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Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial

Jul 2020  
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402 participant HCQ prophylaxis RCT with results not reported over 3 years after completion. Authors note 283 patients completed the trial, but no results are available to date.
38 HCQ RCTs have results missing long after expected Abu-Helalah, Ajili, Akram, Al Ansari, Aston, Borrie, Burney, Butler, Chauffe, Connor, El-Sherbiny, Farooq, Gagneux-Brunon, Genton, Ghanem-Zoubi, González, Granados-Montiel, Gül, Hawari, James, Kara, Kim, Levi, Mežnar, Moraes, Morales-Asencio, Mordmüller, Nanni, Niriella, Okasha, Pellegrini, Pineda, Sarwar, Sarwar (B), Sow, Treluyer, WellStar, White
The trials report a total of 25,149 patients, with 13 trials having actual enrollment of 8,689, and the remainder estimated.
Niriella et al., 3 Jul 2020, Double Blind Randomized Controlled Trial, placebo-controlled, trial SLCTR/2020/011.
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Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial
Madunil A Niriella, Dileepa S Ediriweera, Arjuna P De Silva, Ranjan Premarathne, Priyantha Balasooriya, Kaluthanthri D Duminda, Neelika G Malavige, Kamani Wanigasuriya, Sarath Lekamwasam, Senanayake A Kularathne, Sisira Siribaddana, Hithanadura J De Silva, Saroj Jayasinghe
Trials, doi:10.1186/s13063-020-04659-7
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
Ethics approval and consent to participate Ethical clearance for the study was obtained from the Ethics Review Committee (ERC) of the Faculty of Medicine, University of Kelaniya, Ragama-P/22/04/2020. Written, informed consent to participate will be obtained from all participants. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Cevik, Bamford, Ho, COVID-19 pandemic -a focused review for clinicians, Clin Microbiol Infect
Das, Pareek, Mathur, Efficacy and safety of hydroxychloroquine sulphate in rheumatoid arthritis: a randomized, doubleblind, placebo controlled clinical trial--an Indian experience, Curr Med Res Opin, doi:10.1185/030079907X219634
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Shelar, BMC to try out hydroxychloroquine as prophylaxis in Dharavi. Worli Koliwada: The Hindu
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Who, Laboratory testing for coronavirus disease (COVID-19) in suspected human cases
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