Recruiting

SARS-CoV-2 Antibodies

Sponsor:

INanoBio Inc.

Code:

NCT04465981

Conditions

COVID-19

SARS-CoV-2 Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sampling

Study Details

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.

Conditions

COVID-19

SARS-CoV-2 Infection

Study ID

NCT04465981

Start date

Jul 3, 2020

Status verified date

Aug, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with lab-confirmed COVID-19

Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR

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)

Interventions

Sampling

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

Primary outcome measure

  • Serological identification of individuals who have been infected with SARS-CoV-2 [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Natalia Elias Calles, MPH

5203275461Research@tmcaz.com

Locations

TMC HealthCare

Recruiting

Tucson, Arizona, United States, 85712

More Information

Sponsor

INanoBio Inc.

Last update posted

Aug 27, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by INanoBio Inc. on 2021-08-27.