Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug1086	Hydroxychloroquine Wiki	0.22
drug947	Fixed Anchoring Strategy Wiki	0.19
drug131	Aerosol-reducing Mask Wiki	0.19
drug265	Azithromycin 250 MG Oral Capsule Wiki	0.19
drug1110	Hydroxychloroquine Sulfate 400 mg twice a day Wiki	0.19
drug1885	Povidone-Iodine 0.5% Wiki	0.19
drug1784	Peginterferon Lambda-1a Wiki	0.19
drug1463	Melatonin 2mg Wiki	0.19
drug1512	Monitoring Visit - Baseline Wiki	0.19
drug1514	Monitoring Visit - Week 8 Wiki	0.19
drug1095	Hydroxychloroquine - Daily Dosing Wiki	0.19
drug2289	Spironolactone 100mg Wiki	0.19
drug1628	Non-Anchoring Strategy Control Wiki	0.19
drug953	Flow cytometry Wiki	0.19
drug1868	Plasma from a volunteer donor Wiki	0.19
drug628	Conestat alfa Wiki	0.19
drug1799	Personal protective equipment Wiki	0.19
drug1025	HCQ & AZ vs HCQ+SIR Wiki	0.19
drug2624	Valsartan (Diovan) Wiki	0.19
drug2077	ResCure™ Wiki	0.19
drug1513	Monitoring Visit - Week 4 Wiki	0.19
drug2088	Retrospective data collection Wiki	0.19
drug2653	Virtual Group Intervention Wiki	0.19
drug1524	Mucodentol Wiki	0.19
drug1111	Hydroxychloroquine Sulfate 600 mg once a day Wiki	0.19
drug2548	Tranexamic acid tablets Wiki	0.19
drug1112	Hydroxychloroquine Sulfate 600 mg twice a day Wiki	0.19
drug2304	Standard Mask Wiki	0.19
drug2494	The standard of care Wiki	0.19
drug2889	metenkefalin + tridecactide Wiki	0.19
drug1265	Isotonic saline 0.9% Wiki	0.19
drug2790	conventional management of patients Wiki	0.19
drug1797	Personal Exercise Intervention Wiki	0.19
drug1101	Hydroxychloroquine Pre-Exposure Prophylaxis Wiki	0.19
drug775	Dipyridamole 100 Milligram(mg) Wiki	0.19
drug2690	Weekly Assessment Wiki	0.19
drug1540	N-Acetyl cysteine Wiki	0.19
drug1527	MultiStem Wiki	0.19
drug561	Chloroquine Diphosphate Wiki	0.19
drug2844	hydroxychloroquine sulfate 200 MG Wiki	0.19
drug1886	Povidone-Iodine 2% Wiki	0.19
drug1118	Hydroxychloroquine and azithromycin treatment Wiki	0.19
drug1801	Personalized Anchoring Strategy Wiki	0.19
drug1097	Hydroxychloroquine - Weekly Dosing Wiki	0.13
drug2665	Vitamin Super B-Complex Wiki	0.13
drug2357	Stellate Ganglion Block Wiki	0.13
drug1178	Imatinib Wiki	0.13
drug24	200 mg EIDD-2801 Wiki	0.13
drug601	Colchicine Wiki	0.13
drug2134	SARS-CoV-2 convalescent plasma Wiki	0.11
drug1108	Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki	0.11
drug1852	Placebo oral capsule Wiki	0.11
drug1087	Hydroxychloroquine (HCQ) Wiki	0.09
drug142	Alirocumab Wiki	0.09
drug876	Evolocumab Wiki	0.09
drug1399	Lung ultrasound Wiki	0.08
drug512	Camostat Mesilate Wiki	0.08
drug560	Chloroquine Wiki	0.07
drug1598	Nitazoxanide Wiki	0.07
drug1822	Placebo Wiki	0.06
drug262	Azithromycin Wiki	0.06
drug2116	Ruxolitinib Wiki	0.06

Correlated MeSH Terms (19)

