COVID-19 Clinical Trial
Official title:
Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment
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.
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