Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care

• Status: Suspended
• Trial end date: 2022-05-27
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborators: Center for Outcomes Research and Education; Providence Cancer Center, Earle A. Chiles Research Institute
• Treatments: Ascorbic Acid; Hydroxychloroquine; Vitamins

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.