Status:
TERMINATED
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )
Lead Sponsor:
Revimmune
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Amarex Clinical Research
Conditions:
COVID-19
Lymphocytopenia
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
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 wee...
Eligibility Criteria
Inclusion
- 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
- Patient receiving active or recent chemotherapy or immunotherapy (within 6 months) for cancer (and/or)
- Patients who have received hematopoietic stem cell transplantation (for a diagnosis other than lymphoma) within the past 1 year (and/or)
- 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)
- Patients receiving hormonal therapy for cancer (and/or)
- Patients who have undergone surgery or radiotherapy for cancer within the past 6 months
- Patients with newly diagnosed (biopsy proven) malignancy who have not yet received cancer treatment but get COVID pneumonia in the interim (Incl. Criteria 11)
- Men and women aged ≥ 25 - 80 (included) years of age
- 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.
- 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
- Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure
Exclusion
- Pregnancy or breast feeding;
- ALT and/or AST \> 5 x ULN
- Known, active auto-immune disease;
- Patients with a history of lymphoid malignancy
- 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
- 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)
- Patients with unresolved grade \> 2 toxicities from prior chemotherapy, immunotherapy, or CAR-T cell therapy
- 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 with a mechanical ventilation support ≥ 7 days
- Patients with chronic kidney dialysis
- Patients with a SOFA score ≥ 9 at baseline
- Patients with a BMI \> 40
- 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)
- 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
Key Trial Info
Start Date :
December 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04426201
Start Date
December 20 2020
End Date
June 30 2022
Last Update
April 11 2024
Active Locations (2)
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1
Memorial sloan kettering
New York, New York, United States, 10065
2
MD Anderson cancer center
Houston, Texas, United States, 77030