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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 2

Conditions: COVID

Treatments: Biological: avdoralimab; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04371367

2020-21

Details and patient eligibility

About

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).

Enrollment: 208 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups, including a placebo group

avdoralimab

Experimental group

Description:

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

Treatment:

Biological: avdoralimab

Placebo

Placebo Comparator group

Description:

intravenous administration of Placebo

Treatment:

Other: Placebo