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.
【저자키워드】 COVID-19, SARS-CoV-2, Hydroxychloroquine, pre-exposure prophylaxis, healthcare personnel, 【초록키워드】 coronavirus disease, Personal protective equipment, Efficacy, Antibody testing, coronavirus, Trial, Hydroxychloroquine, Infection, RT-PCR, Prophylaxis, COVID 19, Randomized, serology testing, IgM/IgG, placebo-controlled trial, PPE, Placebo, HCQ, patients, dose, COVID-19 symptom, acute respiratory syndrome, Side effect, Participants, Enrollment, control group, subject, experimental group, clinical benefit, participant, confirmed COVID-19 case, objective, Prevent, hcp, Result, tested, evaluate, significantly, reported, the patient, conducted, treated, exhibiting, study outcome, 【제목키워드】 exposure to, Controlled,