CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D003141: Communicable Diseas NIH

(Synonyms: Communicable, Communicable D, Communicable Di, Communicable Dis, Communicable Disea, Communicable Diseas, Communicable Disease, Communicable Diseases)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (255)


Name (Synonyms) Correlation
drug591 Hydroxychloroquine Wiki 0.30
drug1016 Placebo Wiki 0.22
drug505 Favipiravir Wiki 0.21
drug1035 Placebo oral tablet Wiki 0.16
drug763 Losartan Wiki 0.15
drug662 Imatinib Wiki 0.14
drug550 HB-adMSCs Wiki 0.14
drug594 Hydroxychloroquine + Azithromycin Wiki 0.14
drug608 Hydroxychloroquine Sulfate Wiki 0.13
drug1475 Vitamin C Wiki 0.12
drug1504 Zinc Wiki 0.11
drug592 Hydroxychloroquine (HCQ) Wiki 0.11
drug686 Interferon Beta-1B Wiki 0.11
drug73 Anakinra Wiki 0.11
drug1042 Placebos Wiki 0.10
drug767 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.10
drug626 Hydroxychloroquine as post exposure prophylaxis Wiki 0.10
drug532 GO2 PEEP MOUTHPIECE Wiki 0.10
drug1030 Placebo of excipient(s) will be administered Wiki 0.10
drug773 Low-dose chloroquine Wiki 0.10
drug601 Hydroxychloroquine - Daily dosing Wiki 0.10
drug1154 Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki 0.10
drug672 Indomethacin Wiki 0.10
drug482 Equipment with smartwatch throughout hospital stay on the general ward Wiki 0.10
drug1400 To assess for development of IgG antibodies against SARS-CoV2 Wiki 0.10
drug649 INC424 / Ruxolitinib Wiki 0.10
drug1136 Recombinant Interferon Alfa-2b Wiki 0.10
drug508 Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine Wiki 0.10
drug1645 remdesivir Wiki 0.10
drug219 Bromhexine Hydrochloride Wiki 0.10
drug460 Eicosapentaenoic acid gastro-resistant capsules Wiki 0.10
drug362 Convalescent Plasma 1 Unit Wiki 0.10
drug584 Human biological samples Wiki 0.10
drug1119 RT PCR SARS-CoV-2 Wiki 0.10
drug553 HCQ & AZ vs HCQ+SIR Wiki 0.10
drug492 Exercise capacity Wiki 0.10
drug1313 Stool collection or fecal swab Wiki 0.10
drug894 Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki 0.10
drug658 IgM and IgG diagnostic kits to SARS-CoV-2 Wiki 0.10
drug655 Icosapent ethyl Wiki 0.10
drug1479 Vitamins Wiki 0.10
drug207 Blood sample for whole genome sequencing Wiki 0.10
drug652 IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care. Wiki 0.10
drug554 HCQ + Intravenous Famotidine Wiki 0.10
drug297 Centricyte 1000 Wiki 0.10
drug1171 Routine standard of care Wiki 0.10
drug755 Lopinavir and Ritonavir Tablets Wiki 0.10
drug512 Favipiravir and Hydroxychloroquine Wiki 0.10
drug615 Hydroxychloroquine Sulfate 400 mg twice a day Wiki 0.10
drug630 Hydroxychloroquine plus standard preventive measures Wiki 0.10
drug3 - Synthetic anti-malarial drugs Wiki 0.10
drug616 Hydroxychloroquine Sulfate 600 mg once a day Wiki 0.10
drug858 NIVOLUMAB Wiki 0.10
drug918 Normobaric oxygen therapy Wiki 0.10
drug560 HOME-CoV rule implementation Wiki 0.10
drug578 High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki 0.10
drug954 Others(No intervention) Wiki 0.10
drug766 Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki 0.10
drug493 Exercise physiology Wiki 0.10
drug564 Health-related quality of life Wiki 0.10
drug761 Lopinavir/ritonavir 400 mg/100 mg Wiki 0.10
drug1351 Tap water Wiki 0.10
drug430 Dipyridamole 100 Milligram(mg) Wiki 0.10
drug412 Degarelix Wiki 0.10
drug1613 non-contact magnetically-controlled capsule endoscopy Wiki 0.10
drug286 Capillary and salivary sampling Wiki 0.10
drug1385 There is no intervention in this study Wiki 0.10
drug483 Ergoferon Wiki 0.10
drug620 Hydroxychloroquine Sulfate Tablets Wiki 0.10
drug1275 Standard Plasma (FFP) Wiki 0.10
drug632 Hydroxychloroquine sulfate &Azithromycin Wiki 0.10
drug610 Hydroxychloroquine Sulfate + Azithromycin Wiki 0.10
drug263 COVID-19 positive via testing Wiki 0.10
drug582 Huaier Granule Wiki 0.10
drug647 ID NOW vs. Accula Wiki 0.10
drug657 IgG test Wiki 0.10
drug1031 Placebo on a 0- and 14-day schedule Wiki 0.10
drug485 Essential oils Wiki 0.10
drug443 Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki 0.10
drug1291 Standard of care treatment Wiki 0.10
drug445 Duodenal biopsy Wiki 0.10
drug198 Blood collection on admission and longitudinally Wiki 0.10
drug1152 ResCure™ Wiki 0.10
drug1127 Ranitidine Wiki 0.10
drug393 DAS181 Wiki 0.10
drug771 Low or upper respiratory tract sample Wiki 0.10
drug1484 WHO recommendations (waiting condition) Wiki 0.10
drug395 DAS181 OL Wiki 0.10
drug1686 washed microbiota transplantation Wiki 0.10
drug208 Blood samples Wiki 0.10
drug1377 The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: Wiki 0.10
drug504 Famotidine Wiki 0.10
drug306 Chinese Herbal Medicine Wiki 0.10
drug1073 Presatovir Wiki 0.10
drug1074 Presatovir placebo Wiki 0.10
drug1032 Placebo on a 0- and 28-day schedule Wiki 0.10
drug809 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.10
drug290 Carrimycin Wiki 0.10
drug549 HB-adMSC Wiki 0.10
drug1628 phone call Wiki 0.10
drug318 Ciclesonide Inhalation Aerosol Wiki 0.10
drug98 ArtemiC Wiki 0.10
drug63 Allogeneic NK transfer Wiki 0.10
drug468 Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet Wiki 0.10
drug617 Hydroxychloroquine Sulfate 600 mg twice a day Wiki 0.10
drug1036 Placebo plus standard preventive measures Wiki 0.10
drug1161 Rintatolimod Wiki 0.10
drug506 Favipiravir (3200 mg + 1200 mg) Wiki 0.10
drug509 Favipiravir (3600 mg + 1600 mg) Wiki 0.10
drug660 Imaging by thoracic scanner Wiki 0.10
drug574 High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki 0.10
drug548 Guided online support program Wiki 0.10
drug537 Gargle/Mouthwash Wiki 0.10
drug500 Extra blood sample Wiki 0.10
drug1677 trimethoprim/sulfamethoxazole Wiki 0.10
drug70 Aluminum hydroxide adjuvant (Alhydrogel®) Wiki 0.10
drug808 Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki 0.10
drug530 GLS-1200 Wiki 0.10
drug1569 hydroxychloroquine in combination with camostat mesylate Wiki 0.10
drug248 COVID-19 IgM/IgG Rapid Testing, mobile device image capture and telemedicine support Wiki 0.10
drug1293 Standard screening strategy Wiki 0.10
drug641 Hyperbaric oxygen therapy Wiki 0.10
drug311 Chloroquine analog (GNS651) Wiki 0.10
drug575 High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki 0.10
drug624 Hydroxychloroquine and azithromycin treatment Wiki 0.10
drug651 IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki 0.10
drug627 Hydroxychloroquine combined with Azithromycin Wiki 0.10
drug595 Hydroxychloroquine + Placebo Wiki 0.10
drug1543 convalescent plasma application to SARS-CoV-2 infected patients Wiki 0.10
drug1545 conventional management of patients Wiki 0.10
drug1020 Placebo 250 cc 24 hours continuous infusion for 15 days Wiki 0.10
drug678 Inhaled beclomethasone Wiki 0.10
drug794 Mannitol Wiki 0.10
drug555 HCQ + Placebo Wiki 0.10
drug758 Lopinavir/ Ritonavir Oral Tablet Wiki 0.10
drug510 Favipiravir + Standard of Care Wiki 0.10
drug1529 blood samples Wiki 0.10
drug621 Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki 0.10
drug1508 Zithromax Oral Product Wiki 0.10
drug1481 VivaDiag™ COVID-19 lgM/IgG Rapid Test Wiki 0.10
drug579 High-dose chloroquine Wiki 0.10
drug562 Halo Placebo Wiki 0.10
drug463 Electric pad for human external pain therapy Wiki 0.10
drug825 Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki 0.10
drug1421 Treatment with Dexmedetomidine Wiki 0.10
drug13 1: Usual practice Wiki 0.10
drug1412 Tradipitant Wiki 0.10
drug466 Elisa-test for IgM and IgG to SARS-CoV-2 Wiki 0.10
drug776 Lung Function tests Wiki 0.10
drug363 Convalescent Plasma 2 Units Wiki 0.10
drug561 Halo Oral Spray Wiki 0.10
drug941 Only Standard Treatment Wiki 0.10
drug320 Clarithromycin Wiki 0.10
drug348 Conestat alfa Wiki 0.10
drug609 Hydroxychloroquine Sulfate (HCQ) Wiki 0.10
drug20 2: Usual practice + SYMBICORT RAPIHALER Wiki 0.10
drug770 Low nitrite/NDMA meals Wiki 0.10
drug606 Hydroxychloroquine Pre-Exposure Prophylaxis Wiki 0.10
drug680 Inhaled nitric oxide gas Wiki 0.10
drug826 Mid-dose chloroquine Wiki 0.10
drug576 High nitrite/NDMA meals Wiki 0.10
drug552 HCQ & AZ Wiki 0.10
drug507 Favipiravir (3200 mg + 1200 mg) combined with Azithromycin Wiki 0.10
drug1006 Phosphate buffered saline Placebo Wiki 0.10
drug1019 Placebo + Placebo Wiki 0.10
drug1587 lung ultrasound (LUS) Wiki 0.10
drug1452 Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki 0.10
drug798 Matched Placebo Hydroxychloroquine Wiki 0.10
drug628 Hydroxychloroquine in combination of Azithromycin Wiki 0.10
drug191 Biospecimen Collection Wiki 0.10
drug147 BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki 0.10
drug1583 lopinavir/ritonavir Wiki 0.10
drug491 Exercise brochure Wiki 0.10
drug394 DAS181 COVID-19 Wiki 0.10
drug1310 Sterile Normal Saline for Intravenous Use Wiki 0.10
drug735 Lactoferrin (Apolactoferrin) Wiki 0.10
drug604 Hydroxychloroquine Only Product in Oral Dose Form Wiki 0.10
drug713 Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki 0.10
drug979 Pacebo: Calcium citrate Wiki 0.10
drug494 Experimental drug Wiki 0.10
drug1519 artus Influenza A/B RT-PCR Test Wiki 0.10
drug489 Examine the impact of COVID-19 during pregnancy Wiki 0.10
drug1212 Saliva Wiki 0.10
drug1107 Questionnaire with precaution information Wiki 0.10
drug1512 additional blood tubes Wiki 0.10
drug276 CYNK-001 Wiki 0.10
drug629 Hydroxychloroquine plus Nitazoxanide Wiki 0.10
drug1138 Recombinant S protein SARS vaccine Wiki 0.10
drug644 IC14 Wiki 0.10
drug744 Liberase Enzyme (Roche) Wiki 0.10
drug1123 Radiation therapy Wiki 0.10
drug495 Experimental: Questionnaire without precaution information Wiki 0.10
drug447 Duvelisib Wiki 0.10
drug202 Blood plasma Wiki 0.10
drug656 Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki 0.10
drug199 Blood collection on their first consultation and 10 to 14 days later Wiki 0.10
drug410 Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days Wiki 0.10
drug881 New screening strategy Wiki 0.10
drug1295 Standard therapy Wiki 0.10
drug1492 Whole Exome Sequencing Wiki 0.10
drug1585 lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Wiki 0.10
drug1476 Vitamin D Wiki 0.09
drug154 BNT162b1 Wiki 0.07
drug1170 Routine care for COVID-19 patients Wiki 0.07
drug897 Nivolumab Wiki 0.07
drug525 Follow up Wiki 0.07
drug15 200 mg EIDD-2801 Wiki 0.07
drug156 BNT162c2 Wiki 0.07
drug551 HCQ Wiki 0.07
drug531 GLS-5300 Wiki 0.07
drug201 Blood draw Wiki 0.07
drug1350 Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki 0.07
drug465 Electronic questionnaire Wiki 0.07
drug401 Data Collection Wiki 0.07
drug310 Chloroquine Sulfate Wiki 0.07
drug1233 Selinexor Wiki 0.07
drug1248 Siltuximab Wiki 0.07
drug1367 Telmisartan Wiki 0.07
drug1002 Peripheral blood draw Wiki 0.07
drug602 Hydroxychloroquine - Weekly Dosing Wiki 0.07
drug612 Hydroxychloroquine Sulfate 200 MG Wiki 0.07
drug864 NORS (Nitric Oxide Releasing Solution) Wiki 0.07
drug95 Arbidol Wiki 0.07
drug153 BNT162a1 Wiki 0.07
drug1523 basic treatment Wiki 0.07
drug1076 Probiotic Wiki 0.07
drug457 Echocardiography Wiki 0.07
drug155 BNT162b2 Wiki 0.07
drug900 No intervention Wiki 0.06
drug1104 Questionnaire Wiki 0.06
drug1280 Standard of Care Wiki 0.06
drug760 Lopinavir/ritonavir Wiki 0.06
drug613 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.06
drug1359 Telemedicine Wiki 0.06
drug893 Nitric Oxide Wiki 0.06
drug749 Lopinavir / Ritonavir Wiki 0.06
drug876 Nasopharyngeal swab Wiki 0.06
drug1060 Povidone-Iodine Wiki 0.06
drug1302 Standard treatment Wiki 0.06
drug685 Interferon Beta-1A Wiki 0.06
drug129 Azithromycin Wiki 0.06
drug354 Control Wiki 0.05
drug1453 Usual Care Wiki 0.05
drug1207 Saline Wiki 0.05
drug1530 blood sampling Wiki 0.05
drug280 Camostat Mesilate Wiki 0.05
drug1365 Telerehabilitation Wiki 0.05
drug1278 Standard care Wiki 0.04
drug1402 Tocilizumab Wiki 0.04
drug472 Enoxaparin Wiki 0.04
drug203 Blood sample Wiki 0.04
drug715 Ivermectin Wiki 0.04
drug1631 placebo Wiki 0.03
drug1285 Standard of care Wiki 0.03
drug1146 Remdesivir Wiki 0.03

Correlated MeSH Terms (55)


Name (Synonyms) Correlation
D007239 Infection NIH 0.66
D045169 Severe Acute Respiratory Syndrome NIH 0.34
D018352 Coronavirus Infections NIH 0.29
D003333 Coronaviridae Infections NIH 0.20
D012327 RNA Virus Infections NIH 0.20
D014777 Virus Diseases NIH 0.19
D012141 Respiratory Tract Infections NIH 0.18
D018357 Respiratory Syncytial Virus Infections NIH 0.15
D003428 Cross Infection NIH 0.14
D018184 Paramyxoviridae Infections NIH 0.11
D004066 Digestive System Diseases NIH 0.10
D030341 Nidovirales Infections NIH 0.10
D005767 Gastrointestinal Diseases NIH 0.10
D009362 Neoplasm Metastasis NIH 0.10
D011649 Pulmonary Alveolar Proteinosis NIH 0.10
D009410 Nerve Degeneration NIH 0.10
D001997 Bronchopulmonary Dysplasia NIH 0.10
D008595 Menorrhagia NIH 0.10
D006470 Hemorrhage NIH 0.10
D003384 Coxsackievirus Infections NIH 0.10
D004660 Encephalitis NIH 0.10
D006929 Hyperaldosteronism NIH 0.10
D000075902 Clinical Deterioration NIH 0.10
D014552 Urinary Tract Infections NIH 0.10
D054990 Idiopathic Pulmonary Fibrosis NIH 0.10
D000309 Adrenal Insufficiency NIH 0.10
D054559 Hyperphosphatemia NIH 0.10
D007008 Hypokalemia NIH 0.10
D017250 Caliciviridae Infections NIH 0.10
D011565 Psoriasis NIH 0.10
D007251 Influenza, Human NIH 0.07
D008171 Lung Diseases, NIH 0.07
D003139 Common Cold NIH 0.07
D007154 Immune System Diseases NIH 0.07
D000257 Adenoviridae Infections NIH 0.07
D008175 Lung Neoplasms NIH 0.07
D058070 Asymptomatic Diseases NIH 0.07
D011024 Pneumonia, Viral NIH 0.07
D012140 Respiratory Tract Diseases NIH 0.06
D011248 Pregnancy Complications NIH 0.06
D009369 Neoplasms, NIH 0.06
D007153 Immunologic Deficiency Syndromes NIH 0.06
D011014 Pneumonia NIH 0.06
D012128 Respiratory Distress Syndrome, Adult NIH 0.05
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.05
D055371 Acute Lung Injury NIH 0.05
D012127 Respiratory Distress Syndrome, Newborn NIH 0.05
D011658 Pulmonary Fibrosis NIH 0.04
D004417 Dyspnea NIH 0.04
D008173 Lung Diseases, Obstructive NIH 0.04
D017563 Lung Diseases, Interstitial NIH 0.04
D012120 Respiration Disorders NIH 0.04
D006973 Hypertension NIH 0.04
D016638 Critical Illness NIH 0.02
D013577 Syndrome NIH 0.01

Correlated HPO Terms (21)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.16
HP:0000132 Menorrhagia HPO 0.10
HP:0002905 Hyperphosphatemia HPO 0.10
HP:0003765 Psoriasiform dermatitis HPO 0.10
HP:0002900 Hypokalemia HPO 0.10
HP:0002383 Encephalitis HPO 0.10
HP:0000846 Adrenal insufficiency HPO 0.10
HP:0002180 Neurodegeneration HPO 0.10
HP:0006517 Alveolar proteinosis HPO 0.10
HP:0000859 Hyperaldosteronism HPO 0.10
HP:0002088 Abnormal lung morphology HPO 0.08
HP:0011024 Abnormality of the gastrointestinal tract HPO 0.07
HP:0002664 Neoplasm HPO 0.06
HP:0002090 Pneumonia HPO 0.06
HP:0002206 Pulmonary fibrosis HPO 0.06
HP:0002721 Immunodeficiency HPO 0.06
HP:0006510 Chronic obstructive pulmonary disease HPO 0.06
HP:0006536 Obstructive lung disease HPO 0.04
HP:0006515 Interstitial pneumonitis HPO 0.04
HP:0002098 Respiratory distress HPO 0.04
HP:0000822 Hypertension HPO 0.04

There are 102 clinical trials

Clinical Trials


1 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

NCT04335084 COVID-19 Coronavirus Infection Sars-CoV2 Corona Virus Infection COVID Coronavirus Coronavirus-19 Coronavirus 19 Drug: Hydroxychloroquine Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc
MeSH:Infection Communicable Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.

Measure: Prevention of COVID-19 symptoms as recorded in a daily diary

Time: 24 weeks

Description: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.

Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

Time: 24 weeks

2 Pandemic Response Network: Duke Community Health Watch

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives. - First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll. - Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation. - Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population. The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).

NCT04320862 COVID-19 SARS-CoV-2 Coronavirus Influenza -Like Illness Lower Resp Tract Infection Upper Resp Tract Infection
MeSH:Infection Communicable Diseas Communicable Diseases

Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

Measure: Number of participants requiring mechanical ventilation

Time: 2 months

Measure: Number of deceased participants

Time: 2 months

3 Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT01302418 QIAGEN ResPlex II Advanced Panel Influenza A Respiratory S Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza B Device: artus Influenza A/B RT-PCR Test
MeSH:Infection Communicable Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections Virus Diseases

Primary Outcomes

Description: The presence of Influenza A or Influenza B virus.

Measure: Detection of Respiratory Viruses

Time: Specimens will be taken within 5 days of the appearance of symptoms.

4 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms. Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

NCT02135614 Respiratory Syncytial Virus Infection Drug: Presatovir Drug: Presatovir placebo
MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

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

Measure: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5

Time: Baseline to Day 5

Secondary Outcomes

Description: The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.

Measure: Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5

Time: Baseline to Day 5

Measure: Number of Hospitalization-Free Days Following Presatovir Administration

Time: Up to Day 28

Description: The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.

Measure: Rate of Unplanned Medical Encounters

Time: Up to Day 28

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

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

NCT02254421 Respiratory Syncytial Virus Infection Drug: Presatovir Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Syncytial Virus Infections

Primary Outcomes

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

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

Time: Baseline to Day 9

Secondary Outcomes

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

Time: Up to Day 28

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

Time: Up to Day 28

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

Time: Up to Day 28

6 A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients

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

NCT02351180 Lung Transplant Infection Drug: Inhaled beclomethasone Drug: Placebo
MeSH:Infection Communicable Diseases Virus Diseases

Primary Outcomes

Measure: Freedom from new or progressive chronic lung allograft dysfunction

Time: 180 days

Measure: Death

Time: 180 days

Secondary Outcomes

Measure: Respiratory virus symptom score

Time: 7 days

Measure: Acute rejection

Time: 180 days

Measure: Lymphocytic bronchiolitis

Time: 180 days

Measure: Donor-specific antibodies

Time: 180 days

Measure: Chronic lung allograft dysfunction

Time: 365 days

7 International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

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

NCT03039621 Acute Respiratory Viral Infections Drug: Ergoferon Drug: Placebo
MeSH:Infection Communicable Diseases Virus Diseases

Primary Outcomes

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

Measure: Time to Alleviation of All ARVI Symptoms.

Time: 14 days of observation.

Secondary Outcomes

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

Measure: Time to Normalization of Body Temperature.

Time: 14 days of observation.

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

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

Time: 14 days of observation.

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

Measure: Time to Alleviation of Respiratory Symptoms.

Time: 14 days of observation.

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

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

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

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

Measure: ARVI Severity.

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

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

Measure: Percentage of Recovered Patients.

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

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

Measure: Rates of Antipyretics Use Per Patient.

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

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

Measure: Percentage of Patients With Worsening of Illness.

Time: 14 days of observation peiod.

8 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

NCT03331445 Respiratory Tract Infections Corona Virus Infection Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
MeSH:In Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: Measure the number of unanticipated adverse events over the duration of the study protocol

Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects

Time: 26 Days

Secondary Outcomes

Description: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy

Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects

Time: Day 5,12,19 and 26

Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy

Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum

Time: Day 19 and 26

Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)

Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score

Time: Day 19 and 26

Other Outcomes

Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.

Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions

Time: Day 26

Description: Measured by death from all causes

Measure: Efficacy in reduction of mortality

Time: Day 26

Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

Measure: Antiviral effect

Time: Day 26

Description: Time to clinical recovery as measured by resolution of clinical signs

Measure: Efficacy on clinical improvement

Time: Day 26

Description: Measured by change in the Modified Jackson Cold Score

Measure: Efficacy on the respiratory symptoms

Time: Day 26

9 Genome-wide CRISPR Screen for Host Factors Associated With Norovirus Infections in Stem Cell-derived Human Intestinal Enteroid Model

The primary objective in this study is to establish a list of host cellular proteins that mediate norovirus infection. Norovirus is one of the most common pathogens attributed to diarrheal diseases from unsafe food. It is also the primary cause of mortality among young children and adults in foodborne infections. Norovirus is not just a foodborne burden. In a recent meta-analysis, norovirus accounts for nearly one-fifth of all causes of (including person-to-person transmission) acute gastroenteritis in both sporadic and outbreak settings and affects all age groups. Undoubtedly, norovirus is of paramount public health concern in both developed and developing countries. Research efforts to better understand norovirus pathobiology will be necessary for targeted intervention. From Middle East respiratory syndrome coronavirus to Zika virus, efforts to identify host factors important for mediating virus infection has always been a research priority. Such information will shed light on potential therapeutic targets in antiviral intervention. Norovirus virus-host interaction studies have been hampered by the lack of a robust cell culture model in the past 20 years. In 2016, norovirus has finally been successfully cultivated in a stem cell-derived three-dimensional human gut-like structure called enteroid or mini-gut. In this study, intestinal stem cells will be isolated from duodenal biopsies collected from participants, followed by differentiation into mini-guts. Genome-wide genetic screening for host essential and restrictive factors will be performed on infected mini-guts by knockout CRISPR and gain-of-function CRISPR SAM, respectively. Shortlisted candidates will undergo preliminary functional validation in cell lines. These data will provide insights into potential therapeutic targets against norovirus infection.

NCT03342547 Gastrointestinal Infection Procedure: Duodenal biopsy Procedure: Saliva
MeSH:Infection Communicable Diseases Caliciviridae Infections

Primary Outcomes

Description: Viability of enteroids as determined by microscopy

Measure: Establishment of human intestinal stem cell-derived enteroids

Time: An average of three months

10 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

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

NCT03808922 Lower Respiratory Tract Infection Parainfluenza Immunocompromised COVID-19 Drug: DAS181 Drug: Placebo Drug: DAS181 COVID-19 Drug: DAS181 OL
MeSH:Infection Communicable Diseases Respiratory Tract Infections Paramyxoviridae Infections
HPO:Respiratory tract infection

Primary Outcomes

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

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

Time: by Day 28

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

Time: Day 14

Secondary Outcomes

Measure: All-cause mortality rate (main study)

Time: at Day 28

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

Time: by Day 21

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

Time: Days 10, 14, 21, 28

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

Time: by Day 28

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

Time: by Days 14, 21, 28 and 35

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

Time: through Day 35

Measure: Total number of inpatient days (main study)

Time: up to Day 35

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

Time: at Day 28

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

Time: at Day 35

Measure: All-cause mortality rate (main study)

Time: at Day 35

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

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

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

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

Measure: Time to RTRA

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

Measure: Time to Clinical stability

Time: Day 14, Day 21, Day 28

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

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

Measure: Time to Clinical deterioration

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

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

Time: Day 14, Day 21, Day 28

Measure: Time to Death (all causes)

Time: Day 14, Day 21, Day 28

11 Washed Microbiota Transplantation for Patients With 2019-nCoV Infection: a Randomized, Double-blind, Placebo-controlled Study

Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.

NCT04251767 COVID-19 Complicated With Refractory Intestinal Infections Other: washed microbiota transplantation Other: placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following): (1) Respiratory distress,respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%;(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following): (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.

Measure: Number of participants with improvement from severe type to common type

Time: 2 weeks

12 A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection

The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .

NCT04252885 Coronavirus Infections Drug: Lopinavir and Ritonavir Tablets Drug: Arbidol
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.

Measure: The rate of virus inhibition

Time: Day 0, 2, 4, 7, 10, 14 and 21

Secondary Outcomes

Description: Body temperature will be followed everyday during time frame.

Measure: The disease prorogation-temperature

Time: Day 0 till day 21

Description: Respiratory rate will be followed everyday during time frame.

Measure: The disease prorogation-respiratory function 1

Time: Day 0 till day 21

Description: Oxygen saturation of blood will be followed everyday during time frame.

Measure: The disease prorogation-respiratory function 2

Time: Day 0 till day 21

Description: Chest imaging will be taken at each time point.

Measure: The disease prorogation-respiratory function 3

Time: Day 0, 4, 7, 10, 14 and 21

Other Outcomes

Description: Blood pressure and heart rate will be followed everyday during time frame.

Measure: Patients health condition-routine test

Time: Day 0 till day 21

Description: Liver function will be assessed as AST, ALT and TBIL at each time point.

Measure: Patients health condition-liver function

Time: Day 0, 4, 7, 10, 14 and 21

Description: Kidney function will be assessed as eGFR and creatine clearance rate at each time point.

Measure: Patients health condition-kidney function

Time: Day 0, 4, 7, 10, 14 and 21

Description: Blood routine and myocardial enzyme will be measured at each time point.

Measure: Patients health condition-other blood routine test

Time: Day 0, 4, 7, 10, 14 and 21

Description: Flow cytometry classification and counting and cytokines will be measured at each time point.

Measure: Patients health condition-blood routine test

Time: Day 0, 4, 7, 10, 14 and 21

13 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404 Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Prior to Tooth Extraction Menorrhagia Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Hypertension, Resistant to Conventional Therapy Fibrinolysis; Hemorrhage Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Menorrhagia Hypertension Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Hemorrhage
HPO:Adrenal insufficiency Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

Primary Outcomes

Measure: Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Elimination rate constant (ke) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Half-life (t1/2) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Absorption rate constant (ka) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: AUC (area under the curve) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Maximum concentration (Cmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Measure: Time to achieve maximum concentration (Tmax) as measured by PK sampling

Time: Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

14 A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China

Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.

NCT04279899 Neonatal Infection Perinatal Problems Infectious Disease
MeSH:Communicable Diseases Infection

Primary Outcomes

Measure: The death of newborns with COVID-19

Time: The date of discharge,an average of 4 weeks after the admission

Description: Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.

Measure: The SARS-CoV-2 infection of neonates born to mothers with COVID-19

Time: within 7days after the admission

Secondary Outcomes

Description: The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.

Measure: The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19

Time: Infants ( ≥35 weeks)are at 6 months after birth;Infants(< 35weeks) are at a corrected age of 6 months.

Description: The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).

Measure: The small for gestational age newborns in the neonates born to mothers with COVID-19

Time: at birth

Description: The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days

Measure: The preterm delivery of neonates born to mothers with COVID-19

Time: at birth

Description: Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese

Measure: The disease severity of neonates with COVID-19

Time: through study completion, estimated an average of 2 weeks

15 Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.

NCT04281693 Novel Coronavirus Infection Pneumonia Diagnostic Test: Standard screening strategy Diagnostic Test: New screening strategy
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The screening accuracy of the two screening strategies were calculated and compared.

Measure: Screening accuracy

Time: 1 month

Secondary Outcomes

Description: The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared.

Measure: Cost-effectiveness analysis

Time: 1 month

16 The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.

NCT04286503 Novel Coronavirus Infectious Disease (COVID-19) Drug: Carrimycin Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Drug: basic treatment
MeSH:Communicable Diseases Infection Coronavirus Infections

Primary Outcomes

Description: Fever to normal time (day)

Measure: Fever to normal time (day)

Time: 30 days

Description: Pulmonary inflammation resolution time (HRCT) (day)

Measure: Pulmonary inflammation resolution time (HRCT) (day)

Time: 30 days

Description: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

Measure: Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment

Time: 30 days

17 Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

NCT04290858 Coronavirus Infections Pneumonia, Viral Dyspnea Drug: Nitric Oxide
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Dyspnea
HPO:Dyspnea Pneumonia Respiratory distress

Primary Outcomes

Description: The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.

Measure: Reduction in the incidence of intubation and mechanical ventilation

Time: 28 days

Secondary Outcomes

Description: Mortality from all causes

Measure: Mortality

Time: 28 days

Description: Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab

Measure: Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Time: 7 days

Description: Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent).

Measure: Time to clinical recovery

Time: 28 days

18 A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.

NCT04298060 Influenza Infection SAD-RV Infection and COVID-19 Drug: DAS181 Drug: Placebo
MeSH:Infection Communicable Diseases Influenza, Human

Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

Description: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

Measure: Percent change of subjects return to baseline oxygen requirement

Time: 7 days

19 Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

NCT04308668 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Coronavirus Coronavirus Infections Drug: Hydroxychloroquine Other: Placebo
MeSH:Infection Co Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Number of participants at 14 days post enrollment with active COVID19 disease.

Measure: Incidence of COVID19 Disease among those who are asymptomatic at baseline

Time: 14 days

Description: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline

Time: 14 days

Secondary Outcomes

Description: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.

Measure: Incidence of Hospitalization

Time: 14 days

Description: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.

Measure: Incidence of Death

Time: 90 days

Description: Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.

Measure: Incidence of Confirmed SARS-CoV-2 Detection

Time: 14 days

Description: Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.

Measure: Incidence of Symptoms Compatible with COVID19 (possible disease)

Time: 90 days

Description: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.

Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal

Time: 14 days

Description: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Measure: Overall symptom severity at 5 and 14 days

Time: 5 and 14 days

Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

Measure: Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry

Time: 14 days

20 Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).

NCT04311177 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Drug: Losartan Other: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.

Measure: Hospital Admission

Time: 15 days

Secondary Outcomes

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: baseline, 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in PROMIS Dyspnea Severity

Time: baseline, 10 days

Description: Participants will report their maximum daily oral temperature to the study team. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days.

Measure: Daily Maximum Temperature

Time: 10 days

Description: Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm.

Measure: Emergency Department/Clinic Presentations

Time: 28 days

Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Disease Severity Rating Day 7

Time: 7 days

Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Disease Severity Rating Day 15

Time: 15 days

Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Disease Severity Rating Day 28

Time: 28 days

Description: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Oropharyngeal Swab Day 9

Time: 9 days

Description: Participants will collect oropharyngeal swabs every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Oropharyngeal Swab Day 15

Time: 15 days

Description: Outcome reported as the mean number of days participants in each arm did not require ventilator use.

Measure: Ventilator-Free Days

Time: 28 days

Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use.

Measure: Therapeutic Oxygen-Free Days

Time: 28 days

Description: Outcome reported as the percent of participants in each arm who require hospital admission by day 15 following randomization.

Measure: Need for Hospital Admission at 15 Days

Time: 15 days

Description: Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization.

Measure: Need for Oxygen Therapy at 15 Days

Time: 15 days

21 Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization

This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.

NCT04312009 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Drug: Losartan Other: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.

Measure: Difference in Estimated (PEEP adjusted) P/F Ratio at 7 days

Time: 7 days

Secondary Outcomes

Description: Outcome reported as the mean number of daily hypotensive episodes (MAP < 65 mmHg) prompting intervention (indicated by a fluid bolus >=500 mL) per participant in each arm.

Measure: Daily Hypotensive Episodes

Time: 10 days

Description: Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension.

Measure: Hypotension Requiring Vasopressors

Time: 10 days

Description: Outcome reported as the number of participants in each arm who experience acute kidney injury as defined by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Increase in serum creatinine by 0.3mg/dL or more within 48 hours OR Increase in serum creatinine to 1.5 times baseline or more within the last 7 days OR Urine output less than 0.5 mL/kg/h for 6 hours.

Measure: Acute Kidney Injury

Time: 10 days

Description: The SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Total score is calculated by entering patient data into a SOFA calculator, a widely-available software. Total scores range from 0-24, with higher scores indicating greater chance of mortality.

Measure: Sequential Organ Failure Assessment (SOFA) Total Score

Time: 10 days

Description: Oxygen saturation (percent) is measured by pulse oximeter. Fraction of inspired oxygen (FiO2) (unitless) is the volumetric fraction of oxygen to other gases in respiratory support. The F/S ratio is unitless.

Measure: Oxygen Saturation / Fractional Inhaled Oxygen (F/S)

Time: 10 days

Description: Outcome reported as the number of participants who have expired at 28 days post enrollment.

Measure: 28-Day Mortality

Time: 28 days

Description: Outcome reported as the number of participants who have expired at 90 days post enrollment.

Measure: 90-Day Mortality

Time: 90 days

Description: Outcome reported as the number of participants in each arm who require admission to the Intensive Care Unit (ICU).

Measure: ICU Admission

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.

Measure: Number of Ventilator-Free Days

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen usage during an in-patient hospital admission.

Measure: Number of Therapeutic Oxygen-Free Days

Time: 10 days

Description: Outcome reported as the mean number of days participants in each arm did not require vasopressor usage during an in-patient hospital admission.

Measure: Number of Vasopressor-Free Days

Time: 10 days

Description: Outcome reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.

Measure: Length of ICU Stay

Time: 10 days

Description: Outcome reported as the mean length of in-patient hospital stay (in days) for participants in each arm.

Measure: Length of Hospital Stay

Time: 10 days

Description: Outcome reported as the number of participants requiring BiPAP OR high flow nasal cannula OR mechanical ventilation OR extracorporeal membranous oxygenation (ECMO) utilization during in-patient hospital care in each arm.

Measure: Incidence of Respiratory Failure

Time: 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. In the 33-item Functional Limitations bank, 33 daily activities are rated in terms of degree of difficulty while engaging in the activity over the past 7 days (0 = no difficulty, 1 = a little difficulty, 2 = some difficulty, 3 = much difficulty). Total scores range from 0 to 99, with higher scores reflecting greater functional limitations.

Measure: Change in PROMIS Dyspnea Functional Limitations

Time: 10 days

Description: The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported Functional Limitations, Severity, Activity Motivation, Activity Requirements, Airborne Exposure, Assistant Devices Resources, Characteristics, Emotional Response, Task Avoidance and Time Extension as they related to dyspnea. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity.

Measure: Change in PROMIS Dyspnea Severity

Time: 10 days

Description: Outcome reported as the number of participants in each arm who fall into each of 7 categories. Lower scores indicate greater condition severity. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Disease Severity Rating

Time: 10 days

Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Nasopharyngeal Swab Day 9

Time: 9 days

Description: Nasopharyngeal swabs will be collected every third day for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Nasopharyngeal Swab Day 15

Time: 15 days

Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Blood Day 9

Time: 9 days

Description: Blood will be collected every third day for viral load assessment for the duration of study participation. Viral load is measured as number of viral genetic copies per mL.

Measure: Viral Load by Blood Day 15

Time: 15 days

22 Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers

Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.

NCT04312243 Coronavirus Infections Healthcare Associated Infection Drug: Inhaled nitric oxide gas
MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Percentage of subjects with COVID-19 diagnosis in the two groups

Measure: COVID-19 diagnosis

Time: 14 days

Secondary Outcomes

Description: Percentage of subjects with a positive test in the two groups

Measure: Positive SARS-CoV-2 rt-PCR test

Time: 14 days

Other Outcomes

Description: Mean/ Median in the two groups

Measure: Total number of quarantine days

Time: 14 days

Description: Percentage in the two groups

Measure: Proportion of healthcare providers requiring quarantine

Time: 14 days

23 Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19

This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.

NCT04316728 Coronavirus Infections Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test

Measure: Number of patients with constant negative results

Time: 30 days

Description: Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive

Measure: Number of patients with positive test with a positive PCR for COVID-19

Time: 30 days

Description: Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Overall Number of patients positive for COVID-19

Time: six months

Description: Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR

Measure: Overall Number of patients negative for COVID-19

Time: six months

Description: Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR

Measure: Number of patients with contrasting results

Time: 30 days

Secondary Outcomes

Description: Number of Invalid results

Measure: Reliability of the test

Time: 30 days

Description: Number of healthcare workers that become positive for COVID-19 IgM or IgG

Measure: Positive HCW

Time: 60 days

Description: Number of Chronic Patients that become positive for COVID-19 IgM or IgG

Measure: Number of Chronic Patients

Time: 60 days

24 Pandemic Response Network: Duke Community Health Watch

Coronavirus Disease 19 (COVID-19) represents an unprecedented challenge to the operations and population health management efforts of health care systems around the world. The "Pandemic Research Network (PRN): Duke Community Health Watch" study leverages technology, clinical research, epidemiology, telemedicine, and population health management capabilities to understand how to safely COVID-19. The target population is individuals in the Duke Health region as well as individuals beyond the Duke Health region who have flu-like symptoms, a viral test order for COVID-19, confirmed COVID-19, or concern for exposure to COVID-19. A subgroup of particular interest within the target population is health care workers (HCW) and families of HCW. Community members will enroll in the study electronically and for 28 days will be reminded via email or SMS to submit signs and symptoms related to COVID-19. Participants who report symptoms will be provided information about COVID-19 testing (if needed) and established mechanisms to seek care within Duke Health. Instructions for telemedicine and in-person visits, which is available publicly at https://www.dukehealth.org/covid-19-update, will be presented to participants. Participants who are unable to report symptoms independently may be contacted via telephone by Population Health Management Office (PHMO) or Clinical Events Classification (CEC) team members. Data collected through the "Pandemic Response Network (PRN): Duke Community Health Watch" study will be used for three objectives. - First, to characterize the epidemiological features of COVID-19. Specifically, we will have a high-risk subgroup of HCW and families of HCW that we enroll. - Second, to develop models that predict deterioration and the need for inpatient care, intensive care, and mechanical ventilation. - Third, to develop forecast models to estimate the volume of inpatient and outpatient resources needed to manage a COVID-19 population. The primary risk to study participants is loss of protected health information. To address this concern, all data will be stored in Duke's REDCap instance and the Duke Protected Analytics Compute Environment (PACE).

NCT04320862 COVID-19 SARS-CoV-2 Coronavirus Influenza -Like Illness Lower Resp Tract Infection Upper Resp Tract Infection
MeSH:Infection Communicable Diseas Communicable Diseases

Primary Outcomes

Measure: Number of participants who experience inpatient admission

Time: 2 months

Secondary Outcomes

Measure: Number of participants admitted to the intensive care unit

Time: 2 months

Measure: Number of participants requiring mechanical ventilation

Time: 2 months

Measure: Number of deceased participants

Time: 2 months

25 The Impact of Camostat Mesilate on COVID-19 Infection: An Investigator-initiated Randomized, Placebo-controlled, Phase IIa Trial

SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.

NCT04321096 Corona Virus Infection Drug: Camostat Mesilate Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale

Measure: Cohort 1: Days to clinical improvement from study enrolment

Time: 30 days

Description: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)

Measure: Cohort 2: Days to clinical improvement from study enrolment

Time: 30 days

Secondary Outcomes

Measure: Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)

Time: 30 days

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30

Time: 30 days

Description: Mortality

Measure: Cohort 1: Day 30 mortality

Time: 30 days

Description: NEWS2

Measure: Cohort 1: Change in NEW(2) score from baseline to day 30

Time: 30 days

Description: ICU

Measure: Cohort 1: Admission to ICU

Time: 30 days

Description: invasive mechanical ventilation or ECMO

Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO

Time: 30 days

Description: Nasal or high-flow oxygen

Measure: Cohort 1: Duration of supplemental oxygen (days)

Time: 30 days

Description: Subjective clinical improvement

Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30

Time: 30 days

Description: No of new COVID-19 infections in the household

Measure: Cohort 2: Number participant-reported secondary infection of housemates

Time: 30 days

Description: Hospital admission

Measure: Cohort 2: Time to hospital admission related to COVID-19 infection

Time: 30 days

26 An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications

This observational study will collect data from patients treated with siltuximab program for treatment of SARS-CoV-2 infection complicated with serious respiratory complications. This observational study will group the patients into two cohorts receiving siltuximab.. Outcome of patients will be compared to a cohort of patients receiving standard treatment without siltuximab. The patients will be divided into 2 cohorts. Those contained in Cohort A were treated after the use of continuous positive airways pressure (CPAP) or non-invasive ventilation (NIV). Patients in Cohort B were treated after intubation

NCT04322188 Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection
MeSH:Infection Communicable Diseases Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort

Measure: mortality in siltuximab treated patients

Time: 30 days

Secondary Outcomes

Description: Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort

Measure: the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support

Time: 30 days

Description: Describe the clinical course of patients treated with siltuximab (Cohort A and B) in terms of ventilatory support and compare the results with the control cohort

Measure: clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy

Time: 30 days

Description: Safety of siltuximab treatment

Measure: Safety Improvement of the lung function assessed by radiologic findings

Time: 30 days

Description: Evaluate the effect of siltuximab on inflammatory parameters (CRP)

Measure: the effect on inflammatory parameters

Time: 30 days

Description: Correlation of outcomes with IL-6 levels

Measure: Correlation of outcomes with IL-6 levels

Time: 30 days

27 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396 Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

Secondary Outcomes

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 days

Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

Measure: Mortality

Time: 30 days

Measure: Length of hospitalization

Time: 14 days

Measure: Days alive and discharged from hospital

Time: 30 days

Measure: Mortality

Time: 90 days

Measure: Mortality

Time: 365 days

Measure: Number of readmissions (all causes)

Time: 30 days

Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days

28 Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

NCT04323761 SARS-CoV2 Infection Drug: Remdesivir
MeSH:Infection Communicable Diseases


29 Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy

This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.

NCT04324866 Coronavirus Infection Diagnostic Test: Nasopharyngeal swab
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Psoriasis
HPO:Palmoplantar pustulosis Psoriasiform dermatitis

Primary Outcomes

Measure: Point prevalence of COVID-19 infection

Time: Baseline up to 6 months

Secondary Outcomes

Measure: Incidence of COVID-19 infection

Time: Baseline up to 6 months

Measure: Percentage of subjects presenting fever or respiratory symptoms

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments

Time: Baseline up to 6 months

Measure: Evaluate the relationship between COVID-19 infection and comorbid medical conditions

Time: Baseline up to 6 months

30 Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.

NCT04326036 Pulmonary Alveolar Proteinosis COPD Idiopathic Pulmonary Fibrosis Viral Pneumonia Coronavirus Infection Interstitial Lung Disease Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Device: Centricyte 1000 Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution Drug: Liberase Enzyme (Roche) Drug: Sterile Normal Saline for Intravenous Use
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Alveolar Proteinosis
HPO:Abnormal lung morphology Alveolar proteinosis Interstitial pneumonitis Interstitial pulmonary abnormality Pulmonary fibrosis

Primary Outcomes

Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 1 month

Secondary Outcomes

Description: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics

Measure: Pulmonary Function Analysis

Time: baseline, 3 Month, 6 months

Description: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

Measure: Digital Oximetry

Time: 3 months, 6 months

31 Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

NCT04326309 COVID-19 Coronavirus Infections Hay Fever Asthma Chronic Obstructive Pulmonary Disease Influenza Common Cold Respiratory Tract Infections Healthy
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Common Cold Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Chronic obstructive pulmonary disease Obstructive lung disease Respiratory tract infection

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days

32 Active Monitoring And Determinants of Incidence Infection of COVDI-19 in a Hospital Population (AMADIICH) Study Protocol

7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population. 8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa . 12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks. 13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.

NCT04326400 Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary objective of this trial is to investigate whether the use of a cell phone App-based platform is a useful tool to monitor the symptoms of a population in risk of SARS-Cov2 infection. The final aim is to assess determinants of incidence of infection of COVID-19 in people working in Hospital during the pandemia of SARS-Cov-2.

Measure: COVID-19 App-based platform

Time: 6 months

Secondary Outcomes

Description: To monitor in real-time COVID-19 symptoms in the hospital workforce, which are a proxy of incident infection (Step 1) To identify in real-time clusters of COVID-19 symptoms and to facilitate control measures. To determine the incidence of new infection of COVID-19. To identify the determinants and risk/protective factors associated with this infection, in a workforce hospital population free of COVID-19 at the start of our study.

Measure: COVID-19 infection

Time: 6 months

33 ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection. On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.

NCT04326426 Coronavirus Infection Drug: Tradipitant Drug: Placebo
MeSH:Infection Co Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Time to improvement on a 7-point ordinal scale as compared to baseline

Time: 14 days or discharge

Secondary Outcomes

Measure: Treatment and prevention of inflammatory lung injury as measured by change in baseline of interleukin-6 (IL-6)

Time: 14 days or discharge

Measure: Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples

Time: 14 days or discharge

Measure: In-hospital mortality

Time: 14 days or discharge

Measure: Mean change in NEWS2 score from baseline

Time: 14 days or discharge

Measure: Understand the effect of genetics for treatment response through whole genome sequence of the participant and the COVID-19 virus

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for cough

Time: 14 days or discharge

Measure: Reduction from baseline of NRS for nausea

Time: 14 days or discharge

Measure: Time to normalization of fever for at least 48 hours

Time: 14 days or discharge

Measure: Time to improvement in oxygenation for at least 48 hours

Time: 14 days or discharge

34 PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study

Coronavirus 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.

NCT04327180 Infection Viral Coronavirus ARDS Pneumonia
MeSH:Infection Communicable Diseases Pneumonia Virus Diseases
HPO:Pneumonia

Primary Outcomes

Measure: Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU

Time: within 24 hours of admission to ICU

Secondary Outcomes

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 days

Description: 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 days

Description: the SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).

Measure: Sequential Organ Failure Assessment (SOFA) Score

Time: during ICU stay, up to 28 days

Description: 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 admission

Description: 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 days

Measure: Number of days on vasopressive amines

Time: during ICU stay, up to 28 days

Measure: Occurrence of an event of venous or arterial thromboembolic disease

Time: during ICU stay, up to 28 days

Measure: Number of days with extra renal treatment (ERA)

Time: during ICU stay, up to 28 days

Measure: Number of patients alive after ICU stay less than 28 days will be tracked

Time: At 28 day

Description: 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 stay

Description: 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 stay

Description: 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 stay

Description: 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 stay

Description: 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 stay

Measure: Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters

Time: until day 28 after admission of ICU

Description: Evolution of viral clearance in nasal and depp PCR during ICU

Measure: Viral clearance

Time: through study completion, an average of 28 days

35 Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in French Guiana

This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in a territory such as French Guiana.

NCT04328129 Coronavirus Infections Severe Acute Respiratory Syndrome SARS-CoV Infection Procedure: Human biological samples
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus

Measure: Evaluation of the extent of the virus transmission within households

Time: 2 years

Secondary Outcomes

Description: The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household

Measure: Characterization of the secondary cases

Time: 2 years

Description: The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.

Measure: Characterization of the secondary cases

Time: 2 years

36 Protective Role of Inhaled Steroids for Covid-19 Infection

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

NCT04331054 Covid-19 Infection Hospitalization in Respiratory Disease Department Drug: 2: Usual practice + SYMBICORT RAPIHALER Other: 1: Usual practice
MeSH:In Infection Communicable Diseases Respiration Disorders Respiratory Tract Diseases

Primary Outcomes

Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.

Measure: Time (in days) to clinical improvement within 30 days after randomization

Time: within 30 days

Secondary Outcomes

Measure: Mortality rate at D30

Time: At day30

Measure: Time (in days) from randomization to death

Time: up to 30 days after randomization

Measure: Number of days alive outside ICU within 30 days

Time: At day30

Measure: Number of days alive free of invasive or non-invasive ventilation within 30 days

Time: At day30

Measure: Number of days alive with oxygen therapy within 30 days

Time: At day30

Measure: Maximal oxygen rate within 30 days

Time: At day30

Measure: Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)

Time: at Day 7

Measure: Number of days alive outside hospital within 30 days

Time: at Day 30

Measure: Use of antibiotics for respiratory (proved or suspected) infection within 30 days

Time: at Day 30

Measure: Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)

Time: at Day 7

Measure: Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.

Time: up to 30 days after randomization

37 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

NCT04332991 Coronavirus Acute Respiratory Infection SARS-CoV Infection Drug: Hydroxychloroquine Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
HPO:Respiratory tract infection

Primary Outcomes

Description: We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Measure: COVID Ordinal Outcomes Scale on Day 15

Time: assessed on study day 15

Secondary Outcomes

Description: Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 15

Time: assessed on study day 15

Description: Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

Measure: all-location, all-cause mortality assessed on day 29

Time: assessed on study day 29

Description: We will determine the COVID Ordinal Scale for all patients on study day 3

Measure: COVID Ordinal Outcomes Scale on Study Day 3

Time: assessed on study day 3

Description: We will determine the COVID Ordinal Scale on study day 8

Measure: COVID Ordinal Outcomes Scale on Study Day 8

Time: assessed on study day 8

Description: We will determine the COVID Ordinal Scale on study day 29

Measure: COVID Ordinal Outcomes Scale on Study Day 29

Time: assessed on study day 29

Description: We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28

Measure: Number of patients dead or with receipt of ECMO between enrollment and Day 28

Time: Enrollment to Day 28

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.

