poor accrual

Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/ kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.

Approximately forty-eight (48) participants will be randomized 1:1 to receive (a) Intramuscular (IM) administration of CYT107 at 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review took place after the first 12 patients. Since the CYT107 was well tolerated, the test dose (3 μg/kg) ceased and the initial dose became the same as the rest of the doses (10 μg/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 μg/kg every 3 to 4 days for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement

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

Exclusion Criteria:

• 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

publication

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