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

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ClinicalTrials.gov Identifier: NCT04426201
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Amarex Clinical Research
M.D. Anderson Cancer Center
Cancer Research Institute, New York City
Information provided by (Responsible Party):
Revimmune

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 7 administrations 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 is dedicated to oncology patients

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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 placebo
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 Oncology Cohort
Actual Study Start Date : December 20, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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: Saline control
Intramuscular (IM) placebo (normal saline) at the same frequency
Drug: Placebo
Same number, volume and frequency of IM administration of saline
Other Name: Saline




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 HospitalDischarge


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: 1 month or HD (whichever occurs first) ]
    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 arm [ 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 ]
    Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for cancer (and/or)
  3. Patients who have received hematopoietic stem cell transplantation (for a diagnosis other than lymphoma) within the past 1 year (and/or)
  4. Patients who received CAR-T cell therapy within the past 1 year (but not within last 30 days- see also exclusion criteria number 6 & 7) (and/or)
  5. Patients receiving hormonal therapy for cancer (and/or)
  6. Patients who have undergone surgery or radiotherapy for cancer within the past 6 months
  7. Patients with newly diagnosed (biopsy proven) malignancy who have not yet received cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)
  8. Men and women aged ≥ 25 - 80 (included) years of age
  9. Hospitalized patients with one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline .

    From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient's clinical status.

  10. 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
  11. Confirmed infection with COVID-19 by any acceptable test available/utilized at each site
  12. Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure

Exclusion Criteria:

  1. Pregnancy or breast feeding;
  2. ALT and/or AST > 5 x ULN
  3. Known, active auto-immune disease;
  4. Patients with a history of lymphoid malignancy
  5. Patients with any malignancy that is present at time of enrollment where treating physician expects life expectancy due to the underlying malignancy to be less than 6 months
  6. Patients who received CAR-T cell therapy within the past 30 days or with unresolved cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS)
  7. Patients with unresolved grade > 2 toxicities from prior chemotherapy, immunotherapy, or CAR-T cell therapy
  8. Patients with past history of Solid Organ transplant.
  9. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
  10. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
  11. Patients with a mechanical ventilation support ≥ 7 days
  12. Patients with chronic kidney dialysis
  13. Patients with a SOFA score ≥ 9 at baseline
  14. Patients with a BMI > 40
  15. 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)
  16. Patients with hospital admission Rockwood Clinical Frailty Scale ≥ 6. (assessed as patient or proxy 4-week recall of chronic health and frailty status prior to COVID infection)

11. Patients under guardianship


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): NCT04426201


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, New York
Memorial sloan kettering Recruiting
New York, New York, United States, 10065
Contact: Stephen Pastores, MD    212-639-6673    pastores@MSKCC.ORG   
United States, Texas
MD Anderson cancer center Recruiting
Houston, Texas, United States, 77030
Contact: Cristina Gutierrez, MD       CGutierrez4@mdanderson.org   
Sub-Investigator: Cassian Yee, MD         
Sponsors and Collaborators
Revimmune
Memorial Sloan Kettering Cancer Center
Amarex Clinical Research
M.D. Anderson Cancer Center
Cancer Research Institute, New York City
Investigators
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Principal Investigator: Steve Pastores, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Marcel van den Brink, MD, PhD Memorial Sloan Kettering Cancer Center
Publications of Results:
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Responsible Party: Revimmune
ClinicalTrials.gov Identifier: NCT04426201    
Other Study ID Numbers: ILIAD-7 COVID US ONCO
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 3, 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