	Name (Synonyms)	Correlation
D003141	Communicable Diseases NIH	0.18
D045169	Severe Acute Respiratory Syndrome NIH	0.16
D007239	Infection NIH	0.15
D018352	Coronavirus Infections NIH	0.14
D045888	Ganglion Cysts NIH	0.13
D012213	Rheumatic Fever NIH	0.13
D001327	Autoimmune Diseases NIH	0.11
D003095	Collagen Diseases NIH	0.09
D012216	Rheumatic Diseases NIH	0.08
D019337	Hematologic Neoplasms NIH	0.07
D013577	Syndrome NIH	0.06
D055371	Acute Lung Injury NIH	0.06
D012127	Respiratory Distress Syndrome, Newborn NIH	0.05
D012128	Respiratory Distress Syndrome, Adult NIH	0.05
D009369	Neoplasms, NIH	0.04
D007249	Inflammation NIH	0.04
D004630	Emergencies NIH	0.04
D014777	Virus Diseases NIH	0.02
D011014	Pneumonia NIH	0.02

Correlated HPO Terms (4)

	Name (Synonyms)	Correlation
HP:0002960	Autoimmunity HPO	0.11
HP:0001909	Leukemia HPO	0.05
HP:0002664	Neoplasm HPO	0.04
HP:0002090	Pneumonia HPO	0.02

There are 29 clinical trials

Clinical Trials

1 Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

NCT04315896 COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: incidence of all-cause mortality

Measure: All-cause hospital mortality

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Secondary Outcomes

Description: Days from ER admission to hospital discharge

Measure: Length of hospital stay

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: need of invasive or non invasive mechanical ventilation

Measure: Need of mechanical ventilation

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization

Measure: Ventilator free days

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

Description: Adverse Reactions

Measure: Grade 3-4 adverse reaction

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days

2 Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

NCT04318015 COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Corona Coronavirus Infections

Primary Outcomes

Description: Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.

Measure: Symptomatic COVID-19 infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Secondary Outcomes

Description: Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.

Measure: Symptomatic non-COVID viral infection rate

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

Description: Number of days absent from labor due to COVID-19 symptomatic infection

Measure: Days of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Absenteeism from labor rate due to COVID-19 symptomatic infection

Measure: Rate of labor absenteeism

Time: From date of randomization until study completion 60 days after treatment start

Description: Rate of severe respiratory COVID-19 disease in healthcare personnel

Measure: Rate of severe respiratory COVID-19 disease in healthcare personnel

Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start

3 Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial

The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.

NCT04318444 COVID-19 Corona Virus Infection Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.

Measure: Number of participants with symptomatic, lab-confirmed COVID-19.

Time: Date of enrollment to 14 days post-enrollment date

4 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

5 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

6 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

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

7 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

NCT04322682 Corona Virus Infection Drug: Colchicine Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.

Measure: Number of participants who die or require hospitalization due to COVID-19 infection

Time: 30 days post randomization

Secondary Outcomes

Description: The secondary endpoint is the occurrence of death in the 30 days following randomization.

Measure: Number of participants who die

Time: 30 days post randomization

Description: The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.

Measure: Number of participants requiring hospitalization due to COVID-19 infection

Time: 30 days post randomization

Description: The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.

Measure: Number of participants requiring mechanical ventilation

Time: 30 days post randomization

8 The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)

The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.

NCT04329923 COVID-19 Drug: Hydroxychloroquine Sulfate 400 mg twice a day Drug: Hydroxychloroquine Sulfate 600 mg twice a day Drug: Hydroxychloroquine Sulfate 600 mg once a day Drug: Placebo oral tablet

Primary Outcomes

Description: Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 days have elapsed since the beginning of symptom onset.

Measure: Median release from quarantine time

Time: 14 days or less

Description: Cohort 2 (hospitalized COVID-19 patients): Rate of participants discharged at or before 14 days

Measure: Rate of hospital discharge

Time: 14 days

Description: Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months

Measure: Rate of infection

Time: 2 months

Secondary Outcomes

Description: Cohort 1 rate of participant-reported secondary infection of housemates

Measure: Rate of housemate infection

Time: 14 days

Description: Cohort 1 rate of hospitalization

Measure: Rate of hospitalization

Time: 14 days

Description: Cohort 1 rate of treatment related adverse events

Measure: Cohort 1 adverse event rate

Time: 14 days

Description: Cohort 2 Time to condition appropriate for discharge. The primary care team indicates the patients has improved to the point of being discharged.

Measure: Time to condition appropriate for discharge

Time: 14 days

Description: Cohort 2 rate of ICU admission from a floor bed in the hospital

Measure: Rate of ICU admission

Time: 14 days

Description: Cohort 2 the number of days between hospital admission and a negative PCR test for SARS-CoV-2.

Measure: Time to PCR negativity

Time: 14 days

Description: Cohort 2 rate of treatment related adverse events

Measure: Cohort 2 adverse events

Time: 14 days

Description: Cohort 3 number of scheduled shifts at the hospital that are missed.

Measure: Scheduled shifts missed

Time: 2 months

Description: Cohort 3 rate of treatment related adverse events

Measure: Cohort 3 adverse events

Time: 2 months

9 Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)

This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.

NCT04334148 COVID-19 Drug: Hydroxychloroquine Drug: Placebo oral tablet

Primary Outcomes

Description: Number of participants with clinical infection with COVID-19 infection(hydroxychloroquine vs placebo)

Measure: Number of participants with clinical infection with COVID-19 infection

Time: 30 days

Secondary Outcomes

Description: Number of participants with COVID-19 infection shedding (hydroxychloroquine vs placebo)

Measure: Number of participants with COVID-19 viral shedding

Time: 30 days

Description: Safety as measured by number of adverse events (hydroxychloroquine vs placebo)

Measure: Safety as measured by number of adverse events

Time: 30 days

10 PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease

Rationale: The current SARS-CoV-2 pandemic has a high burden of morbidity and mortality due to development of the so-called acute respiratory distress syndrome (ARDS). The renin-angiotensin-system (RAS) plays an important role in the development of ARDS. ACE2 is one of the enzymes involved in the RAS cascade. Virus spike protein binds to ACE2 to form a complex suitable for cellular internalization. The downregulation of ACE2 results in the excessive accumulation of angiotensin II, and it has been demonstrated that the stimulation of the angiotensin II type 1a receptor (AT1R) increases pulmonary vascular permeability, explaining the increased lung pathology when activity of ACE2 is decreased. Currently available AT1R blockers (ARBs) such as valsartan, have the potential to block this pathological process mediated by angiotensin II. There are presently two complementary mechanisms suggested: 1) ARBs block the excessive angiotensin-mediated AT1R activation, and 2) they upregulate ACE2, which reduces angiotensin II concentrations and increases the production of the protective vasodilator angiotensin 1-7. In light of the above, ARBs may prevent the development of ARDS and avert morbidity (admission to intensive care unit (ICU) and mechanical ventilation) and mortality. Objective: To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Death. Study design: A double-blind, placebo-controlled 1:1 randomized clinical trial Study population: Adult hospitalized SARS-CoV-2-infected patients (n=651). Intervention: The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160mg b.i.d. and the placebo arm will receive a matching placebo also titrated to blood pressure. Treatment duration will be 14 days or up to hospital discharge < 14 days or occurrence of the primary endpoint if < 14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death.

NCT04335786 Acute Respiratory Distress Syndrome SARS-CoV-2 COVID COVID-19 Severe Acute Respiratory Syndrome Drug: Valsartan (Diovan) Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Death is defined as all-cause mortality

Measure: first occurrence of intensive care unit admission, mechanical ventilation or death

Time: within 14 days

Secondary Outcomes

Description: All-cause mortality; and time to all-cause mortality

Measure: Death

Time: Within 14 days, 30 days, 90 days and at 1 year

Description: Occurrence of mechanical ventilation and time to ventilation

Measure: Mechanical ventilation

Time: within 14 days

Description: Occurrence of ICU admission and time to admission

Measure: Intensive care unit admission

Time: within 14 days

Description: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2

Measure: Occurrence of acute kidney injury

Time: Within 14 days

11 Exploratory Studies of the Effect of Tranexamic Acid Treatment on the Progression of COVID19 in Outpatients

A controlled trial of the drug tranexamic acid (TXA) in outpatients who were recently diagnosed with COVID-19. It is hypothesized that TXA will reduce the infectivity and virulence of the virus.

