Clinical trial NCT04379492: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Clinical improvement on the Ordinal Scale for Clinical Improvement (OSCI)
timeFrame: 14 days
measure: Number of participants requiring mechanical ventilation for respiratory failure
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Genovefa Papanicolaou, MD
role: PRINCIPAL_INVESTIGATOR
References: