COVID-19, SARS-CoV-2 Infection
Conditions
Brief 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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTSampling
Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.
Sponsors
TMC HealthCare
INanoBio Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serological identification of individuals who have been infected with SARS-CoV-2 | Through study completion, an average of 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify antibody and/or immune signatures in COVID-19 patients | Through study completion, an average of 1 year | 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 |
Countries
United States
Contacts
Primary ContactNatalia Elias Calles, MPH
Outcome results
None listed