VICO Trial: A multi center randomized open label trial on the safety and efficacy of chloroquine for the treatment of hospitalized adults with laboratory confirmed SARS-CoV-2 infection in Vietnam

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19. We hypothesise that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines of viral load in throat/nose swabs. This viral attenuation should be associated with improved patient outcomes. - Study design The study is an open label, randomised, controlled trial with 2 parallel arms of standard of care (control arm) versus standard of care with 10 days of chloroquine (intervention arm) with a loading dose over the first 24 hours, followed by 300mg base orally once daily for 9 days. The study will recruit patients in three sites in Ho Chi Minh City, Viet Nam: the Hospital for Tropical Diseases, the Cu Chi Field Hospital, and the Can Gio COVID-19 hospital. The primary endpoint is the time to viral clearance from throat/nose swab defined as the time following randomization until the midpoint between the last positive and the first of the negative throat/nose swabs. Viral presence will be determined using RT-PCR to detect SARS-CoV-2 RNA. Prior to the randomization stage, there will be a 10-patient prospective observational pilot study following the same entry and exclusion criteria as for the randomized trial, undergoing the same procedures, to deliver preliminary feasibility and safety data. - Discussion The results of the study will add to the evidence-based guidelines for management of COVID-19. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19.