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Completed

NCT Number: NCT04371367

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

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).

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Key information

Conditions

COVID

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

avdoralimab

Biological

intravenous administration of avdoralimab

Other names: IPH5401

Placebo

Other

intravenous administration of placebo

Primary outcomes

  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 outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: day 28

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Collaborators

  • Innate Pharma

Registry information

Official study title

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

Acronym: FORCE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 1, 2020
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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