InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )

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
• 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 Criteria

• 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)
• Patients under guardianship