InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )
- Registration Number
- NCT04426201
- Lead Sponsor
- 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
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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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
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Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for cancer (and/or)
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Patients who have received hematopoietic stem cell transplantation (for a diagnosis other than lymphoma) within the past 1 year (and/or)
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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)
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Patients receiving hormonal therapy for cancer (and/or)
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Patients who have undergone surgery or radiotherapy for cancer within the past 6 months
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Patients with newly diagnosed (biopsy proven) malignancy who have not yet received cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)
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Men and women aged ≥ 25 - 80 (included) years of age
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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.
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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
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Confirmed infection with COVID-19 by any acceptable test available/utilized at each site
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Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure
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Pregnancy or breast feeding;
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ALT and/or AST > 5 x ULN
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Known, active auto-immune disease;
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Patients with a history of lymphoid malignancy
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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
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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)
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Patients with unresolved grade > 2 toxicities from prior chemotherapy, immunotherapy, or CAR-T cell therapy
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Patients with past history of Solid Organ transplant.
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Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
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Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
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Patients with a mechanical ventilation support ≥ 7 days
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Patients with chronic kidney dialysis
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Patients with a SOFA score ≥ 9 at baseline
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Patients with a BMI > 40
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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)
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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)
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Patients under guardianship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CYT107 Treatment CYT107 Intramuscular (IM) administration of CYT107 twice a week for 3 weeks Saline control Placebo Intramuscular (IM) placebo (normal saline) at the same frequency
- Primary Outcome Measures
Name Time Method 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 one month A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or HospitalDischarge
- Secondary Outcome Measures
Name Time Method Physiological status through NEWS2 evaluation compared to Placebo arm 30 days Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
frequency of secondary infections through day 45 compared to placebo arm 45 days Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
a significant decline of SARS-CoV-2 viral load through day 30 or HD 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)
length of stay in ICU compared to placebo arm 45 days Number of days in ICU during index hospitalization
number of readmissions to ICU compared to placebo arm 45 days Readmissions to ICU through Day 45
To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD. one month to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by 11 steps WHO clinical improvement score
organ support free days compared to placebo arm 45 days Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
level of other known biomarkers of inflammation: Ferritin compared to placebo arm 30 days Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
length of hospitalization compared to placebo arm 45 days Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
CD4+ and CD8+ T cell counts compared to placebo arm 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
Frequency of re-hospitalization through day 45 compared to placebo arm 45 days Number of readmissions to the hospital through Day 45
All-cause mortality through day 45 compared to placebo arm 45 days All-cause mortality through Day 45
Level of other known biomarkers of inflammation: CRP compared to placebo arm 30 days Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Level of other known biomarkers of inflammation: D-dimer compared to placebo arm 30 days Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Trial Locations
- Locations (2)
MD Anderson cancer center
🇺🇸Houston, Texas, United States
Memorial sloan kettering
🇺🇸New York, New York, United States