Acute Respiratory Distress SyndromePhase 2NCT04615429
Double-blind, Randomized, Controlled Clinical Trial to Assess Efficacy of MSC in Patients With COVID-19 ARDS
A Phase 2 study testing Mesenchymal stromal cells in people with Acute Respiratory Distress Syndrome and COVID-19 Pneumonia, run by Cristina Avendaño Solá at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID-19 Pneumonia
- What is being tested?
- Mesenchymal stromal cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2020to 1 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Adult patients ≥18 years of age at the time of enrolment.
- 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.
- Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
- Patients requiring invasive ventilation are eligible within 72 hours from intubation.
- Eligible for ICU admission, according to the clinical team.
Who cannot join
- Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
- "Do Not Attempt Resuscitation" order in place.
- Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
- History of a moderate/severe lung disorder requiring home-based oxygen therapy.
- Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
- Current diagnosis of pulmonary embolism.
Show all 11Show fewer
- Active neoplasm, except carcinoma in situ or basalioma.
- Known allergy to the products involved in the allogenic MSC production process.
- Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
- 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).
- Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222
About this study
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
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.
Read the 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.).
- Being tested
- Mesenchymal stromal cells, Placebo
- Keywords
- Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, Mesenchymal stromal cells, Coronavirus, SARS-CoV-2
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stromal cellsBiological
Administration of one single dose of allogenic Mesenchymal stromal cells
PlaceboOther
Administration of placebo (solution identical to experimental treatment, without the MSC)
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stromal cells | Experimental | Approximately 1x10E6 MSC/kg Receives: Biological: Mesenchymal stromal cells |
| Control group | Placebo comparator | Solution identical to experimental treatment, without the MSC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration
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
Measured: 7 days
Secondary outcomes (11)
Improvement of ≥1 Category at World Health Organization 7 Point Scale
Secondary endpoint.
Categories:
- Not hospitalized, no limitations on activities.
- Not hospitalized, limitation on activities.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, on non-invasive ventilation or high flow oxygen devices.
- Hospitalized, on invasive mechanical ventilation or ECMO .
- Death.
Measured: From baseline until day 7, and on day 28 after treatment
Time to Improvement of ≥1 Category at WHO 7-point Scale
Measured: 28 days
Patients That Had Oxygen Therapy Withdrawn by Day 28
Measured: 28 days
Time to Discontinuation of Oxygen Therapy (WHO ≤3)
Measured: 28 days
Proportion of Patients That Were Discharged at Day 28
Measured: 28 days
Duration of Hospitalization
Measured: 28 days
Proportion of Patients That Required ICU Admission
Measured: 12 months
Duration of ICU Admission
Measured: 12 months
Mortality at Day 28
Measured: 28 days
Mortality at 12 Months
Measured: 12 months
New Onset Fibrosis at 12 Months
New onset fibrosis at 12 months based on CT/X-ray imagine and pulmonary function tests.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start15 Sep 2020
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristina Avendaño Solá
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristina Avendaño Solá, Puerta de Hierro University Hospital
- Investigators
- Rafael F Duarte, MD, PhD, Study chair, Hematology Department. Hospital Universitario Puerta de HierroCristina Avedano-Sola, MD, PhD, Study chair, Clinical Pharmacology Department. Hospital Universitario Puerta de HierroJuan J Rubio, MD, PhD, Principal investigator, ICU. Hospital Universitario Puerta de HierroRosa Malo, MD, Principal investigator, Respiratory Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615429
- Sponsor's protocol ID
- COVID-AT
- Other IDs
- 2020-002193-27
- Status last verified
- Feb 2026
- First submitted
- 25 Oct 2020
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33407777Martinez-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.
PubMed 38409332
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04615429
- Acronym / sponsor ID
- COVID-AT
- Keywords
- Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, Mesenchymal stromal cells, Coronavirus, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cristina Avendaño SoláUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 17 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stromal cells | Experimental | Biological: Mesenchymal stromal cellsApproximately 1x10E6 MSC/kg |
| Control group | Placebo comparator | Other: PlaceboSolution identical to experimental treatment, without the MSC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Adult patients ≥18 years of age at the time of enrolment.
- 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.
- Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96 hours at the time of randomization.
- Patients requiring invasive ventilation are eligible within 72 hours from intubation.
Key exclusion criteria (11 listed)
- Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
- "Do Not Attempt Resuscitation" order in place.
- Any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment.
- History of a moderate/severe lung disorder requiring home-based oxygen therapy.
- Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stromal cellsAdministration of one single dose of allogenic Mesenchymal stromal cells | Biological | Mesenchymal Stromal cells |
| PlaceboAdministration of placebo (solution identical to experimental treatment, without the MSC) | Other | Control group |
Primary outcome
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
11 secondary outcomes
Improvement of ≥1 Category at World Health Organization 7 Point Scale
Time frame: 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
Patients That Had Oxygen Therapy Withdrawn by Day 28
Time frame: 28 days
Time to Discontinuation of Oxygen Therapy (WHO ≤3)
Time frame: 28 days
Proportion of Patients That Were Discharged at Day 28
Time frame: 28 days
Duration of Hospitalization
Time frame: 28 days
Proportion of Patients That Required ICU Admission
Time frame: 12 months
Duration of ICU Admission
Time frame: 12 months
Mortality at Day 28
Time frame: 28 days
Mortality at 12 Months
Time frame: 12 months
New Onset Fibrosis at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33407777Payares-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.
- Derived from this study: PubMed 38409332Martinez-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.
- PubMed linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael F Duarte, MD, PhD study chair
Hematology Department. Hospital Universitario Puerta de Hierro
Cristina Avedano-Sola, MD, PhD study chair
Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro
Juan J Rubio, MD, PhD principal investigator
ICU. Hospital Universitario Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stromal cells in people with Acute Respiratory Distress Syndrome and COVID-19 Pneumonia, run by Cristina Avendaño Solá at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the PaO2/FiO2* Ratio From Baseline to Day 7 of Treatment Administration (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615429, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.