Tocilizumab in nonventilated patients hospitalized with Covid-19 pneumonia

  1. Carlos Salama
  2. Jian Han
  3. Linda Yau
  4. William G. Reiss
  5. Benjamin Kramer
  6. Jeffrey D. Neidhart
  7. Gerard J. Criner
  8. Emma Kaplan-Lewis
  9. Rachel Baden
  10. Lavannya Pandit
  11. Miriam L. Cameron
  12. Julia Garcia-Diaz
  13. Victoria Chávez
  14. Martha Mekebeb-Reuter
  15. Ferdinando Lima Menezes
  16. Reena Shah
  17. Maria F. González-Lara
  18. Beverly Assman
  19. Jamie Freedman
  20. Shalini V. Mohan
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Abstract

Background

Coronavirus disease 2019 (Covid-19) pneumonia is often associated with hyperinflammation. Safety and efficacy of the anti–interleukin-6 receptor antibody tocilizumab was evaluated in patients hospitalized with Covid-19 pneumonia.

Methods

Nonventilated patients hospitalized with Covid-19 pneumonia were randomized (2:1) to tocilizumab (8 mg/kg intravenous) or placebo plus standard care. Sites enrolling high-risk and minority populations were emphasized. The primary endpoint was cumulative proportion of patients requiring mechanical ventilation or who had died by Day 28.

Results

Of 389 randomized patients, 249 patients received tocilizumab and 128 received placebo in the modified intent-to-treat population (Hispanic/Latino, 56.0%; Black/African American, 14.9%; American Indian/Alaska Native, 12.7%; White, 12.7%; other/unknown, 3.7%). The cumulative proportion (95% confidence interval [CI]) of patients requiring mechanical ventilation or who had died by Day 28 was 12.0% (8.52% to 16.86%) and 19.3 % (13.34% to 27.36%) for the tocilizumab and placebo arms, respectively (log-rank P=0.0360; hazard ratio, 0.56 [95% CI, 0.33 to 0.97]). Median time to clinical failure up to Day 28 favored tocilizumab over placebo (hazard ratio 0.55 [95% CI, 0.33 to 0.93]). All-cause mortality by Day 28 was 10.4% with tocilizumab and 8.6% with placebo (weighted difference, 2.0% [95% CI, – 5.2% to 7.8%). In the safety population, serious adverse events occurred in 15.2% of tocilizumab patients (38/250 patients) and 19.7% of placebo patients (25/127).

Conclusions

This trial demonstrated the efficacy and safety of tocilizumab over placebo in reducing the likelihood of progression to requiring mechanical ventilation or death in nonventilated patients hospitalized with Covid-19 pneumonia.

Trial registration

ClinicalTrials.gov <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04372186">NCT04372186</ext-link>

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