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

Paused · Phase 4

Conditions studied: COVID-19, Corona Virus Infection, SARS-CoV-2, 2019-nCoV, 2019 Novel Coronavirus

In brief

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

Key facts

Study ID

NCT04334967

Run by

Providence Health & Services

People needed

13

Starts

2020-03-30

Expected to finish

2022-05-27

Last updated by the study team

2020-09-16

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Portland Providence Medical Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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