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Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19

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ClinicalTrials.gov Identifier: NCT04615429
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Cristina Avendaño Solá, Puerta de Hierro University Hospital

Brief Summary:
A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome COVID-19 Pneumonia Biological: Mesenchymal stromal cells Other: Placebo Phase 2

Detailed Description:

A double-blind, randomized, controlled, clinical trial to evaluate the efficacy and safety of MSC (mesenchymal stromal cells) intravenous administration in patients with COVID-induced ARDS compared to a control arm.

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.).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Controlled, Clinical Trial to Assess the Efficacy of Allogenic Mesenchymal Stromal Cells in Patients With Acute Respiratory Distress Syndrome Due to COVID-19
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022


Arm Intervention/treatment
Experimental: Mesenchymal Stromal cells
Approximately 1x10E6 MSC/kg
Biological: Mesenchymal stromal cells
Administration of one single dose of allogenic Mesenchymal stromal cells

Placebo Comparator: Control group
Solution identical to experimental treatment, without the MSC
Other: Placebo
Administration of placebo (solution identical to experimental treatment, without the MSC)




Primary Outcome Measures :
  1. Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration [ Time Frame: 7 days ]
    Primary endpoint


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Days 7, 14, and 28 after treatment ]
    Secondary endpoint

  2. Time to PaO2/FiO2 ratio greater than 200 mmHg [ Time Frame: 12 months ]
    Secondary endpoint

  3. Clinical status on the World Health Organization ordinal scale [ Time Frame: Baseline, daily until day 14, and on day 28 after treatment ]

    Secondary endpoint.

    Categories:

    1. Not hospitalized, no limitations on activities.
    2. Not hospitalized, limitation on activities.
    3. Hospitalized, not requiring supplemental oxygen.
    4. Hospitalized, requiring supplemental oxygen.
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices.
    6. Hospitalized, on invasive mechanical ventilation or ECMO .
    7. Death.

  4. PaO2/FiO2 ratio [ Time Frame: Baseline and days 2, 4, 14 and 28 after treatment ]
    Secondary endpoint

  5. SOFA score [ Time Frame: Baseline and days 2, 4, 7, 14 and 28 after treatment ]
    Secondary endpoint Sequential Organ Failure Assessment score (0-24)

  6. Oxygen therapy-free days [ Time Frame: Day 28 ]
    Secondary endpoint

  7. Duration of hospitalization [ Time Frame: 12 months ]
    Secondary endpoint

  8. Duration of ICU admission [ Time Frame: 12 months ]
    Secondary endpoint

  9. Incidence of non-invasive ventilation [ Time Frame: Day 28 ]
    Secondary endpoint Proportion of patients with non-invasive ventilation

  10. Incidence of invasive mechanical ventilation [ Time Frame: Day 28 ]
    Secondary endpoint Proportion of patients with invasive mechanical ventilation

  11. Duration of non-invasive ventilation [ Time Frame: Day 28 ]
    Secondary endpoint (number of days)

  12. Duration of invasive mechanical ventilation [ Time Frame: Day 28 ]
    Secondary endpoint (number of days)

  13. Mechanical ventilation-free days [ Time Frame: Day 28 ]
    Secondary endpoint

  14. Survival rate [ Time Frame: 3 and 12 months. ]
    Secondary endpoint

  15. Cumulative incidence SAEs, Grade 3 and 4 AEs, ADR and AEs of special interest. [ Time Frame: 12 months ]
    Secondary endpoint


Other Outcome Measures:
  1. Analytical endpoints [ Time Frame: Baseline and days 2, 4, 7, 14 and 28 after treatment ]
    Exploratory endpoint Analytical markers (e.g., neutrophil and lymphocyte counts). Changes from baseline to set time points will be calculated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible.
  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:

  1. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
  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).
  10. Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
  11. Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.

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): NCT04615429


Contacts
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Contact: Cristina Avendano-Sola, MD, PhD +34911916479 cavendano@salud.madrid.org
Contact: Maria C Payares, MD, PhD concepcion.payares@salud.madrid.org

Locations
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Spain
Hospital Universitario Puerta de Hierro-Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Rafael F Duarte, MD, PhD    +34911916662    rduarte.work@gmail.com   
Principal Investigator: Rafael F Duarte, MD, PhD         
Principal Investigator: Juan J Rubio, MD, PhD         
Principal Investigator: Rosa Malo, MD         
Sponsors and Collaborators
Cristina Avendaño Solá
Investigators
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Study Chair: Rafael F Duarte, MD, PhD Hematology Department. Hospital Universitario Puerta de Hierro
Study Chair: Cristina Avedano-Sola, MD, PhD Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro
Principal Investigator: Juan J Rubio, MD, PhD ICU. Hospital Universitario Puerta de Hierro
Principal Investigator: Rosa Malo, MD Respiratory Medicine Department
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cristina Avendaño Solá, Head of Clinical Pharmacology Deptarment, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT04615429    
Other Study ID Numbers: COVID-AT
2020-002193-27 ( EudraCT Number )
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
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
Keywords provided by Cristina Avendaño Solá, Puerta de Hierro University Hospital:
Acute Respiratory Distress Syndrome
COVID-19 Pneumonia
Mesenchymal stromal cells
Coronavirus
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury