Pre-exposure Prophylaxis With Various Doses of Hydroxychloroquine Among Healthcare Personnel With High-Risk Exposure to COVID-19: A Randomized Controlled Trial.

Fibhaa Syed,Muhammad Hassan,Junaid Arshad,Mohammad Ali Arif,Sadia Batool,Rauf Niazi,Sadia Ashraf,Ume E Laila

doi:10.7759/cureus.20572

Abstract

ObjectiveThis 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).MethodsA 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).ResultsOut 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).ConclusionIt is concluded that the PrEP HCQ does not significantly prevent COVID-19 among high-risk HCPs.

Highlights

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has by far affected almost all countries
The precautionary use of personal protective equipment (PPE) significantly varied; initially more than 80% of the exposed healthcare personnel (HCP) were not ensuring PPE being used by the patients treated by them, which gradually developed over time
Given the HCP exposed to COVID-19 patients are at high risk of viral transmission [6], the fight against COVID-19 is in continuance and its success relies on the adherence to the preventive measures that are being explored for disease containment

Summary

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has by far affected almost all countries. For the proper management of this pandemic, the most crucial step is the conservation of workforce safety. This outbreak has taken a heavy toll on the frontline healthcare personnel (HCP) as they are three times more likely to be infected than unexposed [2]. This pandemic has affected us physically and psychologically; the exposed frontline workers frequently develop depressive symptoms, anxiety, fear, and stress [3-5]. Remdesivir is the only drug approved by the Food and Drug Administration

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Results

Conclusion