Status:
TERMINATED
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection ( ILIAD-7-US-I )
Lead Sponsor:
Revimmune
Collaborating Sponsors:
Washington University School of Medicine
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
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04442178
Start Date
September 15 2020
End Date
March 30 2022
Last Update
April 8 2022
Active Locations (5)
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1
University of Florida College of Medicine
Gainesville, Florida, United States, 32608
2
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
3
Rutgers Health
New Brunswick, New Jersey, United States, 08901
4
Stony Brook Medicine
Stony Brook, New York, United States, 11794