Coronavirus infection MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: avdoralimab
Product Code: IPH5401
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: avdoralimab
CAS Number: 2226393-85-5
Current Sponsor code: IP
Sponsors
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Cohort 1: Evaluate the clinical improvement of patients on the basis of the WHO scale (Ordinal Scale for Clinical Improvement - Annex) calculated on D14 and D28 -Cohort 2 (COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in intensive care unit): Number of days living without mechanical ventilation at D28 (Ventilator-free days or VFD28) (avdoralimab patients vs placebo patients) - Cohort 3: Evaluate the clinical improvement of patients on the basis of the WHO scale calculated on D14 and D28 ;Secondary Objective: -Evaluate the improvement in the rate of patients discharged alive from hospital on D14 - WHO scale at D14 and at D28 - Evaluate the clinical improvement in patients based on the WHO scale calculated on D14 and D28 (cohort 2) -Evaluate the decrease of the number of patients transferred to intensive care (cohort 1) -Evaluate the decrease of hospital stay duration -Evaluate the decrease of intensive care unit hospitalization duration -Evaluate the number of days living without mechanical ventilation at D14 (VFD14) and at D28 (VDF28)for patients hospitalized in intensive care unit -Evaluate the decrease of mortality at D28 -Evaluate the improvement of the SOFA (organ failure) score of patients at D14 for patients hospitalized in intensive care unit -Evaluate the number of sepsis (SEPSIS-3 definition) -Evaluate avdoralimab safety ;Primary end point(s): -Cohort 1: Clinical improvement on the WHO scale on D14 and D28 Difference between experimental arm and control arm - Cohort 2: Number of days living without mechanical ventilation on D28 (Ventilator-free days or VFD28) Difference between experimental arm and control arm - Cohort 3: Clinical improvement on the WHO scale on D14 and D28 Difference between experimental arm and control arm ;Timepoint(s) of evaluation of this end point: Cohort 1 : Day 14 and Day 28 Cohort 2: Day 28 Cohort 3: Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Clinical respiratory score at Day 14 and Day 28 -VFD14 for patients hospitalized in intensive care unit -Admission rate in intensive care units -Mortality at D28 -Hospital stay duration -Intensive care unit hospitalization duration -SOFA (organ failure) score at D14 for patients hospitalized in intensive care unit -Number of sepsis (SEPSIS-3 definition) in experimental arms -Adverse events number for avdoralimab patients vs placebo patients ;Timepoint(s) of evaluation of this end point: -Day 14: Clinical respiratory score; VFD14; SOFA (organ failure) score; -Day 28: Clinical respiratory score; Mortality -Throughout the duration of the study: Admission rate in intensive care units; Hospital stay duration; Intensive care unit hospitalization duration; Number of sepsis (SEPSIS-3 definition); Adverse events | — |
Countries
France
Contacts
Public ContactDirection de la Recherche Santé
aphm
Outcome results
None listed