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

Revimmune

Status and phase

Terminated

Phase 2

Conditions

COVID-19

Lymphocytopenia

Treatments

Drug: Interleukin-7

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04407689

CLI107 COVID FR (ILIAD-7-FR)

Details and patient eligibility

About

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

Enrollment

34 patients

Sex

All

Ages

25 to 80 years old

Volunteers

No Healthy Volunteers

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