Background The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients. Methods/design This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days. Discussion This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread. Trial registration Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011 . Registered on 04 May 2020
【저자키워드】 COVID-19, Randomized controlled trial, SARS-CoV-2, Hydroxychloroquine, Prophylaxis, Sri Lanka, post-exposure, HCQ, 【초록키워드】 coronavirus, clinical trial, Trial, quarantine, Infection, Symptom, virus, Spread, Randomized, Adults, rRT-PCR, outbreak, clinical, Patient, Effectiveness, Study design, Placebo, Coronavirus 2019, registry, recruitment, early stage, patients, placebo-controlled, Evidence, public health measure, acute respiratory syndrome, Confirmed COVID-19 infection, rapid increase, Prevent, polymerase chain, carried, healthy, reported, provided, unique, changed, receive, test negative, 【제목키워드】 Study protocol, randomized, controlled trial,