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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03039-30 | Other Identifier | ID-RCB |
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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 respiratory distress syndrom (ARDS). Therapeutic plasma exchange (TPE) have been reported to be efficient for improving the hyperinflammatory condition state and the respiratory function, which has been described in case reports or small series.
The study aims to remove cytokines during cytokine storm and anti-IFN auto-antibodies (when present) to prevent developpement of an inappropriate immune response and to improve the clinical response to reanimation treatment, in particular the respiratory parameters leading to a rapid improvement of clinical status. To that aim, the study investigates to compare a treatment using TPE plus usual treatments in intensive care unit (experimental arm) versus usual treatments in intensive care unit (routine arm) in a randomised trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPE + usual treatments in intensive care unit according to the current state of knowledge. | Experimental | TPE + usual treatments in intensive care unit according to the current state of knowledge : 3 TPE sessions i.e. one per day during 3 consecutive days on day 1-3 (day 0 = inclusion Visit date)) + usual treatments in intensive care unit. Usual treatments of patients in intensive care unit with hyperinflammatory condition due to Covid-19 infection consist in supporting respiratory function, oxygen supplementation, non invasive ventilation, invasive ventilation, antibiotic, vasopressive support and corticosteroids (in absence of bacterial secondary infection) |
|
| Usual treatments in intensive care unit according to the current state of knowledge | Active Comparator | Usual treatments of patients in intensive care unit with hyperinflammatory condition due to Covid-19 infection consist in supporting respiratory function, oxygen supplementation, non invasive ventilation, invasive ventilation, antibiotic, vasopressive support and corticosteroids (in absence of bacterial secondary infection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic plasma exchange : 3 sessions in 3 consecutive days (day 1 to day 3) | Other | Therapeutic plasma exchange (TPE) ; 3 sessions in 3 consecutive days (Day 1 to Day 3) in intensive care unit in addition to usual treatments. Plasma removed is replaced by thawed fresh frozen plasma. Plasma blood volume exchanged : 1.2 Apheresis type: centrifugation |
| Measure | Description | Time Frame |
|---|---|---|
| Use of intubation and invasive ventilation (IV) between Day 0 (Inclusion Visit) and Day 10 | Proportion of patients requiring intubation between Day 0 and Day 10. Intubation use will be measured in both arms at Day 10. | At day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the adverse events according to CTCAE v5.0 | Adverse events according to CTCAE v5.0 measured throughout the study, in both groups, including tolerance to TPEs in the experimental group over the course of the study sessions. | Throughout the study : Day 1 to Day 10 and to the end of the study (Day 60 +/- 2 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier HEQUET, MD, PhD | Hospices Civils de Lyon - Etablissement Français du Sang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier William Morey | Chalon-sur-Saône | 71100 | France | |||
| Hôpital Edouard Herriot |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39896810 | Result | Guironnet-Paquet A, Hamzeh-Cognasse H, Berard F, Cognasse F, Richard JC, Yonis H, Mezidi M, Desebbe O, Delannoy B, Demeret S, Marois C, Saheb S, Le QV, Schoeffler M, Pugliesi PS, Debord S, Bastard P, Cobat A, Casanova JL, Pescarmona R, Viel S, Nicolas JF, Nosbaum A, Vocanson M, Hequet O. Therapeutic plasma exchange accelerates immune cell recovery in severe COVID-19. Front Immunol. 2025 Jan 17;15:1492672. doi: 10.3389/fimmu.2024.1492672. eCollection 2024. |
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|
| Usual treatments in intensive care unit according to the current state of knowledge | Other | Usual treatments of patients in intensive care unit with hyperinflammatory condition due to Covid-19 infection consist in supporting respiratory function, oxygen supplementation, non invasive ventilation, invasive ventilation, antibiotic, vasopressive support and corticosteroids (in absence of bacterial secondary infection) |
|
| PaO2/FIO2 (Partial Pressure of Oxygen/Fraction of Inspired Oxygen) (mmHg) at day 4 after inclusion (PaO2/FiO2 is a usual parameter for assessing evolution of ARDS) |
PaO2/FIO2 (mmHg) at day 4 after inclusion. This parameter will be compared between day 4 and day 0.The change corresponds to an increase of PaO2/FIO2 ratio equal or superior than 20%. The proportion of patients with a PaO2/FiO2 change at Day 4 will be compared between both arms. |
| At Day 4 |
| Percentage of patients weaned from non invasive ventilation | Percentage of patients weaned from high flow oxygen. This parameter is compared between both arms (experimental and control arms). | At day 10 |
| O2 weaning capacity and duration of O2 dependence | This parameter is compared between both arms (experimental and control arms). | At day 60 |
| Survival at day 10 | Percentage of patients alive at day 10 after inclusion. This parameter is compared between both arms. | At day 10 |
| Survival at 2 months | Percentage of patients alive at 2 months after inclusion. This parameter is compared between both arms. | At day 60 (+/- 2 days) |
| Percentage of patients without any increase in inflammatory parameters (analysis of C-reactive protein, Fibrinogen,D-Dimers, procalcitonin, Ferritin) | Percentage of patients without any increase in inflammatory parameters (analysis of C-reactive protein, Fibrinogen,D-Dimers, procalcitonin, Ferritin ) at day 4 compared to values at day 0. This parameter is compared between both arms. | At day 4 |
| Variation in cytokine and chemokine levels in the cytokine storm | Percentage of patients without any increase in cytokine or chemokine levels. Leucocyte and platelet cytokine or chemokine levels in ng/ml are assessed in both arms. Analysis of the entire panel of cytokines or chemokines defines an improvement or not. Comparison between both arms. | At day 4 |
| Percentage of patients with improved phenotype (decreased phenotype of exhausted cells) and improved function (improved proliferation) | Lymphocyte and NK (Natural Killer) labeling and analysis by flow cytometry at day 0 and day 7. Analysis of lymphocyte proliferation (after stimulation) at day 0 and day 7. Analysis of percentage of patients with improved phenotype (decreased phenotype of exhausted cells) and improved function (improved proliferation) ; this parameter is compared between both arms. | At day 7 |
| Percentage of patients with decreased platelet activation | Phenotype of platelets and flow cytometry analysis performed before and after TPE or usual treatment. Percentage of patients with decreased platelet activation at day 4 ; this parameter is compared between both arms. | At Day 4 |
| Percentage of patients with decreased platelet activation | Phenotype of platelets and flow cytometry analysis performed before and after TPE or usual treatment. Percentage of patients with decreased platelet activation at day 7 ; this parameter is compared between both arms. | At Day 7 |
| Change in anti-IFN auto-antibodies type I (α and ω) level | Change in anti-IFN auto-antibodies type I (α and ω) level at day 0 and day 4. | Day 0 and Day 4 |
| Lyon |
| 69003 |
| France |
| Hôpital Croix Rousse | Lyon | 69004 | France |
| Clinique de la Sauvegarde | Lyon | 69337 | France |
| Groupement Hospitalier Porte de Valence - Montélimar | Montélimar | 26216 | France |
| Hôpital Pitié Salpétrière - Assistante Publique des Hôpitaux de Paris | Paris | 75013 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Medipole Villeurbanne | Villeurbanne | 69100 | France |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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