Status:
TERMINATED
InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort
Lead Sponsor:
Revimmune
Collaborating Sponsors:
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 two 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 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week ...
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 one absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, collected at baseline or no more than 72h before baseline
- Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at \>2L 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
- Private insurance or government support (through NHS or other)
Exclusion
- Pregnancy or breast feeding;
- Refusal or inability to practice contraception regardless of the gender of the patient;
- 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.
- Patients whose respiratory condition is showing significant deterioration as indicated by:
- requirement for a persistent and sustained increase in inspired oxygen concentrations of 20% or more over the past 24 hours to maintain SpO2 at greater than or equal to 88% (this 20 % limit does not apply to O2 delivered by nasal canula)
- or need for invasive mechanical ventilation
- Patients with chronic kidney dialysis
- 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 a SOFA score ≥ 9 at baseline
- Patients with a BMI \> 40
- Patients with baseline 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
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04379076
Start Date
May 14 2020
End Date
March 30 2022
Last Update
April 7 2022
Active Locations (13)
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1
Sandwell Birmingham Hospital
Birmingham, United Kingdom, B18 7QH
2
Sandwell Birmingham Hospital
Birmingham, United Kingdom
3
Bradford Institute for Health Research
Bradford, United Kingdom, BD9 6RJ
4
ST JAMES's UNIVERSITY HOSPITAL
Leeds, United Kingdom, LS9 7TF