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

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Brief Title

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

Official Title

A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in France and Belgium

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 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
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first

Secondary Outcome

 To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD.

Condition

COVID-19

Intervention

Interleukin-7

Study Arms / Comparison Groups

 CYT107
Description:  Intra-muscular administration of CYT107 twice a week for a total of 5 administrations

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

34

Start Date

June 8, 2020

Completion Date

March 30, 2022

Primary Completion Date

March 30, 2022

Eligibility 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
      

Gender

All

Ages

25 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Bruno François, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04407689

Organization ID

CLI107 COVID FR (ILIAD-7-FR)


Responsible Party

Sponsor

Study Sponsor

Revimmune

Collaborators

 University Hospital, Limoges

Study Sponsor

Bruno François, MD, Study Chair, University Hospital, Limoges


Verification Date

March 2022