Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia
CELMA
1 other identifier
interventional
30
0 countries
N/A
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 area, that could surpase the resourses of the any health system in the world. There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people. It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started Jul 2020
Shorter than P25 for phase_2 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedJune 12, 2020
June 1, 2020
2 months
June 10, 2020
June 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical deterioration or death
Change in two or more degrees in the NEWS scale
4 weeks
Study Arms (2)
Experimental
EXPERIMENTALUsual tratment for COVID-19 plus MSC
Control
PLACEBO COMPARATORUsual treatment for COVID-19
Interventions
Eligibility Criteria
You may qualify if:
- Severe COVID-19.
- Infection confirmed by PCR test.
- Hospitalized in general room (respiratory isolation area).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trustemlead
- Fundación Universitaria de Ciencias de la Saludcollaborator
- Hospital de San Josecollaborator
- Hospital Infantil Universitario de San Josecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guillermo Sánchez-Vanegas, MD, PhD
Fundación Universitaria de Ciencias de la Salud
- STUDY DIRECTOR
Carlos Escobar-Soto, MD, PhD
Trustem
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
July 1, 2020
Primary Completion
September 1, 2020
Study Completion
November 1, 2020
Last Updated
June 12, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share