Status:
SUSPENDED
Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
Center for Outcomes Research and Education
Providence Cancer Center, Earle A. Chiles Research Institute
Conditions:
COVID-19
Corona Virus Infection
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19
Detailed Description
Hydroxychloroquine has primarily been raised as a potential treatment of SARS-Cov-2 based on in vitro antiviral activity. A draft paper was released recently in March by Didier Raoult from Aix-Marseil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04334967
Start Date
March 30 2020
End Date
May 27 2022
Last Update
September 16 2020
Active Locations (1)
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1
Portland Providence Medical Center
Portland, Oregon, United States, 97213