NCT04338074 COVID-19 Drug: Tranexamic acid tablets Drug: Placebo oral tablet

Primary Outcomes

Description: Admission to hospital for COVID-19 treatment

Measure: Hospitalization

Time: Randomization to 7 days after randomization

12 Will Hydroxychloroquine Impede or Prevent COVID-19: WHIP COVID-19 Study

This is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Southeast Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.

NCT04341441 COVID-19 Coronavirus Coronavirus Infections SARS-CoV 2 Drug: Hydroxychloroquine - Daily Dosing Drug: Hydroxychloroquine - Weekly Dosing Other: Placebo oral tablet Diagnostic Test: Monitoring Visit - Baseline Diagnostic Test: Monitoring Visit - Week 4 Diagnostic Test: Monitoring Visit - Week 8 Other: Weekly Assessment

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: We will measure the difference in new cases of COVID-19 disease between randomized treatment arms. Plan statistical analyses will include the assumption that up 10% of HCW at risk will become infected if no prophylactic treatment is provided. Therefore we expect that HCQ treatment arm will provide a reduction in the number of SARS-CoV 2 infections by 30%, with an expected study retention rate of 90%, a sample size of ~1500 participants per group, will have an 80% power to detect the difference at p=0.05.

Measure: To determine if the use of hydroxychloroquine as preventive therapy decreases the rate of acquisition of SARS-CoV 2 infections and clinical COVID-19 disease in Study Participants for each randomized treatment arm as compared to placebo.

Time: 8 Weeks

Secondary Outcomes

Description: Compare the rates of SARS-CoV 2 infections between the randomized treatment arms and the control arms to determine the effect of HCQ dose in the prevention of COVID-19 viremia and disease as determined by study visits, weekly questionnaires, and blood samples.

Measure: Determine the effect of hydroxychloroquine dose in the prevention of COVID-19 viremia and disease.

Time: 8 Weeks

Description: Comparison of the rates of SARS-CoV 2 infections in the non-randomized comparator arm to the randomized groups to assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention via weekly questionnaire and/or blood samples.

Measure: Assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention.

Time: 8 Weeks

Description: Measurement of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo via blood samples.

Measure: Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo.

Time: 8 Weeks

Description: Measurement of the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo via blood samples.

Measure: Compare the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo.

Time: 8 Weeks

Description: Measurement of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm and via weekly questionnaire and/or blood samples.

Measure: Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm.

Time: 8 Weeks

Description: Review of the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care via weekly questionnaire.

Measure: To examine the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care.

Time: 8 Weeks

Description: Measurement of the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events reported via weekly questionnaire.

Measure: Determine the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events.

Time: 8 Weeks

Description: Examination of other clinical determinants contributing to the risk of SARS-CoV 2 infection including demographics, work type and location, positive COVID-19 partners, possible exposures and clinical symptoms via study visits and weekly questionnaire.

Measure: To examine other clinical determinants contributing to the risk of SARS-CoV 2 infection in healthcare workers and first responders.

Time: 8 Weeks

Description: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results via weekly questionnaire and/or blood samples.

Measure: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results.

Time: 8 Weeks

Description: Identification of immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease via study visits, weekly questionnaire, and blood samples.

Measure: identify immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease.

Time: 8 weeks

13 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

14 Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial

This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).

NCT04342650 COVID-19 SARS-CoV Infection Severe Acute Respiratory Syndrome (SARS) Pneumonia Clinical Trial Drug: Chloroquine Diphosphate Drug: Placebo oral tablet

MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome

HPO:Pneumonia

Primary Outcomes

Description: Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.

Measure: Proportion of patients with onset of severe acute respiratory syndrome (SARS)

Time: 7 days after randomization

Secondary Outcomes

Description: Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization

Measure: Mortality rate

Time: after randomization, up to 28 days

Description: Proportion of participants in need and duration of intensive care support after randomization

Measure: Number of participants in need of intensive care support

Time: during and after intervention, up to 28 days

Description: Viral load change in blood and oropharyngeal swab samples

Measure: Viral concentration

Time: After randomization, up to 7 days

Description: Incidence of serious adverse events during and after treatment

Measure: Cumulative incidence of serious adverse events

Time: During and after intervention, up to 28 days

Description: Incidence of grade 3 and 4 adverse events during and after treatment

Measure: Cumulative incidence of grade 3 and 4 adverse events

Time: During and after intervention, up to 28 days

Description: proportion of discontinuation or temporary suspension of treatment (for any reason)

Measure: Proportion of patients with discontinued treatment

Time: after randomization, up to 28 days

Description: proportion of patients with increased levels of troponin I

Measure: Incidence of cardiac lesions

Time: after randomization, up to 120 days

Description: proportion and magnitude of QTcF interval increases higher than 500ms

Measure: Incidence of cardiac disfunctions

Time: after randomization, up to 120 days

Description: Changes measured on day 120 will be compared to baseline, through spirometry.

Measure: Change in respiratory capacity

Time: Day 120 after randomization

15 The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients

This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.

NCT04345887 Respiratory Distress Syndrome, Adult Drug: Spironolactone 100mg Drug: Placebo oral tablet

MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: improvement in oxygenation

Measure: p/f ratio

Time: 5 days

Secondary Outcomes

Description: improvement in SOFA Score

Measure: SOFA

Time: 5 days

16 Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to SARS-Cov-2

This is a PILOT STUDY, a Phase III double-blind, randomized, placebo-controlled clinical study in which we assess the clinical effect of the prophylactic administration of hydroxychloroquine vs. placebo to healthcare workers working at our University Hospital (HUN). Participants in each arm (n = 43) will be administered with a unique loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days. The population to be studied (uninfected healthcare personnel) will be highly exposed to SARS-CoV-2 infection. An active search should be made for individuals who become infected while participating in the study, hence, once the informed consent form is signed, the molecular test for the diagnosis of SARS-CoV-2 infection by RT-PCR will be carried out every 4 days in order to determine as closely as possible the moment the participant becomes positive. The results of the diagnostic RT-qPCR tests will be confronted with: (i) the results of immune monitoring of at least 30 immunological parameters in leukocytes and in plasma (levels of selected cytokines and chemokines analyzed by automated flow cytometry software and (ii) the daily recording of data for the presence or absence of signs and symptoms associated with SARS-Cov-2 infection. For the recording of immune monitoring 20mL blood samples will be taken at eight-time points throughout the 90 days of the stud.

NCT04346329 COVID Drug: Hydroxychloroquine Drug: Placebo oral tablet

Primary Outcomes

Description: Number of participants with treatment-related adverse events as associated administration of hydroxychloroquine or placebo.

Measure: Adverse effects

Time: six months after administration of hydroxychloroquine or placebo

Secondary Outcomes

Description: Percentage of expression of immune senescence in cells of the immune system of individuals highly exposed to COVID-19 who receive hydroxychloroquine prophylactically vs. placebo.

Measure: Immune-score

Time: six months after administration of hydroxychloroquine or placebo

Description: Correlate the immunological profile of highly exposed individuals with SARS-CoV-2 with the clinic of COVID-19.

Measure: COVID-19 prevention

Time: six months after administration of hydroxychloroquine or placebo

Description: Determine the clinical outcome in observation timeframe of highly exposed personnel when receiving hydroxychloroquine vs. placebo prophylactically.

Measure: Clinical response

Time: six months after administration of hydroxychloroquine or placebo

17 Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study

Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study

NCT04349228 COVID19 Sars-CoV2 Hydroxychloroquine Prophylaxis Healthcare Worker Drug: Hydroxychloroquine (HCQ) Drug: Placebo oral tablet

Primary Outcomes

Description: Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: Cough Dyspnea Fever Myalgia Arthralgia Rhinorrhea Anosmia Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. Biological Examination : Measurement of viral load Ion, liver, kidney, haematological assessment Electrical Examination: ECG

Measure: Symptomatic COVID(+) infection rate

Time: 60 days

18 Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID

The primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status.

NCT04349371 COVID Drug: Chloroquine Drug: Placebo oral tablet

Primary Outcomes

Description: Symptomatic illness is defined as COVID infection guidelines and confirmed with anti-COVID antibodies that will be done on serum collect at the final visit. Symptoms include fever, chills, muscle pain, cough, shortness of breath, and diarrhea.

Measure: Number of symptomatic illness in at risk healthcare workers

Time: Up to 3 months

Description: Diagnosis is based on symptoms of COVID-19 and confirmatory anti-COVID antibodies and when available, COVID-19 PCR.

Measure: Number of healthcare workers with symptomatic COVID infections

Time: Up to 3 months

Description: Severe illness includes worsening of symptoms.

Measure: Number of severe illness in at risk healthcare workers

Time: Up to 3 months

Secondary Outcomes

Description: Confirmation with polymerase chain reaction (PCR) when available.

Measure: Number of sero-conversions in at risk healthcare workers

Time: Up to 3 months

Description: Adverse events that are NCI-CTCAE Grade 3 or higher will be counted.

Measure: Percentage of patients with adverse events Grade 3 or higher

Time: Up to 3 months

Description: GI intolerance to chloroquine will be documented and recorded.

Measure: Percentage of patients with GI intolerance

Time: Up to 3 months

19 Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial

This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).

NCT04352946 Prophylaxis COVID-19 Health Care Worker Hydroxychloroquine Drug: Hydroxychloroquine Pre-Exposure Prophylaxis Drug: Placebo oral tablet

Primary Outcomes

Description: Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers

Measure: Cumulative Incidence of COVID-19 Infection

Time: 90 days

Secondary Outcomes

Description: Incidence of reported and grade of adverse events

Measure: Adverse events incidence

Time: 90 days

Description: Duration in days of symptomatic COVID-19 disease in HCW who had disease

Measure: Duration of symptomatic COVID-19 disease

Time: 90 days

Description: Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease

Measure: Days hospitalized attributed to COVID-19

Time: 90 days

Description: Number of HCW with respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation in HCW who developed disease

Measure: Number or respiratory failure attributable to COVID-19 disease

Time: 90 days

Description: Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease

Measure: Mortality Incidence

Time: 90 days

Description: Number of days unable to work attributed to COVID-19 in HCW who developed disease

Measure: Days of work lost

Time: 90 days

Other Outcomes

Description: Proportion of participants with plasma able to neutralize SARS-CoV-2 virus (plaque reduction neutralization test) in vitro.

Measure: Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus

Time: 90 days

Description: Number of participants with severity markers of host immune and endothelial activation measured at clinical presentation and their ability to predict severity and outcome.

Measure: Number of participants with severity markers of host immune and endothelial activation

Time: 90 days

20 Multicenter Randomized Controlled Trial of the Efficacy of Melatonin in the Prophylaxis of SARS-coronavirus-2 Infection Among High Risk Contacts.

There is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.

NCT04353128 Covid19 SARS-CoV 2 Coronavirus Infection Drug: Melatonin 2mg Drug: Placebo oral tablet

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of confirmed (positive CRP) symptomatic infections in each treatment group

Measure: SARS-CoV 2 infection rate

Time: up to 12 weeks

21 Randomized Trial Evaluating Effect of Outpatient Hydroxychloroquine on Reducing Hospital Admissions in Pregnant Women With SARS-CoV-2 Infection: HyPreC Trial

COVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.

NCT04354441 COVID-19 SARS-CoV-2 Pregnant Women Hydroxychloroquine Drug: hydroxychloroquine sulfate 200 MG Drug: Placebo oral tablet

Primary Outcomes

Description: COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.

