Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT04379492
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04379492
Study Brief:
Protocol Section:
NCT04379492