COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04407689

Bruno François

Not reported

2020-05-29

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - a written, signed informed consent, or emergency oral consent, by the patient or the patient's legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing study participation - men and women aged ≥ 25 - 80 (included) years of age - hospitalized patients with one absolute lymphocyte count (alc) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline - hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >4l per minute nasal cannula or greater to keep saturations >90%, non-invasive positive pressure ventilation (e.g., bipap) for respiratory failure - confirmed infection with covid-19 by any acceptable test available/ utilized at each site - patient with medical insurance or government support

- pregnancy or breast feeding; - refusal or inability to practice contraception regardless of the gender of the patient; - alt and/or ast > 5 x uln - known, active auto-immune disease; - ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing; - patients with past history of solid organ transplant. - active tuberculosis, uncontrolled active hbv or hcv infection, hiv with positive viral load. - patients whose respiratory condition is showing significant deterioration as indicated by: - 8a requirement for an increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain spo2 at greater than or equal to 88% - 8b or need for invasive mechanical ventilation - patients showing an increase of the news2 score by more than 6 points during the screening / baseline period (48 to 72 hrs prior to first administration) - patients with chronic kidney dialysis - patients with a sofa score ≥ 9 at baseline - patients with a bmi > 40 - patients receiving any agent with immune suppressive effects,such as anti-il6 treatments like tocilizumab or sarilumab which should preferably be minimized - presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) < 1.5x109/l, platelets < 50,000 per mm3 - patients with uncontrolled pre-existing severe major organ dysfunction (cardiac, liver or renal failure) - vaccination with live attenuated vaccines in the month preceding the inclusion - use of chronic oral corticosteroids ≥ 10mg prednisone equivalent a day for a non-covid-19 related condition - patients with baseline rockwood clinical frailty scale ≥ 6. - patients with known hypersensitivity to natural or recombinant interleukin-7 or to any of the excipients - patients under guardianship

2

Revimmune

25

80

France

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

34

Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first

None

Phase 2

[{"arm_notes": "", "treatment_id": 678, "treatment_name": "Interleukin-7", "treatment_type": "Interleukins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]