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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.
Full description
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
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Inclusion criteria
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:
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
Primary purpose
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Interventional model
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34 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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