InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )

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Brief Title

InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )

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. US Infectious Cohort

Brief Summary

      Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for
      three 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 10 μg/kg followed, after 72hrs of
      observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to
      patient's length of stay in the hospital) 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.

      This cohort excludes oncology patients on treatment
    

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

 "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD.

Condition

COVID-19

Intervention

CYT107

Study Arms / Comparison Groups

 CYT107 Treatment
Description:  Intramuscular (IM) administration of CYT107 twice a week for 3 weeks

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

48

Start Date

September 15, 2020

Completion Date

December 31, 2021

Primary Completion Date

October 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. 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

          2. Men and women aged ≥ 25 - 80 (included) years of age

          3. Hospitalized patients with two absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, at
             two time points at least 24 hours apart, following HOSPITALIZATION:

          4. 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), or patients intubated / ventilated for
             respiratory failure

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

          6. Willingness and ability to practice contraception regardless of the gender of the
             patient during 5 month after last drug exposure

          7. Private insurance or government / institution financial support (through CMS or other)

        Exclusion Criteria:

          1. Pregnancy or breast feeding

          2. ALT and/or AST > 5 x ULN

          3. Known, active auto-immune disease;

          4. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy
             within last 3 months and/or ongoing

          5. Patients with past history of Solid Organ transplant

          6. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral
             load

          7. Hospitalized patients with refractory hypoxia, defined as inability to maintain
             saturation >85% with maximal available therapy for >6 hours

          8. Patients receiving any agent with immune suppressive effects, other than steroids at
             dosages less than 300 mg/day equivalent hydrocortisone and/or anti-IL-6R treatments
             like Tocilizumab or Sarilumab or anti-IL-1 treatment like Anakinra which should
             preferably be minimized

          9. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission

         10. 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)

         11. Patients under guardianship
      

Gender

All

Ages

25 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Richard Hotchkiss, MD PhD, +33603357060, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04442178

Organization ID

ILIAD-7 COVID US INFECTIOUS


Responsible Party

Sponsor

Study Sponsor

Revimmune

Collaborators

 Washington University School of Medicine

Study Sponsor

Richard Hotchkiss, MD PhD, Principal Investigator, Washington University School of Medicine


Verification Date

February 2021