A double-blind, randomized study versus placebo of avdoralimab (IPH5401), an anti-C5aR antibody, in patients with COVID-19 induced pneumonia

Phase 1

• Conditions: Coronavirus infection; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001686-36-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

*patient over 18 years of age
*Patient under 80 years of age
*COVID-19 hypoxemic pneumonia (cohort 1)defined by :
o Need for oxygen therapy = 5 l/min to maintain SpO2 > 93%(conventional oxygen therapy and / or high flow oxygen therapy)
o PCR SARS-CoV-2 positive
*For patients immediately included in intensive care : (cohort 2)
o Patient under mechanical invasive ventilation with a PaO2/FiO2 ratio < 300 for more than 24 hours.
o PCR SARS-CoV-2 positive and / or chest scanner in favor of the diagnosis of COVID-19
Pour les patients inclus d’emblée en réanimation (cohort3):
-Patient sous ventilation mécanique invasive depuis moins de 72h et avec un rapport PaO2/FiO2 inférieur ou égal à 200 et supérieur ou égal à 60 au moment de la randomisation
-PCR SARS-CoV-2 positive

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

-Pregnant or breastfeeding woman
-Patient deprived of liberty
-Patient refusal to participate in the study
-Patient already included in another clinical trial or within 2 weeks prior to randomization
-Patient for whom measures of therapeutic limitations have been issued for non-admission to intensive care units
- Uncontrolled sepsis of bacterial or fungal origin
Additional non-inclusion criteria for cohort 1:
- Patients who have already been treated with high flow oxygen therapy and / or non-invasive ventilation if the patient is included on conventional oxygen therapy
- Patient who received invasive mechanical ventilation prior to randomization
Additional non-inclusion criteria for cohort 3:
- Patients under invasive mechanical ventilation for more than 72 hours
- Patients on ECMO at the time of randomization
Additional non-inclusion criteria for cohorts 1 and 3
-Treatment with chloroquine or hydroxychloroquine at the time of randomization
- Patient decompensating a chronic pulmonary pathology: asthma, COPD, cystic fibrosis
- Chronic dialysis patients or justifying extra-renal purification at the time of randomization
- Organ transplants within 3 months prior to randomization
- Patient with NYHA stage III-IV chronic congestive heart failure
- Cirrhotic patients Child B-C
- Patients who presented with cardiac arrest within 2 weeks prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified