search
Back to results

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

Primary Purpose

COVID-19, COVID19, Sars-CoV2

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Sars-CoV2, SARS-Cov-2, COVID-19, COVID19, Hydroxycholoroquine, Memorial Sloan Kettering Cancer Center, 20-187

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Memorial Sloan - Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A - hydroxycholoroquine

Arm B - placebo

Arm Description

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 placebo

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2020
Last Updated
October 29, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04379492
Brief Title
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Emerging evidence does not support the use of HCQ for treatment or prevention of SARS -CoV2 infection. No pts have been enrolled.
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
September 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, COVID19, Sars-CoV2, SARS-Cov-2
Keywords
Sars-CoV2, SARS-Cov-2, COVID-19, COVID19, Hydroxycholoroquine, Memorial Sloan Kettering Cancer Center, 20-187

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A - hydroxycholoroquine
Arm Type
Experimental
Arm Description
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 Title
Arm B - placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI)
Description
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
Time Frame
14 days
Title
Number of participants requiring mechanical ventilation for respiratory failure
Description
Clinical improvement is defined as no mechanical ventilation for respiratory failure attributed to SARS-CoV-2 within 14 days of randomization.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Genovefa Papanicolaou, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs