monthsDescription: Determine the most frequent location of viruses inPPE
Measure: Place in PPE contamination Time: 2 monthDescription: using the information found, carry out tips to reduce the risk of contagion
Measure: Prevention risk advice Time: 2 monthThis is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.
Description: Defined as the proportion of subjects with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment. A dose limiting toxicity is defined as any acute GvHD (> grade 2), grade ≥3 CRS or ICANS, grade ≥3 hematologic toxicity or grade ≥3 non-hematologic adverse events related to the T cell product within 14 days of the VST infusion and that are not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Measure: Dose Escalation Phase: Rate of Dose Limiting Toxicities by CTCAE 5.0 [14 days post infusion] Time: 14 days post infusionDescription: Clinical Response is defined as the proportion of subjects reporting an increase in 2 or more points on the WHO Ordinal Scale. Clinical Response will be measured daily using the WHO Ordinal scale [Scored on a scale from 0 to 8; where 0 = Uninfected and 8 =Dead] or until patient is discharged. The proportion of response in patients in the treatment arm will be compared to the proportion of response in the control arm who have a clinical response by day 7 post-randomization.
Measure: Randomized Trial: Rate of Clinical Response as assessed by the World Health Organization (WHO) Ordinal Scale [7 days post-randomization or hospital discharge] Time: 7 Days post-randomization or at time of hospital dischargeDescription: Defined as the proportion of subjects with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment. Treatment-related adverse events (tAE) are defined as any acute GvHD (> grade 2), grade ≥3 CRS or ICANS, grade ≥3 hematologic toxicity or grade ≥3 non-hematologic adverse events related to the T cell product within 14 days of the VST infusion and that are not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Measure: Randomized Trial: Rate of Treatment-related adverse events (tAE) by CTCAE 5.0 [14 days post-randomization] Time: 14 days post-randomizationBackground: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done. ...
Description: To characterize lymphopenia and immunologic phenotypes and inflammatory responses including inflammasome responses and coagulopathy in patients with COVID-19.
Measure: Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery. Time: Throughout the studyDescription: 1. Correlation of lymphopenia, immunologic phenotypes, and inflammatory responses with clinical outcomes. 2. Characterization of complement activation in patients with COVID-19. 3. Evaluation of activationinduced cell death and activated T cell autonomous death through measurement of intracellular reactive oxygen species in monocyte, natural killer (NK), and T cell subsets in peripheral blood and correlation with double stranded (ds)-DNA damage ( >=-H2AX), FAS/FasL, BCL-2, caspase-1 activation, and activation-induced proliferation. 4. Evaluation of homing receptors to lymphoid, skin, and mucosal surfaces on B and T cells and correlate with ACE2, bradykinin, and homing chemokine levels.
Measure: Evaluation of inflammatory pathways that may contribute to COVID-19 disease pathogenesis. Time: Throughout the studyTo ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies
The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.
Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)
Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease Time: Measuring during 28-day period since randomization (Intention to treat analysis)Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)
Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization Time: Measuring during 14-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.
Measure: Time to clinical improvement Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;
Measure: Time to clinical failure Time: Measuring during 28-day period since randomizationDescription: Proportion of participants with hospitalization for any cause
Measure: Hospitalization for any cause Time: Measuring during 28-day period since randomizationDescription: Evaluation of adverse events evaluated as associated to any of study arms
Measure: Proportion of participants who presented with adverse events Time: Measuring during 28-day period since randomizationDescription: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.
Measure: Time to improvement on respiratory scale symptoms Time: Measuring during 28-day period since randomizationThe purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA). COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.
Description: Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Measure: Successful production of viral specific T-cells Time: Within 30 days post culture initiationDescription: Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Measure: Presence of viral-specific T-cells Time: At 30 days after infusionIn this pilot trial, 150 confirmed COVID-19 individuals will be randomly assigned to 1 of 5 groups: distilled water, CloSYS (Rowpar Pharmaceutical Inc., USA), Oral-B Mouth Sore (Oral-B, USA), Crest Pro-Health Multi-Protection (Crest, USA), or Listerine (Johnson and Johnson, USA). Study participants will be asked to rinse/gargle with 10ml (2 teaspoons) of the assigned solutions 4 times per day, for 30 seconds, for 4 weeks.
Description: Change in saliva wash RT-PCR SARS-Cov-2 viral load
Measure: Change in SARS-Cov-2 viral load Time: Baseline to 4 weeksDescription: Change in self-reported (questionnaire) clinical symptom onset. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Measure: Change in self-reported clinical symptom onset Time: Baseline to 4 weeksDescription: Change in healthcare utilization and hospitalization
Measure: Change in healthcare utilization and hospitalization Time: Baseline to 4 weeksDescription: Change in saliva wash RT-PCR SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers
Measure: Change in SARS-Cov-2 viral load in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksDescription: Change in self-reported (questionnaire) clinical symptom onset in tobacco users, marijuana smokers, or vapers. A symptom checklist will include: cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye.
Measure: Change in self-reported clinical symptom onset in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksDescription: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers
Measure: Change in healthcare utilization and hospitalization in tobacco users, marijuana smokers, or vapers Time: Baseline to 4 weeksThis observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
Measure: Identification of requirement of mechanical ventilation Time: 3 weeksDescription: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Measure: Prediction of requirement of mechanical ventilation Time: 3 weeksDescription: Descriptive assessment of clinical parameters and LUS-score over time
Measure: Association of LUS to clinical parameters Time: 3 weeksDescription: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
Measure: Description of findings on LUS Time: 3 weeksBased on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2
Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3. Time: Visit 3 (90 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Time: Visit 4 (135 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Time: Visit 5 (180 +/- 5 days)Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled
Measure: Prevalence of IgG/IgM against SARS-CoV-2 Time: Screening Visit and Visit 3 (90 +/- 5 days)Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit
Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19. Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.
Measure: The impact of new cardiovascular events between the two study groups Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.
Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed
Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Covid 19 is a pandemic infection developed in late 2019
Description: The proper knowledge about covid-19
Measure: The number of pregnant women who have knowledge about covid-19 Time: one monthThe aim of the project is to evaluate the immunological features of COVID-19 patients. Patients are recruited without any pharmacological treatments restriction. The number of samples is estimated on the basis of feasibility, that means on the maximum number of patients with COVID-19, who are expected to be able to be enrolled by the units involved. Based on the investigators' experience, gained in the onco-immunological field, considering the time and economic resources available, the investigators expect to enroll at least 80 patients.
Description: Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]
Measure: COVID-19 associated immune disorder Time: 24 hoursDescription: Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]
Measure: COVID-19 associated inflammation Time: 48 hoursDescription: Ratio of arterial oxygen tension (mmHg) to fraction of inspired oxygen (PaO2/FiO2)
Measure: Oxygenation Time: 24 hoursDescription: SARS-CoV-2 infection will be tested by PCR using nasopharyngeal swab
Measure: Diagnostic of COVID disease composite Time: On admission of hospitalDescription: Quantification of plasma levels of different solubles factors (GM-CSF, G-CSF, M-CSF, IFN-γ, IFN-α, IL-1, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, IL-34, MIP-3α/CCL20, CCL2, TNF-α, TNF-β, TGFβ) [pg/ml]
Measure: Changes at the cytokine pattern Time: 14 DaysDescription: Enumeration of circulating cell subsets by flow cytometry [Cell count/µl]
Measure: Changes at circulating immune cell composition Time: 14 DaysDescription: Proportion of patients with Intensive Care Unit Admission requirement
Measure: Intensive Care Unit Admission Time: Day 7-14Description: Days of Hospitalization
Measure: Length of hospital stay Time: Day 7-14Description: Clinical status assessed according to the World Health Organization guideline
Measure: Clinical Status Time: Day 7-14Description: Proportion of death patients at days
Measure: Mortality Time: Day 7-14This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.
Description: vaccine events such as fever, rash, abnormal vital signs
Measure: frequency of vaccine events Time: day 0 to day 28Description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response
Measure: Proportion of subjects with positive T-cell response Time: day 0 to 1 yearDescription: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B
Measure: Proportion of subjects able to suppress viral propagation Time: day 0 to 1 yearPharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage. The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial. The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone. The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.
Description: Viral load will be measured by Real Time-Polymerase Chain Reaction (RT-PCR)
Measure: Time to negative conversion of SARS-CoV-2 nasopharyngeal swab Time: From baseline to day 29Description: Defined as percentage of patients reporting each severity rating on a 7-point ordinal scale
Measure: Improvement in clinical severity score (a) Time: Baseline, days 7, 15, 21, 29Description: Defined as the time to clinical improvement of two points from the time of randomization on a 7-category ordinal scale or live discharge from the hospital, whichever comes first
Measure: Improvement in clinical severity score (b) Time: Baseline, days 7, 15, 21, 29Description: Measured with artificial intelligence and expressed as cc and percent values of diseased lung (lung consolidation, ground glass opacities and disease free)
Measure: Changes from baseline in pulmonary computed tomography (CT) imaging severity score Time: Baseline, day 21; extra follow up at 90 daysThe novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research in China suggests that children are no more susceptible to COVID-19 infection than adults and that children with confirmed COVID-19 have generally presented with milder symptoms. However, the impact of COVID-19 among Canadian children remains unclear. The prevalence of COVID-19 in children in Canada is currently unknown and no published research exists regarding the risk factors of COVID-19 in children or its potential long-term health effects on physical health or development. Using TARGet Kids!, Canada's largest children's cohort study with over 11,000 children involved, the researchers will conduct a longitudinal observational study aimed to evaluate the cumulative incidence of COVID-19 in children and parents; differences among infected and uninfected children in terms of age, sex, and income; risk factors of COVID-19; and longer term health effects of COVID-19 among children. Given the rapid spread of COVID-19 and the unknown health effects of the virus in children, research must be conducted to determine the extent of infections of COVID-19 in children, disease severity, risk factors for infection, and how the virus affects children as they become older.
Description: To evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada
Measure: Cumulative Incidence of COVID-19 Time: 12 monthsDescription: To determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions
Measure: Risk Factors for COVID-19 Time: 12 monthsDescription: To determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.
Measure: Parent-reported probable case definition of COVID-19 Time: 12 monthsDescription: To determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.
Measure: Dynamics of COVID-19 Time: 12 monthsDescription: To determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.
Measure: Risk to family members Time: 12 monthsDescription: To determine the severity of laboratory-confirmed COVID-19 in healthy children and parents
Measure: Severity of COVID-19 Time: 12 monthsDescription: To determine the longer term effects of COVID-19 infection in healthy children and parents on physical health
Measure: Longer term effects of COVID-19 on physical health Time: 12 monthsDescription: To determine the longer term effects of COVID-19 infection in healthy children and parents on mental health
Measure: Longer term effects of COVID-19 on mental health Time: 12 monthsDescription: To determine the longer term effects of COVID-19 infection in healthy children and parents on child development
Measure: Longer term effects of COVID-19 on child development Time: 12 monthsDescription: To determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning
Measure: Longer term effects of COVID-19 on family functioning Time: 12 monthsDescription: To determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours
Measure: Longer term effects of COVID-19 on health behaviours Time: 12 monthsDescription: To determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization
Measure: Longer term effects of COVID-19 on healthcare utilization Time: 12 monthsDescription: To determine the effect of preventive measures on COVID-19 infection
Measure: Effects of preventive measures on infection Time: 12 monthsDescription: To determine the effect of preventive measures on physical health
Measure: Effects of preventive measures on physical health Time: 12 monthsDescription: To determine the effect of preventive measures on mental health
Measure: Effects of preventive measures on mental health Time: 12 monthsDescription: To determine the effect of preventive measures on child development
Measure: Effects of preventive measures on child development Time: 12 monthsDescription: To determine the effect of preventive measures on family functioning
Measure: Effects of preventive measures on family functioning Time: 12 monthsDescription: To determine the effect of preventive measures on health behaviours
Measure: Effects of preventive measures on health behaviours Time: 12 monthsDescription: To determine the effect of preventive measures on healthcare utilization
Measure: Effects of preventive measures on healthcare utilization Time: 12 monthsEvaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.
Description: Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo. Extraction of genomic material will be performed using a QIAgen mini kit (QIAmp viral RNA) validated by the CDC (United States Center for Disease Control and Prevention (https://www.fda.gov/media/134922/download) (CDC-006-00019) Viral load will be quantified with the following detection kits: Commercial Kit: PCR-EUA-CDC-nCoV-IFU. Commercial KIT SENTINEL - STAT-NAT Covid 19B (Berlín). Rational: In mild cases of COVID-19, 50% of the patients eradicated the virus within a period of 3 weeks, 25% eradicated the virus before the 13th day, 75% during the first month and the rest were " late eradicators." This latter subgroup of patients has been associated with severe cases of COVID-19 disease.
Measure: Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th. Time: 7 dayDescription: Consequently, in mild cases, viral eradication will likely occur more frequently during the first to second week of COVID-19 disease; less than 15% could eradicate the virus during the first week of symptom onset. From an epidemiological point of view, increasing the viral eradication rate from less than 15% to more than 35% during the first two weeks of treatment would be clinically relevant.(seven), 14 (fourteen) and 35 (thirty-five) after starting treatment compared to the baseline measurement.
Measure: Comparative decrease of the viral load Time: 3 - 35 daysDescription: Clinical improvement according to the WHO COVID-19 ordinal scale. Minimun 0 (zero), (best), maximum 8 (eight) (worst)
Measure: Clinical improvement Time: 1 - 35 daysDescription: Percentage of pneumonia patients meeting severity criteria.
Measure: Pneumonia patients meeting severity criteria. Time: 1 - 35 daysDescription: Number of days with fever (axillary temperature higher than 37.5°C).
Measure: Number of days with fever Time: 1 - 35 daysDescription: Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.
Measure: Patients requiring mechanical ventilation Time: 1 - 35 daysDescription: Mortality rate.
Measure: Mortality rate. Time: 1- 35 daysDescription: Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).
Measure: Lymphocyte recovery Time: 7 dayDescription: Days of ICU hospitalization.
Measure: ICU hospitalization. Time: 1 - 35 daysDescription: Oxygen saturation (SpO2) > 92% (at ambient FiO2).
Measure: Oxygen saturation Time: 1 - 35 daysDescription: Days of hospitalization
Measure: Days of hospitalization Time: 1 - 35 daysDescription: Respiratory rate per minute (in afebrile state conditions).
Measure: Respiratory rate Time: 1 - 35 daysThe overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.
Measure: Survival without needs of ventilator utilization at day 14 Time: day 14Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at day 7 and 14 Time: day 7 and day 14Description: Overall survival
Measure: Overall survival at 14, 28, 60 and 90 days Time: 14, 28, 60 and 90 daysDescription: Cumulative incidence of discharge alive
Measure: Cumulative incidence of discharge alive at 14 and 28 days Time: 14 and 28 daysDescription: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of mechanical ventilation at day 1 Time: day 1Description: Cumulative incidence of oxygen supply independency
Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days Time: 14 and 28 daysThe first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.
Description: Postbariatric surgery COVID-19 infection, mortality and complications
Measure: Postoperative COVID-19 infection Time: 30 postoperative daysDescription: Complications, reoperations for any reason related to bariatric surgery.
Measure: Complications related to bariatric surgery Time: 30 postoperative daysThe clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.
Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events Time: First dose date up to Day 30 Follow-up AssessmentDescription: This will be assessed at various time points by clinical laboratory tests and vital signs.
Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities Time: First dose date up to Day 30 Follow-up AssessmentDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 7 daysDescription: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 7 daysHospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this "COVID-19 wave", these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers. This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate. Since june 2020, all staff in French health establishments could benefit a serological test. Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.
Description: Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver).
Measure: Number of subjects with a COVID-19 seroconversion Time: through study completion, an average of 5 monthThe purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.
Description: metabolite of vitamin D
Measure: Change in total circulating 25(OH)D concentration Time: monthly in COVID-19 negative participants through study completion for 1 yearDescription: metabolite of vitamin D
Measure: Change in total circulating 25(OH)D concentration in COVID-19 positives Time: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participantsDescription: The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.
Measure: Change in SARS-CoV-2 antibody titers Time: every 3 months up to 12 monthsDescription: At baseline, 3, 6, 9 and 12 months, inflammatory cytokines will be measured in participant plasma samples. Cytokines to be measured are Interferon-gamma (IFN-g), Interleukin-1beta (IL-1B), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13, and Tumor Necrosis Factor-alpha (TNFa). Values of these cytokines at baseline will compared to those at 3, 6, 9, and 12 months
Measure: Change in inflammatory cytokine concentration (10 cytokine panel Elisa: Interferon (INF)-gamma, Interleukin (IL)-1beta, IL-2, IL-3, IL-4, IL-6, IL-8, IL-10, IL-13, Tumor Necrosis Factor (TNF)-alpha Time: baseline and every 3 months up to 12 monthsDescription: COVID-19 positive participants or if COVID-19 negatives develop respiratory symptoms will complete this respiratory survey daily for 2 weeks
Measure: Respiratory symptoms Time: daily for 2 weeksDescription: Inventory of signs and symptoms of rhino/sinusitis. These signs include sneezing, running nose, cough, dizziness, fatigue, and sense of smell. Each sign is rated on a scale of 0 to 5, with 0 indicating not problem, for instance 1 indicating mild problem, 4 indicating severe problem and 5 indicating problem as bad as it can be.
