NCT04470999

Changes in Cellular Immune Profile During COVID-19 Infection

Cellular Immune Profile Changes in Individuals With Active or Past COVID-19 Infection

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Serhat Gumrukcu, MD PhD · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Clinical specimens are collected from individuals either recovered from or with active SARS-CoV-2 infection to support process and analytical development for a potential cell-based immunotherapy in preclinical research, SRPH-CVD-01. SRPH-CVD-01 is an allogeneic cell-based immunotherapy candidate to be investigated in a subsequent clinical trial under a future FDA IND to treat people suffering from COVID-19. Enrolled participants provide a venous blood specimen (up to 40mL) to be used in preclinical studies and research and development of SRPH-CVD-01. Subjects may eventually be asked to undergo leukapheresis for peripheral blood mononuclear cell (PBMC) collection and their specimens will be used to further develop the SRPH-CVD-01 cell product, including a cGMP compliant process to be applied under the future FDA IND.

Detailed description

This protocol is to collect blood and PBMC specimens from individuals with active of past COVID-19 infection. The first blood draw will be done at the first study visit and if eligible, the second collection will be done via leukapheresis at the second visit. The leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for leukapheresis. Donors will be males or females between and including the ages of 18 years and 60 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 180 days (6 months). The study will be conducted in accordance with human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a future clinical trial under FDA IND.

Conditions

• Covid19
• SARS-CoV-2

Interventions

Type	Name	Description
OTHER	Leukapheresis	Blood collection and PBMC collection via apheresis machine will be conducted

Timeline

• Start date: 2020-04-15
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2020-07-14
• Last updated: 2022-05-24

Locations

1 site across 1 country: United States