Study of investigational medicinal product of CYT107 in patients with COVID-19 infection who have low number of lymphocytes in their blood (ILIAD 7 trial)

Recombinant InterLeukin-7 (CYT107) to Improve clinical outcomes in lymphopenic pAtients with COVID-19 infection “ILIAD 7 trial” - ILIAD

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001786-36-GB

Enrollment

200

Registered

2020-04-15

Start date

2020-05-06

Completion date

Unknown

Last updated

2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphopenia and T cell exhaustion in COVID-19 patients

Interventions

Product Name: CYT107 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use

Eligibility

Sex/Gender

All

Inclusion 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) = 700 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) 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. Patient with medical insurance or government support Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breast feeding; 2. Refusal or inability to practice contraception regardless of the gender of the patient; 3. ALT and/or AST > 5 x ULN 4. Known, active auto-immune disease; 5. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing; 6. Patients with past history of Solid Organ transplant. 7. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load. 8. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours 9. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300mg/day and/or anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized 10. Patients with baseline Rockwood Clinical Frailty Scale = 6. 11. Patients under guardianship

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the Study is to improve the absolute lymphocyte count (ALC) of lymphopenic (ALC=700/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever comes first.;Secondary Objective: a) 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 b) To determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD c) To compare the incidence of grade 3-4 adverse events for CYT107 versus placebo through day 45 d) To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 e) To compare the effect of CYT107 versus placebo on the length of hospitalization f) To compare the effect of CYT107 versus placebo on the length of stay in ICU g) To compare the effect of CYT107 versus placebo on readmissions to ICU h) To compare the effect of CYT107 versus placebo on organ support free days i) To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 j) To assess the impact of CYT107 on all-cause mortality through day 45 AND objectives k, l, m and n ;Primary end point(s): An improvement in the absolute lymphocyte count (ALC) is defined as a statistically significant increase from randomization to day 30 or HD, and will also be assessed at defined timepoints (as indicated in the Schedule of Activities, to include all Study drug administration days).;Timepoint(s) of evaluation of this end point: Day -1, 0, 1, 3, 6/7, 9/10/11, 12-18, 21, 30/Hospital discharge Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks	—

Measure

Time frame

Main Objective: The primary objective of the Study is to improve the absolute lymphocyte count (ALC) of lymphopenic (ALC=700/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever comes first.;Secondary Objective: a) 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 b) To determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD c) To compare the incidence of grade 3-4 adverse events for CYT107 versus placebo through day 45 d) To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 e) To compare the effect of CYT107 versus placebo on the length of hospitalization f) To compare the effect of CYT107 versus placebo on the length of stay in ICU g) To compare the effect of CYT107 versus placebo on readmissions to ICU h) To compare the effect of CYT107 versus placebo on organ support free days i) To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 j) To assess the impact of CYT107 on all-cause mortality through day 45 AND objectives k, l, m and n ;Primary end point(s): An improvement in the absolute lymphocyte count (ALC) is defined as a statistically significant increase from randomization to day 30 or HD, and will also be assessed at defined timepoints (as indicated in the Schedule of Activities, to include all Study drug administration days).;Timepoint(s) of evaluation of this end point: Day -1, 0, 1, 3, 6/7*, 9/10/11*, 12-18*, 21, 30/Hospital discharge *Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks

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Secondary

Measure	Time frame
Secondary end point(s): a) 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 (Cao, NEJM 2020). Comparative analysis of improvement time course to be performed for CYT107 group vs placebo. b) 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). Viral load is measured from nasal or pharyngeal swabs (plus endotracheal secretions if accessible). The time course of the viral load drop will be compared between the CYT107 group and the placebo group. c) Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity) d) Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45 e) Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD) f) Number of days in ICU during index hospitalization g) Readmissions to ICU through Day 45 h) Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.) i) Number of readmissions to the hospital through Day 45 j) All-cause mortality through Day 45 k) Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD l) Examination and evaluation of effect of CYT107 on immune biomarkers: monocyte HLA-DR expression at SoA timepoints m) Track and evaluate other known biomarkers of inflammation, CRP, D-dimer, and Ferritin, at SoA timepoints n) Evaluate improvement of the NEWS2 score value ;Timepoint(s) of evaluation of this end point: Day -1, 0, 1, 3, 6/7, 9/10/11, 12-18, 21, 30/Hospital discharge Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks	—

Measure

Time frame

Secondary end point(s): a) 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 (Cao, NEJM 2020). Comparative analysis of improvement time course to be performed for CYT107 group vs placebo. b) 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). Viral load is measured from nasal or pharyngeal swabs (plus endotracheal secretions if accessible). The time course of the viral load drop will be compared between the CYT107 group and the placebo group. c) Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity) d) Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45 e) Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD) f) Number of days in ICU during index hospitalization g) Readmissions to ICU through Day 45 h) Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.) i) Number of readmissions to the hospital through Day 45 j) All-cause mortality through Day 45 k) Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD l) Examination and evaluation of effect of CYT107 on immune biomarkers: monocyte HLA-DR expression at SoA timepoints m) Track and evaluate other known biomarkers of inflammation, CRP, D-dimer, and Ferritin, at SoA timepoints n) Evaluate improvement of the NEWS2 score value ;Timepoint(s) of evaluation of this end point: Day -1, 0, 1, 3, 6/7*, 9/10/11*, 12-18*, 21, 30/Hospital discharge *Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks

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Countries

Belgium, France, Italy, Spain, United Kingdom, United States

Contacts

Public ContactMichel Morre

RevImmune SAS France

mmorre@revimmune.com33603357060

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026