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

October 29, 2020 updated by: Memorial Sloan Kettering Cancer Center

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2020

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

September 25, 2020

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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