MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
1 other identifier
interventional
20
1 country
1
Brief Summary
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
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
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedAugust 26, 2020
August 1, 2020
3 months
July 31, 2020
August 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Intrahospital mortality
28 days
Secondary Outcomes (6)
Length of stay in the ICU and Hospital
28 days
Days without mechanical ventilation in 28 days
28 days
PaO2 / FiO2 ratio
Day 1, Day 2 and Day 7 after cell infusion
Incidence of secondary infections
28 days
Incidence of adverse events
28 days
- +1 more secondary outcomes
Study Arms (4)
Control
NO INTERVENTIONPatients will receive standard care.
MSC - low dose (2.5x10ˆ7)
EXPERIMENTALPatients will receive standard care plus cell therapy.
MSC - intermediate dose (5x10ˆ7)
EXPERIMENTALPatients will receive standard care plus cell therapy.
MSC - high dose (10x10ˆ7)
EXPERIMENTALPatients will receive standard care plus cell therapy.
Interventions
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of COVID-19 confirmed by RT-PCR;
- Thorax CT image suggestive of viral pneumonia;
- Respiratory failure (SaO2 \<93% with O2 at 5L / min)
- Tracheal intubation (first 48 h);
You may not qualify if:
- Pregnancy or breastfeeding;
- Patients with a history of cancer, chemotherapy in the past 2 years;
- Life expectancy less than 6 months or in exclusive palliative care;
- Severe liver failure, with Child-Pugh score\> 12;
- High probability of death in the following 48 h;
- Previous renal failure: patients who were already on dialysis or patients with RFG \<30ml / min / 1.73 m2;
- Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital São Rafael
Salvador, Estado de Bahia, 41253-190, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 25, 2020
Study Start
July 1, 2020
Primary Completion
September 30, 2020
Study Completion
October 31, 2020
Last Updated
August 26, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share