Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19
NCT ID: NCT04615429
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-09-15
2022-02-28
Brief Summary
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Detailed Description
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All trial participants will receive SOC\*.
Randomization will be 1:1 between:
* Treatment arm: allogenic MSC.
* Control arm: Placebo (solution with the same composition as the experimental treatment, without the MSC).
* SOC can include any medicines that are being used in clinical practice (e.g. lopinavir/ritonavir; hydroxy/chloroquine, tocilizumab, etc.).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mesenchymal Stromal cells
Approximately 1x10E6 MSC/kg
Mesenchymal stromal cells
Administration of one single dose of allogenic Mesenchymal stromal cells
Control group
Solution identical to experimental treatment, without the MSC
Placebo
Administration of placebo (solution identical to experimental treatment, without the MSC)
Interventions
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Mesenchymal stromal cells
Administration of one single dose of allogenic Mesenchymal stromal cells
Placebo
Administration of placebo (solution identical to experimental treatment, without the MSC)
Eligibility Criteria
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Inclusion Criteria
2. Adult patients ≥18 years of age at the time of enrolment.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigenic tests) are also acceptable as laboratory confirmation if their specificity has been accepted by the Sponsor.
4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
5. Patients requiring invasive ventilation are eligible within 72 hours from intubation.
6. Eligible for ICU admission, according to the clinical team.
Exclusion Criteria
2. "Do Not Attempt Resuscitation" order in place.
3. Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
4. History of a moderate/severe lung disorder requiring home-based oxygen therapy.
5. Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
6. Current diagnosis of pulmonary embolism.
7. Active neoplasm, except carcinoma in situ or basalioma.
8. Known allergy to the products involved in the allogenic MSC production process.
9. Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
11. Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.
18 Years
ALL
No
Sponsors
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Cristina Avendaño Solá
OTHER
Responsible Party
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Cristina Avendaño Solá
Head of Clinical Pharmacology Deptarment
Principal Investigators
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Rafael F Duarte, MD, PhD
Role: STUDY_CHAIR
Hematology Department. Hospital Universitario Puerta de Hierro
Cristina Avedano-Sola, MD, PhD
Role: STUDY_CHAIR
Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro
Juan J Rubio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ICU. Hospital Universitario Puerta de Hierro
Rosa Malo, MD
Role: PRINCIPAL_INVESTIGATOR
Respiratory Medicine Department
Locations
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Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Rafael F Duarte, MD, PhD
Role: primary
References
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Martinez-Munoz ME, Payares-Herrera C, Lipperheide I, Malo de Molina R, Salcedo I, Alonso R, Martin-Donaire T, Sanchez R, Zafra R, Garcia-Berciano M, Trisan-Alonso A, Perez-Torres M, Ramos-Martinez A, Ussetti P, Rubio JJ, Avendano-Sola C, Duarte RF. Mesenchymal stromal cell therapy for COVID-19 acute respiratory distress syndrome: a double-blind randomised controlled trial. Bone Marrow Transplant. 2024 Jun;59(6):777-784. doi: 10.1038/s41409-024-02230-5. Epub 2024 Feb 26.
Payares-Herrera C, Martinez-Munoz ME, Vallhonrat IL, de Molina RM, Torres MP, Trisan A, de Diego IS, Alonso R, Zafra R, Donaire T, Sanchez R, Rubio JJ, Duarte Palomino RF, Sola CA. Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 6;22(1):9. doi: 10.1186/s13063-020-04964-1.
Other Identifiers
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2020-002193-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COVID-AT
Identifier Type: -
Identifier Source: org_study_id