Randomized Evaluation of COVID-19 Therapy - RECOVERY (Tocilizumab)

Jun 01, 2021
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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:
UK Research and Innovation (Medical Research Council), National Institute for Health Research.
Date Published:
05/01/2021
Date Updated:
06/01/2021
Original Posted Date:
06/01/2021
References

Contribution To Literature:

The RECOVERY trial showed that tocilizumab compared with usual care was beneficial at preventing death.

Description:

The goal of the trial was to evaluate tocilizumab compared with usual care among patients admitted to the hospital with coronavirus disease 2019 (COVID-19) infection. Tocilizumab is a recombinant anti-interleukin-6 receptor monoclonal antibody.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients admitted to the hospital with COVID-19 infection were randomized to tocilizumab (n = 2,022) versus usual care (n = 2,094). Tocilizumab was administered weight based (400-800 mg). A second dose could be given 12-24 hours later if the clinical condition did not improve.

  • Total number of enrollees: 4,116
  • Duration of follow-up: 28 days
  • Mean patient age: 63 years
  • Percentage female: 34%
  • Percentage with diabetes: 28%

Inclusion criteria:

  • Patients ≥18 years of age with COVID-19 infection requiring hospitalization
  • Hypoxia, oxygen saturation <92% on room air, or requiring oxygen therapy
  • Systemic inflammation, C-reactive protein ≥75 mg/L

Principal Findings:

The primary outcome, all-cause mortality at 28 days, occurred in 31% of the tocilizumab group compared with 35% of the usual care group (p = 0.0028). Results were the same in all tested subgroups.

Secondary outcomes:

  • Discharged from the hospital within 28 days: 57% of the tocilizumab group compared with 50% of the usual care group (p < 0.0001)
  • Invasive mechanical ventilation or death: 35% of the tocilizumab group compared with 42% of the usual care group (p < 0.0001)

Interpretation:

Among hospitalized patients with COVID-19 infection, hypoxia, and systemic inflammation, tocilizumab was beneficial. Tocilizumab was associated with a lower incidence of mortality within 28 days and a lower incidence of invasive mechanical ventilation or death compared with usual care. Tocilizumab was associated with a higher incidence of discharge from the hospital within 28 days. Benefit was consistent across all subgroups.

References:

RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomized, controlled, open-label, platform trial. Lancet 2021;May 1:[Epub ahead of print].

Editorial Comment: Gupta S, Leaf DE. Tocilizumab in COVID-19: some clarity amid controversy. Lancet 2021;May 1:[Epub ahead of print].

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

Keywords: Antibodies, Monoclonal, Humanized, Coronavirus, COVID-19, C-Reactive Protein, Hypoxia, Brain, Inflammation, Oxygen, Patient Discharge, Primary Prevention, Receptors, Interleukin-6, Respiration, Artificial, Ventilation


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