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.
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.).
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)
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.
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain
Investigator: Rafael F Duarte, MD, PhD
Contact: +34911916662
rduarte.work@gmail.com
Investigator:
Cristina Avendano-Sola, MD, PhD
+34911916479
cavendano@salud.madrid.org
Maria C Payares, MD, PhD
concepcion.payares@salud.madrid.org