MedTrace Logo

Changes in Cellular Immune Profile During COVID-19 Infection

NCT04470999 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-05-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Leukapheresis

Blood collection and PBMC collection via apheresis machine will be conducted

Sponsors & Collaborators

  • The Scripps Research Institute

    collaborator OTHER

  • Serhat Gumrukcu, MD PhD

    lead OTHER

Principal Investigators

  • Serhat Gumrukcu, MD PhD · Seraph Research Institute

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2023-09-30
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04470999 on ClinicalTrials.gov