MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

• ClinicalTrials.gov Identifier: NCT04525378
• Recruitment Status: Unknown
• First Posted: August 25, 2020
• Last Update Posted: August 26, 2020
• Sponsor: D'Or Institute for Research and Education
• Information provided by (Responsible Party): D'Or Institute for Research and Education

Tracking Information

• First Submitted Date: July 31, 2020
• First Posted Date: August 25, 2020
• Last Update Posted Date: August 26, 2020
• Actual Study Start Date: July 1, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 22, 2020): Intrahospital mortality [ Time Frame: 28 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 24, 2020)

• Length of stay in the ICU and Hospital [ Time Frame: 28 days ]
• Days without mechanical ventilation in 28 days [ Time Frame: 28 days ]
• PaO2 / FiO2 ratio [ Time Frame: Day 1, Day 2 and Day 7 after cell infusion ]
• Incidence of secondary infections [ Time Frame: 28 days ]
• Incidence of adverse events [ Time Frame: 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

Original Secondary Outcome Measures (submitted: August 22, 2020)

• Length of stay in the ICU and Hospital [ Time Frame: 28 days ]
• Days without mechanical ventilation in 28 days [ Time Frame: 28 days ]
• PaO2 / FiO2 ratio [ Time Frame: Day 1, Day 2 and Day 7 after cell infusion ]
• Incidence of secondary infections [ Time Frame: 28 days ]
• Incidence of adverse events [ Time Frame: 28 days ]
• Quantification of inflammatory response markers [ Time Frame: Day 1, Day 3 and Day 7 and Day 14 after cell infusion ]
  Exploratory evaluation of changes from baseline (%) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Covid19
• ARDS, Human

Intervention

Other: Mesenchymal stromal cell-based therapy

Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

Study Arms

• No Intervention: Control
  Patients will receive standard care.
• Experimental: MSC - low dose (2.5x10ˆ7)
  Patients will receive standard care plus cell therapy.
  Intervention: Other: Mesenchymal stromal cell-based therapy
• Experimental: MSC - intermediate dose (5x10ˆ7)
  Patients will receive standard care plus cell therapy.
  Intervention: Other: Mesenchymal stromal cell-based therapy
• Experimental: MSC - high dose (10x10ˆ7)
  Patients will receive standard care plus cell therapy.
  Intervention: Other: Mesenchymal stromal cell-based therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 22, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04525378
• Other Study ID Numbers: PCL02/2020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: D'Or Institute for Research and Education
• Original Responsible Party: Same as current
• Current Study Sponsor: D'Or Institute for Research and Education
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: D'Or Institute for Research and Education
• Verification Date: August 2020