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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04379492

Collaborator

(none)

Enrollment

Location

Arms

4.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 COVID19 Sars-CoV2 SARS-Cov-2	Drug: Hydroxychloroquine Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 5, 2020

Actual Primary Completion Date :

Sep 25, 2020

Actual Study Completion Date :

Sep 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: Arm B - placebo Participants will receive placebo	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Placebo Comparator: Arm B - placebo

Participants will receive placebo

Other: 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.

Outcome Measures

Primary Outcome Measures

Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI) [14 days]
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
Number of participants requiring mechanical ventilation for respiratory failure [14 days]
Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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