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

NCT04369469 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-05-24

Study results available
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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

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.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-10
Primary Completion
2021-02-08
Completion
2021-04-08
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04369469 on ClinicalTrials.gov