Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS

February 23, 2026 updated by: Cristina Avendaño Solá

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro-Majadahonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration
Time Frame: 7 days

Change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7.

If an arterial blood gas result cannot be obtained, the SaO2/FiO2 ratio could be substituted for the PaO2/FiO2 ratio
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Hospitalization
Time Frame: 28 days
28 days
Improvement of ≥1 Category at World Health Organization 7 Point Scale
Time Frame: From baseline until day 7, 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.
From baseline until day 7, and on day 28 after treatment
Time to Improvement of ≥1 Category at WHO 7-point Scale
Time Frame: 28 days
28 days
Patients That Had Oxygen Therapy Withdrawn by Day 28
Time Frame: 28 days
28 days
Time to Discontinuation of Oxygen Therapy (WHO ≤3)
Time Frame: 28 days
28 days
Proportion of Patients That Were Discharged at Day 28
Time Frame: 28 days
28 days
Proportion of Patients That Required ICU Admission
Time Frame: 12 months
12 months
Duration of ICU Admission
Time Frame: 12 months
12 months
Mortality at Day 28
Time Frame: 28 days
28 days
Mortality at 12 Months
Time Frame: 12 months
12 months
New Onset Fibrosis at 12 Months
Time Frame: 12 months
New onset fibrosis at 12 months based on CT/X-ray imagine and pulmonary function tests.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and days 2, 4, 7, 14 and 28 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristina Avendaño Solá

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

October 25, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-AT
  • 2020-002193-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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