Measure: COVID-19-related hospital admissions

Time: Hospital Admission at any point from study enrollment to delivery

Secondary Outcomes

Description: Measurement of reported symptoms using a validated questionnaire on Day 3, 7, 10, and every 2 weeks. The FLU-PRO Questionnaire instructs respondents to rate the severity of 37 influenza symptoms over the past 24 hours, including those related to the nose, throat, eye, chest, head, stomach, fatigue, and body aches/pains. For 32 of 37 items, respondents rated the severity of each symptom on 5-point Likert-type scales from 0 ("Not at all), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), to 4 ("Very much"). For the five remaining items, severity is expressed as frequency of occurrence: vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times), and sneezing, coughing, and coughed up mucus or phlegm on a scale from 0 ("Never") to 4 ("Always"), with higher scores indicating more severe symptoms.

Measure: Symptoms related to COVID-19 infection

Time: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery

Description: Side effects related to hydroxychloqoruine

Measure: Adverse Events

Time: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to delivery

Description: Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)

Measure: Maternal outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

Description: If had cesarean delivery, indication for cesarean section

Measure: Maternal outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

Description: Miscarriage or stillbirth (Yes/No)

Measure: Maternal outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

Description: Labor induction or augmentation (Yes/No) and indication

Measure: Maternal outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

Description: Epidural use (Yes/No)

Measure: Maternal outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.

Description: Gestational age at delivery (weeks)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Description: Sex (female/male)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Description: Birth weight (kg) Birth weight (kg)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Description: Need for resuscitation (Yes/No)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Description: NICU admission (Yes/No)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Description: Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

Description: Current disposition of baby (home or hospital)

Measure: Newborn outcomes

Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.

22 VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.

NCT04363203 SARS-CoV-2 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Placebo oral tablet

Primary Outcomes

Measure: Days to resolution of cough, fever and shortness of breath

Time: 30-days

Secondary Outcomes

Measure: Days to resolution of all COVID-19 symptoms

Time: 30-days

Measure: All cause hospitalization

Time: 30-days

Measure: All cause mortality

Time: 30-days

Measure: COVID-19 specific mortality

Time: 30-days

Measure: COVID-19 specific hospitalization

Time: 30-days

23 Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection

The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.

NCT04367168 COVID Drug: Colchicine Drug: Placebo oral tablet

MeSH:Inflammation

Primary Outcomes

Description: Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin

Measure: Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels

Time: Up to 24 days

Description: At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg

Measure: Progression to severe disease

Time: Up to 10 days

24 Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial

Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.

NCT04370015 SARS-CoV-2 Healthcare Workers Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Infection

Primary Outcomes

Description: Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm

Measure: Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period

Time: From date of randomization until study completion 12 weeks after treatment initiation

Description: To assess the presence or absence of side effects from HCQ treatment.

Measure: Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Secondary Outcomes

Description: Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.

Measure: Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Description: Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.

Measure: Clinical disease severity in confirmed SARS-CoV-2 participants

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

Description: Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).

Measure: Incidence of any acute respiratory infection

Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation

25 Protecting Frontline Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Multi-Site Trial in Toronto, Canada

On 11 March 2020, the World Health Organization declared SARS-CoV-2 (commonly called COVID-19) a global pandemic. As in any pandemic, maintaining the health and safety of the healthcare workforce is of great importance as health care workers (HCW) remain a critical line of defence against the spread of COVID-19 and play a vital role in the recovery of those already infected. Frontline HCW, such as those in the emergency department (ED), are at high risk of contracting COVID-19 due to their close proximity to patients who may have the virus. The impact of frontline HCW becoming ill and thus unable to go to work is equally high, and of grave risk to the function of the healthcare system and the ability to minimize the impact of the current pandemic. This study aims to evaluate whether hydroxychloroquine (HCQ), a well-tolerated drug typically used in the prevention of malaria transmission and rheumatic disease, taken before and during exposure to patients with COVID-19, is effective at reducing COVID-19 infections among ED health care workers.

NCT04374942 Pre-Exposure Prophylaxis Coronavirus SARS-CoV 2 Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Coronavirus Infections

Primary Outcomes

Description: This is a composite endpoint which includes any positive result from a validated SARS-CoV-2 diagnostic assay including detection of viral RNA, or seroconversion by day 104 (14 days after end of the randomization period).

Measure: Microbiologically confirmed COVID-19 (SARS-CoV-2 infection)

Time: Samples collected at day 0, 30, 60, 90 and 120

Secondary Outcomes

Description: Assessed using the DAIDS Table for Grading the Severity of Adverse Events

Measure: Adverse events

Time: Assessed at day 30, 60, 90, and day 120

Description: Collected weekly from participants via self-report, sent by email

Measure: Symptom duration of COVID-19

Time: Collected every 7 days from day 7 to day 120

Description: The number of days (or partial days) spent admitted to an acute care hospital during the study period

Measure: Days of hospitalization attributable to COVID-19

Time: Collected every 7 days from day 7 to day 120

Description: the number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation during the study period

Measure: Respiratory failure requiring ventilatory support attributable to COVID-19

Time: Collected every 7 days from day 7 to day 120

Description: Mortality attributable to COVID-19 and all-cause mortality during the study period

Measure: Mortality

Time: Collected every 7 days from day 7 to day 120

Description: Number of days ineligible/unable to work due to COVID-19

Measure: Impact on work eligibility

Time: Collected every 7 days from day 7 to day 120

Description: COVID-19 reactive serology

Measure: Seropositivity

Time: Blood collected at day 0, 30, 60, 90, 120

Description: Short-term psychological impact of exposure to COVID-19 measured using the K10, a validated measure of non-specific psychological distress, with a standard cutoff score of ≥16

Measure: Short-term psychological impact

Time: Measured at day 1, 60, 120

26 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. 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

27 Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies

The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.

NCT04392128 COVID19 Hematologic Malignancy Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Drug: Azithromycin 250 MG Oral Capsule Drug: Placebo oral tablet Drug: Placebo oral capsule

MeSH:Hematologic Neoplasms Neoplasms

HPO:Hematological neoplasm Leukemia Neoplasm

Primary Outcomes

Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.

Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.

Time: 5 days of treatment

Secondary Outcomes

Description: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)

Measure: Clinical evolution

Time: up to 3 months

Description: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock

Measure: Proportion of patients progressing to a severe form

Time: up to 3 months

Description: Date and cause of death

Measure: Mortality

Time: up to 1 and 3 months

Description: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples

Measure: Evaluation of viral load drop

Time: at day 10

Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)

Measure: Tolerance of study treatment

Time: up to 3 months

Description: Collection of serum to realize serological tests

Measure: Evaluation of the seroconversion

Time: at inclusion, day 10, day 30 and day 90 after treatment

Description: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.

Measure: NK immunological study

Time: at day 10 and day 30 after treatment

Description: Duration of hospitalisation (conventional, intensive care, reanimation)

Measure: Hospitalisation duration

Time: up to 3 months

Description: Patient follow-up during 3 months : hematological status and associated therapy

Measure: Impact of the study treatment on the treatment of the hematological disease

Time: up to 3 months

Description: ECG (using connected machine to allow monitoring at home)

Measure: Monitoring of the QT space

Time: at inclusion, day 2, day 5, day 10

Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.

Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine.

Time: at day 5 and day 10

Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.

Measure: T immunological study

Time: at day 10 and day 30 after treatment

28 Randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults With COVID-19

This study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19

NCT04394416 COVID-19 Drug: Imatinib Drug: Placebo oral tablet

Primary Outcomes

Description: The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.

Measure: The proportion of patients with a two-point change using the 8-category ordinal scale

Time: Day 14 from baseline

Secondary Outcomes

Description: All-cause mortality post baseline

Measure: All-Cause mortality

Time: Day 28 and Day 60 post baseline

Description: Time to a 2-point clinical change difference

Measure: Time to a 2-point clinical change