Changes in Cellular Immune Profile During COVID-19 Infection

NCT ID: NCT04470999

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2023-12-31

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.

Conditions

Covid19; SARS-CoV-2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single arm

Venous blood and apheresis collection will be conducted

Group Type: EXPERIMENTAL

Leukapheresis

Intervention Type: OTHER

Blood collection and PBMC collection via apheresis machine will be conducted

Interventions

Leukapheresis

Blood collection and PBMC collection via apheresis machine will be conducted

Intervention Type: OTHER

Other Intervention Names

Mononuclear cell collection

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scripps Research Institute

OTHER

Sponsor Role: collaborator

Serhat Gumrukcu, MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Serhat Gumrukcu, MD PhD

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Serhat Gumrukcu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seraph Research Institute

Locations

Seraph Research Institute

Los Angeles, California, United States

Countries

United States

Other Identifiers

SRPH-CVD-01

Identifier Type: -

Identifier Source: org_study_id