hydroxychloroquine in patients with newly diagnosed covid-19 compared to standard of care

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

Summary: this study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with covid-19

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-marseille university in france on a preliminary trial of 36 covid-19 patients. in this trial, 6 patients were asymptomatic, 22 had upper respiratory symptoms, and 8 had lower respiratory symptoms. between early and mid-march, they treated 20 of these patients with 600 mg of hydroxychloroquine daily in a hospital setting. some patient also received the antibiotic azithromycin. 16 patients served as the controls. they observed a significant reduction in viral load in patients with hydroxychloroquine. after 6 days, 70% of the treated patients were considered cured (no virus detected in their samples) compared to 12.5% of controls. all 6 patients who received both hydroxychloroquine and azithromycin were negative for the virus after 6 days. this was an unblinded, non-randomized trial. vitamin c has multiple in-vivo effects on immune modulation that may, in sum, limit the development of the cytokine excess associated with critical illness. it is currently being studied in a clinical trial as a treatment for severe sars-cov-2 pneumonia in china and recommended as a supplement in standard treatment of covid-19. there are no medications currently approved for treatment of covid-19. hydroxychloroquine is a known drug with low toxicity that may reduce progression of respiratory symptoms and resulting hospitalizations. this randomized control study will assess its potential as an off-label treatment in reducing the rates of hospitalization and subsequent mechanical ventilation from covid-19 infection compared to standard of care treatment with vitamin c. a randomized control trial with placebo is impractical due to the increasing availability of this medication to the public.

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.