Barcelona Postexposure Prophylaxis Study Against SARS-CoV-2 - BCN-PEP-CoV2

Dec 02, 2020
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Crowdfunding campaign YoMeCorono, Generalitat de Catalunya, Zurich Seguros, Synlab Diagnósticos, Laboratorios Rubió, and Laboratorios Gebro Pharma.
Date Published:
11/24/2020
Original Posted Date:
12/02/2020
References

Contribution To Literature:

The BCN-PEP-CoV2 trial failed to show that hydroxychloroquine was superior to placebo at preventing SARS-CoV-2 infection after recent high-risk exposure.

Description:

The goal of the trial was to evaluate hydroxychloroquine compared with placebo among patients with recent high-risk exposure to a patient with polymerase-chain-reaction (PCR)–confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19).

Study Design

  • Randomized
  • Parallel
  • Open-label
  • Cluster randomization

Patients with recent high-risk exposure to a SARS-CoV-2–infected patient were randomized to hydroxychloroquine 800 mg on day 1, followed by 400 mg once daily for 6 days (n = 1,225) versus placebo (n = 1,300).

  • Total number of enrollees: 4,399
  • Duration of follow-up: 14 days
  • Mean patient age: 49 years
  • Percentage female: 73%

Inclusion criteria:

  • Asymptomatic patients ≥18 years of age with recent high-risk exposure to a patient with SARS-CoV-2 infection
  • No SARS-CoV-2 symptoms during the 2 weeks before enrollment
  • Increased risk of infection (i.e., health care worker, a household contact, a nursing home worker or resident)

Principal Findings:

The primary outcome, PCR-confirmed symptomatic SARS-CoV-2 infection at 14 days, occurred in 5.7% of the hydroxychloroquine group compared with 6.2% of the placebo group (p = nonsignificant). The results were the same among those who were SARS-CoV-2 negative and SARS-CoV-2 positive at baseline.

Secondary outcomes:

  • SARS-CoV-2 infection, defined as either PCR-confirmed SARS-CoV-2 or any symptoms compatible with SARS-CoV-2 infection at 14 days: 18.7% of the hydroxychloroquine group compared with 17.8% of the placebo group (p = nonsignificant)
  • Any adverse event: 56.1% of the hydroxychloroquine group compared with 5.9% of the placebo group (p < 0.001)
  • Treatment-related serious adverse events: 0% of the hydroxychloroquine group compared with 0% of the placebo group (p = nonsignificant)

Interpretation:

Among patients with recent high-risk exposure to SARS-CoV-2, hydroxychloroquine was not beneficial. Hydroxychloroquine was not associated with a reduction in the incidence of SARS-CoV-2 infection at 14 days. Adverse events were more frequent in the hydroxychloroquine group; however, there were no treatment-related adverse events in either group. Multiple studies have failed to show that hydroxychloroquine is beneficial in preventing or treating SARS-CoV-2 infection.

References:

Mitjà O, Corbacho-Monné M, Ubals M, et al. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. N Engl J Med 2020;Nov 24:[Epub ahead of print].

Clinical Topics: COVID-19 Hub, Prevention, Novel Agents, Statins

Keywords: Coronavirus Infections, COVID-19, Health Personnel, Hydroxychloroquine, Nursing Homes, Polymerase Chain Reaction, Post-Exposure Prophylaxis, Primary Prevention, Risk Assessment, severe acute respiratory syndrome coronavirus 2, Treatment Outcome


< Back to Listings