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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-05

Study Completion Date

2020-09-25

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A - hydroxycholoroquine

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.

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

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.

Arm B - placebo

Participants will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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Hydroxychloroquine

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.

Intervention Type DRUG

Placebo

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No