COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04869397

None

None

2021-05-03

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - male or female, aged 18 years-old or older - laboratory-confirmed sars-cov-2 infection determined by reverse-transcription polymerase chain reaction (rt-pcr) prior to randomization - hospitalized patients - severe covid-19 pneumonia defined as patients who cannot saturate > 96% on 4 l/min but are not on "non-invasive" ventilation nor invasive mechanical ventilation nor extracorporeal membrane oxygenation (ecmo). patients on high flow would be eligible if they receive treatment in a non-critical care unit only. - use of contraception or acceptable birth control for the duration of the study in women of childbearing potential - provision of written or verbal informed consent by the patient or designated substitute decision maker

- inability to provide informed consent - patients expected to survive less than 24 hours - advanced directives of patient's wishes to refuse intubation. - patients on mechanical ventilation - pregnant women [pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hcg) laboratory test] - breastfeeding - weight > 100 kg or < 50 kg - cancer not in remission or active serious illness unrelated to covid-19. - any of the following laboratory results at screening: absolute neutrophil count (anc) ≤ 1.0 x 109/l, platelets (plt) < 50 g /l, alanine transaminase (alt) or aspartate transaminase (ast) > 5n, egfr < 30 ml/min - current documented bacterial infection - known infection with human immunodeficiency virus, treponema pallidum, hepatitis b antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or hepatitis c - on-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months - known allergies to a component of the protrans® product - pre-existing chronic respiratory diseases requiring long-term oxygen therapy or severe pulmonary hypertension (paps >30 mm hg) or pulmonary fibrosis - pre-existing cirrhosis with basal child and pugh of c

2

McGill University Health Centre/Research Institute of the McGill University Health Centre

18

100

Canada

Severe disease at enrollment

6: Severe disease at enrollment

19

Composite endpoint

None

Phase 2

[{"arm_notes": "", "treatment_id": 66, "treatment_name": "Allogeneic wharton's jelly-mscs (wj-msc)", "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"}]