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

AbstractObjectives1. To assess the efficacy of Mesenchymal Stromal Cells (MSC) versus a control arm as described in the primary endpoint.2. To evaluate the effects of MSC on the secondary efficacy endpoints.3. To evaluate the safety and tolerability profiles of MSC.4. To study soluble and cellular biomarkers that might be involved in the course of the disease and the response to the investigational product.Trial designA double-blind, randomized, controlled, trial to evaluate the efficacy and safety of MSC intravenous administration in patients with COVID-induced Acute Respiratory Distress Syndrome (ARDS) compared to a control arm.ParticipantsThe trial is being conducted at a third level hospital, Hospital Universitario Puerta de Hierro, in Majadahonda, Madrid (Spain).Inclusion criteria1. 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 Polymerase Chain Reaction (PCR), in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. Alternative tests (e.g., rapid antigen 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 ...
Source: Trials - Category: Research Source Type: clinical trials