Changes in Cellular Immune Profile During COVID-19 Infection

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

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.

Study Overview

• Status: Suspended
• Conditions: Covid19; SARS-CoV-2
• Intervention / Treatment: Other: Leukapheresis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90067
      • Seraph Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Venous blood and apheresis collection will be conducted	Other: Leukapheresis; Blood collection and PBMC collection via apheresis machine will be conducted; Other Names: Mononuclear cell collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 100 days
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.	Up to 100 days

Collaborators and Investigators

• Sponsor: Serhat Gumrukcu, MD PhD
• Collaborators: The Scripps Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Immunotherapy; Coronavirus; COVID; COVID19; Cell therapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SRPH-CVD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No