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
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2020
CompletedFirst Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 27, 2021
August 1, 2021
1.9 years
July 7, 2020
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Identify antibody and/or immune signatures in COVID-19 patients
Through study completion, an average of 1 year
Study Arms (2)
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
Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.
Eligibility Criteria
COVID-19 tested patients
You may qualify if:
- 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)
You may not qualify if:
- Subject or legal representative not willing to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- INanoBio Inc.lead
- TMC HealthCarecollaborator
Study Sites (1)
TMC HealthCare
Tucson, Arizona, 85712, United States
Biospecimen
Serum will be isolated from periodic clinical blood specimens during the entire duration of the patient's hospital stay. Whole blood and plasma may also be collected. The CoV-2 protein serology assay will be performed on each sample.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Scott
TMC HealthCare
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 10, 2020
Study Start
July 3, 2020
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
August 27, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share