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

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

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.

Condition or disease Intervention/treatment Phase
Covid19 ARDS, Human Other: Mesenchymal stromal cell-based therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020


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.
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)

Experimental: MSC - intermediate dose (5x10ˆ7)
Patients will receive standard care plus cell therapy.
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)

Experimental: MSC - high dose (10x10ˆ7)
Patients will receive standard care plus cell therapy.
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)




Primary Outcome Measures :
  1. Intrahospital mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Length of stay in the ICU and Hospital [ Time Frame: 28 days ]
  2. Days without mechanical ventilation in 28 days [ Time Frame: 28 days ]
  3. PaO2 / FiO2 ratio [ Time Frame: Day 1, Day 2 and Day 7 after cell infusion ]
  4. Incidence of secondary infections [ Time Frame: 28 days ]
  5. Incidence of adverse events [ Time Frame: 28 days ]
  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525378


Contacts
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Contact: Bruno SF Souza, MD PHD +557132816455 bruno.souza@hsr.com.br

Locations
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Brazil
Hospital São Rafael Recruiting
Salvador, Bahia, Brazil, 41253-190
Contact: Andre Gobatto, MD PHD         
Sponsors and Collaborators
D'Or Institute for Research and Education
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Responsible Party: D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT04525378    
Other Study ID Numbers: PCL02/2020
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury