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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04379492
• Other study ID #: 20-187
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 5, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: October 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19
• SARS-Cov-2
• Sars-CoV2

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center