Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV-2 Virus II - COALITION II

Sep 25, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
COALITION COVID-19 Brazil and EMS
Date Published:
09/04/2020
Date Updated:
09/25/2020
Original Posted Date:
09/25/2020
References

Contribution To Literature:

The COALITION II trial failed to show that azithromycin was superior to usual care in severe COVID-19 infection.

Description:

The goal of the trial was to evaluate azithromycin compared with usual care among patients admitted to the hospital with coronavirus disease (COVID-19) infection and one additional severity criterion.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients admitted to the hospital with COVID-19 infection were randomized to azithromycin 500 mg daily for 10 days (n = 214) versus usual care (n = 183). All patients received hydroxychloroquine 400 mg twice daily.

  • Total number of enrollees: 447
  • Duration of follow-up: 29 days
  • Mean patient age: 59 years
  • Percentage female: 35%
  • Percentage with diabetes: 38%

Inclusion criteria:

  • Suspected or confirmed COVID-19 infection (<14 days of symptoms) plus one additional severity criterion (>4 L/minute of supplemental oxygen, high-flow nasal cannula, noninvasive mechanical ventilation, or invasive mechanical ventilation)

Exclusion criteria:

  • Use of hydroxychloroquine, chloroquine, or macrolides >48 hours’ duration
  • History of severe ventricular arrhythmia
  • QTc interval of ≥480 ms

Principal Findings:

The primary outcome, score on a 6-point ordinal scale at 15 days, was similar between the azithromycin and usual care groups (odds ratio [OR] 1.36, p = 0.11). Higher points on the scale correlate with worse outcomes.

Secondary outcomes:

  • Mortality at 29 days: 42% of the azithromycin group compared with 40% of the standard care group (p = 0.63)
  • Score on a 6-point ordinal scale at 29 days was similar between the azithromycin and usual care groups (OR 1.43, p = 0.083)

Interpretation:

Among patients admitted to the hospital with COVID-19 infection, azithromycin was not superior compared with usual care. Usual care in this trial included hydroxychloroquine. Mortality was also similar between treatment groups. The routine use of azithromycin in addition to hydroxychloroquine for severe COVID-19 infection cannot be endorsed.

References:

Furtado RH, Berwanger O, Fonseca HA, et al. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial. Lancet 2020;Sep 4:[Epub ahead of print].

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

Keywords: Azithromycin, Coronavirus, Coronavirus Infections, COVID-19, Hydroxychloroquine, Primary Prevention, Respiration, Artificial, severe acute respiratory syndrome coronavirus 2, Standard of Care, Ventilation


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