Dataset Information

HyPE study: hydroxychloroquine prophylaxis-related adverse events' analysis among healthcare workers during COVID-19 pandemic: a rising public health concern.

ABSTRACT:

Background

The rising burden of Coronavirus disease (COVID-19) has led to the mass use of hydroxychloroquine by healthcare workers (HCWs). Adverse event profile of this drug when used as prophylaxis is not well known in the literature.

Methods

A retrospective, cross-sectional study was conducted across the country using semi-structured web-based questionnaire among COVID-19 negative and asymptomatic healthcare workers, taking hydroxychloroquine prophylaxis. Descriptive and multivariate logistic-regression models were applied for analysis.

Results

Of the 166 participants, at least one adverse event was experienced by 37.9% participants, gastrointestinal being the most common (30.7%). Risk was higher in participants <40 years age (odd's ratio (OR): 2.44, 95% confidence interval (CI): 1.18-5.05) and after first dose of hydroxychloroquine (51.2%, OR: 2.38, 95%CI: 1.17-4.84). Hydroxychloroquine prophylaxis was initiated without electrocardiography by 80.1% of HCWs. Only 21.6% of those with cardiovascular disease could get prior ECG.

Conclusions

A higher incidence of adverse events was observed when results were compared with studies involving patients on long-term hydroxychloroquine therapy. Younger age and first dose were associated with greater incidence of adverse events though all were self-limiting. Monitoring prior and during prophylaxis was inadequate even among those with cardiovascular disease and risk-factors. However, no serious cardiovascular events were reported.

SUBMITTER: Nagaraja BS

PROVIDER: S-EPMC7313915 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing coronavirus disease 2019 (COVID-19) pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure.MethodsWe conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, COVID-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine loading dose then 400 mg once or twice weekly for 12 weeks. The primary endpoint was confirmed or probable COVID-19-compatible illness. We measured hydroxychloroquine whole-blood concentrations.ResultsWe enrolled 1483 healthcare workers, of whom 79% reported performing aerosol-generating procedures. The incidence of COVID-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events/person-year with once-weekly and 0.28 events/person-year with twice-weekly hydroxychloroquine compared with 0.38 events/person-year with placebo. For once-weekly hydroxychloroquine prophylaxis, the hazard ratio was .72 (95% CI, .44-1.16; P = .18) and for twice-weekly was .74 (95% CI, .46-1.19; P = .22) compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed COVID-19-compatible illness (154 ng/mL) versus participants without COVID-19 (133 ng/mL; P = .08).ConclusionsPre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed COVID-19 or COVID-19-compatible illness among healthcare workers.Clinical trials registrationClinicaltrials.gov NCT04328467.

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