Measure: Signs and symptoms of rhino/sinusitis Time: Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positivesDescription: Dietary intake assessment
Measure: NCI Dietary Intake Time: baseline then at 6 and 12 monthsDescription: Survey of participant health problems
Measure: Charlson Comorbidity survey Time: baseline then at 6 and 12 monthsDescription: Assessment of physical activity of each participant
Measure: Paffenberger Physical Activity Assessment Time: Baseline then at 6 and 12 monthsDescription: Each participant will complete the Perceived Stress Scale Questionnaire (PSS) to assess their perceived stress. Assessments are base on a scale of 0 to 4, with 0 indicating "never" and 4 indicating "very often"
Measure: Perceived stress Time: monthly for 1 yearDescription: Each participant will complete the and Pandemic Stress Index Questionnaire (PSI) to assess their perceived stress cause by the pandemic. Assessments are base on a scale of 0 to 6, with 0 indicating "not at all" and 5 indicating "extremely," and 6 indicating "decline to answer."
Measure: Pandemic stress Time: monthly for 1 yearDescription: Personality characteristics of each participant
Measure: NEO-Personality Inventory Time: baseline visitDescription: A health assessment will be completed by each participant monthly for 1year. This health. This is for information on health status only and not for comparative assessment.
Measure: GrassrootsHealth Monthly Health assessment Time: baseline, 6, and 12 monthsWhile novel drug discovery and vaccine studies are time taking process, re-purposing old drugs against the COVID-2019 epidemic can help identify treatments, with known pre-clinical, pharmacokinetic, pharmacodynamic, and toxicity profiles, which can rapidly enter Phase 3 or 4 or can be used directly in clinical settings. Immunofree has many of the herbs which have been evaluated by other trials published for Covid-19 treatment. The Immunofree tablet of the test product is an Ayurvedic proprietary medicine and is a combination of polyherbal mixture. The components of this formulation are known for their anti-viral and immunomodulatory effects. Also, Reginmune, owing to its immunomodulatory effect might help in easing the symptoms and decrease the viral load.
Description: This includes overall time it takes for negative covid-19 results, improvement based on a customized questionnaire for fever, cough, body ache, loss of taste or smell, or other similar conditions
Measure: Time (Days) to clinical improvement from study enrollment Time: Day 0 - Day 10Description: Being an important part, each patient has to be monitored for oxygen saturation level, and this would help us analyze when a subject enters from Mild to moderate stage
Measure: Proportion of participants in each group with oxygen saturation more than 94% on room air for more than 24h Time: Day 0, Day 5±1 and Day of discharge i.e Day 10±1Description: D Dimer levels has to be measured to study the D dimer levels of the patient as most researchers claiming covid-19 to be relative to coagulation. This study will help us identity the same.
Measure: Value of coagulation indicators Time: Day 0, Day 5±1 and Day of discharge i.e Day 10±1Description: via ICMR recognized RT-PCR to identify when a patient is coronavirusfree
Measure: Time to first negative SARS-CoV-2 PCR in NP swab Time: Day 0, Day 5±1 and Day of discharge i.e Day 10±1Description: To identify how long a patient needs oxygen therapy in certain case
Measure: Duration of oxygen therapy Time: upto day 10+1Description: This is considered as a part of pharmacovigilance, as how many people enters moderate to severe case, if any
Measure: Proportion of participants in each group with need for mechanical ventilation Time: upto day 10+1Description: most mild cases that becomes asymptomatic are sent back from hospital and treated at home quarantine. this is to identify when a patient becomes asymptomatic
Measure: Duration of hospitalization Time: upto day 10+1Parallel group, Wait-list design, with treatment delayed for 3 months. Participants will be randomized on a 1:1 ratio with 500 participants per group in Australia. Group 1: Wait-list control. One capsule OM85 (7.0 mg) will be given daily for 3 months, commencing in Month 3, with 3 months follow-up off treatment. Group 2: Initial treatment. One capsule OM85 (7.0 mg) will be given daily for 3 months, commencing on day 0, with 3 months follow-up off treatment.
Description: The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 3 months.
Measure: Acute Respiratory Infection necessitating workforce removal Time: 3 monthsDescription: The time to the first ARI necessitating workforce removal in the initial treatment and wait-list control groups.
Measure: Time to ARI necessitating workforce removal. Time: 12 monthsDescription: The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 6 and 12 months
Measure: The proportion of Health Care Workers contracting an Acute Respiratory Infection necessitating workforce removal Time: 12 monthsDescription: The proportion of HCW in the initial treatment and wait-list control group with Cov infection documented by molecular techniques of seroconversion
Measure: The proportion of HCW with documented Cov infection. Time: 12 monthsDescription: The time to the first LRI necessitating workforce removal in the initial treatment and wait-list control groups.
Measure: Time to Lower respiratory infection (LRI) necessitating workforce removal. Time: 12 monthsDescription: The proportion of Health Care Workers contracting LRI necessitating workforce removal in the initial treatment and wait-list control groups assessed at the end of 3, 6 and 12 months
Measure: The proportion of Health Care Workers contracting a LRI necessitating workforce removal Time: 12 monthsDescription: The proportion of HCW in the initial treatment and wait-list control group with LRI due to Cov infection documented by molecular techniques of seroconversion
Measure: The proportion of HCW with documented Cov LRI. Time: 12 monthsThis study evaluates the newborns who had respiratory symptoms at the neonatal intensive care admission
Description: Demographical characteristics will be recorded
Measure: General Characteristics of the infants with respiratory infection at the NICU admission Time: 5 monthsThe purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.
Description: The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.
Measure: Evidenced of active and trained innate immunity Time: Day 61 and 90 (post vaccination)Description: cases ( nasal swab for viral antigen and antibody testing), symptoms (symptom checklist), hospitalizations (MDS 3.0 report/chart reviews) and deaths (MDS 3.0 report/chart reviews) associated with flu, pneumonia, and COVID-19.
Measure: Respiratory Disease Severity (6 month) Time: Days 90 through 180Investigators aimed to compare clinical and radiographic markers between SARS-CoV-2 positive and RSV positive infants
Description: Total neonatal intensive care duration, total duration of oxygen supplement
Measure: Oxygen status and evaluation of neonatal intensive care stay Time: 3 monthsThis QI project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered COVID-19 (SARS-CoV-2) nasal samples with and with the use of HEPA-filtered, positive pressure isolation booths.
Description: Samples acquired per hour using the Hexapod booth will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.
Measure: Change in Testing Throughput After Hexapod Implementation Time: Up to 22 weeksDescription: Gowns utilized per test will be assessed as an average over a minimum of 12 weeks of testing compared to baseline throughput before April 16th.
Measure: Change in Isolation Gowns Utilized After Hexapod Utilization Time: Up to 22 weeksDescription: The difference in costs of collecting test samples before and after hexapod utilization will be calculated.
Measure: Change in Cost per Test After Hexapod Implementation Time: Up to 22 weeksDescription: The retail cost of the Hexapod booth will be divided by the average daily cost differential for testing observed and at maximum volume.
Measure: Return on Investment Time: Up to 22 weeksDescription: The difference in median shift salaries before and after Hexapod implementation will be calculated.
Measure: Change in Testing Personnel Cost Per Test Time: Up to 22 weeksDescription: Outcome 2 will be utilized to calculate the range of the change in cost of isolation gowns utilized compared to baseline usage for samples acquired before April 16th utilizing actual and quoted costs of gowns to Materials Management at MGH.
Measure: Change in Cost of Isolation Gowns Utilized Time: Up to 22 weeksDescription: The Materials Management costs of durable gloves, sleeves, and filters will be be calculated from the manufacturer's recommended monthly replacements of each per booth.
Measure: Cost of Additional Consumable Supplies Utilized Time: Up to 22 weeksA multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. ARM 1 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with no COVID-19 infection or no known COVID-19 positive contacts. ARM 2 is evaluating the effect of interferon-alpha (vs placebo) on the incidence of COVID-19 infection in cancer patients with confirmed exposure to COVID-19 virus. ARM 3 is evaluating the effect of Selinexor (vs placebo) on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. ARM 4 is evaluating the effect of Lenzilumab (vs placebo) on the treatment of COVID-19 infection in cancer patients with severe COVID-19 infection. Participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment of COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.
