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NCT04371367 Clinical Trial

Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )

COVID Clinical Trial

— FORCE  

Official title:
A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04371367
Other study ID # 2020-21
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 27, 2020
Est. completion date March 30, 2021

Study information
Verified date May 2021
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).

Recruitment information / eligibility
Status Completed
Enrollment 208
Est. completion date March 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - COVID-19 severe pneumonia patients need for oxygen therapy = 5 l/min or high-flow oxygen therapy - COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation Exclusion Criteria: - Pregnant woman - Uncontrolled sepsis of bacterial or fungal origin

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• avdoralimab
intravenous administration of avdoralimab
Other:
• Placebo
intravenous administration of placebo

Locations
Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (2)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille Innate Pharma

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical improvement using WHO ordinal scale improvement of WHO ordinal scale day 28
Primary Number of ventilator-free days at Day 28 (VFD28) Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU day 28
Secondary Number of participants with treatment-related adverse events day 28
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