COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04379076

Manu Shankar-Hari

Not reported

2020-05-07

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 >2l per minute nasal cannula or greater to keep saturations >90%, non-invasive positive pressure ventilation (e.g., bipap), or patients intubated/ventilated for respiratory failure - confirmed infection with covid-19 by any acceptable test available/utilized at each site - private insurance or government support (through nhs or other)

- 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: - requirement for a persistent and sustained increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain spo2 at greater than or equal to 88% (this 20 % limit does not apply to o2 delivered by nasal canula) - or need for invasive mechanical ventilation - patients with chronic kidney dialysis - 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 a sofa score ≥ 9 at baseline - patients with a bmi > 40 - patients with baseline rockwood clinical frailty scale ≥ 6.(assessed as patient or proxy 4-week recall of chronic health and frailty status prior to covid infection) - patients under guardianship

2

Revimmune

25

80

United Kingdom

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

35

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), whicheve

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"}]