Description: Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19 (COVID-19 confirmed by qPCR from respiratory swab)
Measure: Incidence of COVID-19 in cancer patients using interferon-alpha as prophylaxis without known positive contact with COVID-19 (COVID-19 confirmed by qPCR from respiratory swab) Time: 3 months from baseline.Description: incidence of any upper or lower community acquired respiratory viral infection (define as identification of respiratory viruses such as coronavirus other than SARS-CoV-2, influenza, parainfluenza, respiratory syncytial virus, rhinovirus, adenovirus, human metapneumovirus). assessed using local standard of care testing (e.g. respiratory swabs, saliva and/or blood)
Measure: incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing Time: 3 months from baseline.Description: incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab .
Measure: incidence of COVID-19 when Interferon alpha is given as post-exposure prophylaxis with a known positive contact or exposure with COVID-19. COVID-19 confirmed by qPCR from respiratory swab . Time: 28 days from baselineDescription: incidence of any upper or lower community acquired respiratory viral infection (define as identification of respiratory viruses such as coronavirus other than SARS-CoV-2, influenza, parainfluenza, respiratory syncytial virus, rhinovirus, adenovirus, human metapneumovirus). Assessed using local standard of care testing (e.g. respiratory swabs, saliva and/or blood)
Measure: incidence of any upper or lower community acquired respiratory viral infection assessed using local standard of care testing Time: 28 days from baselineDescription: composite outcome: incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records
Measure: incidence of death and/or need for invasive or non-invasive ventilation. assessed using medical records Time: 60 days from baselineDescription: time to clinical improvement (defined as a two point reduction in clinical progress ordinal scale) or discharge from hospital, whichever occurs first. assessed using medical records
Measure: time to clinical improvement or discharge from hospital assessed using medical records Time: 28 days from baselineDescription: ARM 1, secondary endpoint 1 Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. (composite either COVID-19 or other respiratory viral infection). assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.
Measure: ARM 1: Duration of acute respiratory/ILI symptoms in case of confirmed respiratory infection during the study period. Assessed using patient symptom Diary PRO tool Time: 120 days from baselineDescription: ARM 1, secondary endpoint 2 Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records
Measure: ARM 1: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). Assessed using patient medical records Time: 120 days from baselineDescription: ARM 1, secondary endpoint 3. Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records
Measure: ARM 1: Time to diagnosis of other respiratory viral infection in case of confirmed other respiratory viral infection diagnosed during the study period (days). assessed using patient medical records Time: 120 days from baselineDescription: ARM 1, secondary endpoint 4 Illness severity in case of confirmed COVID-19 diagnosed during the study period, defined as the maximal score on the World Health Organization (WHO)'s clinical progression scale ranging from 0 (uninfected) to 10 (death)
Measure: ARM 1: Illness severity in case of confirmed COVID-19 diagnosed during the study period using WHO clinical progression scale Time: 120 days from baselineDescription: ARM 1, secondary endpoint 5 Incidence of unplanned all-cause hospital admission during the study period. Composite measure: duration of hospital stay if outcome met. assessed using medical records
Measure: ARM 1: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records Time: 120 days from baselineDescription: ARM 1, secondary endpoint 6 Incidence of unplanned infection-related hospital admission during the study period. Composite measure: duration of hospital stay if outcome met. assessed using medical records
Measure: ARM 1: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records Time: 120 days from baselineDescription: ARM 1, secondary endpoint 7 Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR
Measure: ARM 1: Incidence of sero-conversion of SARS-CoV-2 at the end of the study period. assessed using qPCR Time: 120 days from baselineDescription: ARM 1, secondary endpoint 8 Incidence of death from any cause during the study period. assessed using patient medical records
Measure: ARM 1: Incidence of death from any cause during the study period. assessed using patient medical records Time: 120 days from baselineDescription: ARM 1, secondary endpoint 9 Incidence of testing for COVID-19 during the study period. Composite measure: frequency of testing if outcome is met. assessed using medical records
Measure: ARM 1: Incidence of testing for COVID-19 during the study period. assessed using medical records Time: 120 days from baselineDescription: ARM 2: secondary outcome 1. Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period (days). assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.
Measure: ARM 2 Duration of acute respiratory symptoms in case of confirmed COVID-19 diagnosed during the study period. assessed with PRO and medical records. Time: 28 days from baselineDescription: ARM 2: secondary outcome 2. Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records
Measure: ARM 2: Time to diagnosis of COVID-19 in case of confirmed COVID-19 diagnosed during the study period (days). assessed using medical records Time: 28 days from baselineDescription: ARM 2: secondary outcome 3. Illness severity in case of confirmed COVID-19 diagnosed during the study period, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)
Measure: ARM 2: Illness severity in case of confirmed COVID-19 diagnosed during the study period. assessed using WHO clinical progression scale. Time: 28 days from baselineDescription: ARM 2: secondary outcome 4. Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records.
Measure: ARM 2: Incidence of unplanned all-cause hospital admission during the study period. assessed using medical records. Time: 28 days from baselineDescription: ARM 2: secondary outcome 5 Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records
Measure: ARM 2: Incidence of unplanned infection-related hospital admission during the study period. assessed using medical records Time: 28 days from baselineDescription: ARM 2: secondary outcome 6 Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR.
Measure: ARM 2: Incidence of seroconversion of SARS-CoV-2 at the end of the study period. assessed using qPCR. Time: 28 days from baselineDescription: ARM 2: secondary outcome 7. Incidence of testing for COVID-19 during the study period. Composite measure: frequency of testing if outcome is met. assessed using medical records
Measure: ARM 2: Incidence of testing for COVID-19 during the study period assessed using medical records Time: 28 days from baselineDescription: ARM 3: secondary outcome 1 Time to clinical improvement defined as Resolution of fever - oral temperature < 38oC for 24 hours without antipyretics AND Respiratory rate < 20 breaths/minute OR Oxygen saturation > 94% on room air OR Hospital discharge assessed using medical records
Measure: ARM 3: Time to clinical improvement assessed using medical records. Time: 60 days from baselineDescription: ARM 3: secondary outcome 2. Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death)
Measure: ARM 3: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale Time: 60 days from baselineDescription: ARM 3: secondary outcome 3 change to clinical condition assessed with Karnofsky Performance score
Measure: ARM 3: change to clinical condition assessed with Karnofsky Performance score Time: 60 days from baselineDescription: ARM 3: secondary outcome 4. Time to progression to severe COVID-19, defined by WHO ordinal scale
Measure: ARM 3: Time to progression to severe COVID-19, defined by WHO ordinal scale Time: 60 days from baselineDescription: ARM 3: secondary outcome 5 Time to all-cause mortality
Measure: ARM 3: Time to all-cause mortality Time: 60 days from baselineDescription: ARM 3: secondary outcome 6. Duration of hospitalisation. assessed using medical records
Measure: ARM 3:Duration of hospitalisation assessed using medical records Time: at discharge or day 60 whichever is soonerDescription: ARM 3: secondary outcome 7 Duration of COVID-19 symptoms assessed using a take-home PRO specifically developed and approved for this study entitled "patient symptom Diary". in combination with any relevant medical records.
Measure: ARM 3: Duration of COVID-19 symptoms assessed using patient reported symptom diary. Time: 60 days from baselineDescription: ARM 3: secondary outcome 8. Duration of oxygen supplementation (days). assessed using medical records.
Measure: ARM 3: Duration of oxygen supplementation (days). assessed using medical records. Time: 60 days from baselineDescription: ARM 3: secondary outcome 9 change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR)
Measure: ARM 3: change in nasopharyngeal SARS-CoV-2 viral load shedding (assessed via qPCR) Time: 60 days from baselineDescription: ARM 3: secondary outcome 10. Safety and tolerability of selinexor defined as listing and documentation of frequency and severity of adverse effects. Outcome assessed using any/all of medical records, patient reported, vital signs, ECG, imaging, other investigative procedure as per standard local practice.
Measure: ARM 3: Safety and tolerability of selinexor using relevant medical records Time: 60 days from baselineDescription: ARM 3: secondary outcome 11. composite outcome: incidence of changes in blood results relevant to clinical improvement. Changes in C-reactive protein (CRP) Changes in ferritin level Changes in lactate dehydrogenase (LDH) level
Measure: ARM 3: incidence of changes in blood results relevant to clinical improvement assessed using medical records Time: 60 days from baselineDescription: ARM 4: secondary outcome 1 Incidence of all cause death by day 28 and 60 assessed using medical records
Measure: ARM 4: Incidence of all cause death by day 28 and 60 Time: day 28 from baseline and day 60 from baselineDescription: ARM 4: secondary outcome 2 Time to all-cause mortality assessed using medical records
Measure: ARM 4: Time to all-cause mortality Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 3 - composite outcome: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale ranging from 0 (uninfected) to 10 (death) Proportion who have recovered (defined as 0-4) Proportion who had 1 point improvement Proportion who had 2 point improvement
Measure: ARM 4: Illness severity of COVID-19, defined as the maximal score on the World Health Organization (WHO)'s clinical progression ordinal scale Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 4 Incidence of ARDS. assessed using medical records
Measure: ARM 4: Incidence of ARDS assessed using medical records Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 5 incidence of HLH. assessed using medical records
Measure: ARM 4: incidence of HLH. assessed using medical records Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 6 Duration of hospitalisation. assessed using hospital medical records.
Measure: ARM 4: Duration of hospitalisation. assessed using hospital medical records. Time: at discharge or by day 60 whichever is soonerDescription: ARM 4: secondary outcome 7 Proportion discharged from hospital. assessed using medical records
Measure: ARM 4: Proportion discharged from hospital. assessed using medical records Time: at dischargeDescription: ARM 4: secondary outcome 8. Incidence of mechanical ventilation up to day 28. assessed using medical records
Measure: ARM 4: Incidence of mechanical ventilation up to day 28. assessed using medical records Time: any time up day 28 from baselineDescription: ARM 4: secondary outcome 9 composite outcome: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records
Measure: ARM 4: Ventilator-free days and proportion who did not receive invasive mechanical ventilation. assessed using medical records Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 10. composite outcome: Organ failure free days and proportion who did not develop organ failure. assessed using medical records.
Measure: ARM 4: Organ failure free days and proportion who did not develop organ failure. assessed using medical records. Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 11 composite outcome: Incidence and duration of ICU admission. assessed using medical records
Measure: ARM 4: Incidence and duration of ICU admission. assessed using medical records Time: at discharge or by day 60 from baseline.Description: ARM 4: secondary outcome 12 composite outcome: incidence and duration of supplemental oxygen use. assessed using medical records
Measure: ARM 4: incidence and duration of supplemental oxygen use. assessed using medical records Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 13. Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours. assessed using medical records
Measure: ARM 4: Time to clinical improvement defined as National Early Warning Score 2 (NEWS2) of <2 maintained for 24 hours. Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 14 incidence of non-invasive ventilation. assessed using medical records
Measure: ARM 4: incidence of non-invasive ventilation. assessed using medical records Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 15. composite outcome: number of participants alive and off oxygen at day 60. assessed using medical records.
Measure: ARM 4: number of participants alive and off oxygen at day 60. assessed using medical records. Time: any time up to 60 days from baselineDescription: ARM 4: secondary outcome 16 proportion of participants who had improved oxygenation for >48 hours. assessed using medical records
Measure: ARM 4: proportion of participants who had improved oxygenation for >48 hours. assessed using medical records Time: any time up to 28 days from baselineDescription: ARM 4: secondary outcome 17 Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records
Measure: ARM 4: Incidence of adverse events based on the national cancer institute CTCAE v5. Assessed using medical records Time: any time up to day 28 from baseline.Description: ARM 4: secondary outcome 18 incidence of SAEs based on NCI CTCAE v5 assessed using medical records
Measure: ARM 4: incidence of SAEs based on NCI CTCAE v5 assessed using medical records Time: any time up to 28 days from baseline.Description: ARM 4: secondary outcome 19 change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR.
Measure: ARM 4: change in nasopharyngeal SARS-CoV-2 viral load shedding. assessed using qPCR. Time: any time up to day 60 from baselineIt is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients with SARS-CoV-2 virus infection and with mild-to-moderate symptoms.
Description: Adverse Events (AEs)
Measure: Frequency of treatment-emergent adverse events (TEAEs) Time: 0 hours up to 41 daysDescription: Adverse Events
Measure: Number of participants who withdraw due to treatment-emergent adverse events (TEAEs) Time: 0 hours up to 41 daysDescription: Adverse Events
Measure: Frequency of treatment-emergent adverse events (TEAEs), causally related to study intervention Time: 0 hours up to 41 daysDescription: Serious Adverse Events
Measure: Frequency of treatment-emergent serious adverse events Time: 0 hours up to 41 daysDescription: Adverse Events
Measure: Frequency of treatment-emergent infusion site reactions Time: 0 hours up to 41 daysDescription: Percent change in laboratory parameters
Measure: Magnitude of abnormal hematologic laboratory findings Time: 0 hours up to 41 daysDescription: Adverse Events
Measure: Frequency of abnormal chemistry values Time: 0 hours up to 41 daysDescription: Adverse Events
Measure: Frequency of abnormal hematologic laboratory findings Time: 0 hours up to 41 daysDescription: Percent change in urinalysis parameters
Measure: Magnitude of abnormal urinalysis findings Time: 0 hours up to 41 daysDescription: ECG parameters
Measure: Change from baseline in PR values Time: 0 hours up to 41 daysDescription: ECG parameters
Measure: Change from baseline in RR values Time: 0 hours up to 41 daysDescription: ECG parameters
Measure: Change from baseline in QTc values Time: 0 hours up to 41 daysDescription: ECG parameters
Measure: Change from baseline in QTcF values Time: 0 hours up to 41 daysDescription: ECG parameters
Measure: Change from baseline in QRS values Time: 0 hours up to 41 daysDescription: Vital sign measurements
Measure: Change from baseline in pulse rate measurements Time: 0 hours up to 41 daysDescription: Vital sign measurements
Measure: Change from baseline in temperature values Time: 0 hours up to 41 daysDescription: Vital sign measurements
Measure: Change from baseline in respiratory rate values Time: 0 hours up to 41 daysDescription: Vital sign measurements
Measure: Change from baseline in systolic blood pressure Time: 0 hours up to 41 daysDescription: Vital sign measurements
Measure: Change from baseline in diastolic blood pressure Time: 0 hours up to 41 daysDescription: Vital sign measurements
Measure: Change from baseline in pulse oximetry/SpO2 measurement Time: 0 hours up to 41 daysDescription: plasma PK parameters
Measure: Change in concentration at 24 hours (C24[end of infusion]) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in concentration, dose normalised, at 24 hours (C24 (dn) [end of infusion]) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in concentration at 120 hours (C120[end of infusion]) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in maximum observed concentration (Cmax) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in maximum observed concentration, dose normalised (Cmax [dn]) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in concentration at steady state (Css) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in concentration at steady state, dose normalised (Css [dn]) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in terminal half life (t1/2) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in clearance (CL) of PF-07304814 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in area-under-the-curve plasma concentration from 0 to time extrapolated to infinity (AUCinf) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in area-under-the-curve plasma concentration from 0 to last quantifiable concentration (AUClast) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in area-under-the-curve plasma concentration from 0 to time extrapolated to infinity, dose normalised (AUCinf [dn]) of PF-07304814 and PF-00835231 Time: 0 to 32 hoursDescription: plasma PK parameters
Measure: Change in steady state volume of distribution (Vss) of PF-00835231 Time: 0 to 32 hoursDescription: urinary PK parameters (Cohort 2 only)
Measure: Cumulative amount of unchanged drug excreted into urine (Ae) Time: 0 to 36 hoursDescription: urinary PK parameters (Cohort 2 only)
Measure: Percent of dose excreted as unchanged drug (Ae%) over dosing period Time: 0 to 36 hoursThe world is currently experiencing a coronavirus (CoV-2) pandemic. A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19. Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012. The mortality rates were >10% for SARS and >35% for MERS. The direct cause of death is generally due to ensuing severe atypical pneumonia and ensuing acute respiratory distress syndrome (ARDS). Pneumonia also is generally the cause of death for people who develop influenza, although the mortality rate is lower (1%-3% for the influenza A H5N1 pandemic of 1918-1919 in the United States). Risk factors for a poor outcome of SARS-CoV-2 infection have so far been found to include older age and co-morbidities including chronic cardiovascular and respiratory conditions and current smoking status. In May 2020, the FDA authorized the emergency use of remdesivir for treatment of COVID-19 disease based on topline date of two clinical trials, even though an underpowered clinical trial did not find significant improvement in COVID- 19 patients treated with remdesivir. Nevertheless, remdesivir is the first and so far, only approved treatment for COVID-19. Additionally further trials and clinical observations have not found a significant benefit of other antiviral drugs. Although the results of several studies are still pending, there is still a desperate need for an effective, safe treatment for COVID-19. Aviptadil, which is a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP), might be beneficial in patients at risk of developing ARDS. Nonclinical studies demonstrate that VIP is highly concentrated in the lung, where it reduces inflammation.
