Status:
COMPLETED
Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
Severe Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Whereas the pandemic due do Covid-19 continues to spread, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes Severe Acute Respiratory Distress Syndrome in 30% of patients with a 3...
Detailed Description
General context: As of March 13, 2020, more than 145,000 cases of 2019-nCoV infection have been confirmed with 5,500 deaths worldwide. As of March 21, 14,469 cases have been confirmed in France, of w...
Eligibility Criteria
Inclusion
- Male or female patient, age \> 18 years,
- Laboratory (RT-PCR)-confirmed infection with SARS-CoV2
- Diagnosis of ARDS according to the Berlin definition of ARDS
- Under invasive, non-invasive ventilation or high-flow nasal oxygen therapy (PEEP ≥ 5 cmH2O)
- Onset of ARDS \<96 hours
- Patient with French Social Security System
- Provision of a written informed consent by the designated substitute decision maker, if present. In the event of absence, the patient can be included by investigator's decision alone.
Exclusion
- Previous history of ARDS in the last month
- Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance
- Allogeneic bone marrow transplantation
- Active cancer
- Liver cirrhosis with basal Child and Pugh of C
- Pulmonary fibrosis
- Patient with end-of-life decision
- Patient not expected to survive for 24 hours
- Patient who received an organ transplant
- Woman known to be pregnant or lactating
- Patient already enrolled in another interventional pharmacotherapy protocol on COVID-19
- Patient has burns to ≥15% of their total body surface area
- Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
- Patient under tutelage
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04333368
Start Date
April 6 2020
End Date
October 26 2021
Last Update
February 18 2022
Active Locations (2)
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1
Hôpital Pitié-Salpêtrière - APHP
Paris, France, 75013
2
Hôpital Européen Georges Pompidou - APHP
Paris, France, 75015