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

Conditions

COVID

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).

Julien Carvelli, Ferhat Meziani, Jean Dellamonica, Pierre‐Yves Cordier, Jérôme Allardet-Servent et al. (27 authors)

Critical Care Medicine2022-10-1026 citations

10.1097/ccm.0000000000005683

Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial.

Vlaar APJ, de Bruin S, Busch M, Timmermans SAMEG, van Zeggeren IE, Koning R, Ter Horst L, Bulle EB, van Baarle FEHP, van de Poll MCG, Kemper EM, van der Horst ICC, Schultz MJ, Horn J, Paulus F, Bos LD, Wiersinga WJ, Witzenrath M, Rueckinger S, Pilz K, Brouwer MC, Guo RF, Heunks L, van Paassen P, Riedemann NC, van de Beek D.

2020-09-28149 citations

10.1016/s2665-9913(20)30341-6

Interventions

BIOLOGICALavdoralimab

intravenous administration of avdoralimab

OTHERPlacebo

intravenous administration of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double (Participant, Investigator)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical improvement using WHO ordinal scale	day 28	improvement of WHO ordinal scale
Number of ventilator-free days at Day 28 (VFD28)	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

Measure	Time frame
Number of participants with treatment-related adverse events	day 28

Countries

France

Outcome results

None listed