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

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ClinicalTrials.gov Identifier: NCT04379076
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
Amarex Clinical Research
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 two weeks on immune reconstitution of lymphopenic COVID-19 patients.

Condition or disease Intervention/treatment Phase
COVID-19 Lymphocytopenia Drug: Interleukin-7 Drug: Placebos Phase 2

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

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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: Double blind
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 in UK
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CYT107
Intra-muscular administration of CYT107 twice a week for a total of 5 administrations
Drug: Interleukin-7
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
Other Name: CYT107

Placebo Comparator: Saline
Intramuscular (IM) administration of saline at the same volume and same time for a total of 5 administrations
Drug: Placebos
Intramuscular (IM) placebo (normal saline) at the same frequency
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), whicheve [ Time Frame: 1 month ]
    A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge


Secondary Outcome Measures :
  1. To obtain "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: 1 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. determine if CYT107 will lead to 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. To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 [ 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. To compare the effect of CYT107 versus placebo on the length of hospitalization [ Time Frame: 45 days ]
    Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)

  5. To compare the effect of CYT107 versus placebo on the length of stay in ICU [ Time Frame: 45 days ]
    Number of days in ICU during index hospitalization

  6. To compare the effect of CYT107 versus placebo on readmissions to ICU [ Time Frame: 45 days ]
    Readmissions to ICU through Day 45

  7. To compare the effect of CYT107 versus placebo on organ support free days [ Time Frame: 45 days ]
    Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)

  8. To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 [ Time Frame: 45 days ]
    Number of readmissions to the hospital through Day 45

  9. To assess the impact of CYT107 on all-cause mortality through day 45 [ Time Frame: 45 days ]
    All-cause mortality through Day 45

  10. To determine the effect of CYT107 on CD4+ and CD8+ T cell counts [ Time Frame: 30 days ]
    Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD

  11. To track and evaluate other known biomarkers of inflammation: Ferritin [ Time Frame: 30 days ]
    Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30

  12. To track and evaluate other known biomarkers of inflammation: CRP [ Time Frame: 30 days ]
    Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30

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

  14. Evaluation of physiological status through NEWS2 score [ Time Frame: 30 days ]
    Evaluate improvement of the NEWS2 score value


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



Information from the National Library of Medicine

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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:

  • 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 two absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:

The FIRST time point should not be performed earlier than 48 hours after Hospitalization, thus first test dose can't be administered before 72 hours after hospitalization (From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient's clinical status)

  • 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
  • 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.
  • Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
  • Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day and/or anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized
  • Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.
  • 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): NCT04379076


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

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RS
Contact: Manu Shankar-Hari, MD         
Sponsors and Collaborators
Revimmune
Amarex Clinical Research
Investigators
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Principal Investigator: Manu Shankar-Hari, MD PhD Guy's and St Thomas' NHS Foundation Trust
Publications:

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Responsible Party: Revimmune
ClinicalTrials.gov Identifier: NCT04379076    
Other Study ID Numbers: CLI107 COVID UK (ILIAD-7-UK)
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
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: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphopenia
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases