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Changes in Cellular Immune Profile During COVID-19 Infection

Primary Purpose

Covid19, SARS-CoV-2

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leukapheresis
Sponsored by
Serhat Gumrukcu, MD PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Covid19 focused on measuring SARS-CoV-2, COVID, COVID19, Coronavirus, Cell therapy, Immunotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Seraph Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Venous blood and apheresis collection will be conducted

Outcomes

Primary Outcome Measures

Cellular immune system profiling
After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs. Data will describe the range of each cell population across participants.

Secondary Outcome Measures

Innate immune system profiling
Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping. Data will report the antiviral phenotypic characteristics of these cells.
Expansion of virus-specific innate immune cells
Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells. These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.

Full Information

First Posted
July 9, 2020
Last Updated
May 17, 2022
Sponsor
Serhat Gumrukcu, MD PhD
Collaborators
The Scripps Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04470999
Brief Title
Changes in Cellular Immune Profile During COVID-19 Infection
Official Title
Cellular Immune Profile Changes in Individuals With Active or Past COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Suspended
Why Stopped
Study suspended due to the move of clinical trial site. It will be resumed when the move is complete.
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Serhat Gumrukcu, MD PhD
Collaborators
The Scripps Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV-2
Keywords
SARS-CoV-2, COVID, COVID19, Coronavirus, Cell therapy, Immunotherapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Venous blood and apheresis collection will be conducted
Intervention Type
Other
Intervention Name(s)
Leukapheresis
Other Intervention Name(s)
Mononuclear cell collection
Intervention Description
Blood collection and PBMC collection via apheresis machine will be conducted
Primary Outcome Measure Information:
Title
Cellular immune system profiling
Description
After the initial venous blood draw, the blood samples will be tested to measure the absolute count and percentage of B cells, monocytes, CD4+ and CD8+ T cells, gammadelta T (gdT) cells, CD3+CD56+ natural killer T (NKT) cells, and natural killer (NK) cells in total PBMCs. Data will describe the range of each cell population across participants.
Time Frame
Up to 20 days
Secondary Outcome Measure Information:
Title
Innate immune system profiling
Description
Innate immune system cells (gdT, NKT, and NK) will be assessed for their SARS-CoV-2 antiviral activity by stimulation and immunophenotyping. Data will report the antiviral phenotypic characteristics of these cells.
Time Frame
Up to 100 days
Title
Expansion of virus-specific innate immune cells
Description
Virus-specific innate immune cells that are relevant to SRPH-CVD-01 clinical product candidate will be expanded under various conditions to assess their therapeutic and protective potential against COVID-19. Data will report the expansion rate of SRPH-CVD-01 cells. These cell will also help validate the assays and processes for the development of the SRPH-CVD-01 cell product to be used in a future clinical trials.
Time Frame
Up to 100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serhat Gumrukcu, MD PhD
Organizational Affiliation
Seraph Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seraph Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Changes in Cellular Immune Profile During COVID-19 Infection

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