NCT04369469

Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.

Conditions

• COVID-19 Severe Pneumonia
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Pneumonia, Viral

Interventions

Type	Name	Description
BIOLOGICAL	Ravulizumab	Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15.
OTHER	BSC	Participants received medications, therapies, and interventions per standard hospital treatment protocols.

Timeline

• Start date: 2020-05-10
• Primary completion: 2021-02-08
• Completion: 2021-04-08
• First posted: 2020-04-30
• Last updated: 2022-05-24
• Results posted: 2022-05-24

Locations

39 sites across 5 countries: United States, France, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study