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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19, Lymphocytopenia

In brief

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

Key facts

Study ID

NCT04442178

Run by

Revimmune

People needed

26

Starts

2020-09-15

Expected to finish

2022-03-30

Last updated by the study team

2022-04-08

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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 month after last drug exposure
• Private insurance or government / institution financial support (through CMS or other)

You may not qualify if…

• Pregnancy or breast feeding
• 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 equivalent hydrocortisone and/or anti-IL-6R treatments like Tocilizumab or Sarilumab or anti-IL-1 treatment like Anakinra which should preferably be minimized
• Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission
• 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 under guardianship

Where it is running

• University of Florida College of Medicine — Gainesville, Florida, United States
• Missouri Baptist Medical Center — St Louis, Missouri, United States
• Rutgers Health — New Brunswick, New Jersey, United States
• Stony Brook Medicine — Stony Brook, New York, United States
• Cleveland Clinic Lerner College of Medicine — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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