Covid19NCT04470999
Changes in Cellular Immune Profile During COVID-19 Infection
A study testing Leukapheresis in people with Covid19 and SARS-CoV-2, run by Serhat Gumrukcu, MD PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV-2
- What is being tested?
- Leukapheresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Seraph Research Institute
Los Angeles, California, 90067
About this study
Official title: 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.
Read the 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
- Being tested
- Leukapheresis
- Keywords
- SARS-CoV-2, COVID, COVID19, Coronavirus, Cell therapy, Immunotherapy
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeukapheresisOther
Also called Mononuclear cell collection
Blood collection and PBMC collection via apheresis machine will be conducted
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Venous blood and apheresis collection will be conducted Receives: Other: Leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Apr 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Study suspended due to the move of clinical trial site. It will be resumed when the move is complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serhat Gumrukcu, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- The Scripps Research Institute
- Responsible party
- Sponsor-investigator, Serhat Gumrukcu, MD PhD, Seraph Research Institute
- Investigators
- Serhat Gumrukcu, MD PhD, Principal investigator, Seraph Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470999
- Sponsor's protocol ID
- SRPH-CVD-01
- Status last verified
- May 2022
- First submitted
- 9 Jul 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Immune Profile Changes in Individuals With Active or Past COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04470999
- Acronym / sponsor ID
- SRPH-CVD-01
- Conditions
- Covid19, SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID, COVID19, Coronavirus, Cell therapy, Immunotherapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended due to the move of clinical trial site. It will be resumed when the move is complete.
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Serhat Gumrukcu, MD PhDUniversity, hospital or other
- Collaborators
- The Scripps Research Institute
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: LeukapheresisVenous blood and apheresis collection will be conducted |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Uncontrolled SARS symptoms
- Oxygen saturation (Pulse Ox) < 90%
- Uncontrolled diabetes
- Uncontrolled hypertension
- Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeukapheresisAlso: Mononuclear cell collectionBlood collection and PBMC collection via apheresis machine will be conducted | Other | Single arm |
Primary outcome
Cellular immune system profiling
Time frame: Up to 20 days
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.
2 secondary outcomes
Innate immune system profiling
Time frame: Up to 100 days
Expansion of virus-specific innate immune cells
Time frame: Up to 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serhat Gumrukcu, MD PhD principal investigator
Seraph Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukapheresis in people with Covid19 and SARS-CoV-2, run by Serhat Gumrukcu, MD PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular immune system profiling (time frame: Up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.