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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Longitudinal, Non-randomized Study to Evaluate the Utility of the INanoBio's Protein Arrays in Detecting Unique Antibodies in COVID-19 Patients

Conditions
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COVID-19, SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: Sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with lab-confirmed COVID-19<br>Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR | Diagnostic Test: Sampling<br>* Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.<br>|
| Patients who are suspected to have or are confirmed to not have COVID-19<br>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) | Diagnostic Test: Sampling<br>* Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 1 year |