Abstract:
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
Keywords: Randomized controlled trial, COVID-19, SARS-CoV-2, Prophylaxis, Post-exposure, Hydroxychloroquine,
HCQ, Sri Lanka
