Recruitment

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: Unblinded Pharmacist will prepare blinded syringes of colorless drug or placeboPrimary 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 10 ?g/kg followed, after 72hrs of observation, by 10 ?g/kg twice a week for 3 weeks (maximum 7 administrations adjusted to patient's length of stay in the hospital) or (b)...

Approximately forty-eight (48) participants will be randomized 1:1 to receive (a) Intramuscular (IM) administration of CYT107 at 10 ?g/kg followed, after 72hrs of observation, by 10 ?g/kg twice a week for 3 weeks (maximum 7 administrations 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 is dedicated to oncology patients

Tracking Information

NCT #
NCT04426201
Collaborators
  • Memorial Sloan Kettering Cancer Center
  • Amarex Clinical Research
  • M.D. Anderson Cancer Center
  • Cancer Research Institute, New York City
Investigators
Principal Investigator: Steve Pastores, MD Memorial Sloan Kettering Cancer Center Principal Investigator: Marcel van den Brink, MD, PhD Memorial Sloan Kettering Cancer Center
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