Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
Navy Hospital, Welisara, Sri Lanka.
Trials. 2020 Aug 27;21(1):748. doi: 10.1186/s13063-020-04659-7.
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.
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.
Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011 . Registered on 04 May 2020.
2020 年 3 月 11 日，斯里兰卡报告了首例 2019 年冠状病毒（COVID-19）感染病例。随着一个拥有超过 4000 人的海军营地中 COVID-19 病例的迅速增加，斯里兰卡的情况发生了变化。这为研究羟氯喹（HCQ）对接触后预防（PEP）的有效性提供了独特的机会，同时采取严格的非药物公共卫生措施来防止传播。我们的目的是研究 HCQ 对接触 COVID-19 阳性患者的海军人员进行 PEP 的有效性和安全性。
方法/设计：这是一项在斯里兰卡海军、国防部海军基地营地和检疫中心进行的安慰剂对照、随机、临床试验。在招募时，接触确诊 COVID-19 感染但逆转实时聚合酶链反应（rRT-PCR）检测病毒阴性的海军人员将被随机分为两组，每组 200 人，分别接受 HCQ 或安慰剂治疗，并监测 14 天内是否出现症状或 rRT-PCR 检测到严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）病毒呈阳性。
这项试验将为 HCQ 作为 COVID-19 PEP 的有效性和安全性提供高质量的证据。由于在相对较早的传播阶段，在一个封闭区域内，在健康成年人中爆发，因此该研究设计是独特的。
斯里兰卡临床试验注册处（SLCTR）SLCTR/2020/011。于 2020 年 5 月 4 日注册。
