Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial

Annane, D; Pittock, SJ; Kulkarni, HS; Pickering, BW; Khoshnevis, MR; Siegel, JL; Powell, CA; Castro, P; Fujii, T; Dunn, D; Smith, K; Mitter, S; Kazani, S; Kulasekararaj, A

doi:10.1016/s2213-2600(23)00082-6

Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial

Lancet Respir MedPublished 20 Mar 2023Randomised controlled trial

Primary result · Overall survival estimates (multiple imputation)ResultRisk difference −0.0205 95% CI −0.1703 to 0.1293

terminated at interim analysis due to futility

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Authors' conclusion

Addition of ravulizumab to BSC did not improve survival or other secondary outcomes.

Study context

Population: Adults hospitalised with confirmed SARS-CoV-2 requiring invasive or non-invasive mechanical ventilation, with severe pneumonia, acute lung injury or ARDS; 31 hospitals in France, Japan, Spain, the UK and the US201 in ITT population
Participants: 202 adults

Comparison: Intravenous ravulizumab plus best supportive care (BSC) vs BSC alone
Ravulizumab plus BSCn = 135
BSCn = 66reference
Primary endpoint: Survival based on all-cause mortality (ITT population)
Follow-up: Day 29

Methodological detailsphase 3, multicentre, open-label, 2:1 randomisation

Phase 3
Multicentre
Open-label
2:1 randomisation

Primary result

Overall survival estimates (multiple imputation)

Risk difference

−0.0205

95% CI −0.1703 to 0.1293

one-sided p=0.61

By group

Ravulizumab plus BSC58%

BSC60%

Ravulizumab plus BSC vs BSC

risk difference −0.0205 (95% CI −0.1703 to 0.1293); one-sided p=0.61

As reported in the abstract

Safety

Treatment-emergent adverse events (safety population)

Ravulizumab plus BSC89%

BSC84%

Infections and infestations

Ravulizumab plus BSC57%

BSC36%

Vascular disorders

Ravulizumab plus BSC31%

BSC18%

Treatment-emergent adverse events (safety population): safety population: 127 vs 67

Serious adverse events related to ravulizumab

Patients with ravulizumab-related serious adverse events (bacteraemia, thrombocytopenia, oesophageal haemorrhage, cryptococcal pneumonia, pyrexia; one each): 5

Original publication

Intravenous ravulizumab in mechanically ventilated patients hospitalised with severe COVID-19: a phase 3, multicentre, open-label, randomised controlled trial. Lancet Respir Med. Published 20 March 2023. doi:10.1016/s2213-2600(23)00082-6

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