Status:
COMPLETED
Therapeutic Plasma Exchange to Alleviate Hyperinflammatory Condition During Severe Covid-19 Infections
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Intensive Care Units
ARDS, Human
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Severe Covid-19 (Coronavirus Disease 2019) infections generate major but inappropriate production of cytokines and, in some cases, generate anti-IFN (Interferon) auto-antibodies, inducing acute respir...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Hospitalized for COVID-19 confirmed by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) or scanner
- Patients with PaO2/FiO2 between 75 and 175 mmHg requiring non invasive ventilation or high flow oxygen
- peripheral venous state allowing PE to be performed, according to the investigator's judgement, or possibility of placing a Sheldon-type veinous central line
- At least two biological results suggesting a cytokine storm or hyperinflammatory condition state among : C-reactive protéine (CRP)\>50mg/L, Procalcitonin (PCT)\>1µg/L, Fibrinogen\>5g/L, D-dimer \>1000ng/mL, Ferritin \> 800ng/mL during the last 72 hours.
- Treatment with corticosteroids (at least 2 intakes of dexamethasone 6 mg or equivalent with another form of corticosteroids)
- Patient affiliated to a social security or similar scheme
- Information and written consent from the patient or if not possible from a confident person
Exclusion
- Ventilated intubated patients
- Patient with advanced cancer and without curative possibility
- Bacterial or viral (HIV) infection explaining the worsening (the main reason)
- Body Mass Index \> 40
- Severe hemodynamic instability with mean arterial pressure \< 65 mmHg (whatever the noradrenaline dosage used)
- Known Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
- Inclusion in another study that could interact with the Covidep study (investigator's judgement)
- Patient under legal protection measure
- Pregnant or breastfeeding women
- In case of allergy to amotosalen (psoralens) or AI-FFP (Amotosalen Inactivated Fresh Frozen Plasma) , use Se-FFP (Secured Fresh Frozen Plasma)
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04751643
Start Date
April 19 2021
End Date
December 19 2022
Last Update
September 3 2025
Active Locations (8)
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1
Centre Hospitalier William Morey
Chalon-sur-Saône, France, 71100
2
Hôpital Edouard Herriot
Lyon, France, 69003
3
Hôpital Croix Rousse
Lyon, France, 69004
4
Clinique de la Sauvegarde
Lyon, France, 69337