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
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 7administrations 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 excludes oncology patients on treatment
Drug: CYT107
IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Other Name: Interleukin-7
Drug: Placebo
IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
Other Name: Saline
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) ≤ 1000 cells/mm3, at
two time points at least 24 hours apart, following HOSPITALIZATION:
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. Willingness and ability to practice contraception regardless of the gender of the
patient during 5 month after last drug exposure
7. Private insurance or government / institution financial support (through CMS or other)
Exclusion Criteria:
1. Pregnancy or breast feeding
2. ALT and/or AST > 5 x ULN
3. Known, active auto-immune disease;
4. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy
within last 3 months and/or ongoing
5. Patients with past history of Solid Organ transplant
6. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral
load
7. Hospitalized patients with refractory hypoxia, defined as inability to maintain
saturation >85% with maximal available therapy for >6 hours
8. 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
9. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission
10. 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)
11. Patients under guardianship
University of Florida College of Medicine
Gainesville, Florida, United States
Missouri Baptist Medical Center
Saint 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
Richard Hotchkiss, MD PhD, Principal Investigator
Washington University School of Medicine