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

COVID-19 Clinical Trial

— SARS-CoV-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465981
• Other study ID #: INANO-CV1
• Status: Recruiting
• Start date: July 3, 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: INanoBio Inc.
• Contact: Natalia Elias Calles, MPH
• Phone: 5203275461
• Email: Research[@]tmcaz.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• Sampling
Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.

Locations

Country	Name	City	State
United States	TMC HealthCare	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
INanoBio Inc.	TMC HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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