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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615429
• Other study ID #: COVID-AT
• Secondary ID: 2020-002193-27
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2020
• Est. completion date: February 2022

Study information

• Verified date: November 2021
• Source: Puerta de Hierro University Hospital
• Contact: Cristina Avendano-Sola, MD, PhD
• Phone: +34911916479
• Email: cavendano[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• COVID-19 Pneumonia
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Biological:
• Mesenchymal stromal cells
Administration of one single dose of allogenic Mesenchymal stromal cells

Other:
• Placebo
Administration of placebo (solution identical to experimental treatment, without the MSC)

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Avendaño Solá

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analytical endpoints	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
Primary	Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration	Primary endpoint	7 days
Secondary	All-cause mortality	Secondary endpoint	Days 7, 14, and 28 after treatment
Secondary	Time to PaO2/FiO2 ratio greater than 200 mmHg	Secondary endpoint	12 months
Secondary	Clinical status on the World Health Organization ordinal 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.	Baseline, daily until day 14, and on day 28 after treatment
Secondary	PaO2/FiO2 ratio	Secondary endpoint	Baseline and days 2, 4, 14 and 28 after treatment
Secondary	SOFA score	Secondary endpoint Sequential Organ Failure Assessment score (0-24)	Baseline and days 2, 4, 7, 14 and 28 after treatment
Secondary	Oxygen therapy-free days	Secondary endpoint	Day 28
Secondary	Duration of hospitalization	Secondary endpoint	12 months
Secondary	Duration of ICU admission	Secondary endpoint	12 months
Secondary	Incidence of non-invasive ventilation	Secondary endpoint Proportion of patients with non-invasive ventilation	Day 28
Secondary	Incidence of invasive mechanical ventilation	Secondary endpoint Proportion of patients with invasive mechanical ventilation	Day 28
Secondary	Duration of non-invasive ventilation	Secondary endpoint (number of days)	Day 28
Secondary	Duration of invasive mechanical ventilation	Secondary endpoint (number of days)	Day 28
Secondary	Mechanical ventilation-free days	Secondary endpoint	Day 28
Secondary	Survival rate	Secondary endpoint	3 and 12 months.
Secondary	Cumulative incidence SAEs, Grade 3 and 4 AEs, ADR and AEs of special interest.	Secondary endpoint	12 months