Status:
COMPLETED
Polyvalent Immunoglobulin in COVID-19 Related ARds
Lead Sponsor:
Centre Hospitalier St Anne
Collaborating Sponsors:
Groupe Hospitalier Universitaire Paris psychiatrie & neurosciences
Laboratoire français de Fractionnement et de Biotechnologies
Conditions:
Acute Respiratory Distress Syndrome
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35500 people died, essentially due to respiratory distress syndrome (ARDS) complicated in 25% of the with acute renal fai...
Detailed Description
As of 30/03/2020, 715600 people have been infected with COVID-19 worldwide and 35 500 people have died, mainly from acute respiratory distress syndrome (ARDS) complicated in 25% of cases with acute re...
Eligibility Criteria
Inclusion
- Any patient in intensive care:
- Receiving invasive mechanical ventilation for less than 72 hours
- ARDS meeting the Berlin criteria
- PCR-proven SARS-CoV-2 infection
- Patient, family or deferred consent (emergency clause)
- Affiliation to a social security scheme (or exemption from affiliation)
Exclusion
- Allergy to polyvalent immunoglobulins
- Pregnant woman or minor patient
- Known IgA deficiency
- Patient with renal failure on admission defined by a 3 times baseline creatinine or 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
Key Trial Info
Start Date :
April 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04350580
Start Date
April 11 2020
End Date
February 20 2021
Last Update
August 19 2021
Active Locations (42)
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1
CHU Sud Amiens
Amiens, France
2
CHU Angers
Angers, France
3
Service de réanimation polyvalente, rond point de Girac
Angoulême, France
4
CH Victor Dupouy
Argenteuil, France