Status:
UNKNOWN
Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia
Lead Sponsor:
Trustem
Collaborating Sponsors:
Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose
Conditions:
COVID-19
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic a...
Detailed Description
Objetive: Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the clinical progresion and mortality of hospitalized COVID-19 patients. Metodology: Fase II, cont...
Eligibility Criteria
Inclusion
- Severe COVID-19.
- Infection confirmed by PCR test.
- Hospitalized in general room (respiratory isolation area).
Exclusion
- Shock or multiorgan disfunction that require continous vital signs monitorization
- Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
- Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
- Pregnant women or breast feeding.
- Advanced hearth failure.
- VIH/AIDS.
- Bacterial or fungical uncontroled infection.
- Permanente use of immunosupresants or have had received an organ trasnplanted in the past six months.
- Imposibility to sign the informent consent format.
- Patients involved in another clinical trial with drugs or interventions.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04429763
Start Date
July 1 2020
End Date
November 1 2020
Last Update
June 12 2020
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