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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371367
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
COVID Biological: avdoralimab Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 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 : April 27, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: avdoralimab

Biological/Vaccine: avdoralimab intravenous administration of avdoralimab

Other Names:

• IPH5401

Biological: avdoralimab
intravenous administration of avdoralimab
Other Name: IPH5401

Placebo Comparator: Placebo
intravenous administration of Placebo
Other: Placebo
intravenous administration of placebo




Primary Outcome Measures :
  1. Clinical improvement using WHO ordinal scale [ Time Frame: day 28 ]
    improvement of WHO ordinal scale

  2. 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


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371367


Contacts
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Contact: Nicolas, SCHLEINITZ, MD 04-91-38-87-62 ext +33 nicolas.schleinitz@ap-hm.fr
Contact: Julien CARVELLI 06.23.52.63.29 ext +33 julien.carvelli@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Julien CARVELLI, MD    04 13 42 96 37 ext +33    julien.carvelli@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Innate Pharma
Investigators
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Study Director: Emilie Garrido-Pradalie Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04371367    
Other Study ID Numbers: 2020-21
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections