Covid19STARTNCT04573634
A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition
An observational study of Covid19 and SARS-CoV Infection, run by Jill M Kolesar at 1 site in United States.
Trial summary
The co-primary objectives of this study are to: 1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection 2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing at the University of Kentucky or individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care testing. Notably, these individuals may not have active COVID infection; they will be assessed for antibodies which is evidence of a prior, asymptomatic COVID infection or infection associated with a known exposure as diagnosed by polymerase chain reaction (PCR).
Who may be able to join
- Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing
- Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing.
- Able to understand and sign the Informed Consent and Research Authorization From.
Who cannot join
- Prisoners
- Patients with psychiatric illness that would limit compliance
- Patients with social situations that would limit compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition (START) - Assessment of COVID19 Penetrance in HCW and Non HCW in Kentucky
The co-primary objectives of this study are to:
- Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection
- Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals
Read the detailed description
This is a prospective cohort study designed to identify the prevalence of IgG antibodies to SARS CoV-2 as well as to assess risk factors for IgG positivity. It will compare rates of positivity and risk factors among healthcare workers and non-healthcare workers and assess the ability of PCR negativity at day 3 or 4, 5, 7, or 10 to predict negativity on day 14 in individuals quarantining after a COVID exposure.
In addition to having a standard of care clinical antibody test, both healthcare workers, quarantining individuals, and patients will be asked to fill out a survey to assess risk factors for COVID infection and provide a research blood sample. Quarantining individuals will also have standard of care PCR testing on days 3 or 4, 5, 7, 10, and 14 of the quarantine period.
Collected blood samples will be used to assess for the presence of neutralizing antibodies and measure antibodies with a research test. An annual blood specimen and survey will be collected from each study participant for up to 2 years total after study entry.
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- prevalance, risk-factor, population, Kentucky, antibody, SARS CoV-2, seroconversion, physical distancing, PCR, quarantine
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health Care Workers | Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. | |
| Eligible Patients | Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. | |
| Quarantining Individuals | Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COVID-19
Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test.
Measured: 2 years
Secondary outcomes (1)
PCR Conversion in Exposed Individuals
Determine the average time point at which PCR conversion occurs following exposure.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 May 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jill M Kolesar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jill M Kolesar, University of Kentucky
- Investigators
- Jill Kolesar, PharmD, MS, Principal investigator, University of KentuckyDerek Forster, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573634
- Sponsor's protocol ID
- PHARM-20-COVID19-START
- Acronym
- START
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition (START) - Assessment of COVID19 Penetrance in HCW and Non HCW in Kentucky
- ClinicalTrials.gov ID
- NCT04573634
- Acronym / sponsor ID
- START / PHARM-20-COVID19-START
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- prevalance, risk-factor, population, Kentucky, antibody, SARS CoV-2, seroconversion, physical distancing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jill M KolesarUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Oct 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.
The co-primary objectives of this study are to:
- Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection
- Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals
Detailed description
This is a prospective cohort study designed to identify the prevalence of IgG antibodies to SARS CoV-2 as well as to assess risk factors for IgG positivity. It will compare rates of positivity and risk factors among healthcare workers and non-healthcare workers and assess the ability of PCR negativity at day 3 or 4, 5, 7, or 10 to predict negativity on day 14 in individuals quarantining after a COVID exposure.
In addition to having a standard of care clinical antibody test, both healthcare workers, quarantining individuals, and patients will be asked to fill out a survey to assess risk factors for COVID infection and provide a research blood sample. Quarantining individuals will also have standard of care PCR testing on days 3 or 4, 5, 7, 10, and 14 of the quarantine period.
Collected blood samples will be used to assess for the presence of neutralizing antibodies and measure antibodies with a research test. An annual blood specimen and survey will be collected from each study participant for up to 2 years total after study entry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Care Workers | – | –Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. |
| Eligible Patients | – | –Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. |
| Quarantining Individuals | – | –Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing at the University of Kentucky or individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care testing. Notably, these individuals may not have active COVID infection; they will be assessed for antibodies which is evidence of a prior, asymptomatic COVID infection or infection associated with a known exposure as diagnosed by polymerase chain reaction (PCR).
Key inclusion criteria (3 listed)
- Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing
- Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing.
- Able to understand and sign the Informed Consent and Research Authorization From.
Key exclusion criteria (3 listed)
- Prisoners
- Patients with psychiatric illness that would limit compliance
- Patients with social situations that would limit compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of COVID-19
Time frame: 2 years
Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test.
1 secondary outcome
PCR Conversion in Exposed Individuals
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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.
Jill Kolesar, PharmD, MS principal investigator
University of Kentucky
Derek Forster, MD principal investigator
University of Kentucky
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 Covid19 and SARS-CoV Infection, run by Jill M Kolesar 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Sep 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of COVID-19 (time frame: 2 years). 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 14 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.