COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04615429

Cristina Avendano-Sola, MD, PhD

cavendano@salud.madrid.org

2020-11-04

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: 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. adult patients ≥18 years of age at the time of enrolment. 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. moderate to severe ards (pao2/fio2 ratio equal or less than 200 mmhg) for less than 96 hours at the time of randomization. patients requiring invasive ventilation are eligible within 72 hours from intubation. eligible for icu admission, according to the clinical team.

imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team). "do not attempt resuscitation" order in place. any end-stage organ disease or condition, which in the investigator's opinion, makes the patient an unsuitable candidate for treatment. history of a moderate/severe lung disorder requiring home-based oxygen therapy. patient requiring ecmo, hemodialysis or hemofiltration at the time of treatment administration. current diagnosis of pulmonary embolism. active neoplasm, except carcinoma in situ or basalioma. known allergy to the products involved in the allogenic msc production process. current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment). 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). any circumstances that in the investigator's opinion compromises the patient's ability to participate in the clinical trial.

2

Cristina Avendaño Solá

18

100

Spain

Critical disease at enrollment

8: Critical disease at enrollment

20

Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration

None

Phase 2

[{"arm_notes": "", "treatment_id": 793, "treatment_name": "Mesenchymal stromal cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]