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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; SARS-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: Sampling

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Natalia Elias Calles, MPH; Phone Number: 5203275461; Email: Research@tmcaz.com

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Recruiting
      • TMC HealthCare
      • Contact: Natalia Elias Calles, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COVID-19 tested patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: INanoBio Inc.
• Collaborators: TMC HealthCare
• Investigators: Principal Investigator: Katherine Scott, TMC HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: INANO-CV1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No