Moderate COVID-19 MedDRA version: 23.0 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: XAV-19
Product Code: XAV-19
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
Nantes CHU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Willing and able to provide written informed consent prior to performing study procedures 2.Male or female = 18 years 3.Hospitalized for COVID-19 4.Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx, saliva, sputum) = 10 days before enrolment 5.Evidence of pulmonary involvement (on lung examination [rales/crackles] and/or chest-imaging [Chest X-ray or computed tomography]) 6.Requiring O2 supplement with SpO2 = 6L/min at screening 7.Requiring O2 supplementation with SpO2 = 94% on O2 therapy at screening 8.First onset of COVID-19 symptoms = 10 days, among fever and/or chills, headache, myalgias, cough, shortness of breath, whichever as occurred fist 9.WOCBP must have a negative urinary pregnancy test the day of inclusion 10.All sexually active male subjects must agree to use an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug and agree to no sperm donation until the end of the study, or for 90 days after the last dose of XAV-19, whichever is longer 11.Patients with French social security 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 92 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 276
Exclusion criteria
Exclusion criteria: 1.Evidence of multiorgan failure (severe COVID-19) 2.Mechanically ventilated (including ECMO) 3.Receipt of immunoglobulins or any blood products in the past 30 days 4.Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the investigator, would affect subject safety and/or compliance 5.End-stage renal disease (eGFR < 15 ml/min/1,73 m2) 6.Child-Pugh C stage liver cirrhosis 7.Decompensated cardiac insufficiency 8.Known allergy, hypersensitivity, or intolerance to the study drug, or to any of its components 9.Females of childbearing potential without contraceptive method, or with positive pregnancy test, breastfeeding, or planning to become pregnant during the study period 10.Current documented and uncontrolled bacterial infection. 11.Prior severe (grade 3) allergic reactions to plasma transfusion 12.Patient participating in another interventional clinical trial 13.Life expectancy estimated to be less than 6 months 14.Patient under guardianship or trusteeship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 2a: The primary objective of the study is to evaluate the Antibody titers of XAV-19 treated patients versus placebo treated patients at Day 8. Phase 2b: The primary objective of the study is to compare duration until weaning supplemental oxygen in the two groups of treatment.;Secondary Objective: Phase 2a: a)Characterize pharmacokinetics (PK) of XAV-19 infected patients over the time from D1 to D29 b)Evaluate the Antibody titers of XAV-19 and to compare Group 1 treated patients versus Group 2 treated patients at Day 8. c)Assess safety and tolerability of XAV-19 vs. placebo and between group 1 and group 2 treated patients over 29 days. d)Describe groups of patients according to clinical variables Phase 2b: a)Evolution of National Early Warning Score (NEWS) b)Changes in the 7-point ordinal scale between baseline and Day 15 c)Improvement of one category from admission using the 7-point ordinal scale d)Normalization of fever e)Duration of oxygen therapy over 29 days f)Oxygen requirement over 29 days g)Transfer to ICU with need for IMV or high flow O2 h)Hospital length of stay i)All cause of mortality j)Safety of XAV-19;Primary end point(s): Phase 2a: The primary endpoint is pharmacokinetic measurement of the antibody titer of XAV-19 measurements of all treated patients and of all patients in the placebo group at Day 8 (3 days after the last administration). Phase 2b: Time to weaning of supplemental oxygen. If patient is still on oxygen at D15 or if the patient is weaned but put back on oxygen then the delay will be censored at 15 days.;Timepoint(s) of evaluation of this end point: Phase 2a: Day 8 Phase 2b: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Phase 2a: a)Pharmacokinetic analysis: at Day 1 (pre-dose, post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day 15, and Day 29. b)The antibody titer of XAV-19 measurements at Day 15. c)Safety of XAV-19 evaluated at every visit d)Clinical aspects at every visit Phase 2b: a)NEWS every Day between D1 and D15 b)Clinical status assessed at D3,D5, D8, D11, D15, and D29 c)Time to improvement using the 7-point ordinal scale at every visit d)Time to first fever normalization at every visit e)Duration of oxygen therapy at every visit f)Oxygen requirement at every visit g)Incidence and duration of non-invasive ventilation or high flow oxygen devices at every visit h)Hospital length of stay at every visit i)All cause mortality at D29 j)Safety of XAV-19 evaluated at every visit;Secondary end point(s): Phase 2a: The secondary endpoints are : a)Pharmacokinetic analysis: Antibody titer measurements at Day 1 (predose, post-dose), at Day 5 (pre-dose, post-dose), Day 8, Day 15, and Day 29. b)The antibody titer of XAV-19 measurements in Group 1 treated patients and Group 2 treated patients at Day 15. c)Safety of XAV-19 evaluated as: •Occurrence of all suspected XAV-19 related adverse effects and incidence of serious adverse events •Proportion of participants with treatment emergent adverse events leading to study drug discontinuation •Incidence of major or bacterial or fungal infections •Incidence of hypersensitivity reactions and infusion reactions •White cell count, hemoglobin, platelets, creatinine, ALT, AST, on D1, D3, D5, D8, D15 and D29 •SARS-CoV-2 viral load over time (D1-D29), as collected by nasopharyngeal swab samples •Time to RT-PCR virus negativity in nasopharyngeal swab samples d)Clinical aspects: •Duration of supplemental oxygen •Transfer to intensive care unit with need for invasive mechanical ventilation or high flow oxygen •Normalization of fever = 24 hours: clinical assessment every day from Day 1 to Day 14. Evaluation to | — |
Countries
France
Contacts
Public ContactLaëtitia Berly
Nantes CHU
Outcome results
None listed