- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525378
MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
August 24, 2020 updated by: D'Or Institute for Research and Education
Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bruno SF Souza, MD PHD
- Phone Number: +557132816455
- Email: bruno.souza@hsr.com.br
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 41253-190
- Recruiting
- Hospital Sao Rafael
-
Contact:
- Andre Gobatto, MD PHD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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);
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Patients will receive standard care.
|
|
Experimental: MSC - low dose (2.5x10ˆ7)
Patients will receive standard care plus cell therapy.
|
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
|
Experimental: MSC - intermediate dose (5x10ˆ7)
Patients will receive standard care plus cell therapy.
|
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
|
Experimental: MSC - high dose (10x10ˆ7)
Patients will receive standard care plus cell therapy.
|
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intrahospital mortality
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay in the ICU and Hospital
Time Frame: 28 days
|
28 days
|
|
Days without mechanical ventilation in 28 days
Time Frame: 28 days
|
28 days
|
|
PaO2 / FiO2 ratio
Time Frame: Day 1, Day 2 and Day 7 after cell infusion
|
Day 1, Day 2 and Day 7 after cell infusion
|
|
Incidence of secondary infections
Time Frame: 28 days
|
28 days
|
|
Incidence of adverse events
Time Frame: 28 days
|
28 days
|
|
Quantification of inflammatory response markers
Time Frame: Day 1, Day 3 and Day 7 after cell infusion
|
Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry
|
Day 1, Day 3 and Day 7 after cell infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Anticipated)
September 30, 2020
Study Completion (Anticipated)
October 31, 2020
Study Registration Dates
First Submitted
July 31, 2020
First Submitted That Met QC Criteria
August 22, 2020
First Posted (Actual)
August 25, 2020
Study Record Updates
Last Update Posted (Actual)
August 26, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- PCL02/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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