Status:
TERMINATED
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection FR BL Cohort
Lead Sponsor:
Revimmune
Collaborating Sponsors:
University Hospital, Limoges
Amarex Clinical Research
Conditions:
COVID-19
Lymphocytopenia
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04407689
Start Date
June 8 2020
End Date
March 30 2022
Last Update
April 8 2022
Active Locations (6)
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1
University Hospital of Limoges
Limoges, France, 87042
2
Hôpital Edouard Herriot
Lyon, France, 69003
3
hopital Edouard Herriot
Lyon, France, 69437
4
Chr Orleans La Source
Orléans, France, 45067