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

NCT04371367 | Completed Phase 2 DMC

• 1 other identifier: 2020-21
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID

Outcome Measures

Primary Outcomes (2)

• Clinical improvement using WHO ordinal scale

  improvement of WHO ordinal scale

  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

  day 28

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events

  day 28

Study Arms (2)

avdoralimab

EXPERIMENTAL

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

Biological: avdoralimab

Placebo

PLACEBO COMPARATOR

intravenous administration of Placebo

Other: Placebo

Interventions

avdoralimab BIOLOGICAL

intravenous administration of avdoralimab

Also known as: IPH5401

avdoralimab

Placebo OTHER

intravenous administration of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman
• Uncontrolled sepsis of bacterial or fungal origin

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead
• Innate Pharma: collaborator

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (2)

• Carvelli J, Meziani F, Dellamonica J, Cordier PY, Allardet-Servent J, Fraisse M, Velly L, Barbar SD, Lehingue S, Guervilly C, Desgrouas M, Camou F, Piperoglou C, Vely F, Demaria O, Karakunnel J, Fares J, Batista L, Rotolo F, Viotti J, Boyer-Chammard A, Lacombe K, Le Dault E, Carles M, Schleinitz N, Vivier E; FOR COVID Elimination (FORCE) Study Group. Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]). Crit Care Med. 2022 Dec 1;50(12):1788-1798. doi: 10.1097/CCM.0000000000005683. Epub 2022 Oct 10.

  PMID: 36218354 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Interventions

avdoralimab

Study Officials

• Emilie Garrido-Pradalie

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: April 27, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)