Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751643
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2021-02-05
Brief Title:
Therapeutic Plasma Exchange to Alleviate Hyperinflammatory Condition During Severe Covid-19 Infections
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Assessment of Therapeutic Plasma Exchange to Improve Respiratory Function by Alleviating Cytokine Storm During Severe Covid-19 Infections Randomised Open-label Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CovidEP
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A03039-30 | OTHER | ID-RCB | None |