With input from Dr Monica Vasudev

1099: HCQ Fails as COVID-19 Pre-Exposure Prophylaxis for HCPs

1. There appeared to be no clinical benefit to hydroxychloroquine (HCQ) as COVID-19 pre-exposure prophylaxis in a small sample of healthcare professionals in a randomized trial that was stopped early owing to futility. 
2. Participants given daily HCQ for 8 weeks reported no significant difference in infection rates compared to those randomized to placebo therapy (6.3% vs 6.6%, respectively, P >0.99).
3. The median change in QTc baseline was not different; however, overall adverse events appeared to be significantly more common in the HCQ group than the placebo group, noted the authors in JAMA Internal Medicine.
4. The trial recruited 123 participants of a planned 200, but was stopped early for futility. Following the second interim analysis, when 100 participants completed the study, four participants in HCQ arm and three participants in placebo arm converted to positive SARS-CoV-2 status. The data safety monitoring board thus recommended early termination of the study.
5. The Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) trial was done at two teaching hospitals in Philadelphia between April 9 and July 14. There were uniform policies with respect to the  use of personal protective equipment, including masks, eyewear, and gowns and screening patients for COVID-19 symptoms.
6. Physicians, nurses, certified nursing assistants, emergency technicians, and respiratory therapists were included, who worked 20 hours or more a week in hospital-based units, had no history of SARS-CoV-2 infection nor COVID-19 symptoms in the 2 weeks prior to enrolment.
7. The primary outcome was the rate of conversion to SARS-CoV-2-positive status through nasopharyngeal swab during the 8 weeks of participation.
8. The 132 initial participants had a median age of 33, nearly 70% were women, and 83% were white. Over half of the participants worked in the emergency department; 37% worked in the internal medicine ward. About two-thirds of participants were nurses, while 21% were physicians.
9. Sixty four participants in the HCQ arm and 61 in the placebo arm were evaluable for the primary outcome.
10. There were eight infections over the study period; none required hospitalization. All were either asymptomatic or had mild disease and recovered completely.
11. Four SARS-CoV-2-positive participants treated with HCQ compared to three treated with placebo had an IgG antibody against SARS-CoV-2.
12. The safety arm included 65 participants in each arm who took at least one dose of the study medication. There was a significantly higher percentage of adverse events among those who took hydroxychloroquine compared to placebo (45% vs 26%, respectively, P=0.03). HCQ participants also reported significantly increased diarrhea in comparison with placebo arm.
13. No differences were evident in cardiac events, such as syncope and arrhythmias, and no significant difference in QTc was noted between the two groups.
14. Limitations to the data include insufficient power, on account of the small sample size. This means that the researchers could not exclude the possibility of an undetected modest potential prophylactic effect of hydroxychloroquine.

[Source: Medpage Today]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA