Safety and Feasibility of Allogenic MSC in the Treatment of COVID-19
COVID19
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm. Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with 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_1 covid19
Started Jul 2020
Shorter than P25 for phase_1 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
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedStudy Start
First participant enrolled
July 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJuly 10, 2020
July 1, 2020
3 months
July 7, 2020
July 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Assessment of Overall survival at 30 days post intervention
60 days
Secondary Outcomes (6)
Changes on inflammatory C-reactive protein
60 days
Hospital stay
60 days
Oxygenation index (PaO2/FiO2)
60 days
Improvement in Liao's score (2020)
60 days
Radiological improvement
60 days
- +1 more secondary outcomes
Study Arms (1)
Intervention
EXPERIMENTALIntravenous 1\*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
Interventions
Intravenous 1\*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
Eligibility Criteria
You may qualify if:
- Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR)
- The patient or legal donor agrees to participate in the study and signs the informed consent.
- Patients with orange or red criteria according to the score proposed by Liao et al (2020)
You may not qualify if:
- Patient with pregnancy, are planning to become pregnant or breastfeeding
- Patients with malignant blood-borne diseases such as HIV or syphilis
- Not consenting for clinical trial
- Patients with other than orange or red criteria according to the score proposed by Liao et al (2020)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucia Silla, MD, PhD
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 10, 2020
Study Start
July 25, 2020
Primary Completion
October 30, 2020
Study Completion
December 30, 2020
Last Updated
July 10, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share