COVID-19 infection MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Sponsors
INSERM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult =18 years of age at the time of enrolment 2. Hospitalized patients with any of the following criteria: a. the presence of pulmonary rales/crackles on clinical exam OR b. SpO2 = 94% on room air OR c. requirement of supplementary oxygen including high flow oxygen devices or non-invasive ventilation 3. A time between onset of symptoms and randomization of less than 11 days 4. A positive SARS-CoV-2 PCR performed on a NP swab within the 5 days preceding randomization 5. The result of a rapid antigen test performed on a NP swab within the 6 hours preceding randomization 6. Contraceptive use by men or women. a. Male participants: Contraception for male participants is required; to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue for 90 days following administration of IMP. b. Female participants: Women of child-bearing potential must agree to use contraception for 365 days following administration of IMP. Acceptable birth control methods are listed in section 8.5. 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 640
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Refusal to participate expressed by patient or legally authorized representative 2. Need for invasive mechanical ventilation and/or ECMO at the time of enrolment 3. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal 4. Glomerular filtration rate (GFR) < 15 mL/min or requiring maintenance dialysis 5. Pregnancy or breast-feeding 6. Anticipated transfer to another hospital, which is not a study site within 72 hours following randomization 7. Known history of allergy or reaction to any component of the study drug formulation. 8. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal or polyclonal antibodies. 9. Any prior receipt of investigational or licensed mAb/biologic indicated for the prevention of SARS-CoV-2 infection or COVID-19, and for those not vaccinated, expected receipt of vaccine in the 30 days following hospital discharge, according to current recommendation in each country. 10. Any medical condition which, in the judgment of the investigator, could interfere with the interpretation of the trial results or that preludes to protocol adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of investigational therapeutics relative to the placebo arm among hospitalized adult patients who have COVID-19. •The primary endpoint is subject clinical status (on a 7-point ordinal scale) at Day 15 ;Secondary Objective: Evaluate clinical efficacy of different therapeutics as compared to the control arm as assessed by: Subject clinical status on an ordinal scale on Day 29, 90, 180 and 365 National Early Warning Score 2 (NEWS-2) : Change from baseline to Days 3, 8, 15 (while hospitalized) and 29 in NEWS-2 •Oxygenation-free days during the first 28 days (to D29) •Incidence and duration of new oxygen use, non-invasive ventilation or high flow oxygen devices during the first 28 days (to D29) •Ventilator-free days during the first 28 days (to D29). •Incidence and duration of invasive mechanical ventilation use during the first 28 days (to D29) •Need for mechanical ventilation or death by D15 •Time to hospital discharge from randomization •In-hospital, D29, D90, D180, D365, D456 mortality •Any hospitalization or confirmed re-infection with SARS-CoV-2 Evaluate the safety of different therapeutics through 456 days of follow-up as compared to the placebo arm ;Primary end point(s): Clinical status of subject on Day 15 (on a 7-point ordinal scale): 1.Not hospitalized, no limitations on activities. 2.Not hospitalized, limitation on activities. 3.Hospitalized, not requiring supplemental oxygen. 4.Hospitalized, requiring supplemental oxygen. 5.Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6.Hospitalized, on invasive mechanical ventilation or ECMO. 7.Death. ;Timepoint(s) of evaluation of this end point: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. For efficacy assessment • Status on an ordinal scale assessed at Day 29, 90, 180 and 365 • NEWS-2 at baseline (Day 1 pre-treatment), at Days 3 and 8, 15 (if patient is still hospitalized), and at Days 29 at baseline and at Days 3, 8, 15 (while hospitalized) and at Day 29 • Duration of supplemental oxygen (if applicable) • Duration of mechanical ventilation (if applicable) • Date of discharge from hospital • Date and cause of death (if applicable) • Mechanical ventilation or death between baseline and Day 15 • Occurrence of new hospitalization between discharge from index hospitalization and Days 90, 180 and 365 • Occurrence of confirmed re-infection with SARS-CoV-2 between discharge and Days 90, 180 and 365 For safety assessment • SAEs • Grade 3 and 4 adverse events • AEs of Special Interest Grade 1-2hypersensitivity-related and infusion related AEs until D29 visit • Discontinuation of investigational therapeutics (for any reason) ;Timepoint(s) of evaluation of this end point: Day 15, Day 29, Day 90, Day 180, Day 365, Day 456 | — |
Countries
Austria, Belgium, Czech Republic, France, Greece, Hungary, Ireland, Norway, Portugal, Slovakia, Spain, Turkey
Contacts
Public ContactChristelle DELMAS
INSERM
Outcome results
None listed