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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT04371367
Collaborator
Innate Pharma (Industry)
208
Enrollment
1
Location
2
Arms
11.1
Actual Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: avdoralimab
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia
Actual Study Start Date :
Apr 27, 2020
Actual Primary Completion Date :
Mar 30, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: avdoralimab

Biological/Vaccine: avdoralimab intravenous administration of avdoralimab Other Names: • IPH5401

Biological: avdoralimab
intravenous administration of avdoralimab
Other Names:
  • IPH5401

    		•
    Placebo Comparator: Placebo

    intravenous administration of Placebo

    Other: Placebo
    intravenous administration of placebo

    Outcome Measures

    Primary Outcome Measures

    1. Clinical improvement using WHO ordinal scale [day 28]

      improvement of WHO ordinal scale

    2. 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

    Secondary Outcome Measures

    1. Number of participants with treatment-related adverse events [day 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assistance Publique Hôpitaux de Marseille Marseille France 13354

    Sponsors and Collaborators

    • Assistance Publique Hopitaux De Marseille
    • Innate Pharma

    Investigators

    • Study Director: Emilie Garrido-Pradalie, Assistance Publique Hôpitaux de Marseille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique Hopitaux De Marseille
    ClinicalTrials.gov Identifier:
    NCT04371367
    Other Study ID Numbers:
    • 2020-21
    First Posted:
    May 1, 2020
    Last Update Posted:
    May 27, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia
    Avdoralimab

    Study Results

    No Results Posted as of May 27, 2021