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

NCT04615429 | Completed Phase 2 Results

• 2 other identifiers: COVID-AT2020-002193-27
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; COVID-19 Pneumonia

Keywords

Acute Respiratory Distress Syndrome; COVID-19 Pneumonia; Mesenchymal stromal cells; Coronavirus; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Secondary Outcomes (11)

• Improvement of ≥1 Category at World Health Organization 7 Point Scale

  From baseline until day 7, and on day 28 after treatment

• Time to Improvement of ≥1 Category at WHO 7-point Scale

  28 days

• Patients That Had Oxygen Therapy Withdrawn by Day 28

  28 days

• Time to Discontinuation of Oxygen Therapy (WHO ≤3)

  28 days

• Proportion of Patients That Were Discharged at Day 28

  28 days

Study Arms (2)

Mesenchymal Stromal cells

EXPERIMENTAL

Approximately 1x10E6 MSC/kg

Biological: Mesenchymal stromal cells

Control group

PLACEBO COMPARATOR

Solution identical to experimental treatment, without the MSC

Other: Placebo

Interventions

Mesenchymal stromal cells BIOLOGICAL

Administration of one single dose of allogenic Mesenchymal stromal cells

Mesenchymal Stromal cells

Placebo OTHER

Administration of placebo (solution identical to experimental treatment, without the MSC)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• Any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.

Sponsors & Collaborators

• Cristina Avendaño Solá: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (2)

• 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.

  PMID: 33407777 BACKGROUND

• 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.

  PMID: 38409332 DERIVED

Related Links

• PubMed link

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Cristina Avendaño-Sola MD, PhD
• Organization: Puerta de Hierro University Hospital

cavendanosola@salud.madrid.org

+34911916479

Study Officials

• 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

  STUDY CHAIR

• Juan J Rubio, MD, PhD

  ICU. Hospital Universitario Puerta de Hierro

  PRINCIPAL INVESTIGATOR

• Rosa Malo, MD

  Respiratory Medicine Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical Pharmacology Deptarment

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: November 4, 2020
• Study Start: September 15, 2020
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)