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

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ClinicalTrials.gov Identifier: NCT04442178
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Washington University School of Medicine
Amarex Clinical Research
Information provided by (Responsible Party):
Revimmune

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Lymphocytopenia Drug: CYT107 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled of treatment vs placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Unblinded Pharmacist will prepare blinded syringes of colorless drug or placeb
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CYT107 Treatment
Intramuscular (IM) administration of CYT107 twice a week for 3 weeks
 Drug: CYT107
IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Other Name: Interleukin-7
Placebo Comparator: Placebo
Intramuscular (IM) administration of Saline twice a week for 3 weeks
 Drug: Placebo
IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Other Name: Saline


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: one month ]
    A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge


Secondary Outcome Measures :
  1. "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. [ Time Frame: one month ]
    The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score

  2. a significant decline of SARS-CoV-2 viral load through day 30 or HD [ Time Frame: one month ]
    The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)

  3. frequency of secondary infections through day 45 compared to placebo arm [ Time Frame: 45 days ]
    Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45

  4. length of hospitalization compared to placebo arm [ Time Frame: 45 days ]
    Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)

  5. Length of stay in ICU compared to placebo arm [ Time Frame: 45 days ]
    Number of days in ICU during index hospitalization

  6. number of readmissions to ICU compared to placebo arm [ Time Frame: 45 days ]
    Readmissions to ICU through Day 45

  7. organ support free days compared to placebo arm [ Time Frame: 45 days ]
    Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)

  8. Frequency of re-hospitalization through day 45 compared to placebo arm [ Time Frame: 45 days ]
    Number of readmissions to the hospital through Day 45

  9. All-cause mortality through day 45 compared to placebo arm [ Time Frame: 45 days ]
    All-cause mortality through Day 45

  10. CD4+ and CD8+ T cell counts compared to placebo arm [ Time Frame: 30 days ]
    Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA)through Day 30 or HD

  11. level of other known biomarkers of inflammation: Ferritin compared to placebo a [ Time Frame: 30 days ]
    Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30

  12. Level of other known biomarkers of inflammation: CRP compared to placebo arm [ Time Frame: 30 days ]
    Level of other known biomarkers of inflammation: CRP compared to placebo arm

  13. Level of other known biomarkers of inflammation: D-dimer compared to placebo arm [ Time Frame: 30 days ]
    Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30

  14. Physiological status through NEWS2 evaluation compared to Placebo arm [ Time Frame: 30 days ]
    Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk


Other Outcome Measures:
  1. Safety assessment through incidence and scoring of grade 3-4 adverse events [ Time Frame: 45 days ]
    Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442178


Contacts
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Contact: Michel Morre, DVM +33603357060 mmorre@revimmune.com
Contact: Frederique Berbille, MHSc +33766459100 fberbille@revimmune.com

Locations
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United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32608
Contact: Scott Brakenridge, MD    352-273-5497      
Contact: Jennifer LANZ, RN    352-273-5497      
United States, Missouri
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: David STRIKER, MD    314-550-2585      
Contact: Jane BLOOD, RN    3145502585      
United States, New Jersey
Rutgers Health Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Jag Sunderram, MD    732-235-6402      
Contact: Anoja Warusawithana, RN    732 235 6402      
United States, New York
Stony Brook Medicine Recruiting
Stony Brook, New York, United States, 11794
Contact: Stephen Kuperberg, MD    631-444-6900      
Contact: Wendy Mattias, RN    631-444-6900      
United States, Ohio
Cleveland Clinic Lerner College of Medicine Recruiting
Cleveland, Ohio, United States, 44195
Contact: Vidula Vachharajani, MD    216-337-8776      
Contact: Alexander King, RN    (216) 337-8776      
Sponsors and Collaborators
Revimmune
Washington University School of Medicine
Amarex Clinical Research
Investigators
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Principal Investigator: Richard Hotchkiss, MD PhD Washington University School of Medicine
More Information
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Publications of Results:

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Responsible Party: Revimmune
ClinicalTrials.gov Identifier: NCT04442178    
Other Study ID Numbers: ILIAD-7 COVID US INFECTIOUS
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphopenia
Leukopenia
Leukocyte Disorders
 Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases