Status:
SUSPENDED
Changes in Cellular Immune Profile During COVID-19 Infection
Lead Sponsor:
Serhat Gumrukcu, MD PhD
Collaborating Sponsors:
The Scripps Research Institute
Conditions:
Covid19
SARS-CoV-2
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 pr...
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 col...
Eligibility Criteria
Inclusion
- Male of female aged 18-60
- Documented current or past (max 3 months prior) diagnosis of COVID19
- Participants who has not participated in a cell or gene therapy trial for COVID19
Exclusion
- Uncontrolled SARS symptoms
- Oxygen saturation (Pulse Ox) \< 90%
- Uncontrolled diabetes
- Uncontrolled hypertension
- Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
- Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate blood collection or leukapheresis procedure
- Systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to leukapheresis
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening
- Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04470999
Start Date
April 15 2020
End Date
December 31 2023
Last Update
May 24 2022
Active Locations (1)
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1
Seraph Research Institute
Los Angeles, California, United States, 90067