ICAR (IgIV in Covid-related ARds)

Phase 1

• Conditions: Cov-2 SARS Disease; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001570-30-FR
• Lead Sponsor: GHU PARIS PSYCHIATRIE ET NEUROSCIENCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 126

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

- 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>;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