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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371367
Recruitment Status : Active, not recruiting
First Posted : May 1, 2020
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE April 29, 2020
First Posted Date  ICMJE May 1, 2020
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE April 27, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
  • Clinical improvement using WHO ordinal scale [ Time Frame: day 28 ]
    improvement of WHO ordinal scale
  • Number of ventilator-free days at Day 28 (VFD28) [ Time Frame: day 28 ]
    Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Number of patients alive and no longer hospitalized at D14 [ Time Frame: day 14 ]
    number of patients alive and discharged from the hospital at Day 14 for COVID-19 severe pneumonia patients who don't require hospitalization in ICU
  • Number of ventilator-free days at Day 28 (VFD28) [ Time Frame: day 28 ]
    Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
Number of participants with treatment-related adverse events [ Time Frame: day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )
Official Title  ICMJE A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE
  • Biological: avdoralimab
    intravenous administration of avdoralimab
    Other Name: IPH5401
  • Other: Placebo
    intravenous administration of placebo
Study Arms  ICMJE
  • Experimental: avdoralimab

    Biological/Vaccine: avdoralimab intravenous administration of avdoralimab

    Other Names:

    • IPH5401

    Intervention: Biological: avdoralimab
  • Placebo Comparator: Placebo
    intravenous administration of Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 11, 2021)
208
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2020)
108
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04371367
Other Study ID Numbers  ICMJE 2020-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Innate Pharma
Investigators  ICMJE
Study Director: Emilie Garrido-Pradalie Assistance Publique Hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP