COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04334967

Brian Kendal

Not reported

2020-04-06

Suspended

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

- 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.

2

Providence Health & Services

45

None

United States

Mild disease at enrollment

1: Mild disease at enrollment

13

Total Hospitalization;Total Mechanical Ventilation

None

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]