Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a ra
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STUDY PROTOCOL
Open Access
Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial Madunil A. Niriella1* , Dileepa S. Ediriweera1, Arjuna P. De Silva1, Ranjan Premarathne1, Priyantha Balasooriya2, Kaluthanthri D. Duminda3, Neelika G. Malavige4, Kamani Wanigasuriya4, Sarath Lekamwasam5, Senanayake A. Kularathne6, Sisira Siribaddana7, Hithanadura J. de Silva1 and Saroj Jayasinghe8
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 (SARSCoV-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
* Correspondence: [email protected] 1 Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka Full list of author information is available at the end of the article
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