COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001573-78/FR

CHU de Limoges - Renaud MARTIN

renaud.martin@chu-limoges.fr

2020-04-14

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. 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 2. Men and women aged ≥ 25 – 80 (included) years of age 3. Hospitalized patients with two absolute lymphocyte count (ALC) ≤ 700 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION: The FIRST time point should not be performed earlier than 48 hours after Hospitalization, thus first test dose can’t be administered before 72 hours after hospitalization (From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient’s clinical status) 4. 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), or patients intubated/ventilated for respiratory failure 5. Confirmed infection with COVID-19 by any acceptable test available/utilized at each site 6. Patient with medical insurance or government support

1. Pregnancy or breast feeding, 2. Refusal or inability to practice contraception regardless of the gender of the patient, 3. ALT and/or AST > 5 x ULN 4. Known, active auto-immune disease, 5. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing, 6. Patients with past history of Solid Organ transplant. 7. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load. 8. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours 9. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300mg/day and/or anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized 10. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6. 11. Patients under guardianship

2

RevImmune

25

80

United States;France

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

40

An improvement in the absolute lymphocyte count (ALC) is defined as a statistically significant increase from randomization to day 30 or HD, and will also be assessed at defined timepoints (as indicated in the Schedule of Activities, to include all Study drug administration days).

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 369, "treatment_name": "Cyt 107", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]