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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379492
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021


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.




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379492


Contacts
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Contact: Genovefa Papanicolaou, MD 212-639-8361 papanicg@mskcc.org
Contact: Susan Seo, MD 212-639-3151 seos@mskcc.org

Locations
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United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Genovefa Papanicolaou, MD    212-639-8361      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Genovefa Papanicolaou, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04379492    
Other Study ID Numbers: 20-187
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Sars-CoV2
SARS-Cov-2
COVID-19
COVID19
Hydroxycholoroquine
Memorial Sloan Kettering Cancer Center
20-187
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents