A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19

Study Overview
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Brief Summary
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This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.

Official Title
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Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Conditions
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COVID-19, COVID19, Sars-CoV2, SARS-Cov-2

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Subjects must have a documented positive test for the SARS-CoV-2 infection within 7 days of randomization Subject must be hospitalized within 72 hours of randomization Subjects must be receiving standard of care for SARS-CoV-2 Subject/Legally Authorized Representative (LAR) must have the ability to understand and give informed consent Subject must be able to take and absorb hydroxychloroquine at the discretion of the investigator Exclusion Criteria: Prior receipt of hydroxychloroquine for treatment or prophylaxis of SARS-CoV-2 or patient is taking hydroxychloroquine for other approved indications (e.g., lupus, rheumatoid arthritis) No documented SARS-CoV-2 infection Mechanical ventilation Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives Preexisting retinopathy documented in medical history Pregnancy or Breastfeeding Concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins (rifampin, rifabutin) Antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide) History of glucose-6-phosphate dehydrogenase deficiency Pre-treatment corrected QT interval (QTc) >500 milliseconds Pressor requirement to maintain blood pressure Alanine aminotransferase (ALT) and/or asparate aminotransferase (AST) level > 5X upper limit of normal Creatinine clearance <30 mL/min or requirement of dialysis or continuous venovenous hemofiltration Concomitant participation in a therapeutic trial for SARS-CoV-2 or receiving any experimental treatment for SARS-CoV-2 within 7 days of randomization Any condition that in the opinion of the principal investigator would prevent participation in the trial or would interfere with the trial endpoints

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A - hydroxycholoroquine<br>Participants will receive hydroxycholoroquine (200-mg tablets) 2 tablets orally q12h for 2 doses on day 1 (load), followed by 1 tablet orally q12h for days 2-5. | Drug: Hydroxychloroquine<br>* Participants will receive hydroxycholoroquine (200-mg tablets) 2 tablets orally q12h for 2 doses on day 1 (load), followed by 1 tablet orally q12h for days 2-5.<br>|
| Placebo Comparator: Arm B - placebo<br>Participants will receive placebo | Other: Placebo<br>* Participants will receive masked placebo given as 2 tablets orally q12h for 2 doses on day 1, followed by 1 tablet orally q12h for days 2-5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI) | Clinical improvement is defined as a composite endpoint of a two-point clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19 | 14 days | 
| Number of participants requiring mechanical ventilation for respiratory failure | Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sars-CoV2, SARS-Cov-2, COVID-19, COVID19, Hydroxycholoroquine, Memorial Sloan Kettering Cancer Center, 20-187