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

Phase 1

• Conditions: COVID-related Acute Respiratory Distress Syndrome; MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002193-27-ES
• Lead Sponsor: Cristina Avendano-Sola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-14
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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.
4.Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 72 hours at the time of randomization.
5.Patients requiring invasive ventilation are eligible within 48 hours from intubation.
6.Eligible for ICU admission, according to the clinical team.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of MSC versus a control arm as described in the primary endpoint.;Secondary Objective: - To evaluate the effects of MSC on the secondary efficacy endpoints. <br>- To evaluate the safety and tolerability profiles of MSC.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: At day 7, after treatment administration