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

Phase 2

Completed

• Conditions: COVID
• Interventions: Other: Placebo; Biological: avdoralimab

• Registration Number: NCT04371367
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	intravenous administration of Placebo
avdoralimab	avdoralimab	Biological/Vaccine: avdoralimab intravenous administration of avdoralimab Other Names: • IPH5401

Primary Outcome Measures

Name	Time	Method
Number of ventilator-free days at Day 28 (VFD28)	day 28	Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU
Clinical improvement using WHO ordinal scale	day 28	improvement of WHO ordinal scale

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	day 28

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France