Study Stopped
Emerging evidence does not support the use of HCQ for treatment or prevention of SARS -CoV2 infection. No pts have been enrolled.
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedStudy Start
First participant enrolled
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2020
CompletedMay 16, 2025
October 1, 2020
5 months
May 5, 2020
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Arm A - hydroxycholoroquine
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants will receive placebo
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Genovefa Papanicolaou, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 7, 2020
Study Start
May 5, 2020
Primary Completion
September 25, 2020
Study Completion
September 25, 2020
Last Updated
May 16, 2025
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
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.