COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04357444

Jean-Michel CONSTANTIN

Jean-michel.constantin@aphp.fr

2020-04-22

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - male or female, age ≥ 18 years - laboratory (rt-pcr) confirmed infection with sars-cov2 - patient is either under invasive or non-invasive mechanical ventilation (including high flow nasal oxygen therapy). - diagnosis of ards according to the berlin definition of ards - onset of ards <96 hours - patient with french social security system - 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 - history of organ allograft. - 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 - woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test - patient already enrolled in another interventional pharmacotherapy protocol on covid-19 - patient with known hypersensitivity to natural or recombinant interleukin-2 or to any of the excipients - presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 1.5x109/l, ast or alt greater than 5 x uln, platelets <50,000 per mm3 - use of chronic oral corticosteroids > 10 mg prednisone equivalent a day for a non-covid-19-related condition - current uncontrolled autoimmune disease - patients with uncontrolled suspected or known active systemic bacterial or fungal infections - patient with severe, uncontrolled pre-existing (chronic) organ failure (myocardial, hepatic or renal) - vaccination with live attenuated vaccines in the month preceding the inclusion - patient with burns to ≥ 15% of their total body surface area - patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support - patient under legal protection (protection of the court, or in curatorship or guardianship).

2

Assistance Publique - Hôpitaux de Paris

18

None

France

Critical disease at enrollment

8: Critical disease at enrollment

30

The PaO2/FiO2 ratio at D11

None

Phase 2

[{"arm_notes": "", "treatment_id": 630, "treatment_name": "Ilt101", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]