Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients

INanoBio Inc.80 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19 SARS-CoV-2 Infection

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subject must meet all of the following criteria to be eligible for treatment in the study: 1. Subject or legal representative understands the nature of the procedure and has signed the Subject Informed Consent Form prior to study procedures 2. For the COVID-19 Cohort * Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR 3. 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

Outcomes

Primary Outcomes

Serological identification of individuals who have been infected with SARS-CoV-2

Distinguish individuals who have been infected with SARS-CoV-2 from those who have not using antibody-based assays and measure antibody levels as a function of time

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Identify antibody and/or immune signatures in COVID-19 patients

Analyze and identify antibody and/or immune signatures in COVID-19 patients that differentiate patients with severe disease versus those without, and determine which antigens are most useful for serological testing