InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort

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Brief Title

InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK 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 UK

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 will take place after the first 12 patients. If the
      CYT107 is well tolerated, the test dose (3 μg/kg) will cease and that initial dose will
      become 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), whicheve

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

35

Start Date

May 14, 2020

Completion Date

March 30, 2022

Primary Completion Date

February 28, 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
             >2L per minute nasal cannula or greater to keep saturations >90%, non-invasive
             positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for
             respiratory failure

          -  Confirmed infection with COVID-19 by any acceptable test available/utilized at each
             site

          -  Private insurance or government support (through NHS or other)

        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:

          -  requirement for a persistent and sustained increase in inspired oxygen concentrations
             of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88%
             (this 20 % limit does not apply to O2 delivered by nasal canula)

          -  or need for invasive mechanical ventilation

          -  Patients with chronic kidney dialysis

          -  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 a SOFA score ≥ 9 at baseline

          -  Patients with a BMI > 40

          -  Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.(assessed as patient or
             proxy 4-week recall of chronic health and frailty status prior to COVID infection)

          -  Patients under guardianship
      

Gender

All

Ages

25 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Manu Shankar-Hari, MD PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04379076

Organization ID

CLI107 COVID UK (ILIAD-7-UK)


Responsible Party

Sponsor

Study Sponsor

Revimmune

Collaborators

 Amarex Clinical Research

Study Sponsor

Manu Shankar-Hari, MD PhD, Principal Investigator, Guy's and St Thomas' NHS Foundation Trust


Verification Date

March 2022