NCT04470999

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

July 9, 2020

Last Update Submit

May 17, 2022

Conditions

Covid19SARS-CoV-2

Keywords

SARS-CoV-2COVIDCOVID19CoronavirusCell therapyImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Innate immune system profiling

    Up to 100 days

  • Expansion of virus-specific innate immune cells

    Up to 100 days

Study Arms (1)

Single arm

EXPERIMENTAL

Venous blood and apheresis collection will be conducted

Other: Leukapheresis

Interventions

LeukapheresisOTHER

Blood collection and PBMC collection via apheresis machine will be conducted

Also known as: Mononuclear cell collection
Single arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seraph Research Institute

Los Angeles, California, 90067, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CytapheresisBiological TherapyTherapeuticsBlood Component RemovalLeukocyte Reduction ProceduresCell SeparationCytological TechniquesClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • Serhat Gumrukcu, MD PhD

    Seraph Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

April 15, 2020

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)