Boston Area COVID-19 Consortium (BACC) Bay Tocilizumab Trial - Tocilizumab in Patients Hospitalized With COVID-19

Dec 10, 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:
Genentech
Date Published:
12/09/2020
Date Updated:
12/10/2020
Original Posted Date:
10/27/2020
References

Contribution To Literature:

The Tocilizumab in Patients Hospitalized With COVID-19 trial failed to show that tocilizumab was superior to placebo at preventing intubation or death.

Description:

The goal of the trial was to evaluate the interleukin-6 receptor blocker tocilizumab compared with placebo among patients hospitalized with coronavirus disease 2019 (COVID-19).

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Double-blind
  • Stratified

Patients hospitalized with COVID-19 infection but not intubated were randomized to tocilizumab (8 mg/kg administered intravenously, to maximum of 800 mg) (n = 161) versus placebo (n = 81).

  • Total number of enrollees: 242
  • Duration of follow-up: 28 days
  • Mean patient age: 60 years
  • Percentage female: 42%
  • Percentage with diabetes: 28%

Inclusion criteria:

  • Patients 19-85 years of age admitted with COVID-19 infection
  • At least two of the following: fever, pulmonary infiltrates, or the need for supplemental oxygen
  • At least one of the following laboratory criteria:
  • C-reactive protein level >50 mg/L
  • Ferritin level >500 ng/ml
  • D-dimer level >1000 ng/ml
  • Lactate dehydrogenase level >250 U/L

Exclusion criteria:

  • Supplemental oxygen >10 L/min
  • Recent treatment with biologic agents or small molecule immunosuppressive therapy
  • Receiving other immunosuppressive therapy that the investigator believed placed them at higher risk for an infection
  • Diverticulitis

Principal Findings:

The primary outcome, intubation or death at 28 days, occurred in 10.6% of the tocilizumab group compared with 12.5% of the placebo group (p = 0.64).

Secondary outcomes:

  • Clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline: 19.3% of the tocilizumab group compared with 17.4% of the placebo group (p = 0.73)
  • Median time to discontinuation of supplemental oxygen: 5.0 days in the tocilizumab group compared with 4.9 days in the placebo group (p = 0.69)
  • Serious infections: 8.1% in the tocilizumab group compared with 17.3% in the placebo group (p = 0.03)

Interpretation:

Among patients hospitalized with COVID-19 infection but not intubated, tocilizumab was not superior to placebo. Tocilizumab did not reduce the incidence of intubation or death at 28 days compared with placebo. Tocilizumab did not shorten the time to discontinuation of oxygen therapy. However, tocilizumab was associated with a reduction in serious infections. Earlier open-label trials had suggested benefit from tocilizumab, thus highlighting the importance of conducting double-blind, placebo-controlled trials.

References:

Stone JH, Frigault MJ, Serling-Boyd NJ, et al., on behalf of the BACC Bay Tocilizumab Trial Investigators. Efficacy of Tocilizumab in Patients Hospitalized With Covid-19. N Engl J Med 2020;383:2333-44.

Editorial: Huang E, Jordan SC. Tocilizumab for Covid-19 — The Ongoing Search for Effective Therapies. N Engl J Med 2020;383:2387-8.

Clinical Topics: COVID-19 Hub, Dyslipidemia, Prevention, Lipid Metabolism, Novel Agents

Keywords: Antibodies, Monoclonal, Humanized, Coronavirus, COVID-19, C-Reactive Protein, Ferritins, Intubation, Intratracheal, Lactate Dehydrogenases, Oxygen Inhalation Therapy, Primary Prevention, Receptors, Interleukin-6, severe acute respiratory syndrome coronavirus 2


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