Description: Time to clinical improvement of a decrease of at least two points on a seven-point ordinal scale of clinical status or discharged alive from hospital. The seven-point scale consists of the following categories: not hospitalized; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; hospitalized, intubation and mechanical ventilation; ventilation and additional organ support - pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); death
Measure: time to clinical improvement Time: Randomization until discharge from hospital but up to maximum 28 daysDescription: Frequency of Patient who need mechanical ventilation during hospital stay
Measure: Frequency of mechanical ventilation Time: Randomization until discharge from hospital up to maximum 28 daysDescription: Frequency of Patient who showed a multi organ dysfunction Syndrome during Hospital stay
Measure: Frequency of Multi organ dysfunction Syndrome (MODS) Time: Randomization until discharge from hospital up to maximum 28 daysDescription: Blood pressure will be assessed daily in mmHg
Measure: Blood pressure Time: Daily until discharge up to maximum 28 daysDescription: Heart rate will be assessed daily in bpm
Measure: Heart rate Time: Daily until discharge up to maximum 28 daysDescription: Respiratory rate will be assessed daily in Counts per minute
Measure: Respiratory rate Time: Daily until discharge up to maximum 28 daysDescription: Body temperature (auricular) will be assessed daily in °C
Measure: Body temperature (auricular) in °C Time: Daily until discharge up to maximum 28 daysDescription: Pulse oximetry will be assessed daily in %
Measure: Pulse oximetry Time: Daily until discharge up to maximum 28 daysDescription: Glasgow Coma Scale will be assessed daily The lowes possible score is 3 = deep coma or death The highest possible score is 15 = Fully awake
Measure: Glasgow Coma Scale Time: Daily until discharge up to maximum 28 daysDescription: Visual analogue scale for dyspnea and cough as patient-related outcome parameter
Measure: Dispnea and caugh Time: Randomization until discharge from hospital up to maximum 28 daysThis is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.
Description: All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.
Measure: Incidence of COVID-19 cases after two-doses of vaccination Time: 14 days after the full course of vaccinationDescription: The protective level of Anti-SARS-CoV-2 NtAbs
Measure: Anti-SARS-CoV-2 neutralizing antobody (NtAb) (immunological surrogate endpoint) Time: 14 days after 2-dose of immunization.A new strain of coronavirus that caused severe respiratory disease in infected individuals was initially identified in China's Wuhan City in December 2019. Severe acute respiratory distress syndrome coronavirus-2 (SARS-CoV-2), which was responsible for the corona virus infectious disease-2019 (COVID-19).The World Health Organization declared that COVID-19 was a Public Health Emergency of International Concern on January 30,2020. The impact of COVID-19 in liver recipients remains largely unknown but accumulating experience is going on. Liver transplant recipients should have been classified as a risk group and should have received regular surveillance for COVID-19 throughout the pandemic. Some reports suggest decreasing immunosuppression for infected recipients, if no recent rejection episodes. Paradoxically, others suggest that a reactive immune response might be the cause for severe tissue damage, and that immunosuppression might be protective from the postulated cytokine storm. Some studies stated that the LT patients who are permanently on immunosuppressants could be particularly susceptible to SARS-CoV-2, and their prognosis could be worse in comparison to the normal population. They recommended that LT recipients should be closely monitored for SARS-CoV-2. The LT society of India (LTSI) highlighted the potential of LT recipients as asymptomatic carriers and source of viral spread, and that SARS-CoV-2 can be transmitted to LT recipients. There are insufficient data on the relationship between immunosuppressive therapy and COVID-19 in LT recipients during this pandemic. However, the Beijing working party for liver transplantation suggested that LT recipients who were infected with SARS-CoV-2 should be treated with steroids for a short period to reduce the severity of pneumonia. They also suggested that immunosuppressive therapies should be continued for both patients with mild COVID-19 and those who were not infected by the virus, and calcineurin inhibitor treatment dosage should be reduced in moderate to severe cases. Neutralizing antibodies (NAbs) play an important role in virus clearance and have been considered as a key immune product for protection or treatment against viral diseases. Virus-specific NAbs, induced through either infection or vaccination, have the ability to block viral infection. SARS-CoV -2 specific NAbs reached their peak in patients from day 10-15 after the onset of the disease and remained stable thereafter in the patients. Antibodies targeting on different domains of S protein, including S1, RBD, and S2, may all contribute to the neutralization. Al-Rajhi Liver Center is the only liver transplantation center in Upper Egypt that performed only 51 living donor liver transplantation (LDLT) cases since 2014, but it was used as isolation Hospital for COVID-19 cases from March to July, 2020. Communication with liver transplant cases during that period was via Telemedicine. Resuming usual Hospital activity as Tertiary Liver Center occurred in 15 August 2020. Similarly, other Hospitals in Egypt were designated as COVID-19 isolation Hospitals.
Wearing face coverings in enclosed public spaces is a key public health measure to limit viral spread during the 2020 Covid-19 pandemic. Health psychologists are interested in developing interventions that can increase the likelihood of health-adherent and protective behaviours being consistently undertaken at a general population level. Mental imagery interventions are one way in which behavioural scientists and health psychologists try to encourage behaviour change. Mental imagery involves thinking about, and then writing about, anticipated positive outcomes or key practical requirements of a defined health-related action (e.g. 'moderate alcohol consumption'; 'engaging in regular physical activity'). For this project, the investigators are exploring a mental imagery intervention created to encourage regular and consistent wearing of face coverings in public places where this is currently required in the UK. The investigators will test whether engaging in a mental imagery exercise results in any improvement in wearing a face covering (or intention to wear a face covering) one month later relative to reading a public health message about face coverings. In addition, the investigators will explore belief-based and personality-related factors that might make a difference to the effectiveness of the mental imagery intervention.
Description: Self-reported single item response statement with a Likert-type response. Minimum value = 1; maximum value = 5 (a higher score indicates a better outcome).
Measure: Face covering wearing consistency Time: 4 weeks post-interventionDescription: Self-reported three item response scale with Likert-type responses. Minimum value = 1; maximum value = 5 (a higher score indicates a better outcome).
Measure: Face covering wearing intention Time: 4 weeks post-interventionDescription: Self-reported 3 item response scale with Likert-type responses. Minimum value = 1; maximum value = 5 (a higher score indicates a worse outcome).
Measure: Attitude toward wearing a face covering Time: 4 weeks post-interventionDescription: Self-reported 2 item response scale with Likert-type responses. Minimum value = 1; maximum value = 5 (a higher score indicates a better outcome).
Measure: Injunctive norm beliefs about wearing a face covering Time: 4 weeks post-interventionDescription: Self-reported 2 item response scale with Likert-type responses. Minimum value = 1; maximum value = 5 (a higher score indicates a better outcome).
Measure: Descriptive norm beliefs about wearing a face covering Time: 4 weeks post-interventionDescription: Self-reported 3 item response scale with Likert-type responses. Minimum value = 1; maximum value = 5 (a higher score indicates a better outcome).
Measure: Perceived behavioural control over wearing a face covering Time: 4 weeks post-interventionDescription: Self-reported 6 item response scale with Likert-type responses. Minimum value = 1; maximum value = 5 (a higher score indicates a better outcome).
Measure: Barrier self-efficacy to wearing a face covering Time: 4 weeks post-interventionThis is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
Description: Safety and tolerability
Measure: Incidence of treatment emergent adverse events Time: Day 1 (Date of Consent) to Day 28Description: Safety and tolerability with adverse event graded at 2 or higher
Measure: Incidence of device related adverse events Time: Day 1 (Date of Consent) to Day 14Description: Safety and tolerability
Measure: Incidence of serious adverse events Time: Day 1 (Date of Consent) to Day 28Description: Length of ICU stay in days
Measure: Length if Stay in ICU Time: Day 1 (Date of Consent) to Day 28Description: Number of deaths during hospitalization
Measure: In-hospital mortality Time: Day 1 (Date of Consent) to Day 28Description: Number of days without ventilatory support
Measure: Days free of ventilatory dependency Time: Day 1 (Date of Consent) to Day 28Description: Number of days without vasopressor support
Measure: Vasopressor-free days Time: Day 1 (Date of Consent) to Day 28Description: SOFA scoring system predicts the clinical outcome of critically ill patients.
Measure: Sequential Organ Failure Assessment (SOFA) Time: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)Description: Measures the severity of disease for adult patients admitted to an ICU
Measure: Acute Physiology and Chronic Health Evaluation (APACHE) Time: Before first daily filter treatment and after the last daily filter treatment (i.e. 4 days or more)Description: Measures viral exposure and levels of circulating virus
Measure: SARS CoV-2 RNA levels in plasma and nasopharyngeal samples Time: Before each filter treatment, every 2 hours during filter treatment and immediately after filter discontinuedDescription: Measurement of lymphocytes as there seems to be a correlation with the disease severity and lymphopenia.
Measure: Total lymphocyte count Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measurement of inflammatory marker levels play a role in systemic vasculitis and cytokine mediated coagulation disorders as the principal actors of multi organ failure in patients with severe COVID-19 complication.
Measure: C-reactive protein (CRP), IL-1, IL-6, and TNF alpha Tests Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measurement of D-dimer levels as levels are elevated in patients with COVID-19 and correlate with disease severity, are a reliable prognostic marker for in-hospital mortality.
Measure: D-dimer Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measurement of Troponin-T as high levels of troponin is found in COVID-19 patients.
Measure: Troponin-T Time: Before first daily filter treatment and after the last daily filter treatment (i.e. at 4 days or more)Description: Measures the levels of SARS-CoV-2 RNA captured in the filter
Measure: Evaluation of SARS-CoV-2 RNA levels post-treatment Hemopurifier cartridges Time: Until study completion, 1 week or for the duration of ICU admissionDescription: Measures the levels of viral particles captured in the filter
Measure: Evaluation of viral particle load post-treatment Hemopurifier cartridges Time: Until study completion, 1 week or for the duration of ICU admissionThis is a double blind randomized placebo controlled study will be conducted on 124 subjects, 50 years and older with mild or asymptomatic COVID-19. If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L). There are no signs of dehydration, sepsis or shortness of breath. The study will be conducted at two centers. There will be a screening visit at Day -4 followed by three visits at the center at Days 1, 7 and 15 and a follow-up visit on Day 28. All participants will be randomized to receive either ViraCide (investigational product) or matching placebo. All subjects will receive SOC therapy. Note: If subject is discharged before Day 15 PI's discretion as per patients health condition, then assessments scheduled for Day 15 will be carried out on the discharge day (as far as possible and those not performed will be noted on appropriate CRF page) and Day 15 visit will be done telephonically.
Description: Time to Clinical Improvement (TTCI) using NEWS Score23 [Time Frame:First treatment date up to discharge day (PI's discretion as per patient's health condition)] The median time in days from the start of treatment with the study drug / placebo to the persistent achievement of all of the following criteria: i. Stopping a fever (which is defined as a decrease in axillary temperature below 37 ° C without the use of antipyretic drugs); ii. Respiratory rate <22 /min; iii. Oxygen saturation (SPO2) > 95% when breathing in atmospheric air. Measured using pulse oximetry iv. Systolic blood pressure ≤200mmHg v. Pulse rate 51-90beats/minute vi. Is conscious and alert
Measure: NEWS Score Time: First treatment date up to day 15Description: TTIC using 7-point ordinal scale3 [Time Frame: First treatment date up to discharge day (PI's discretion as per patients health condition)]
Measure: 7-point ordinal scale Time: First treatment date up to day 15Description: Rate of progression to severe/critical COVID-19 disease based on NEWS score
Measure: Rate of progression on NEWS score Time: First treatment date up to 15 daysDescription: Rate of progression to severe/critical COVID-19 disease based on 7-point
Measure: Rate of progression on 7 point ordinal score Time: First treatment date up to 28daysDescription: Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Measure: Time to COVID-19 nucleic acid testing Time: Time Frame: First treatment date up to 28daysDescription: Incidence of ICU admissions
Measure: ICU admissions Time: Time Frame: 28daysDescription: Subject survival rate
Measure: survival rate Time: Time Frame: 28 daysDescription: Incidence of mechanical ventilation
Measure: mechanical ventilation Time: Time Frame: First treatment date up to 28 days]Description: Time to COVID-19 nucleic acid testing negativity in oropharyngeal/nasal swab)
Measure: Time to COVID-19 nucleic acid testing Time: Time Frame: Days 1, 7, 15Description: Change in clinical or laboratory assessment of comorbid condition
Measure: Assessmentofcomorbidcondition Time: Time Frame: First treatment date up to 28days]Description: Percent of participants with worsening comorbid condition
Measure: worsening comorbid condition Time: Time Frame: First treatment date up to 28days]An observational study is carried out in the university population of the University of Salamanca to know the impact of the COVID-19 pandemic and the influence of physical exercise on the severity of symptoms.
Description: Number of positives
Measure: Impact of COVID-19 Time: Through study completion, an average of 3 monthsDescription: Quantity of physical exercise
Measure: Influence of exercise in COVID-19 infection Time: Through study completion, an average of 3 monthsDescription: Change at exercise habits on University population
Measure: Change in the practice of physical exercise after home confinement Time: Through study completion, an average of 3 monthsProject is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.
Description: Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.
Measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population. Time: 8 monthsDescription: Prevalence of asymptomatic cases into seropositive population
Measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies Time: 8 monthsThe aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.
Description: Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.
Measure: Prevalence of myocardial scars Time: Day 0Description: Measured in mL
Measure: CMR feature : Location and size of myocardial scars Time: Day 0Description: Measured in milliseconds
Measure: CMR feature : native T1 and T2 values Time: Day 0Description: Measured in percentage
Measure: CMR feature : extracellular volume fraction Time: Day 0Description: Measured in mL/m2
Measure: CMR feature : ventricular volumes Time: Day 0Description: Measured in percentage
Measure: CMR feature : ejection fraction Time: Day 0Description: Measured in percentage
Measure: CMR feature : myocardial strain Time: Day 0Description: Repolarization abnormalities, T wave inversion, ST segment abnormalities, QRS fractionation, atrial arrhythmias, premature ventricular beats or ventricular tachycardia.These will be assessed at the time of CMR study on a resting 12-lead ECG recording and on exercise 12-lead ECG and 24-hour Holter ECG recordings.
Measure: ECG features Time: Baseline and month 3Description: Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes. Measured in percentage.
Measure: Biological feature : positivity of COVID-19 serology Time: Baseline and month 3Description: Measured in fg/ml
Measure: Biological feature : troponin level Time: Day 0Description: Markers of inflammation and fibrosis will be sought. The Th1/Th2/activation/inflammation/apoptosis markers will be measured in the sera by a Luminex test allowing the detection of 48 analytes.
Measure: Biological feature : inflammatory markers level Time: Day 0Description: Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19
Measure: Genetic profile research Time: Day 0There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode. Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.
Description: To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients six months after laboratory-confirmed diagnosis of SARS-CoV-2
Measure: Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients Time: Month 6Description: To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients 12 months after laboratory-confirmed diagnosis of SARS-CoV-2
Measure: Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients Time: Month 12Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.
Description: Defined as WHO Clinical Progression score of <6 [patient alive, not requiring invasive, non-invasive, or high flow oxygen therapy, vasopressors, dialysis or Extracorporeal membrane oxygenation (ECMO)].
Measure: Treatment Success at day 14 Time: Day 14Description: Change in WHO Clinical Progression Score between day 1 and day 7 [WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)]
Measure: Change in WHO Clinical Progression Score Time: Day 7Description: Time to ICU admission up to 28 days
Measure: Time to ICU admission Time: Day 28Description: Incidence of adverse events up to 28 days
Measure: Incidence of Adverse Events Time: Day 28Description: Length of hospital stay up to 28 days
Measure: Length of hospital stay Time: Day 28Description: All-cause mortality rate at hospital discharge or at 28 days, whichever is first
Measure: All-cause Mortality Time: Day 28To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.
Description: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.
Measure: Differential expression of biomarkers between COVID-19 and controls Time: up to 90 daysDescription: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection
Measure: Differential expression of biomarkers between severe and non-severe COVID-19 Time: up to 90 daysDescription: Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality.
Measure: Correlation of biomarkers with disease severity Time: up to 90 daysDescription: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.
Measure: Biomarkers depending on therapy Time: up to 90 daysDescription: Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.
Measure: Biomarkers depending on bacterial co-infection Time: up to 90 daysDescription: Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.
Measure: Correlation of biomarkers with viral load Time: up to 90 daysThis is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.
Description: Blood will be collected every third day for the duration of study participation. D-dimer Neutrophils Lymphocytes Platelets (PLT) Glucose Lactate C-Reactive Protein (CRP) Cardiac Troponin (TRO) Ferritin
Measure: Difference in Plasma markers at 14 days Time: 14 daysDescription: Outcome reported as the number of participants who have expired at 14 days post enrollment.
Measure: 14-Day Mortality Time: 14 daysDescription: 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.
Measure: Difference in Estimated P/F Ratio at 14 days Time: 14 daysDescription: Nasopharyngeal swabs will be collected every fourth day for the duration of study participation. as number of viral genetic copies per mL.
Measure: Viral Clearance by Nasopharyngeal Swab Time: 14 daysDescription: Outcome reported as the mean number of days participants in each arm had 2 or more abnormal plasma levels of: D-dimer Neutrophils Lymphocytes Platelets (PLT) Glucose Lactate C-Reactive Protein (CRP) Cardiac Troponin (TRO) Ferritin
Measure: Number of Abnormal Biomarker Days Time: 14 daysDescription: 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) and Expiratory Pressure.
Measure: Difference in Estimated PEEP adjusted P/F Ratio at 14 days Time: 14 daysDescription: PaO2 or SaO2 and FiO2. Partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry. FiO₂ is estimated from oxygen flow/delivery rates
Measure: Difference in Oxygenation at 14 days Time: 14 daysDescription: Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL, new treatment with pressures, increase in 50% pressure or fluid rate) per participant in each arm.
Measure: Daily Hypotensive Episodes Time: 14 daysDescription: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.
Measure: Hypotension Requiring Vasopressors Time: 14 daysDescription: 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: 14 daysDescription: 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 risk of mortality.
Measure: Sequential Organ Failure Assessment (SOFA) Total Score Time: 14 daysDescription: 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: 14 daysDescription: Outcome reported as the number of participants who have expired at 28 days post enrollment.
Measure: 28-Day Mortality Time: 28 daysDescription: Outcome reported as the number of participants who have expired at 90 days post enrollment.
Measure: 90-Day Mortality Time: 90 daysDescription: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).
Measure: ICU Admission Time: 14 daysDescription: 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: 14 daysDescription: 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: 14 daysDescription: 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: 14 daysDescription: 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: 14 daysDescription: Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.
Measure: Length of Hospital Stay Time: 14 daysDescription: 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: 14 daysDescription: 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: 14 daysDescription: 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: 14 daysDescription: 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: 14 daysDescription: Nasopharyngeal swabs will be collected every fourth 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 Time: 14 daysDescription: 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 Time: 14 daysDescription: Blood will be collected every third day for viral load assessment for the duration of study participation. clearance is measured as fold change in viral genetic copies per mL.
Measure: Viral Clearance by Blood Time: 14 daysRespiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.
Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record
Measure: Describe the aetiology of influenza-like illness in hospitalised adults Time: Day 0 to Day 28Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.
Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults Time: Day 0 to Day 28Description: Cytokine levels (in pg/mL) will be measured in plasma and nasal lining fluid samples by MesoScale Discovery
Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults Time: Day 0 to Day 28Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.
Description: To describe the age category of the 1st possible contaminant in the index case to show the preponderance of possible adult and adolescent contaminants in the SARS-Cov-2 contamination. Percentage of possible contaminants, adults, adolescents and children, in matched children and adults with Covid-19.
Measure: Percentage of possible contaminants, adults, adolescents and children with Covid-19 Time: at inclusionA multicenter, 3-arm randomized dose finding study in UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate.
Background: Recent reports increasingly recognize neurological manifestations in COVID-19 patients. However, the full spectrum of the disease and risk factors are not well understood. Aim: To describe the full spectrum of neurological manifestations in COVID-19 and assess the clinical characteristics, risks and prognostic factors. Outcomes: Identification of COVID-19 associated neurological disease is the primary outcome while requirement for admission to critical care unit, mortality, length of hospital stay, quality of life, and neurological disability are the secondary outcomes. Participants: Patients above Age more than 18 years enrolled based on new-onset acute neurological disease and COVID19 positive will serve as cases while patient with confirmed COVID-19 without neurological manifestation will serve as controls. Design and Procedures: The study is prospective case control in design and is divided into three phases in India, Brazil and Malawi ; the first phase will address role of hypoxia in causation of neurological diseases, the second phase will compare characteristics of patients hospitalized with COVID-19 with and without neurological disease and the third phase will assess the long-term follow up (at 3 months and 9 months) of cases.
Description: A score made up of 11 elements. Total min 0; max 42. Lower is better; 0 can be scored if the person has full function in every element of the assessment.
Measure: Severity of stroke using National Institutes of Health Stroke Scale (NIHSS) Time: Day 30 of admission, or at discharge, or at death, whichever is earlierDescription: An ordinal scale, from 1 = death (minimum; worst outcome) to 8 = upper good recovery (maximum; best outcome).
Measure: Glasgow Outcome Scale Extended Time: Discharge (or day 30), 3 months and 9 monthsDescription: Modified Rankin Score using a simplified algorithm by Bruno et al 2010. An ordinal scale, from 0 = no symptoms at all (minimum; best outcome) to 6 = dead (maximum; worst outcome).
Measure: Modified Rankin Score Time: Discharge (or day 30), 3 months and 9 monthsDescription: Montreal Cognitive Assessment (MoCA), using a full test at discharge (or day 30) and a telephone test at 3 months and 9 months
Measure: Montreal Cognitive Assessment (MoCA) Time: Discharge (or day 30), 3 months and 9 monthsDescription: Development of new onset neurological sequelae e.g.epilepsy, new/recurrent stroke, cognitive decline, encephalitis
Measure: Development of new onset neurological sequelae Time: Discharge (or day 30), 3 months and 9 monthsDescription: A questionnaire scoring 5 domains of quality of life at ordinal levels of 1-3 each (1 = best; 3 = worst), plus an overall health state score from 0 to 100 on a visual analog scale (0 = worst; 100 = best).
Measure: European QoL-5D (EQ-5D-3L) overall health utility quality of life score Time: Discharge (or day 30), 3 months and 9 monthsThis is a prospective, randomized placebo-controlled double blinded clinical trial in frontline healthcare workers managing COVID-19 patients. Participants will be weekly tested for SARS-CoV-2 and a panel of respiratory viruses. Treatment will be 3times a day for 84 days one puff into each nostirl and 3 puffs into mouth. Daily a symptom score will be recorded. The primary objective of the trial is to demonstrate that prophylactic treatment of health care workers managing COVID-19 patients with iota-carrageenan reduces symptoms of SARS-CoV-2 infections as well as infections with other respiratory viruses when compared to a placebo-treated control group.
Description: daily assessment of subjective COVID-19 symptom score
Measure: Presence of COVID-19 symptoms including symptoms of respiratory viral infection documented in a diary Time: 84 daysDescription: weekly assessment of SARS-CoV-2, Influenza A, Human Metapneumovirus, Influenza A - subtype H1, Adenovirus, Influenza A - subtype H3, Parainfluenza 1, Influenza A - subtype 2009 H1N1, Parainfluenza 2, Influenza B, Parainfluenza 3, Parainfluenza 4, Coronavirus HKU1, Respiratory Syncytial Virus A, Coronavirus N63L, Respiratory Syncytial Virus B, Coronavirus OC43, Rhinovirus/Enterovirus, Coronavirus 229E, Human Bocavirus, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila
Measure: Nasal swabs for analysis of viruses by PCR Time: 84 daysDescription: beginn and end of trial
Measure: Serology of antibodies against SARS-CoV-2 Time: 84 daysDescription: weekly nasal swabs for analysis of viruses
Measure: Number of viral co-infections dedected by PCR Time: 84 daysThe pandemic caused by SARS-CoV-2 is a global emergency present in 6 continents including 66 countries, incurring a shortage of effective and safe therapeutic alternatives that can contribute to reducing the risk of contamination, as well as helping to reduce the viral load of the positive patient. This requires a coordinated, effective and immediate action on the part of governments, companies, academic entities and even at the individual level. In the search for new therapeutic and prevention alternatives, the application of hypochlorous acid (HClO) to the nasal mucosa is proposed, a broad-spectrum and fast-acting antimicrobial solution, whose safety has been proven in preclinical trials. The efficacy of HClO has been tested against enveloped and non-enveloped viruses, reducing virus particles without affecting human cells. This solution could contribute to reducing the viral load and the risk of contamination of patients and professionals. This could have an impact on controlling the COVID-19 pandemic.
Description: Number of participants who get COVID19 infection during the application of S-HClO
Measure: Prevention of infection by COVID19 Time: Through study completion, an average of 6 monthsDescription: Determine the occurrence of ADR by the use of S-HClO
Measure: Adverse drug reaction (ADR) Time: Through study completion, an average of 6 monthsDescription: Determine the frequency of seroconversion due to COVID 19
Measure: Seroconversion Time: Through study completion, an average of 6 monthsDescription: Number of participants who fell ill from COVID-19 and was not hospitalized
Measure: Hospitalization Time: Through study completion, an average of 6 monthsDescription: Number of participants who fell ill from COVID-19 and was hospitalized in ICU
Measure: ICU Time: Through study completion, an average of 6 monthsIL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose
Description: by RT-PCR
Measure: Viral load Time: 7-15 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports