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

Assistance Publique Hopitaux De Marseille208 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

208

Conditions

COVID

Interventions

avdoralimabBIOLOGICAL

intravenous administration of avdoralimab

PlaceboOTHER

intravenous administration of placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Assistance Publique Hôpitaux de Marseille

Marseille, France

Outcomes

Primary Outcomes

Clinical improvement using WHO ordinal scale

improvement of WHO ordinal scale

Time frame: day 28

Number of ventilator-free days at Day 28 (VFD28)

Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU

Time frame: day 28

Secondary Outcomes

Number of participants with treatment-related adverse events

Time frame: day 28

Data from ClinicalTrials.gov

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