Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    INanoBio Inc.
Updated on 19 February 2024
covid-19
SARS
coronavirus infection
acute respiratory syndrome (sars)

Summary

SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment.

The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable.

Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.

Description

A longitudinal, non-randomized study to evaluate the utility of the INanoBio's protein arrays in detecting unique antibodies in COVID-19 patients. To study the feasibility of utilizing a viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and prognosis of SARS-CoV-2 infections during and after the course of disease. The sample size is to include 80 subjects: 40 diagnosed with COVID-19 and 40 suspected to have COVID-19. The goal will be to assess antibodies throughout the subject's disease course compared to controls.

Details
Condition Corona Virus Infection, Covid 19
Age 18-100 years
Treatment Sampling
Clinical Study IdentifierNCT04465981
SponsorINanoBio Inc.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must meet all of the following criteria to be eligible for treatment
in the study
Subject or legal representative understands the nature of the procedure and has signed the Subject Informed Consent Form prior to study procedures
For the COVID-19 Cohort
Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR
For the PUI Cohort
Subject has suspected COVID-19 according to medical evaluation, but does not yet have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested negative by RT-PCR)

Exclusion Criteria

Subject or legal representative not willing to consent
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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