COVID-19SARS-CoV-2NCT04465981
Investigation of Antibody and Immune Responses to SARS-CoV-2 Proteins in COVID-19 Patients
An observational study of COVID-19 and SARS-CoV-2 Infection, run by INanoBio Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- Sampling
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: COVID-19 tested patients
Who may be able to join
- 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)
Who cannot join
- Subject or legal representative not willing to consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
TMC HealthCare
Tucson, Arizona, 85712
Natalia Elias Calles, MPH
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- Sampling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingDiagnostic test
Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lab-confirmed COVID-19 | Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR Receives: Diagnostic Test: Sampling | |
| 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) Receives: Diagnostic Test: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start3 Jul 2020
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INanoBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TMC HealthCare
- Responsible party
- Sponsor
- Investigators
- Katherine Scott, Principal investigator, TMC HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465981
- Sponsor's protocol ID
- INANO-CV1
- Acronym
- SARS-CoV-2
- Status last verified
- Aug 2021
- First submitted
- 7 Jul 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04465981
- Acronym / sponsor ID
- SARS-CoV-2 / INANO-CV1
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- INanoBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- TMC HealthCare
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with lab-confirmed COVID-19 | – | Diagnostic Test: SamplingSubject has lab-confirmed diagnosis of COVID-19 by RT-PCR |
| Patients who are suspected to have or are confirmed to not have COVID-19 | – | Diagnostic Test: SamplingSubject 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 tested patients
Key inclusion criteria (6 listed)
- 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
- For the PUI Cohort
Key exclusion criteria (1 listed)
- Subject or legal representative not willing to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplingTest is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins. | Diagnostic test | Patients who are suspected to have or are confirmed to not have COVID-19, Patients with lab-confirmed COVID-19 |
Primary outcome
Serological identification of individuals who have been infected with SARS-CoV-2
Time frame: 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
1 secondary outcome
Identify antibody and/or immune signatures in COVID-19 patients
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Scott principal investigator
TMC HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2 Infection, run by INanoBio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalia Elias Calles, MPH (5203275461, Research@tmcaz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.