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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04334967
Eligibility Criteria:
Inclusion Criteria:
* Must have positive nasopharyngeal swab for SARS-CoV-2 diagnosed via outpatient testing within the previous 48 hours
* Age ≥ 45 years
* Not hospitalized at the time of enrollment
* Established care with Providence provider
* Ability to understand a written or electronic informed consent document
* Reliable access to a computer or smartphone that can facilitate study communications via remote messaging or telephone and willingness to provide daily verbal check ins
Exclusion Criteria:
* Hypersensitivity to chloroquine or hydroxychloroquine
* History of retinal disease (macular degeneration, diabetic retinopathy, retinal rear/detachment, retinitis pigmentosa)
* History of seizure disorder
* History of ventricular tachycardia/fibrillation, history of long-QT syndrome, or ICD
* Current creatinine clearance \<10 ml/min or on hemodialysis (as evidenced in EMR)
* Known G6PD deficiency
* Current use of the following medications: digoxin, amiodarone, flecainide, procainamide, oral dapsone. If other meds of concern, route to pharmacist to evaluate
* Concomitant use of the following only at Pharmacist/Investigator discretion: Abiraterone acetate, agalsidase, conivaptan, dabrafenib, dacomitinib, dapsone (systemic), digoxin, enzalutamide, fexinidazole, flecainide, fusidic acid (systemic), idelalisib, mifepristone, mitotane, pimozide, amiodarone, digoxin, procainamide, propafenone, stiripentol
* Currently on hospice
* Women of childbearing potential must not be pregnant, and must avoid becoming pregnant while on treatment and for 30 days following treatment discontinuation. Men must avoid fathering a child while on treatment and for 30 days following treatment discontinuation
* Any clinical factors such as bleeding, active infection, or psychiatric factors that in the judgment of the investigator would preclude safe participation and compliance with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04334967
Study Brief:
Protocol Section:
NCT04334967