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Title: | Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial |
Authors: | Niriella, M.A. Ediriweera, D.S. de Silva, A.P. Premaratna, R. Balasooriya, P. Duminda, K.D. Malavige, N.G. Wanigasuriya, K. Lekamwasam, S. Kularathne, S.A. Siribaddana, S. de Silva, H.J. Jayasinghe, S. |
Keywords: | Clinical Protocols Randomized Controlled Trial |
Issue Date: | 2020 |
Publisher: | BioMed Central |
Citation: | Trials. 2020;21(1):748. |
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: COVID-19; HCQ; Hydroxychloroquine; Post-exposure; Prophylaxis; Randomized controlled trial; SARS-CoV-2; Sri Lanka. |
Description: | Indexed in MEDLINE, Scopus, SCIE |
URI: | http://repository.kln.ac.lk/handle/123456789/21274 |
ISSN: | 1745-6215 (Electronic) 1745-6215 (Linking) |
Appears in Collections: | Journal/Magazine Articles |
Files in This Item:
File | Description | Size | Format | |
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Hydroxychloroquine for post-exposure.pdf | 381.48 kB | Adobe PDF | View/Open |
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