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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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04615429
Study type Interventional
Source Puerta de Hierro University Hospital
Contact Cristina Avendano-Sola, MD, PhD
Phone +34911916479
Email cavendano@salud.madrid.org
Status Recruiting
Phase Phase 2
Start date September 15, 2020
Completion date February 2022
View Details
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