Syed Fibhaa, Hassan Muhammad, Arif Mohammad Ali, Batool Sadia, Niazi Rauf, Laila Ume E, Ashraf Sadia, Arshad Junaid
Internal Medicine, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, PAK.
Neurology, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, PAK.
Cureus. 2021 Dec 21;13(12):e20572. doi: 10.7759/cureus.20572. eCollection 2021 Dec.
Objective This trial aimed to evaluate the safety and efficacy of pre-exposure prophylaxis (PrEP) with various hydroxychloroquine (HCQ) doses against a placebo among healthcare personnel (HCP) with high-risk exposure to coronavirus disease 2019 (COVID 19). Methods A phase II, randomized, placebo-controlled trial was conducted including 200 subjects with no active or past severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (antibody testing and reverse transcription-polymerase chain reaction (RT-PCR) were taken at the time of enrollment). Subjects of experimental groups one to three received HCQ in various doses and the control group received a placebo. The study outcomes in terms of safety and efficacy were monitored. Participants exhibiting COVID-19 symptoms were tested for SARS-CoV-2 during the study and by the end of week 12 with RT-PCR or serology testing (COVID-19 IgM/IgG antibody testing). Results Out of the total participants, 146 reported exposure to a confirmed COVID-19 case in the first month, and 192 were exposed by week 12 of the study. Moreover, the precautionary use of personal protective equipment (PPE) significantly varied; initially more than 80% of the exposed HCPs were not ensuring PPE being used by the patients treated by them, which gradually developed over time. Mild treatment-related side effects were observed among the interventional and placebo arm patients. There was no significant clinical benefit of PrEP with HCQ as compared to placebo (p>0.05). Conclusion It is concluded that the PrEP HCQ does not significantly prevent COVID-19 among high-risk HCPs.
目的 本试验旨在评估在有2019冠状病毒病（COVID-19）高风险暴露的医护人员（HCP）中，不同剂量羟氯喹（HCQ）暴露前预防（PrEP）相对于安慰剂的安全性和有效性。方法 开展一项II期随机安慰剂对照试验，纳入200名无当前或既往严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的受试者（入组时进行抗体检测和逆转录聚合酶链反应（RT-PCR））。实验组1至3的受试者接受不同剂量的HCQ，对照组接受安慰剂。监测安全性和有效性方面的研究结果。在研究期间，出现COVID-19症状的参与者通过RT-PCR或血清学检测（COVID-19 IgM/IgG抗体检测）进行SARS-CoV-2检测，并在第12周结束时进行检测。结果 在所有参与者中，146人报告在第一个月接触过确诊的COVID-19病例，到研究第12周时，192人有过接触。此外，个人防护装备（PPE）的预防性使用差异很大；最初，超过80%的暴露医护人员没有确保他们治疗的患者使用PPE，这种情况随着时间逐渐发展。在干预组和安慰剂组患者中均观察到与治疗相关的轻微副作用。与安慰剂相比，HCQ进行PrEP没有显著的临床益处（p>0.05）。结论 得出结论，HCQ进行PrEP在高风险医护人员中不能显著预防COVID-19。
