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.
Drug: Hydroxychloroquine
Treatment arm medication will be administered on an outpatient basis. Due to the emergent health crisis, study drug will be delivered to patients by institution staff or contract courier using a non-contact protocol.
Dietary Supplement: Vitamin C
Control arm supplement will be administered on an outpatient basis. Due to the emergent health crisis, study supplies will be delivered to patients by institution staff or contract courier using a non-contact protocol.
Other Name: ascorbic acid
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.
Portland Providence Medical Center
Portland, Oregon, United States