Clinical trial NCT04470999: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Covid19
SARS-CoV-2
Keywords: SARS-CoV-2
COVID
COVID19
Coronavirus
Cell therapy
Immunotherapy
Lead sponsor: Seraph Research Institute
Sponsor class: OTHER
Collaborators: name: The Scripps Research Institute
First posted: 2020-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Cellular immune system profiling
timeFrame: Up to 20 days
Secondary outcomes:
measure: Innate immune system profiling
timeFrame: Up to 100 days
measure: Expansion of virus-specific innate immune cells
timeFrame: Up to 100 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Seraph Research Institute
state: California
Study officials:
affiliation: Seraph Research Institute
name: Serhat Gumrukcu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: