InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Lymphocytopenia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: randomized controlled of treatment vs placeboMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 25 years and 80 years
- Gender
- Both males and females
Description
Approximately forty-eight (48) participants will be randomized 1:1 to receive (a) Intramuscular (IM) administration of CYT107 at 3 ?g/kg followed, after 48hrs of observation, by 10 ?g/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safe...
Approximately forty-eight (48) participants will be randomized 1:1 to receive (a) Intramuscular (IM) administration of CYT107 at 3 ?g/kg followed, after 48hrs of observation, by 10 ?g/kg twice a week for 2 weeks or (b) Intramuscular (IM) placebo (normal saline) at the same frequency. An interim safety review will take place after the first 12 patients. If the CYT107 is well tolerated, the test dose (3 ?g/kg) will cease and that initial dose will become the same as the rest of the doses (10 ?g/kg). So, the remaining patients will be randomized to receive 5 administrations of (a) CYT107 at 10 ?g/kg every 3 to 4 days for 2 weeks 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
Tracking Information
- NCT #
- NCT04379076
- Collaborators
- Amarex Clinical Research
- Investigators
- Principal Investigator: Manu Shankar-Hari, MD PhD Guy's and St Thomas' NHS Foundation Trust
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