Measure: Oxygen-free days through Day 28

Time: 28 days after randomization

Description: Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

Measure: Ventilator-free days through Day 28

Time: 28 days after randomization

Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.

Measure: Vasopressor-free days through Day 28

Time: 28 days after randomization

Description: The number of days spent out of the ICU to day 28.

Measure: ICU-free days to Day 28

Time: 28 days after randomization

Description: Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.

Measure: Hospital-free days to Day 28

Time: 28 days after randomization

Other Outcomes

Description: We will determine the number of patients that experience seizure between randomization and day 28

Measure: Number of patients with seizures to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28

Measure: Number of patients with atrial or ventricular arrhythmia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience cardiac arrest between randomization and day 28

Measure: Number of patients with cardiac arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28

Measure: Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute pancreatitis between randomization and day 28

Measure: Number of patients with acute pancreatitis arrest to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience acute kidney injury between randomization and day 28

Measure: Number of patients with acute kidney injury to day28

Time: 28 days after randomization

Description: We will determine the number of patients that experience renal replacement therapy between randomization and day 28

Measure: Number of patients with receipt of renal replacement therapy to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28

Measure: Number of patients with symptomatic hypoglycemia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28

Measure: Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28

Time: 28 days after randomization

Description: We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28

Measure: Number of patients with severe dermatologic reaction to day 28

Time: 28 days after randomization

Description: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

Measure: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

Time: 28 days after randomization

38 Prospective, Controlled, Randomized, Multicenter Study to Compare the Efficacy of a Chloroquine Analog (GNS561), an Anti PD-1 (Nivolumab) and an Anti-interleukine-6 Receptor (Tocilizumab) vs Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection

A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of a chloroquine analog (GNS561), an anti PD-1 (nivolumab) and an anti-interleukine-6 receptor (tocilizumab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: - COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-PD1 vs standard of care (randomization ratio 1:1:1). - COHORT 2 (moderate/severe symptoms): GNS561 vs anti-IL6 vs standard of care (randomization ratio 1:1:1).

NCT04333914 SARS-CoV-2 (COVID-19) Infection Advanced or Metastatic Hematological or Solid Tumor Drug: Chloroquine analog (GNS651) Drug: Nivolumab Drug: Tocilizumab Other: Standard of care
MeSH:Infection Communicable Diseases Neoplasm Metastasis

Primary Outcomes

Description: 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization. The 28-day survival rate will be described in each arm of each cohort.

Measure: 28-day survival rate

Time: 28 days from randomization

Secondary Outcomes

Description: Time to clinical improvement defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale (WHO-ISARIC) or live discharge from the hospital, whichever comes first.

Measure: Time to clinical improvement

Time: 28 days from randomization

Description: Clinical status will be assessed using a 7-point ordinal scale : Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; 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: Clinical status

Time: Day 7, Day 14, Day 28

Description: Mean change in clinical status from baseline will be assessed using a 7-point ordinal scale.

Measure: Mean change in clinical status from baseline to days

Time: Day 7, Day 14, Day 28

Description: Overall survival will be defined by the time from date of randomization until date of death, regardless of the cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Measure: Overall survival

Time: 3 months (i.e. at the the time of last patient last visit)

Description: The length of stay in Intensive Care Unit (from the date of admission in the Unit to the date of discharge).

Measure: Length of stay in Intensive Care Unit

Time: 3 months (i.e. at the the time of last patient last visit)

Description: The duration of mechanical ventilation or high flow oxygen devices (from the date of intubation to the stop date of mechanical ventilation or high flow oxygen)

Measure: Duration of mechanical ventilation or high flow oxygen devices

Time: 3 months (i.e. at the the time of last patient last visit)

Description: The duration of hospitalization (from the date of hospitalization to the date of definitive discharge for live patients)

Measure: Duration of hospitalization

Time: 3 months (i.e. at the the time of last patient last visit)

Measure: Rate of throat swab negativation

Time: Day 7, Day 14, Day 28

Measure: Quantitative SARS-CoV-2 virus in throat swab and blood samples

Time: Day 7, Day 14, Day 28

Measure: Rate of secondary infection by other documented pathogens

Time: Day 7, Day 14, Day 28 (if available)

Description: Changes from baseline in neutrophils count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Treatment-Emergent Adverse Events, Serious Adverse Events, Suspected Unexpected Serious Adverse Reactions, New Safety Issues described using the NCI-CTC AE classification v5. Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.

Measure: Cost-Effectiveness Analyses (CEA)

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in lymphocytes count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in platelets count (G/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in hemoglobin count (g/dL)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in CRP count (mg/L)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

Description: Changes from baseline in pro-inflammatory cytokine (IL6)

Measure: Biological parameters

Time: 3 months (i.e. at the the time of last patient last visit)

39 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

NCT04334512 COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy

Time: 12 weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

Description: Assess the symptom response to study therapy as measured by the survey in the EDC

Measure: Assess the safety of Quintuple Therapy

Time: 12 weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

Description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks

40 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

NCT04335084 COVID-19 Coronavirus Infection Sars-CoV2 Corona Virus Infection COVID Coronavirus Coronavirus-19 Coronavirus 19 Drug: Hydroxychloroquine Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc
MeSH:Infection Communicable Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.

Measure: Prevention of COVID-19 symptoms as recorded in a daily diary

Time: 24 weeks

Description: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.

Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events

Time: 24 weeks

41 Multi-Center, Randomized, Controlled, Phase II Clinical Efficacy Study Evaluating Nitric Oxide Releasing Solution Treatment for the Prevention and Treatment of COVID-19 in Healthcare Workers and Individuals at Risk of Infection

This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.

NCT04337918 Corona Virus Infection Drug: NORS (Nitric Oxide Releasing Solution) Drug: NORS (Nitric Oxide Releasing Solution)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Measure the proportion of subjects with either swab positive COVID-19 or presentation of clinical symptoms as measured by fatigue with either fever >37.2 (oral)and/or a persistent cough.

Measure: Prevention Study: Measure the effect of NORS on the prevention of COVID-19 infection among health care professionals at risk of exposure to COVID-19

Time: 14 days

Description: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.

Measure: Treatment Sub Study: Measure the efficacy of NORS at reducing the progression of COVID- 19

Time: 21 days

Secondary Outcomes

Description: Measure the proportion of participants requiring requiring hospitalization for COVID-19/flu-like symptoms and/or needing oxygen therapy, BIPAP/CPAP, intubation and mechanical ventilation following enrollment.

Measure: Prevention Study: Measure the effect of NORS on the prevention of progression of COVID- 19

Time: 21 days

Description: Measure the tolerability of the NORS treatments as determined by number of adverse events, pain, discomfort or discontinuations of treatment.

Measure: Prevention Study: Measure the tolerability of NORS treatments

Time: 21 days

Description: Measure the median number of days to negative conversion of SARS-CoV-2 RT-PCR from a nasopharyngeal swabs.

Measure: Treatment Sub Study: Measure the virucidal effect of NORS Treatments

Time: 21 days

Description: Determine the time to clinical recovery in participants with COVID-19 by measuring the median number of days from enrollment to discharge (if admitted), or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air).

Measure: Treatment Sub Study: Determine effect of NORS on the speed of clinical recovery

Time: 21 days

Description: Measure the reduction clinical symptoms in participants with COVID- 19 by the magnitude of the change in Modified Jackson Cold Score Diary Score (5-unit change is a substantial clinical benefit).

Measure: Treatment Sub Study: Determine the reduction in clinical symptoms

Time: 21 days

Description: Measure the proportion of participants that have a positive sero-conversion for SARS-CoV-2

Measure: Treatment & Sub Study: Determine positive sero-conversion for SARS-CoV-2

Time: 21 days

42 HOME-CoV: Hospitalization or Outpatient ManagEment of Patients With Confirmed or Probable SARS-CoV-2 Infection. A Before and After Implementation of a Consensus Help-decision Making Rule Study

COVID-19 pandemic has developed worldwide in less than 4 months. The clinical presentations are variable widely, ranging from simple rhinitis to major lung damage that can lead to death. In many countries involved in the ongoing health disaster due to SARS-CoV-2 infection, hospital are overloaded. In this context, the decision to hospitalize or to manage COVID-19 patients at home is crucial and defining reliable and consensual criteria is a major issue. HOME-CoV study is a multicentre quasi-experimental interventional study, before and after implementation of a help-decision making rule (HOME-CoV rule), developed via the Delphi method. Our main hypothesis is that a strategy based on the consensual HOME-CoV rule compared to current practice is at least as safe as regards the 7-day-rate of adverse events (safety criterion) and more effective as regards the rate of patients eventually managed as outpatients (efficacy criterion).

NCT04338841 Coronavirus Infection Other: HOME-CoV rule implementation
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Adverse outcomes include intubation with mechanical ventilation requirement and death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 7 days after inclusion.

Measure: the composite rate of adverse outcomes

Time: day 7

Description: The rate of patients hospitalized after admission to the emergency room including patients discharged home more than 24 hours after admission. It will be analyzed in a hierarchical approach, only if first primary objective is positive i.e. non-inferiority of HOME-CoV strategy versus current practice on the rate of adverse outcomes.

Measure: The rate of hospitalization

Time: 24 hours

43 French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study

Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.

NCT04340466 Pneumonia, Viral Critically Ill Corona Virus Infection Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Critical Illness
HPO:Pneumonia

Primary Outcomes

Description: Mortality at day 28

Measure: Mortality at day 28

Time: day 28

Secondary Outcomes

Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / No

Measure: severe complications

Time: up to day 28

Description: Delay in imaging in hours

Measure: Imaging

Time: day 1

Description: delay in microbiological diagnosis in hours

Measure: Delay in Microbiological diagnosis

Time: day 1

Description: Antiviral therapy Yes / no

Measure: Antiviral therapy

Time: up to day 28

Description: Antibiotic therapy Yes / No

Measure: Antibiotic therapy

Time: day 28

Description: Covid-19 treatments Yes / No

Measure: Covid-19 treatments

Time: up to day 28

Description: number

Measure: Patients receiving renal replacement therapy

Time: up to day 28

Description: number

Measure: Patients receiving mechanical ventilation

Time: up to day 28

Description: Patient alive at day 28 : yes / No

Measure: Vital status

Time: day 28

44 Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection

The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.

NCT04340557 SARS-CoV Infection Drug: Losartan
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure

Measure: Mechanical ventilation

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Secondary Outcomes

Description: Number of subjects transferred from non-ICU bed to an ICU bed

Measure: ICU transfer

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Description: Number of days requiring oxygen therapy

Measure: Oxygen therapy

Time: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

45 CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection, Nested In The CORIMUNO-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-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 Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

NCT04341584 Corona Virus Infection Drug: Anakinra
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

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. 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 ventilator utilization at day 14

Time: 14 days

Description: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.

Measure: WHO progression scale ≤ 5

Time: 4 days

Description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.

Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14

Time: 14 days

Description: Proportion of patients with a decrease of WHO score of at least 1 point at day 4

Measure: Decrease of at least one point in WHO progression scale score

Time: 4 days

Secondary Outcomes

Description: 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

Time: 7 and 14 days

Description: Overall survival.

Measure: Survival

Time: 14, 28 and 90 days

Measure: 28-day ventilator free-days

Time: 28 days

Description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.

Measure: Respiratory acidosis

Time: 4 days

Description: Evolution of PaO2/FiO2 ratio.

Measure: PaO2/FiO2 ratio

Time: day 1 to day 14

Description: Time to oxygen supply independency.

Measure: Time to oxygen supply independency

Time: 14 days

Description: Duration of hospitalization.

Measure: Duration of hospitalization

Time: 90 days

Description: Time to negative viral excretion.

Measure: Time to negative viral excretion

Time: 90 days

Description: Time to ICU discharge.

Measure: Time to ICU discharge

Time: 90 days

Description: Time to hospital discharge.

Measure: Time to hospital discharge

Time: 90 days

46 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: 42 days

47 Hydroxychloroquine for Outpatients With Confirmed COVID-19

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

NCT04342169 Coronavirus Infection Coronavirus Infectious Disease Drug: Hydroxychloroquine Drug: Placebo oral tablet
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Duration of viral shedding

Time: Days 1-14

Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: Everyday through 6 months

Measure: Hospitalization

Time: within 14 days of enrollment

Measure: Duration of viral shedding

Time: Days 1-14 and Day 28

Measure: Adult household contact viral acquisition

Time: Days 1-14 and Day 28

48 Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19

Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.

NCT04342195 COVID-19 Coronavirus Infection Corona Virus Infection Procedure: Blood draw
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.

Measure: Number of antibodies against coronaviruses isolated and identified from patient samples

Time: Up to 12 months after collection visit

49 A Study on the Prospective Cohort Library of Novel Coronavirus Pneumonia in Southeran

This is a multi-centre population-based follow-up study for all 504 patients with laboratory-confirmed COVID-19. This study establishes a standardized and structured clinical database to provide complete and multidimensional clinical diagnosis and treatment data of novel coronavirus pneumonia, which also support future epidemiological, infectious disease study and patients' prognosis, by collecting clinical data and the related data of patients with novel coronavirus pneumonia in Southern Zhejiang province.

NCT04342702 Follow-up COVID-19 Infectious Diseases Respiratory
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: sum score of SF 36 form in each time frame

Measure: 36-Item Short Form Survey Instrument (SF-36)

Time: one month, three month, six month and one year after discharge, minimum score

Measure: the value of FEV1 by lung function test

Time: one month, three month, six month and one year after discharge

Measure: the ratio of FEV1 to FVC by lung function test

Time: one month, three month, six month and one year after discharge

Secondary Outcomes

Measure: the predicted value of FEV1 by lung function test

Time: one month, three month, six month and one year after discharge

Measure: the predicted ratio of FEV1 to FVC by lung function test

Time: one month, three month, six month and one year after discharge

Description: laboratory result

Measure: Lymphocyte value

Time: one month, three month, six month and one year after discharge

Description: laboratory result

Measure: Neutrophil value

Time: one month, three month, six month and one year after discharge

Description: laboratory result

Measure: DDI value

Time: one month, three month, six month and one year after discharge

Description: collect the number of applying ACEIs/ARBs medication and calculate the proportion

Measure: the proportion of applying ACEIs/ARBs medication

Time: from the date of hospital admission to the day of hospital discharge

Description: clinical symptoms

Measure: number of clinical symptoms after hospital discharge

Time: one month, three month, six month and one year after discharge

Measure: number of cases returning to positive result in RT-PCR test

Time: one month, three month, six month and one year after discharge

Measure: Number of positive outcome of IgG for antibody of COVID-19

Time: one month, three month, six month and one year after discharge

50 Testing for COVID-19 Infection in Asymptomatic Persons

Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.

NCT04345510 COVID-19 Infection
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: COVID-19 infection

Time: 6 weeks

51 Assessment of COVID-19 IgM/IgG Self-testing Using Virtual Point-of-care

The goal of the research is to assess candidate COVID-19 rapid (5-15 min) antibody tests in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by a mobile device camera acquisition software and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of finger-stick capillary blood self-testing assisted by mobile device imaging and telemedicine remote support.

NCT04348864 Communicable Disease COVID-19 Sars-CoV2 Infectious Disease Coronavirus Virus Diseases Diagnostic Test: COVID-19 IgM/IgG Rapid Testing, mobile device image capture and telemedicine support Other: Telemedicine
MeSH:Communicable Diseases Infection Virus Diseases

Primary Outcomes

Description: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and the results of a PCR-based reference test

Measure: Clinical accuracy of the antibody-based rapid tests compared to PCR-based test result

Time: 1 year

Description: Accuracy refers to the amount of agreement between the results of the antibody-based rapid test and a clinical diagnosis of COVID-19

Measure: Clinical accuracy of the rapid tests based on Clinical diagnosis

Time: 1 year

Description: Clinical accuracy of the subject's visual interpretation of the test result vs image analysis from clinician

Measure: Self-test interpretation of result vs expert clinical image interpretation of result

Time: 1 year

Secondary Outcomes

Description: Subjects will complete a survey to rate the testing procedure for ease of use and convenience. The survey will ask subjects to rate the ease of use on a scale from 1 (easiest procedure to complete and understand) to 10 (most complicated and confusing procedure)

Measure: Ease of self-testing procedure

Time: 1 year

52 A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo.

NCT04349098 Coronavirus Infection Drug: Selinexor Other: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale

Time: Baseline to Day 14

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI)

Time: Up to Day 28

Measure: Overall Death Rate

Time: Day 14, Day 28

Measure: Rate of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Mechanical Ventilation

Time: Up to Day 28

Measure: Overall Survival

Time: Up to Day 28

Measure: Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale

Time: Baseline, Day 28

Measure: Time to Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Rate of Intensive Care Unit (ICU) Admission

Time: Up to Day 28

Measure: Length of Stay in Hospital

Time: Up to Day 28

Measure: Percentage of Participants Discharged from Hospital

Time: Up to Day 28

Measure: Length of Stay in Intensive Care Unit (ICU)

Time: Up to Day 28

Measure: Duration of Oxygen Supplementation

Time: Up to Day 28

Measure: Duration of Mechanical Ventilation

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants ≤ 70 Years Old

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants > 70 Years Old

Time: Up to Day 28

Measure: Time to Clinical Improvement in Participants with Pre-existing Diseases

Time: Up to Day 28

Measure: Change in Oxygenation Index

Time: Up to Day 28

Measure: Time to Improvement of One Point Using WHO Ordinal Scale Improvement

Time: Up to Day 28

Measure: Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point

Time: Up to Day 28

Measure: Change from Baseline in C-reactive protein (CRP) Levels

Time: Up to Day 28

Measure: Change from Baseline in Ferritin Levels

Time: Up to Day 28

Measure: Change from Baseline in Lactate Dehydrogenase (LDH) Levels

Time: Up to Day 28

Measure: Changes from Baseline in Blood Plasma Cytokines Levels

Time: Up to Day 28

Measure: Number of Participants with Adverse Events (AE)

Time: From start of study drug administration up to Day 28

53 Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

NCT04350086 COVID-19 Infection Sars-cov-2 Respiratory Failure Palliative Situation Drug: Treatment with Dexmedetomidine
MeSH:Infection Communicable Diseases Respiratory Insufficiency

Primary Outcomes

Description: Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.

Measure: Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.

Time: Day 30

Secondary Outcomes

Description: Overall survival time in days from inclusion.

Measure: Overall survival of patients on Dexmedetomidine

Time: Day 30

Description: The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.

Measure: Daily analgesic effect of Dexmedetomidine

Time: Day 30

Description: Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.

Measure: Other sedative pharmacological agents

Time: Day 30

Description: Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation

Measure: Average dosage required for Dexmedetomidine to achieve mild to moderate sedation

Time: Day 30

54 Austrian COVID-19 Registry (AGMT_COVID-19)

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate. Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

NCT04351529 Infectious Dis Infectious Disease COVID-19
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Measure: Documentation of natural course and the therapeutic landscape of patients with COVID-19.

Time: 2 years

55 Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy

Coronavirus 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.

NCT04353245 COVID19 Corona Virus Infection Myocardial Injury Pneumonia Other: BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Virus Diseases
HPO:Pneumonia

Primary Outcomes

Description: presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry

Measure: Fibrosis

Time: 12 months

Description: Decreased functional capacity on ergospirometers

Measure: Ergospirometers

Time: 12 monthes

56 Study of Immune Response During SARS-CoV-2 Infection

Study of the cellular immune response during the SARS-CoV-2 infection and identify cytokinic profiles in caregivers exposed to the virus with asymptomatic forms of COVID19, patients with an asymptomatic form followed in ambulatory care and patients hospitalized in the infectious disease department or in resuscitation at the CHU de Nice COVID-19 according to their clinical symptomatology and the kinetics of clinical aggravation using functional tests evaluating the Th1 type immune response. The project is divided into a clinical component comprising the study of the immune response in different populations and a cellular component focusing on the in vitro study of different immunomodulating treatments on their ability to induce an anti-viral Th1

NCT04355351 New Coronavirus Disease (COVID-19), Infection With SARS-CoV-2 Other: blood sampling Other: additional blood tubes
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Peripheral T lymphocytes will be stimulated with an anti-CD3 for 16-24h. The Level of IFN-gamma (pg/mL) will be defined using an automated ELISA test (Protein Simple) on the stimulated and non-stimulated plasma.

Measure: Level of IFN-gamma after a non-specific stimulation of T lymphocytes

Time: 6 months

57 Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse: Cases of Synthetic Antimalarial Drugs and Anti-hypertensive Drugs

The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold. Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome [ARDS] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19. Treatments currently being investigated include: - Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS; - Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists. We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease. Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are - Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors). - Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities. This in order to: - To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD. - To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

NCT04356417 AMD, ACEi's/ARB Prevent/Worsen Risk of COVID-19 Infection Other: - Synthetic anti-malarial drugs
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Participants as those with the emergency ICD-10 (international classification of diseases, 10th revision) code of U07.1 which was assigned to the disease diagnosis of COVID-19.

Measure: Identification of serious COVID-19 infections

Time: From 2020/01/01 to 2020/06/30

Secondary Outcomes

Measure: Pneumonia infections

Time: From 2020/01/01 to 2020/06/30

Measure: ICU stay

Time: From 2020/01/01 to 2020/06/30

Measure: Oro-tracheal intubation

Time: From 2020/01/01 to 2020/06/30

Measure: Death

Time: From 2020/01/01 to 2020/06/30

58 Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)

This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 65 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).

NCT04356495 Corona Virus Infection Sars-CoV2 Dietary Supplement: Vitamins Drug: Hydroxychloroquine Drug: Imatinib Drug: Favipiravir Drug: Telmisartan
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Proportion of participants with an occurrence of hospitalization

Time: From inclusion (day0) to day 14

Description: Proportion of participants with an occurrence of death

Measure: Death

Time: From inclusion (day0) to day 14

Secondary Outcomes

Measure: Proportion of hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Description: Proportion of deaths, overall and by cause, in each group

Measure: Death and causes of death

Time: From inclusion (day0) to day 28

Measure: Proportion of intensive care hospitalizations, overall and by cause, in each group

Time: From inclusion (day0) to day 28

Measure: Proportion of participants with negative nasopharyngeal SARS-CoV-2 RT-PCR

Time: day 7 and day 14

Measure: Proportion of participants with a loss of autonomy evaluated by the ADL and IADL scale

Time: day 14 and day 28

Description: Evolution of Haematological markers in each group : Complete Blood Count, prothrombin level, INR

Measure: Haematological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of Biochemical markers in each group : ferritin, serum creatinine, urea, sodium, potassium, chlorine, calcium, magnesium, albumin, bicarbonates / tCO2, LDH, CPK, ASAT, ALAT, uricemia

Measure: Biochemical markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of Inflammatory markers in each group : PCT, CRP

Measure: Inflammatory markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Evolution of immunological markers in each group : B ans T Cells phenotypic profiles

Measure: Immunological markers evolution

Time: from inclusion (day 0) to day 7 and day 14

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse events

Time: from inclusion (day 0) to day 14

Description: Number and proportion of grade 1,2,3,4 adverse events in each group

Measure: Adverse reactions

Time: from inclusion (day 0) to day 14

Description: Plasma concentration of the study drugs at D7

Measure: Plasma concentration

Time: day 7

Description: Acceptability of the treatment by participant will be assessed with an interview

Measure: Acceptability of the treatment

Time: from inclusion (day 0) to day 10

59 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

In 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. Also due to the potential co-existing immunodysfunction in the context of SARS-CoV-2 infection patients will also receive trimethoprim/sulfamethoxazole as part of chemoprophylaxis.

NCT04357366 COVID-19 Virus Dis Virus Diseases Corona Virus Infection Lower Respiratory Tract Infection Viral Drug: Anakinra Drug: trimethoprim/sulfamethoxazole
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

Description: The primary study endpoint is the ratio of patients who will not develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered non-achieving the primary endpoint.

Measure: The ratio of patients who will not develop serious respiratory failure (SRF)

Time: Visit study day 14

Secondary Outcomes

Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with historical comparators from Hellenic Sepsis Study Group Database

Measure: Comparison of the rate of patients who will not develop serious respiratory failure (SRF) until day 14 with historical comparators from Hellenic Sepsis Study Group Database

Time: Visit study day 14

Description: 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 7

Description: 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 14

Description: 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 7

Description: 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 14

Description: Change of cytokine stimulation from peripheral blood mononuclear cells of enrolled subjects will be compared between days 1 and 7

Measure: Change of cytokine production between days 1 and 7

Time: Visit study day 1, visit study day 7

Description: 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 7

60 A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

NCT04359836 Gut Microbiome Gastrointestinal Microbiome COVID COVID-19 Corona Virus Infection Coronavirus Coronaviridae Infections Coronavirus 19 Coronavirus-19 COVID 19 Other: There is no intervention in this study
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections

Primary Outcomes

Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

Time: One year

Secondary Outcomes

Description: To validate the methods used to sequence samples

Measure: Validation of Sequencing Methods

Time: One year

61 A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity

In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

NCT04361253 COVID Infectious Disease Biological: High-Titer COVID-19 Convalescent Plasma (HT-CCP) Biological: Standard Plasma (FFP)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.

Measure: Modified WHO Ordinal Scale (MOS) score

Time: Day 14

62 Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection - MARNEVO-Covid

Emergence of Covid-19 virus is associated with high frequency of extremely severe clinical pictures, with minor signs of CNS impairment (e.g. anosmia, headache). Since neurotropism is a common feature of coronavirus infection in animals, the investigators examine if indirect signs of CNS lesion are observed in association with severe Covid-19 infection.

NCT04361344 COVID-19 Infection Encephalitis Biological: blood samples
MeSH:Infection Communicable Diseases Encephalitis Nerve Degeneration
HPO:Encephalitis Neurodegeneration

Primary Outcomes

Description: Change of neurofilament light chain (NFL) (pg/ml) level between first day of hospitalisation and one week; and change of GFAP (pg/ml) level between first day of hospitalisation and one week.

Measure: Change of neurodegeneration markers level

Time: Level of neurofilament light chain (NFL) is dosed at inclusion (day 0) and week 1. Level of GFAP is dosed at inclusion (day 0) and week 1 (day 7).

63 ACCESS (American COVID-19 Collaborative, Enabling Seamless Science) Master Digital Surveillance and Associated Clinical Trials Protocol for COVID-19

ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.

NCT04363268 Coronavirus COVID COVID-19 COVID19 Corona Virus Infection Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To use multifaceted participant data consisting of participant reported outcomes, environmental surface and presence or absence of COVID-19 based on testing results, prescription medications (including off-label use), claims, lab, and medical record data to develop population-based models of disease risk, short and long-term outcomes, and efficacy of interventions and prevention measures.

Measure: Development of population-based models of disease risk

Time: Up to 10 years

Description: To leverage geolocation and lab results to provide population-level real-time data regarding disease burden at the community, state and national levels.

Measure: Relation between disease burden and geolocation

Time: Up to 10 years

Description: To specifically identify medications and regimens that address disease symptoms

Measure: Effect of medications on symptoms of COVID19

Time: Up to 10 years

Description: To specifically identify medications and regimens that treat and reduce disease severity.

Measure: Effect of medications on disease severity of COVID19

Time: Up to 10 years

Secondary Outcomes

Description: To identify regional variations in disease incidence and outcomes.

Measure: Rate of COVID19 infection and disease outcomes

Time: Up to 10 years

Description: To understand long-term outcomes such as risk of pulmonary and cardiovascular disease complications.

Measure: Effect of COVID19 on health outcomes

Time: Up to 10 years

Description: To conduct long-term follow up of individuals who tested positive for COVID-19 compared to demographically matched individuals that did not.

Measure: Long-term follow up and recontact

Time: Up to 10 years

64 Multi-centre EuRopean Study of MAjor Infectious Disease Syndromes (MERMAIDS) - Acute Respiratory Infections (MERMAIDS ARI) 2.0

Background Rapid European COVID-19 Emergency Research response (RECoVER), is a project involving 10 international partners that has been selected for funding by the European Union under the Horizon 2020 research framework responding to call topic SC1-PHE-CORONAVIRUS-2020: Advancing knowledge for the clinical and public health response to the SARS-CoV-2 epidemic. MERMAIDS 2.0 is the hospital care study within RECOVER. Rationale Detailed patient-oriented studies are needed to determine the spectrum of SARS-CoV-2 disease and the combined influences of age, comorbidities and pathogen co-infections on the development of severe disease, together with virological and immunological profiles. This research is key to understanding the pathophysiology and epidemiology of this new disease, as well as to identifying potential targets for therapeutic or preventive interventions. Objective To establish the prevalence, disease spectrum and severity, clinical features, risk factors, spread and outcomes of novel 2019 coronavirus infection (SARS-CoV-2) in Hospital Care. Study design Prospective observational cohort study in selected European countries. Study population Children and adults with 1) acute respiratory illness (ARI) presenting to hospital care during the SARS-CoV-2 epidemic (including both COVID-19 and non-COVID-19 patients) and 2) patients with confirmed COVID-19 infection, but with atypical presentation (non-ARI) or with nosocomial acquisition. Sites can optionally participate in the following tiers: Tier 0 (Clinical data collection only) - Clinical data will be collected but no biological samples will be obtained for research purposes. Summary of the illness episode and outcome, including a selection of risk factors and comorbidities and medications. Tier 1 (Clinical data and biological sampling) - Clinical samples and data will be collected on enrolment day and then at scheduled time points. Tier 2 (Clinical data an extended biological sampling). Optional add-on study In a subset of sites and patients, COVID-19 positive patients will be followed post-discharge for 6 months to study clinical recovery and long-term sequelae Main study parameters/endpoints: Prevalence of COVID-19 among patients with acute respiratory illness. COVID-19 disease spectrum and host and pathogen risk factors for severity. Long-term sequelae of COVID-19 requiring hospital care. Proportion hospital-acquired COVID-19 infections and characteristics of nosocomial transmission. Study Duration Scheduled 2 years and based on COVID-19 dynamics. Nature and extent of the burden associated with participation, benefit and group relatedness This study is observational in nature. There will be no direct benefit to research participants. The study may include biological sampling in addition to sampling required for medical management. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.

NCT04364711 COVID-19 SARS-CoV 2
MeSH:Communicable Diseases Infection

Primary Outcomes

Measure: Pneumonia Severity indexes

Time: 2 years

Measure: Need for supplemental oxygen; non-invasive or invasive mechanical ventilation; extra-corporeal life support

Time: 2 years

Measure: Hospital - and ICU/HCU length of stay

Time: 2 years

Measure: In-hospital mortality

Time: 2 years

Measure: Activities of daily life, quality of life, variations in home living status and employment status

Time: 2 years

Measure: Proportion of SARS-CoV2 positive patients

Time: 2 years

65 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

This 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 hospitalized patients with moderate COVID-19 disease.

NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Virus Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

Primary Outcomes

Description: Number and severity of adverse events

Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

Time: Up to 12 months

Description: 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 12 months

Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score or radiologic evaluation as measured by protocol-defined radiologic evaluation score.

Measure: Phase 1: Rate of clinical improvement

Time: Up to 12 months

Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. 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 days

Description: 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 days

Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by Radiologic Evaluation Score.

Measure: Phase 2: Time to Clinical Improvement by radiologic evaluation score

Time: Up to 28 days

Secondary Outcomes

Description: Number and severity of adverse events

Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

Time: up to 12 months

Description: Time to medical discharge as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by time to medical discharge

Time: up to 12 months

Description: Hospital utilization will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by hospital utilization

Time: up to 12 months

Description: Mortality rate will be measured as an assessment of overall clinical benefit

Measure: Overall Clinical Benefit by measuring mortality rate

Time: up to 12 months

Description: 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 days

Description: 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 days

Description: Proportion of subjects who achieved clinical improvement of cough

Measure: Rate of Clinical Improvement of cough

Time: Up to 28 days

Description: For ventilatory support subjects, the days with supplemental oxygen-free.

Measure: Supplemental oxygen-free days

Time: Up to 28 days

Description: Proportion of subjects who need invasive or non-invasive ventilation

Measure: Proportion of subjects requiring ventilation

Time: Up to 28 days

Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

Measure: Rate of Clearance of SARS-CoV-2

Time: Up to 12 months

66 Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers

This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers

NCT04366154 COVID-19 Cancer Other: Questionnaire
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: Proportion of patients with modification of the treatments administered

Measure: To assess the impact of the COVID-19 pandemic on the modifications of treatments administered in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change in the rate of treatment administration

Measure: To assess the impact of the COVID-19 pandemic on the change in the rate of treatment administration in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change in the number of cures administered

Measure: To assess the impact of the COVID-19 pandemic on the number of cures administeredin hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Description: Proportion of patients with change of modality of administration (home administration to replace day hospital administration, teleconsultation uses)

Measure: To assess the impact of the COVID-19 pandemic on change of modality of administration in hospital (day units) to patients with cancer or malignant hemopathy

Time: up to 6 months

Secondary Outcomes

Description: Score of questionnaires of Perceived Stress Scale [0-40 points]

Measure: Evaluate the perceived stress on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

Measure: Evaluate the post-traumatic stress on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of sleep disorders (ISI scale, 0-28 points)

Measure: Evaluate the sleep disorders on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of quality of life (FACT-G scale)

Measure: Evaluate the quality of life on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of cognitive complaints (Fact-Cog scales; 0-148 points)

Measure: Evaluate the cognitive complaints on cancer patients treated in unit day of hospital

Time: up to 6 months

Description: Score of questionnaires of Perceived Stress Scale [0-40 points]

Measure: Evaluate the perceived stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of Impact of Event Scale-Revised [0-88 points]

Measure: Evaluate the post-traumatic stress on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of burnout ((Maslach Burn Out Inventory scale, 0-132 points)

Measure: Evaluate the burnout on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

Description: Score of questionnaires of feeling of personal effectiveness (0-30 points)

Measure: Evaluate the feeling of personal effectiveness on caregivers (perceived stress, post-traumatic stress, burnout, feeling of personal effectiveness)

Time: up to 3 months

67 ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection

Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19

NCT04367740 Asymptomatic Condition Infection Viral Coronavirus Infections Severe Acute Respiratory Syndrome Coronavirus 2 Coronaviridae Infections RNA Virus Infections Virus Diseases Communicable Disease Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Asymptomatic Diseases Virus Diseases

Primary Outcomes

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 enrollment

Secondary Outcomes

Description: swab for presence of SARS-CoV-2 virus

Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.

Time: at enrollment

68 Observational Study of COVID-19 Treatment Efficacy

To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.

NCT04369989 Coronavirus Coronavirus Infection Corona Virus Infection COVID Sars-CoV2 Coronavirus as the Cause of Diseases Classified Elsewhere SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere COVID-19 Coronavirus Disease Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere Other: No intervention
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Measure: Mortality during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

Measure: ICU admission during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

Measure: Ventilator use during the COVID-19 treatment hospital encounter

Time: up to 6 weeks

69 Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19. Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future. Primary Objective - To determine the clinical characteristics and outcomes of Covid-19 in children. - To characterize the clinical risk factors of Covid-19 in children.. Secondary Objectives - To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children. - To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

NCT04371315 Corona Virus Infection Pediatric Cancer Adult Children Cancer
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Clinical characteristics, including demographics, underlying diagnosis, and signs/symptoms, and outcomes, such as hospitalization, oxygen requirements, and mortality, will be summarized with counts and percentages.

Measure: Characteristics and outcomes of acute respiratory infections due to COVID-19 in children.

Time: Baseline-Day 60

Description: Pearson or Spearman's correlation of clinical risk factors such as age, underlying diagnosis, immunosuppression with outcomes as detailed in primary objective 1 will be evaluated.

Measure: Clinical risk factors of acute respiratory infection due to COVID-19 in children.

Time: Baseline-day 60

Secondary Outcomes

Description: Immunological (e.g., Absolute lymphocyte/monocyte counts, Immunoglobulin level) and serological (antibodies against the virus) response measures will be summarized with mean, standard deviation, median and range.

Measure: Immunologic response to acute respiratory infection due to COVID-19 in children.

Time: Baseline-day 60

Description: The duration of viral shedding, defined as the time between the first positive test date and the first negative test date, will be summarized for all participants with mean, standard deviation, median and range.

Measure: Duration of viral shedding and evolution in children longitudinally.

Time: Baseline-Day 60

70 COVID-19 in People Living With HIV: Evaluation of Risk Factors and Outcomes in Resource-limited Settings. A Pooled Substudy of ADVANCE, D²EFT, DolPHIN2 and NAMSAL

COHIVE is an observational cohort nested in four antiretroviral therapy research studies (ADVANCE - NCT03122262; D²EFT - NCT03017872; DolPHIN2 - NCT03249181 and NAMSAL-ANRS12313 - NCT02777229). COHIVE will include participants who are possible COVID-19 cases with symptoms or confirmed COVID-19 cases, and participants who agree to have a serology testing for SARS-CoV-2 regardless of COVID-19 history.

NCT04371835 HIV-infection/Aids Coronavirus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To characterise the clinical features of symptomatic COVID-19 in PLWH (cardio-respiratory and other clinical signs or symptoms), described overall and by HIV and comorbid disease factors including pregnancy status.

Measure: Clinical features of symptomatic COVID-19 in people living with HIV (PLWH)

Time: At baseline

Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.

Measure: Clinical outcomes of symptomatic COVID-19 in PLWH

Time: At Day 28

Description: To characterise the clinical outcomes of symptomatic COVID-19 in PLWH, assessing the outcomes of patients including the percentage of patients who are fully recovered, required hospitalisation, developed severe illness (ICU admission or equivalent) or died.

Measure: Clinical outcomes of symptomatic COVID-19 in PLWH

Time: At Month 3

Secondary Outcomes

Description: To determine seroprevalence of COVID-19 in all parent study participants regardless of COVID-19 history.

Measure: Seroprevalence of COVID-19 in all parent study participants

Time: Through study completion, an average of one year

71 Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma

This 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.

NCT04376034 COVID19 Coronavirus Infection Coronavirus Virus Diseases RNA Virus Infections Biological: Convalescent Plasma 1 Unit Biological: Convalescent Plasma 2 Units Other: Standard of Care
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Virus Diseases

Primary Outcomes

Description: Time it takes to identify eligible donors whom are willing to donate

Measure: Plasma Donor

Time: Measured in days for 365 days

Description: 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 days

Description: Time from consent to infusion

Measure: Plasma Recipient

Time: Measured evey 24 hours up to 30 days

Description: Survival

Measure: Plasma Recipient

Time: Measured in days with 30 day from discharge follow-up

Secondary Outcomes

Description: Time until plasma is donated

Measure: Plasma Donor

Time: Measured every 24 hours up to 1 year

Description: Incident of treatment-Emergent Adverse Events [Safety and Tolerability]

Measure: Plasma Recipient

Time: Day 1, 2, 3, 4, 7, and 30 day

Description: Morbidity reduction

Measure: Plasma Recipient

Time: Day 1, 2, 3, 4, 7, and 30 day

Description: Reduced Length of Stay in hospital

Measure: Plasma Recipient

Time: Measured every 24 hours until patient discharged from hospital up to 1 year

Description: Reduced Length of Stay on Advance Respiratory Support

Measure: Plasma Recipient

Time: Measured every 24 hours until Off Advanced Respiratory Support up to 1 year

72 Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis. In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional. Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response. In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

NCT04376476 Infection, Coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 Biological: Blood sample Biological: Low or upper respiratory tract sample Biological: Stool collection or fecal swab Genetic: Blood sample for whole genome sequencing Other: phone call
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Describe the immune response (biological profile in blood samples) of children and adults with COVID-19 infection and correlate it with the initial clinical presentation measurement of the following parameters in blood at time of inclusion: white blood cell count, C-reactive protein, procalcitonin, hepatic and renal functions, ferritin, vitamin C and D, fibrinogen, prothrombin time test and partial thromboplastin time in order to correlate them with the initial clinical presentation.

Measure: Initial biological profile of children and adults with COVID-19 infection

Time: Day 0

Description: measurement of the following parameters in blood at time of inclusion: interferon alpha and gamma, Tumor necrosis factor (TNF) alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte Human Leukocyte Antigen - DR isotype (HLA-DR) expression in order to correlate them with the initial clinical presentation.

Measure: Initial immunological profile of children and adults with COVID-19 infection

Time: Day 0

Secondary Outcomes

Description: Determine whether the initial biological and immunological profiles (see primary outcome measures) are predictive of a secondary worsening (i.e., admission to intensive care unit, and/or increase in NEWS-2 score, and/or increase in oxygen dependence level) of COVID-19 infection

Measure: Clinical worsening

Time: Within 21 days following inclusion

Description: measurement of the following parameters in blood at day 7, and at time of worsening: interferon alpha and gamma, TNF alpha, interleukins 6 and 10, transcriptomic signature of interferon, lymphocyte phenotyping and monocyte HLA-DR expression in order to correlate them with with the secondary worsening

Measure: Evolution of the immunological profile of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured at day 0 and correlation to the initial clinical presentation

Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19

Time: Day 0

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured at day 0 and correlation to the initial clinical presentation

Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19

Time: Day 0

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured at day 0 and correlation to the initial clinical presentation

Measure: titers in specific Immunoglobulin M (IgM) antibodies of children and adults with COVID-19

Time: Day 0

Description: Nasopharyngeal swabs SARS-CoV-2 viral loads (copies/mL) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: Nasopharyngeal swabs SARS-CoV-2 viral loads of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin G (IgG) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: titers in specific Immunoglobulin G (IgG) antibodies of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Serological SARS-CoV-2 results (titers in specific Immunoglobulin M (IgM) antibodies) measured within 21 days following inclusion, and correlation to the secondary worsening

Measure: titers in specific Immunoglobulin G (IgM) antibodies of children and adults with COVID-19

Time: Within 21 days following inclusion

Description: Genotyping using the whole exome sequencing technic (by Illumina HiSEQ 2500) in order to correlate with the initial clinical presentation.

Measure: Genetic profile of adults with COVID-19 infection

Time: Day 0

Description: Genotyping using the whole exome sequencing technic (Illumina HiSEQ 2500) in order to correlate with with the secondary worsening

Measure: Genetic profile of adults with COVID-19 infection

Time: Within 21 days following inclusion

73 Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection

This phase I/IIa trial studies the side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

NCT04379518 Malignant Neoplasm SARS Coronavirus 2 Infection Biological: Recombinant Interferon Alfa-2b Drug: Rintatolimod
MeSH:Infection Communicable Diseases Neoplasms
HPO:Neoplasm

Primary Outcomes

Description: This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0).

Measure: Incidence of adverse events (AEs)

Time: Up to 30 days post treatment intiation

Measure: Reduction of progression of infection requiring hospitalization

Time: Up to 30 days post treatment initiation

Description: ARDS will be defined by Berlin criteria.

Measure: Reduction of acute respiratory distress syndrome (ARDS)

Time: Up to 30 days post treatment initiation

Description: The binary endpoint of 30-day mortality will be analyzed using a logistic regression model.

Measure: 30-day mortality

Time: At 30 days post treatment initiation

Secondary Outcomes

Description: Will be analyzed using quantitative polymerase chain reaction (PCR).

Measure: Kinetics of viral load in the peripheral blood and nasal swabs

Time: During the course of treatment up to day 28

Description: The circulatory inflammatory mediators include C-reactive protein (CRP), cytokines, chemokines, interferons.

Measure: Kinetics of changes of the immune subsets and circulating inflammatory mediators in peripheral blood

Time: During the course of treatment up to day 28

Other Outcomes

Measure: ARDS severity

Time: Up to 30 days post treatment initiation

74 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults

The trial has two parts: a dose-finding part (Part A) with four dose cohorts (treatment groups) for each vaccine and one pre-defined and one optional dose level for a de-escalation approach and, a second part (Part B) dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, and BNT162b2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will be administered using a Single dose (SD) regimen.

NCT04380701 Infections, Respiratory Virus Diseases Infection Viral Vaccine Adverse Reaction RNA Virus Infections Biological: BNT162a1 Biological: BNT162b1 Biological: BNT162b2 Biological: BNT162c2
MeSH:Infection Communicable Diseases Respiratory Tract Infections RNA Virus Infections Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

Time: up to 7 days following each dose administration

Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

Time: up to 7 days following each dose administration

Description: For BNT162a1, BNT162b1, BNT162b2 (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 administration

Description: For BNT162a1, BNT162b1, BNT162b2 (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 administration

Secondary Outcomes

Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B):

Time: up to 162 days following dose administration

Description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B):

Time: up to 162 days following dose administration

Description: 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, 63±5 days, and 162±7 days after the boost immunization.

Measure: For BNT162a1, BNT162b1, BNT162b2 (P/B):

Time: up to 162 days following dose administration

Description: Functional antibody responses at 7±1 days, 21±2 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 administration

Description: Fold increase in functional antibody titers at 7±1 days, 21±2 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 administration

Description: 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, 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 administration

75 Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study

The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.

NCT04380870 Coronavirus Infection Dietary Supplement: Chinese Herbal Medicine
MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Patient reported change

Measure: Patient reported main complaint

Time: 24 hours

Description: Patient reported change

Measure: Patient reported main complaint

Time: 48 hours

Description: Patient reported change

Measure: Patient reported main complaint

Time: 3 months

Description: Patient reported change

Measure: Patient reported main complaint

Time: 12 months

Secondary Outcomes

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 24 hours

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 48 hours

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 3 months

Description: Patient interview notes as written by clinicians.

Measure: Conduct qualitative analyses of data

Time: 12 months

76 Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital Huddinge, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is time (in days) of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.

NCT04381364 Covid-19 Pneumonia, Viral ARDS ARDS, Human Sars-CoV2 Coronavirus Infection Corona Virus Infection Drug: Ciclesonide Inhalation Aerosol
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Distress Syndrome, Adult
HPO:Pneumonia

Primary Outcomes

Description: Time (in days) of received supplemental oxygen therapy (defined as being alive and discharged from hospital to home or at least 48 h of not receiving oxygen therapy during hospitalization).

Measure: Duration of received supplemental oxygen therapy

Time: 30 days after study inclusion

Secondary Outcomes

Description: Rate of and time to (in days) received invasive mechanical ventilation or all-cause death

Measure: Invasive mechanical ventilation or all-cause death

Time: 30 days after study inclusion

Description: Rate of and time to (in days) death of any cause

Measure: All cause death

Time: 30 days after study inclusion

Description: Rate of and time to (in days) received invasive mechanical ventilation

Measure: Invasive mechanical ventilation

Time: 30 days after study inclusion

Description: Maximum received oxygen therapy during hospitalization in liters per minute

Measure: Maximum oxygen therapy

Time: 30 days after study inclusion

Description: Time (in days) from study inclusion to discharge from hospital.

Measure: Duration of hospitalization

Time: 30 days after study inclusion

Description: Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale

Measure: Remaining dyspnea symptoms

Time: 3 and 6 months after inclusion. (Only for patients hospitalized at S:t Goran's Hospital)

77 A Phase II, Controlled Clinical Study Designed to Evaluate the Effect of ArtemiC in Patients Diagnosed With COVID-19

Agent Name and Study Duration ArtemiC is a medical spray comprised of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (=Boswellia) (15 mg/ml) and vitamin C (60 mg/ml) in micellar formulation for spray administration. Patients will receive up to 6 mg Artemisinin, 20 mg Curcumin, 15 mg Frankincense and 60 mg vitamin C given daily as an add-on therapy (in addition to standard care) in two divided doses, on Days 1 and 2. Patients will be randomized in a manner of 2:1 for study drug (ArteminC) and Standard of Care to Placebo and Standard of Care. Patient follow-up will last 2 weeks. During this time, patients will be monitored for adverse events. Additional time will be required for follow up (until hospital discharge) in order to check side effects and study drug efficacy. Placebo, composed of the same solvent but without active ingredients, will be given in the placebo group as add-on therapy, 2 times a day, on Days 1 and 2. Overall rationale A preparation of ArtemiC, comprising Artemisinin, Curcumin, Boswellia, and Vitamin C in a nanoparticular formulation, is proposed as a treatment for the disease associated with the novel corona virus SARS-CoV-2. It is readily available in light of its status as a food supplement. This initiative is presented under the urgent circumstances of the fulminant pandemic caused by this lethal disease, which is known as COVID-19 and has spread across the globe causing death and disrupting the normal function of modern society. The grounds for the proposal are rooted in existing knowledge on the components and pharmacological features of this formulation and their relevance to the current understanding of the disease process being addressed. Leading among these considerations are well established immuno-modulatory activities of the active ingredients as established in vitro and in vivo and published over the years. These activities as apparent, for example, in diminishing activity of TNF alpha and IL-6 levels are acknowledged to be relevant to the pathophysiology processes involved in the progressive form of COVID-19. The active agents have in addition prominent anti-oxidant, anti-inflammatory as well as anti-aggregant and anti-microbial activities. Based on these activities and observations in animal models, together with clinical experience of the separate ingredients and in various combinations in other contexts it is proposed to evaluate their effect in the context of COVID-19. Study Purpose This study is designed to evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19. Methodology 50 adult patients who suffer from COVID-19 infection studied in parallel groups treated with active agent or placebo as add on to standard care. Safety will be assessed through collection and analysis of adverse events, blood and urine laboratory assessments and vital signs.

NCT04382040 COVID-19 Corona Virus Infection SARS-CoV 2 Coronavirus Coronavirus Infection Drug: ArtemiC Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: patient will be assessed using a scoring table for changes in clinical signs

Measure: Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of Time: 24 hours

Description: Adverse events caused by the study drug will be assessed

Measure: Percentage of participants with definite or probable drug related adverse events

Time: 14 days

Secondary Outcomes

Measure: Time to negative COVID-19 PCR

Time: 14 days

Measure: Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms

Time: 14 days

Measure: COVID-19 related survival

Time: 14 days

Measure: Incidence and duration of mechanical ventilation

Time: 14 days

Measure: Incidence of Intensive Care Init (ICU) stay

Time: 14 days

Measure: Duration of ICU stay

Time: 14 days

Measure: Duration of time on supplemental oxygen

Time: 14 days

78 Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.

NCT04382508 Immune Suppression Immune Deficiency Infection COVID Children, Adult Other: Questionnaire
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Primary Outcomes

Description: To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year

Measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting

Time: 1 year

Secondary Outcomes

Description: Patient/parent reported positive tests for COVID19

Measure: Number of children/adults tested positive for COVID19

Time: 1 year

Description: Patient/parent reported admissions in hospital because of COVID19

Measure: Number of children/adults admitted in hospital because of COVID19

Time: 1 year

Description: Patient/parent reported effect of COVID19 on daily activities

Measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children

Time: 1 year

79 Genetic Factors Influencing the Response to Infection With SARS-COV-2

We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy

NCT04384250 Genetic Basis of COVID-19 Infection Diagnostic Test: Whole Exome Sequencing
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Genetic susceptibility to COVID-19

Measure: Mutations leading to increase susceptibility to SARS-COV-2 infection

Time: 12 months

80 COVIDAge Study- Hospital Des Trois-Chêne

In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.

NCT04385212 Coronavirus Infection Sars-CoV2 Elderly Infection Old Age; Debility
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: We measure functional score of comorbidities

Measure: To evaluate the relative contributions of comorbidities on intra-hospitalized death

Time: 1 month

Secondary Outcomes

Description: We measure Functional Independence Measure scale

Measure: To evaluate the relative contributions of functional characteristics on intra-hospitalized death

Time: 1 month

Description: We describe the role fo geriatric syndrome such as delirium, falls

Measure: To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes

Time: 1 month

81 NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

NCT04387656 Asymptomatic COVID-19 Infection Laboratory-Confirmed Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed Procedure: Biospecimen Collection Other: Data Collection
MeSH:Infection Communicable Diseases Laboratory Infection Neoplasms
HPO:Neoplasm

Primary Outcomes

Description: Distinguish the likelihood of severe COVID19 (for example, requiring hospitalization, requiring intensive care unit [ICU] treatment or requiring a ventilator) and death due to COVID-19 for patients with versus without the factor. Among subgroups of at least 50 patients, evaluate using chi-square tests as well as death and hospitalization rates.

Measure: Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity

Time: Up to 2 years

Description: Describe the degree to which COVID-19 interrupts, delays, or otherwise alters cancer treatment for subgroups of patients defined by cancer type and/or treatment modality. Describe the association between changes in cancer therapy and clinical outcomes. Evaluate association of COVID-19 with outcome by comparison to historical controls in subgroups of at least 50 patients using log rank tests to assess time to survival event.

Measure: Effects of COVID-19 on cancer therapy and association with clinical outcomes

Time: Up to 2 years

Other Outcomes

Description: Analysis will include time to development of antibodies, prevalence of cytokine abnormalities, and genome-wide association study (GWAS) to define genetic polymorphisms associated with severe COVID-19 disease/mortality.

Measure: Collection of blood specimens for future biomarker studies

Time: Up to 2 years

82 Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial

In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks. It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance. Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system. This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.

NCT04389333 Gastrointestinal Disease Infectious Disease Capsule Endoscopy Device: non-contact magnetically-controlled capsule endoscopy
MeSH:Communicable Diseases Infection Gastrointestinal Diseases Digestive System Diseases
HPO:Abnormality of the gastrointestinal tract

Primary Outcomes

Description: Maneuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction.

Measure: Maneuverability score

Time: During the procedure

Secondary Outcomes

Description: GET was defined as the time time taken for the endoscopist to complete the gastric examination to his or her satisfaction

Measure: Gastric examination time(GET)

Time: During the procedure

Description: The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient

Measure: the comfort and acceptability of patients

Time: After the procedure(within 5 days)

Description: Diagnosis based on the data of nc- MCE by two endoscopist

Measure: diagnostic yield

Time: after the procedure(within 5 days)

Other Outcomes

Description: Adverse events during and after the procedure

Measure: Adverse events

Time: During and within 2 weeks after the procedure

Description: Complete observation of the mucosa (>90% of the mucosa observed) in gastric cardia, fundus, body, angulus, antrum and pylorus

Measure: Clinical success

Time: During the procedure

83 Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe Coronavirus Disease 2019 Infectious Disease (COVID-19)

This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.

NCT04389944 Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection) Other: convalescent plasma application to SARS-CoV-2 infected patients
MeSH:Communicable Diseases Infection Coronavirus Infections Clinical Deterioration

Primary Outcomes

Description: Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection

Measure: Serious adverse events in convalescent plasma treated patients

Time: From baseline (enrolment) to 24 hours follow-up

Description: Change in SARS-CoV2 quantitative in nasopharyngeal swab

Measure: Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

Description: Transfer to ICU

Measure: Transfer to ICU

Time: at Baseline (admission to Covid-ward) until day 28

Description: in-hospital death

Measure: in-hospital death

Time: at Baseline (admission to Covid-ward) until day 28

Description: Change in SARS-CoV2 quantitative in plasma

Measure: Virologic clearance in plasma of convalescent plasma treated patients

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

Secondary Outcomes

Description: Duration of hospitalisation

Measure: Time to discharge from hospital after enrolment

Time: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)

Description: Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)

Measure: Humoral immune response

Time: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28

84 Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission

SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.

NCT04390022 Covid-19 Coronavirus Infection SARS-CoV-2 Infection Drug: Ivermectin Drug: Placebo
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment

Measure: Proportion of patients with a positive SARS-CoV-2 PCR

Time: 7 days post-treatment

Secondary Outcomes

Description: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swab

Measure: Mean viral load

Time: Baseline and on days 4, 7, 14 and 21

Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trial

Measure: Fever and cough progression

Time: Up to and including day 21

Description: Proportion of participants with positive IgG at day 21

Measure: Seroconversion at day 21

Time: Up to and including day 21

Description: Proportion of drug-related adverse events

Measure: Proportion of drug-related adverse events

Time: 7 days post treatment

Description: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assay

Measure: Levels of IgG, IgM and IgA

Time: Up to and including day 28

Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometry

Measure: Frequency of innate immune cells

Time: Up to and including day 7

Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometry

Measure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells

Time: Up to and including day 7

Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)

Measure: Results from cytokine Human Magnetic 30-Plex Panel

Time: Up to and including day 28

85 Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted to University of Michigan. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

NCT04391179 COVID Corona Virus Infection Covid-19 SARS-CoV-2 Infection Drug: Dipyridamole 100 Milligram(mg) Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Increase in plasma D-dimer level compared with baseline at enrollment.

Measure: Change in D-dimer

Time: baseline, up to approximately 28 days after last study drug administration

Secondary Outcomes

Description: Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.

Measure: Global composite rank score

Time: up to approximately 28 days after last study drug administration

86 Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care

It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease. The lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training. In the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient. Peng and al in Intensive Care Medicine accentuate the usefulness of this particular technic. In the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient. In Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause. Another researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality. And a new applicability in the pulmonary recruitment by PEEP titration has been presented. The aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.

NCT04393402 COVID Procedure: lung ultrasound (LUS)
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), > 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.

Measure: LUS applicability with COVID 19

Time: 10 months

Secondary Outcomes

Description: Comparison between Xray / CT scan exam and LUS

Measure: Radiographic correlation (chest Xray and tomodensitometry)

Time: 10 months

Description: according to LUS score, ventilatory mode and parameters, medical history and bood analysis results

Measure: LUS Mortality prediction

Time: 10 months

Description: comparison of LUS score depending of the position used for performing LUS

Measure: Prediction of Prone position response

Time: 10 months

87 A Phase I Study of ResCure™ to Treat COVID-19 Infection

This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.

NCT04395716 COVID Covid-19 Corona Virus Infection Sars-CoV2 Coronavirus-19 SARS SARS Pneumonia SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Biological: ResCure™
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using ResCure™

Time: 12 Weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or progression of symptomatic days

Time: 12 Weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via pulse

Time: 12 Weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via oxygen saturation

Time: 12 Weeks

Description: EKG from baseline to 12 weeks

Measure: Assess the safety of ResCure™ via EKG

Time: 12 Weeks

Description: Assess Adverse Events and Serious Adverse Events due to ResCure™

Measure: Assess Tolerability of ResCure™

Time: 12 Weeks

88 Anti-inflammatory Clarithromycin to Improve SARS-CoV-2 (COVID-19) Infection Early: The ACHIEVE Open-label Non-randomized Clinical Trial

Recent 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.

NCT04398004 COVID-19 Virus Diseases Corona Virus Infection Drug: Clarithromycin
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

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 8

Description: 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 8

Secondary Outcomes

Description: 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 8

Description: 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 8

Description: 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 4

Description: 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 4

Description: 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 14

Description: 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 14

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

Description: 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 8

89 Characteristics of COVID-19 Infection Among PREGnant Women

In December 2019, Coronavirus infection (COVID-19) was identified as causing serious respiratory infection in humans. Initially COVID-19 was propagated by infected symptomatic individuals; currently the disease is disseminated by asymptomatic COVID-19 positive subjects. The prevalence of asymptomatic COVID-19 individuals is unknown. Due its physiologic immune suppression, pregnancy is a vulnerable time for severe respiratory infections including COVID-19. Limited information is available regarding the impact of COVID-19 in pregnancy and the prevalence and demographic profile of asymptomatic pregnant women. Despite reports of 15-20% positive COVID-19 tests in women admitted to Labor and Delivery, professional obstetric medical societies still recommend not prioritizing testing of patients who are asymptomatic. In the USA, COVID-19 symptomatic patients come predominantly from lower income, Black and Latino communities. No data are available on the rate and demographic distribution of asymptomatic positive COVID-19 pregnant women. To minimize the risk of inadvertent exposure asymptomatic individuals, recently our institution started COVID-19 testing in all admitted pregnant women. The investigators expect to gain knowledge on the impact of COVID-19 in pregnant women especially if asymptomatic and compare to other respiratory infections.

NCT04398264 Corona Virus Infection Pregnancy Related Other: COVID-19 positive via testing
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Rate of asymptomatic pregnant women who test positive for COVID-19 at the time of hospital admission

Measure: Asymptomatic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Secondary Outcomes

Description: Rate of Hispanic pregnant women among those asymptomatic COVID-19 positive on admission

Measure: Asymptomatic Hispanic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Description: Rate of asymptomatic positive pregnant women who later will develop COVID-19 related symptoms

Measure: Follow up of asymptomatic COVID-19 positive pregnant women

Time: Through completion of the study, an average of 1 year

Description: Prevalence of COVID-19 positive newborns from infected mothers

Measure: COVID-19 positive newborns

Time: Through completion of the study, an average of 1 year

Description: Rate of COVID-19 positive pregnant women who develop respiratory / multi-organ complications requiring admission to Medicine or Intensive Care units / maternal death related to COVID-19

Measure: Severe COVID-19 disease in pregnant women

Time: Through completion of the study, an average of 1 year

90 The Effectiveness of Ozone Therapy in the Prevention of COVID-19 Infection

Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection. In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.

NCT04400006 Corona Virus Infection
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: It involved questions about age, gender, height, weight, occupation, comorbidities, and concurrent medications, in addition to a detailed query for COVID-19 infection

Measure: The survey that was taken by telephone calls

Time: Day 0

91 Prevention of COVID19 Infection by the Administration of Hydroxychloroquine to Institutionalized Older People and Nursing Home Staff. A Cluster Randomized Controlled Stepped-wedge Trial (PREVICHARM Study)

Professionals and residents of nursing homes are one of the most vulnerable groups in this public health crisis of COVID-19, since they have the highest rate of positives for COVID-19, despite the restriction measures carried out, such as prohibition of family visits to these centers, the infection occurs by cross transmission with the care staff of the centers, or with other residents. At the moment, there are no clinical trials to test the hypothesis that hydroxychloroquine is effective in coronavirus treatment. Although what has been observed is a better prognosis in infected patients, since this drug inhibits the replication of the virus and its expansion to other tissues. This study is a clinical trial to test the effectiveness of hydroxychloroquine as a preventive drug for SARS-CoV-2 infection. This drug will be applied to 1050 people residing in nursing home care and 880 professionals who work in close contact with these people and who have not yet contracted the infection. This project will be carried out in the territories of Madrid, Navarra, Aragon and Andalusia (Spain). Hydroxychloroquine is a widely known drug that is used in two scenarios, against autoimmune diseases, such as lupus or rheumatoid arthritis, and as an antimalarial drug. It is also intended to demonstrate that the presumed reduction in viral load that would be obtained with hydroxychloroquine prophylaxis, would have no effect in development of immunity against the virus. This fact can create a new paradigm for the de-escalation of the confinement to which the population has been subjected to stop the virus spread, allowing the development of general immunity in controlled populations until reaching total immunity. In addition to testing the effect of this drug, a non-pharmacological intervention based on a safety record will be tested in the management of infection on nursing home, to assess its effectiveness in detecting risk areas or bad practices carried out in this vulnerable environment. The study is led by researchers of the Institute of Biomedicine of Malaga (Spain), and has obtained a financing of 1,024,199 euros from Carlos III Health Institute (Spain). The period of execution of the clinical trial is one year, and with this intervention, the intention is to reduce cross-infection in residents by a minimum threshold of 15%, as well as to decrease infection in the professionals.

NCT04400019 Sars-CoV2 Coronavirus Infection Prevention Prevention & Prevention & Control Nursing Home Hydroxychloroquine Drug: Hydroxychloroquine Only Product in Oral Dose Form
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Discrete quantitative variable. Residents with active viral load (diagnosed by polymerase chain reaction test) will be considered infected.

Measure: Number of secondary cases of SARS-CoV2 infection among residents at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable

Measure: SARS-CoV-2 infection in nursing home staff who provide direct care at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Secondary Outcomes

Description: Dichotomous qualitative variable (1: Death 0: Survival)

Measure: Mortality

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Continous variable. It will be evaluated with the AIDS Clinical Trials Group method: investigation of medications not taken in a period of 4 days prior to the interview)% adherence = (total prescribed galenic units for that period-total units not taken) / total prescribed galenic units for that period

Measure: Compliance with treatment

Time: It will be evaluated during the five days that the chemoprophylaxis with hydorxychloroquine is administered

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at six days

Time: This outcome will be evaluated at 6 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. The participant presents symptoms compatible with SARS-CoV-2 infection. High temperature, cephalea, dyspnea,diarrhea, vomiting, arthro-myalgia, pharynx pain, abdominal pain, anosmia, cough.

Measure: Symptoms of SARS-CoV-2 infection at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Dichotomous categorical variable. Participant requires hospital admission attributable to SARS-CoV-2 infection

Measure: Hospitalization

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at six days

Time: This outcome will be evaluated at six days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 14 days

Time: This outcome will be evaluated at 14 days from the administration of chemoprophylaxis with hydroxychloroquine

Description: Polycotomic categorical variable. Collected by clinical interview and also monitored simultaneously by external trial monitors

Measure: Adverse events at 28 days

Time: This outcome will be evaluated at 28 days from the administration of chemoprophylaxis with hydroxychloroquine

92 Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"

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.

NCT04403100 COVID-19 Coronavirus Infection Virus Disease Acute Respiratory Infection SARS-CoV Infection Drug: Hydroxychloroquine Sulfate Tablets Drug: Lopinavir/ Ritonavir Oral Tablet Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Drug: Placebo
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
HPO:Respiratory tract infection

Primary Outcomes

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)

Measure: Proportion of participants who died due to COVID-19 progression and/ or complications

Time: Measuring during 28-day period since randomization (Intention to treat analysis)

Secondary Outcomes

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 randomization

Description: 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 randomization

Description: 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 randomization

Description: Proportion of participants with hospitalization for any cause

Measure: Hospitalization for any cause

Time: Measuring during 28-day period since randomization

Measure: Proportion of participants who died due to pulmonary complications

Time: Measuring during 28-day period since randomization

Measure: Proportion of participants who died due to cardiovascular complications

Time: Measuring during 28-day period since randomization

Description: 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 randomization

Description: 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 randomization

Measure: proportion of non-adherent participants to any of study drugs

Time: Measuring during 10-day period since randomization

93 A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate Infectious Virus Detection in Persons With COVID-19

This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19

NCT04405570 SARS-CoV 2 Drug: 200 mg EIDD-2801 Drug: Placebo
MeSH:Communicable Diseases Infection

Primary Outcomes

Description: The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding stratified log-rank test (to account for the "early" versus "late" time from symptom onset randomization strata)

Measure: Virologic Efficacy

Time: 28 days

Description: Measure the safety and tolerability of EIDD-2801 by estimating in the randomization arm the probability of 1) any adverse events (AEs) leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AE (not already present at baseline), and 4) study drug-related new grade 3 or higher AE. The cumulative probability of each safety and each tolerability endpoint (4 endpoints) by using the Kaplan-Meier approach and stratified log-rank test.

Measure: Number of Participants with any Adverse Events (AEs) as Assessed by Kaplan Meier Approach

Time: 28 days

Secondary Outcomes

Description: Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs by using the Kaplan-Meier approach and stratified log-rank test.

Measure: Number of Participants With any Adverse Events (AEs), Grade 2 or higher as Assessed by Kaplan Meier Approach

Time: 28 days

94 A Phase III Prospective, Interventional, Cohort, Superiority Study to Evaluate the Benefit of Rapid COVID-19 Genomic Sequencing (the COVID-19 GENOMICS UK Project) on Infection Control in Preventing the Spread of the Virus in United Kingdom NHS Hospitals

Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers. Infection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams. There is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. It is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit. The study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.

NCT04405934 Covid-19 Nosocomial Infection Coronavirus Coronavirus Infection SARS-CoV 2 Other: Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures
MeSH:Infection Communicable Diseases Cross Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Incidence rate of IPC-defined HOCIs, measured as incidence rate of recorded cases per week per 100 inpatients, during each phase of the study based on case report forms.

Measure: Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs)

Time: 6 months

Description: Identification of nosocomial transmission using sequencing data in potential HOCIs in whom this was not identified by pre-sequencing IPC evaluation, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing

Time: 6 months

Secondary Outcomes

Description: Incidence rate of IPC-defined hospital outbreaks, defined as cases of hospital transmission linked by location and with intervals between diagnoses of no greater than 2 weeks (relevant data extracted from case report forms), measured as incidence rate of outbreak events per week per 100 inpatients during each phase of the study.

Measure: Incidence rates of IPC-defined hospital outbreaks

Time: 6 months

Description: Incidence rate of IPC+sequencing-defined hospital outbreaks, defined by retrospective review of all available sequencing and epidemiological data for identification of transmission clusters and measured as outbreak events per week per 100 inpatients during each phase of the study.

Measure: Incidence rates of IPC+sequencing-defined hospital outbreaks

Time: 6 months

Description: Changes to IPC actions implemented following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Changes to IPC actions following viral sequence reports

Time: 6 months

Description: Changes to IPC actions that would ideally have been implemented (given unlimited resources) following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.

Measure: Recommended changes to IPC actions following viral sequence report - not implemented

Time: 6 months

Description: Health economic benefit of standard and rapid sequencing reports to IPC measured using bespoke health economic case report data comparison between baseline, standard and rapid sequencing phases.

Measure: Health economic benefit to IPC of standard vs rapid sequencing reports

Time: 6 months

Description: Number of HCW days off work measured from sampling these data points on case report forms at all study phases.

Measure: Impact of both standard and rapid sequencing reports on number of HCW days off work

Time: 6 months

95 Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease: a Randomised Controlled Trial

This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease

NCT04405999 Increased Risk of SARS-CoV-2 Infection Drug: Bromhexine Hydrochloride
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Negative PCR of SARS-CoV-2 and the absence of clinical manifestations of COVID-19 infection in individuals taking Bromhexine hydrochloride 4 weeks after randomization.

Measure: Polymerase chain reaction (PCR)

Time: 4 weeks after randomization

Secondary Outcomes

Description: Time to clinical symptoms of a respiratory infection with positive PCR SARS-CoV-2

Measure: Time to symptoms

Time: 14 days after last contact

Description: Time to detect positive SARS-CoV-2 PCR

Measure: Time to positive PCR

Time: 14 days after last contact

Description: The number of asymptomatic cases of SARS-CoV-2 infection

Measure: Number of cases

Time: 14 days after last contact

Description: The number of mild, moderate and severe forms of the disease COVID-19 with Bromhexine hydrochloride

Measure: Case severity

Time: 14 days after last contact

Description: Evaluation of adverse events

Measure: Drug tolerance

Time: 14 days after last contact

96 Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection

Observational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

NCT04407143 Lung Cancer COVID Corona Virus Infection Diagnostic Test: IgG test
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Neoplasms
HPO:Neoplasm of the lung

Primary Outcomes

Description: Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.

Measure: Description of the characteristics of patients

Time: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks

97 Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection in Healthcare Personnel

This clinical trial will evaluate the safety, tolerability and effectiveness of topical GLS-1200 nasal spray to reduce the incidence of confirmed, symptomatic SARS-CoV-2 infection.

NCT04408183 SARS-CoV 2 Infection Drug: GLS-1200 Drug: Placebo
MeSH:Infection Communicable Diseases

Primary Outcomes

Measure: Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0

Time: 4 weeks of treatment

Measure: Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group

Time: 4 weeks of treatment

Secondary Outcomes

Measure: Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.

Time: 4 weeks of treatment

98 Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

NCT04412395 Corona Virus Infection Middle East Respiratory Syndrome (MERS) Acute Respiratory Distress Syndrome Coronavirus Infection COVID-19 SARS-CoV 2 Dietary Supplement: Lactoferrin (Apolactoferrin) Drug: Placebo of excipient(s) will be administered
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respira Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Comparing the influence of the intervention on the Survival rate.

Measure: Survival rate.

Time: up to 8 weeks.

Description: For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients.

Measure: Rate of disease remission.

Time: up to 4 weeks.

Description: Comparing the influence of the intervention on the PCR negative results.

Measure: The number of patients with PCR negative results.

Time: up to 4 weeks.

Secondary Outcomes

Description: Recording the changes from severe to moderate or mild and the time taken.

Measure: Mean change in the disease severity (clinical assessment).

Time: up to 4 weeks.

Description: Recording the changes in blood pressure mmHg.

Measure: Mean change in blood pressure.

Time: up to 4 weeks.

Description: Recording the changes in heart rate in beat/second.

Measure: Mean change in heart beats.

Time: up to 4 weeks.

Description: Recording the changes in body temperature in Celsius.

Measure: Mean change in body temperature.

Time: up to 4 weeks.

Description: Recording the changes in the respiratory rate in breath/minute.

Measure: Mean change in body respiratory rate.

Time: up to 4 weeks.

Description: Recording the changes in arterial oxygen saturation in mmHg.

Measure: Mean change in oxygen saturation.

Time: up to 4 weeks.

Description: Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Measure: Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).

Time: up to 4 weeks.

Description: Recording the changes in complete blood picture (CBC) in cells per liter.

Measure: Mean change in complete blood picture (CBC).

Time: up to 4 weeks.

Description: Recording the changes in C reactive protein (CRP) in mg/L.

Measure: Mean change in C reactive protein (CRP).

Time: up to 4 weeks.

Description: Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr.

Measure: Mean change in erythrocyte sedimentation rate (ESR).

Time: up to 4 weeks.

Description: Recording the changes in D-dimer in ng/mL.

Measure: Mean change in D-dimer.

Time: up to 4 weeks.

Description: Recording the changes in ferritin in ng/mL.

Measure: Mean change in ferritin.

Time: up to 4 weeks.

Description: Recording the changes in liver Albumin in g/L.

Measure: Mean change in liver Albumin.

Time: up to 4 weeks.

Description: Recording the changes in total and direct Bilirubin in mg/dL.

Measure: Mean change in total and direct Bilirubin.

Time: up to 4 weeks.

Description: Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR).

Measure: Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).

Time: up to 4 weeks.

Description: Recording the changes in aspartate aminotransferase (AST) in IU/L.

Measure: Mean change in aspartate aminotransferase (AST).

Time: up to 4 weeks.

Description: Recording the changes in Alanine Aminotransferase (ALT) in IU/L.

Measure: Mean change in Alanine Aminotransferase (ALT).

Time: up to 4 weeks.

Description: Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL.

Measure: Mean change in Blood Urea Nitrogen (BUN).

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in mg/dL.

Measure: Mean change in Serum Creatinine.

Time: up to 4 weeks.

Description: Recording the changes in Serum Creatinine in ml/min.

Measure: Mean change in Serum Creatinine clearance.

Time: up to 4 weeks.

Description: Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2.

Measure: Mean change in Glomerular filtration rate (GFR ).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-1 (IL-1) in pg/ml.

Measure: The mean change in serum interleukin-1 (IL-1).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-6 (IL-6) in pg/ml.

Measure: The mean change in serum interleukin-6 (IL-6).

Time: up to 4 weeks.

Description: Recording the changes in interleukin-10 (IL-10) in pg/ml.

Measure: The mean change in serum interleukin-10 (IL-10).

Time: up to 4 weeks.

Description: Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml.

Measure: The mean change in serum tumor necrosis factor-alpha (TNF alpha).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin G (IgG) in ng/ml.

Measure: Mean changes in immunoglobulin G (IgG).

Time: up to 4 weeks.

Description: Recording the changes in immunoglobulin M (IgM) in ng/ml.

Measure: Mean changes in immunoglobulin M (IgM).

Time: up to 4 weeks.

Description: Recording the changes in PCR viral load in copies/mL.

Measure: The mean change in PCR viral load.

Time: up to 4 weeks.

Description: Recording the changes in lung CT.

Measure: Mean change in lung CT manifestation.

Time: up to 4 weeks.

Description: Recording any unexpected Adverse Events of the intervention.

Measure: Nature and severity of Adverse Events.

Time: up to 4 weeks.

Description: Recording the changes (the average time of lung imaging recovery), as assessed by lung CT.

Measure: Time for lung recovery.

Time: up to 8 weeks.

Description: Recording the changes the event of missed drug doses.

Measure: The number of missed drug doses among each treatment group.

Time: up to 4 weeks.

99 Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

This 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.

NCT04412551 Corona Virus Infection Virus Diseases Coronaviridae Infections
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections Virus Diseases

Primary Outcomes

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 weeks

Secondary Outcomes

Description: 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 weeks

Description: Descriptive assessment of clinical parameters and LUS-score over time

Measure: Association of LUS to clinical parameters

Time: 3 weeks

Description: 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 weeks

100 Study of the Efficiency and Security of NIVOLUMAB Therapy, Used in Immuno-stimulation, in Hospitalized Obese Individuals at Risk to Evolve Towards Severe Forms of COVID-19 Infection. Multicentric, Paralleled, Randomized, Controlled Trial

Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

NCT04413838 Obesity, COVID-19 Infection Drug: NIVOLUMAB Other: Routine standard of care
MeSH:Infection Communicable Diseases

Primary Outcomes

Description: Patient's clinical state will be evaluated by the proportion of patients able to be weaned of oxygen at D15 after randomization (randomization date is the day where the experimental treatment (i.e. NIVOLUMAB) is administered).

Measure: Patient's clinical state

Time: 15 days after randomization

Secondary Outcomes

Description: Proportion of in-coming patients in ICU at D7 and D15 post-randomization

Measure: Readmission

Time: 7 days and 15 days after randomization

Description: Proportion of death at D7 and D15 post-randomization

Measure: Mortality

Time: 7 days and 15 days after randomization

Description: Proportion of patients weaned out of oxygen at D7 post-randomization

Measure: Oxygen flow needs

Time: 7 days after randomization

Description: Mean oxygen flow needed

Measure: Requirement of oxygen

Time: 7 days and 15 days after randomization

Description: Proportion of out-coming patients from hospitalization at D7 and D15 post-randomization

Measure: Discharge from hospital

Time: 7 days and 15 days after randomization

Description: Report of all adverse events linked or not to experimental treatment during the study

Measure: Adverse events

Time: Within 15 days post-randomization and 90 days and 6 months after randomization

Description: Presence or not of nasopharyngeal SARS-CoV-2 determined by PCR response

Measure: Presence of nasopharyngeal SARS-CoV-2

Time: On day 0 before randomization and 15 days after randomization

Description: Presence or not of nasopharyngeal SARS-CoV-2 Quantified by PCR

Measure: nasopharyngeal SARS-CoV-2 viral charge

Time: On day 0 before randomization and 15 days after randomization

Description: Number of total LT (using immuno-phenotyping) will explore the immune response

Measure: Number of total Lymphocytes T

Time: On day 0 before randomization and 15 days after randomization

Description: Number of CD3+ LT (using immuno-phenotyping) will explore the immune response

Measure: Number of CD3+ Lymphocytes T(lymphocyte subpopulation of CD3+ T cells)

Time: On day 0 before randomization and 15 days after randomization

Description: Number of total CD4+ LT (using immuno-phenotyping) will explore the immune response

Measure: Number of CD4+ Lymphocytes T(lymphocyte subpopulation of CD4+ T cells)

Time: On day 0 before randomization and 15 days after randomization

Description: Evaluation of number of CD8+ LT (using immuno-phenotyping) will explore the immune response

Measure: Number of CD8+ Lymphocytes T(lymphocyte subpopulation of CD8+ T cells)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of IL-6 will explore the inflammatory response

Measure: Interleukin 6 (IL-6)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of IL-10 will explore the inflammatory response

Measure: Interleukin 10 (IL-10)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of TNFα will explore the inflammatory response

Measure: Tumor Necrosis Factor alpha (TNFα )

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of IFNγ will explore the inflammatory response

Measure: Interferon gamma (IFNγ)

Time: On day 0 before randomization and 15 days after randomization

Description: Systemic concentration measurement of type I IFN will explore the inflammatory response

Measure: Type I Interferon (type I IFN)

Time: On day 0 before randomization and 15 days after randomization

Description: Evaluation of Tim3 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19

Measure: Tim3 expression

Time: On day 0 before randomization and 15 days after randomization

Description: Evaluation of PD1 expression on CD4+ and CD8+ lymphocytes will explore the fundamental research on obesity and COVID-19

Measure: PD1 expression

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of PD-L1 expression on monocytes will explore explore the fundamental research on obesity and COVID-19

Measure: PD-L1 expression

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of HLA-DR expression on monocytes will explore explore the fundamental research on obesity and COVID-19

Measure: Human Leukocyte Antigen - DR isotype gene expression (HLA-DR expression)

Time: On day 0 before randomization and 15 days after randomization

Description: The cytotoxic LT production of IFNγ will explore the fundamental research on obesity and COVID-19

Measure: Production of IFNγ by lymphocytes T

Time: On day 0 before randomization and 15 days after randomization

Description: The cytotoxic LT production of granzyme B will explore the fundamental research on obesity and COVID-19

Measure: Production of granzyme B by lymphocytesT

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of LPS will explore the endotoxemia and perform fundamental research on obesity and COVID-19

Measure: Lipopolysaccharides (LPS)

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of LBP (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19

Measure: LBP(LPS-Binding Protein)

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of sCD14 (endotoxin transporter) will explore the endotoxemia and perform fundamental research on obesity and COVID-19

Measure: sCD14

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of High Density Lipoproteins proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19

Measure: High Density Lipoproteins

Time: On day 0 before randomization and 15 days after randomization

Description: Measurement of apolipoprotein proteomic will explore the lipoprotein metabolism and perform fundamental research on obesity and COVID-19

Measure: Apolipoprotein

Time: On day 0 before randomization and 15 days after randomization

101 Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).

The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

NCT04414631 Coronavirus Infections Drug: Conestat alfa
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.

Measure: Disease severity

Time: on day 7

Secondary Outcomes

Description: Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)

Measure: Time to clinical improvement

Time: within 14 days after enrolment

Description: Proportion of participants alive and not having required invasive or non-invasive ventilation

Measure: Proportion of participants alive and not having required invasive or non-invasive ventilation

Time: at 14 days after enrolment

Description: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Measure: Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Time: within 14 days after enrolment

Other Outcomes

Description: Changes in the ordinal WHO scale

Measure: Changes in the ordinal WHO scale

Time: from baseline over 14 days

Description: Length of hospital stay in survivors

Measure: Length of hospital stay in survivors

Time: until day 28

Description: Proportion of participants progressing to mechanical ventilation

Measure: Proportion of participants progressing to mechanical ventilation

Time: on day 7 and day 14

Description: Proportion of participants requiring ICU treatment

Measure: Proportion of participants requiring ICU treatment

Time: on day 7 and 14

Description: Length of ICU stay

Measure: Length of ICU stay

Time: until day 28

Description: 28 Ventilator-free days

Measure: 28 Ventilator-free days

Time: until day 28

Description: All-cause mortality

Measure: All-cause mortality

Time: time from randomisation to death within four weeks

Description: Changes in biomarker level CRP

Measure: Changes in biomarker level CRP (mg/l)

Time: until day 14

Description: Changes in biomarker level LDH

Measure: Changes in biomarker level LDH (U/l)

Time: until day 14

Description: Changes in biomarker level D-Dimer

Measure: Changes in biomarker level D- Dimer (yg/ml)

Time: until day 14

Description: Changes in biomarker level Ferritin

Measure: Changes in biomarker level Ferritin (ng/ml)

Time: until day 14

Description: Changes in biomarker level IL-6

Measure: Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml)

Time: until day 14

Description: Changes in lymphocyte count

Measure: Changes in lymphocyte count (cells per microliter of blood)

Time: until day 14

Description: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Measure: Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Time: time from enrolment to first of 2 negative assays at least 12 hours apart

Description: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Measure: Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Time: within 14 days

Description: Time to defervescence (temperature <38.0°C)

Measure: Time to defervescence (temperature <38.0°C)

Time: sustained for at least 48 hours

Description: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)

Measure: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28

Time: until day 28

Description: Duration of supplemental oxygen

Measure: Duration of supplemental oxygen

Time: until day 28

Description: Peak serum concentration of conestat alfa will be measured

Measure: Change in pharmacokinetics of conestat alfa

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date

Description: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

Measure: Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date

102 COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

NCT04416373 Coronavirus Infection Pregnancy Complications Vertical Transmission of Infectious Disease Breastfeeding Neonatal Infection Diagnostic Test: RT PCR SARS-CoV-2
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Pregnancy Complications

Primary Outcomes

Description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples

Measure: SARS-CoV-2 Neonatal Infection

Time: 7 days

Secondary Outcomes

Description: stillbirths and deaths in the first week of life

Measure: Perinatal mortality

Time: 35 weeks

Description: maternal ICU admission due to COVID-19

Measure: ICU maternal admission

Time: 35 weeks

Description: Newborn 5 minute Apgar Score < 7

Measure: 5 minute Apgar Score < 7

Time: 1 day

Description: Delivery between 24 and 36 weeks

Measure: Preterm labour

Time: 35 weeks

Description: Preterm premature rupture of the membranes between 24 and 36 weeks

Measure: PPROM

Time: 35 weeks

Description: spontaneous pregnancy loss before 24 weeks

Measure: Miscarriage

Time: 14 weeks


HPO Nodes