InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection FR BL Cohort

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Revimmune
• Collaborators: Amarex Clinical Research; University Hospital, Limoges

Criteria

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