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

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ClinicalTrials.gov Identifier: NCT04407689
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborators:
University Hospital, Limoges
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: Placebo 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 France and Belgium
Actual Study Start Date : June 8, 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: Placebo
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), whichever occurs first [ 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. "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. 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 tp 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 timepoints 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 severity)



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:

  • 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
  • Patient with medical insurance or government support

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
  • Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) < 1.5x109/L, Platelets < 50,000 per mm3
  • Patients with uncontrolled pre-existing severe major organ dysfunction (cardiac, liver or renal failure)
  • Vaccination with live attenuated vaccines in the month preceding the inclusion
  • Use of chronic oral corticosteroids ≥ 10mg prednisone equivalent a day for a non-COVID-19 related condition
  • Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.
  • Patients with known hypersensitivity to natural or recombinant Interleukin-7 or to any of the excipients
  • 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): NCT04407689


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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France
University Hospital of Limoges Recruiting
Limoges, France, 87042
Contact: Bruno FRANCOIS, MD    33 (0)5 55 05 62 74    bruno.francois@chu-limoges.fr   
Contact: Thomas Daix, MD    33 (0)5 55 05 62 74    thomas.daix@chu-limoges.fr   
Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Thomas RIMMELE, MD    33472111196 ext 33472111196    thomas.rimmele@chu-lyon.fr   
Contact: Jean-François CARABALONA, MD    33472111196 ext 33472111196    jean-francois.carabalona@chu-lyon.fr   
Sponsors and Collaborators
Revimmune
University Hospital, Limoges
Amarex Clinical Research
Investigators
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Study Chair: Bruno François, MD University Hospital, Limoges
Publications of Results:
Other Publications:
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Responsible Party: Revimmune
ClinicalTrials.gov Identifier: NCT04407689    
Other Study ID Numbers: CLI107 COVID FR (ILIAD-7-FR)
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 22, 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
Additional relevant MeSH terms:
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Lymphopenia
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases