Cov-2 SARS Disease MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Clairyg 50mg/ml, Solution for infusion
Product Name: Clairyg 50mg/ml, Solution for infusion
Product Code: J06BA02
Pharmaceutical Form: Infusion
Pharmaceutical form of the placebo: Infusion
Sponsors
GHU PARIS PSYCHIATRIE ET NEUROSCIENCES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) VM (mechanical ventilation) invasive for less than 36 hours 2) ARDS meeting the Berlin criteria (Ref) 3) SARS-CoV-2 infection proven by PCR 4) Consent of the patient, a relative or relative or deferred (emergency clause). 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 126 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Allergy to polyvalent immunoglobulins. - Pregnant woman or minor patient - Known IgA deficiency. - Patient with renal failure on admission defined by a 3-fold increase in baseline creatinine or serum creatinine> 354 micromol / L or a diuresis of less than 0.3 mL / Kg for 24 hours or anuria for 12 hours. - Participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the administration of IVIG at a dose of 2 g / kg over 4 consecutive days (i.e. 0.5 g / Kg / D) started during the first 24 to 120 hours of invasive mechanical ventilation (VM) of a patient suffering from d 'A post-SARS-CoV-2 ARDS improves the number of days living without VM on D28. ;Secondary Objective: The secondary objectives are to assess the impact of IVIg on mortality, organ failure, complications of resuscitation and the functional and psychological sequelae at D28 as well as their side effects.;Primary end point(s): Survival without invasive ventilatory assistance (i.e. ventilator-free days) until D28. The score is calculated by summing the days on which the patient has not had a VM; but in the event of death before D28, the score is zero. The 28-day delay was recommended because the average duration of VM for post-SARS-CoV-2 ARDS patients is 20 days.;Timepoint(s) of evaluation of this end point: 28 day delay | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Mortality at D28 and D90 ? Organ failures according to the SOFA score performed on D1, D3 and D7, D14, D21 and D28. ? Clinical efficacy criteria: Radiological score, P / F ratio value, pulmonary compliance on D1, D3 and D7, D14, D21 and D28 ? Biological efficacy criteria: inflammatory syndrome on D1, D3 and D7, D14, D21 and D28: perhaps specify on what: CRP, fibrinognene, d.dimers, dosages of complement C3, C4, CH50, proteinuria of 24 hours ? Immunological profile: quantity of CD4 HLA-DR + and CD38 +, CD8 lymphocytes strongly expressing perforin for a subgroup of 10 patients. If a bronchiolo-alveolar lavage, the formula will be studied. ? Administration of other treatments (corticosteroids, antiretrovirals, plaquenil) ? Occurrence of deep vein thrombosis of a pulmonary embolism detected clinically and proven by a Doppler ultrasound of the lower limbs. Occurrence of pulmonary embolism evidenced by a pulmonary angiogram. ? Total duration of mechanical ventilation, ventilatory withdrawal, curarization ? KDIGO score and need to resort to extrarenal purification (Annex 2) ? Occurrence of an adverse event linked to immunoglobulins (renal insufficiency, hypersensitivity manifestations with skin or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, post-transfusion respiratory distress syndrome (TRALI) ? Occurrence of an NMAR will be evaluated by the MRC sum score on waking (Annex 3). ? Onset of pneumonia acquired under mechanical ventilation defined by an evocative radio-clinical context associated with a bacteriological sample by culture of tracheal secretions, bronchiolo-alveolar lavage or a protected distal sample.;Timepoint(s) of evaluation of this end point: J28 and J90 | — |
Countries
France
Contacts
Public ContactAWASSI
GHU PARIS PSYCHIATRIE ET NEUROSCIENCES
Outcome results
None listed