COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04333368

Antoine MONSEL

antoine.monsel@aphp.fr

2020-04-03

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - male or female patient, age > 18 years, - laboratory (rt-pcr)-confirmed infection with sars-cov2 - diagnosis of ards according to the berlin definition of ards - under invasive, non-invasive ventilation or high-flow nasal oxygen therapy (peep ≥ 5 cmh2o) - onset of ards <96 hours - patient with french social security system - provision of a written informed consent by the designated substitute decision maker, if present. in the event of absence, the patient can be included by investigator's decision alone.

- previous history of ards in the last month - chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance - allogeneic bone marrow transplantation - active cancer - liver cirrhosis with basal child and pugh of c - pulmonary fibrosis - patient with end-of-life decision - patient not expected to survive for 24 hours - patient who received an organ transplant - woman known to be pregnant or lactating - patient already enrolled in another interventional pharmacotherapy protocol on covid-19 - patient has burns to ≥15% of their total body surface area - patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support - patient under tutelage

2

Assistance Publique - Hôpitaux de Paris

18

None

France

Critical disease at enrollment

8: Critical disease at enrollment

47

Respiratory efficacy evaluated by the increase in PaO2/FiO2 ratio from baseline to day 7 in the experimental group compared with the placebo group

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1335, "treatment_name": "Umbilical cord wharton\u2019s jelly derived mesenchymal stem 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"}]