Status:
UNKNOWN
Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Covid 19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Acute Respiratory Distress Syndrome (ARDS) is the main cause of death from COVID-19. One of the main mechanisms for ARDS is the violent storm of cytokines and chemokines, which cause uncontrolled fata...
Detailed Description
Acute Respiratory Distress Syndrome (ARDS) is the main cause of death from COVID-19. One of the main mechanisms for ARDS is the storm of cytokines and chemokines, which cause uncontrolled fatal system...
Eligibility Criteria
Inclusion
- Bilateral pneumonia due to COVID-19
- With SARS-Cov2 PCR RNA detection test, positive
- Severe ARDS
- PaO2/FiO2 \<150
- Leukocytes \< 800
- Chest TAC with pneumonia bilateral
- persistant fever
- increase 50% D-Dimer, respect to basal value
- Ferritin \> 1000
- SOFA \< 11
- Medical treatment during 48 hr according to de Institutional Medical center
- With knowledge of the patient and / or his relatives responsible that it is a rescue treatment, in experimental phase.
Exclusion
- Pneumonia or ARDS caused by COVID-19, mild and moderate.
- More than three organic failures
- Expectations of survival less than 48 hr in the opinion of the treating service
- Pneumonia or SIRA not caused by COVID-19
- Advance will of the patient to refuse rescue or experimental treatment.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04416139
Start Date
May 1 2020
End Date
May 1 2021
Last Update
June 4 2020
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14080