A clinical trial of hydroxychloroquine as pre-exposure SARS-CoV-2 prophylaxis among healthcare workers (HCW) has been terminated early after the drug demonstrated no clinical benefit
The randomised, double-blind, placebo-controlled Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) study was conducted at two tertiary urban hospitals, with enrollment from April 9, 2020, to July 14, 2020. Follow-up ended August 4, 2020.
The trial randomised 132 full-time, hospital-based HCWs, of whom 125 were initially asymptomatic and had negative results for SARS-CoV-2 by nasopharyngeal swab. Participants received hydroxychloroquine 600 mg daily or placebo orally for eight weeks. The trial was terminated early for futility before reaching a planned enrollment of 200 participants.
The study found no significant difference in infection rates with hydroxychloroquine compared with placebo (6.3% vs 6.6%; P>.99). Mild adverse events were more common in participants taking hydroxychloroquine vs placebo (45% vs 26%; P=.04). Discontinuation rates were similar in both arms (19% vs 16%; P=.81). The median change in QTc (baseline to four-week evaluation) did not differ between arms (P=.98).
Presenting the findings in JAMA Internal Medicine, the study authors say, based on the results, they cannot recommend the routine use of hydroxychloroquine in HCWs to prevent COVID-19.