Status:
UNKNOWN
Plasma Exchange in Covid-19 Patients With Anti-interferon Autoantibodies
Lead Sponsor:
Centre Hospitalier St Anne
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
COVID-19 associated mortality remains high despite the advances in therapeutics such as dexamethasone. The severity of COVID-19 results from direct viral cytotoxicity, and the inflammatory response, w...
Detailed Description
As of 11/09/2020, 50,000,000 people have been infected with COVID-19 worldwide, and 1,200,000 people have died, mainly from acute respiratory distress syndrome (ARDS ). Only Dexamethasone has shown su...
Eligibility Criteria
Inclusion
- SARS-CoV-2 infection proven by PCR.
- Positive detection of anti-interferon antibodies.
- Patient, family or deferred consent (emergency clause).
- Affiliation to a social security scheme (or exemption from affiliation). Inclusions are possible also for protected patient (under guardianship and tutornship).
Exclusion
- Pregnant women, parturients and nursing mothers
- Minor patient
- Participation in another interventional trial in progress, with the objective, even secondary, of reducing mortality
- Indication to EPT for another associated pathology
- Contra-indication to EPT, known allergy to albumin 5%.
- Persons under court protection,
- Disturbance of the haemostasis balance (PT\<50%, APTT\>1.5 and fibrinogen \<1g/L)
- Patient presenting a hemorrhagic diathesis (intracranial or digestive bleeding or threatening the functional prognosis)
- Any progressive and advanced pathology whose life expectancy is less than one month
- Bacterial or viral infectious disease (HIV) explaining most of the aggravation
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 22 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05182515
Start Date
December 22 2021
End Date
March 22 2022
Last Update
January 10 2022
Active Locations (1)
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1
GHU Paris Psychiatrie et Neurosciences
Paris, France, 75014