Back to resultsMSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
Primary Purpose
Covid19, ARDS, Human
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Mesenchymal stromal cell-based therapy
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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.
Sites / Locations
- Hospital São RafaelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control
MSC - low dose (2.5x10ˆ7)
MSC - intermediate dose (5x10ˆ7)
MSC - high dose (10x10ˆ7)
Arm Description
Patients will receive standard care.
Patients will receive standard care plus cell therapy.
Patients will receive standard care plus cell therapy.
Patients will receive standard care plus cell therapy.
Outcomes
Primary Outcome Measures
Intrahospital mortality
Secondary Outcome Measures
Length of stay in the ICU and Hospital
Days without mechanical ventilation in 28 days
PaO2 / FiO2 ratio
Incidence of secondary infections
Incidence of adverse events
Quantification of inflammatory response markers
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
Full Information
NCT ID
NCT04525378
First Posted
July 31, 2020
Last Updated
August 24, 2020
Sponsor
D'Or Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT04525378
Brief Title
MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
Official Title
Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, ARDS, Human
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive standard care.
Arm Title
MSC - low dose (2.5x10ˆ7)
Arm Type
Experimental
Arm Description
Patients will receive standard care plus cell therapy.
Arm Title
MSC - intermediate dose (5x10ˆ7)
Arm Type
Experimental
Arm Description
Patients will receive standard care plus cell therapy.
Arm Title
MSC - high dose (10x10ˆ7)
Arm Type
Experimental
Arm Description
Patients will receive standard care plus cell therapy.
Intervention Type
Other
Intervention Name(s)
Mesenchymal stromal cell-based therapy
Intervention Description
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
Primary Outcome Measure Information:
Title
Intrahospital mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Length of stay in the ICU and Hospital
Time Frame
28 days
Title
Days without mechanical ventilation in 28 days
Time Frame
28 days
Title
PaO2 / FiO2 ratio
Time Frame
Day 1, Day 2 and Day 7 after cell infusion
Title
Incidence of secondary infections
Time Frame
28 days
Title
Incidence of adverse events
Time Frame
28 days
Title
Quantification of inflammatory response markers
Description
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
Time Frame
Day 1, Day 3 and Day 7 after cell infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno SF Souza, MD PHD
Phone
+557132816455
Email
bruno.souza@hsr.com.br
Facility Information:
Facility Name
Hospital São Rafael
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Gobatto, MD PHD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
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