Asymptomatic ConditionNCT04367740
ScreenNC, a Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the Virus That Causes COVID-19
An observational study of Asymptomatic Condition and Infection Viral, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asymptomatic Condition, Infection Viral, Coronavirus Infections
- What is being tested?
- To assess for development of IgG antibodies against SARS-CoV2
- How many people
- 6,313 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 28 Feb 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 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients seen at UNC Outpatient clinics who are asymptomatic for COVID-19 infection
Who may be able to join
- Individuals aged 18-99 who arrive at any participating UNC Healthcare clinic for care and who have a medical record in UNC EPIC.
- Patients may be included if they have completed the quarantine as recommended by the CDC and at least 4 weeks since the initial positive COVID-19 NP test.
Who cannot join
- Any individual arriving at any participating UNC Healthcare clinic for diagnosis or treatment of respiratory symptoms meeting the following COVID-19 clinical evaluation criteria:
- Developed non-allergy respiratory symptoms of cough or shortness of breath in the past 7 days
- AND
- Meet ONE OR MORE of these criteria
- Had close contact (within 6 feet for 10 or more minutes) with a person diagnosed with COVID-19
- Works in a healthcare setting
Show all 18Show fewer
- Is pregnant or postpartum within 2 weeks of delivery
- Is morbidly obese: BMI = 40 or 100 pounds over ideal body weight
- Diabetes mellitus
- Immunosuppression, including caused by medications or by HIV infection
- Pulmonary disease, including asthma
- Cardiovascular disease
- Hypertensive disease
- Renal disease
- Hepatic disease
- Hematologic disease, including sickle cell disease
- Neurological condition that limits movement
- Moderate to severe developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
Official title: ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection
Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Read the detailed description
ScreenNC is design ed for comprehensive virus screening and serology to assess exposure to SAR-CoV2 in persons not-indicated for COVID-19 testing as per the CDC screening algorithm and implemented at UNC Health Care (at the time of activation). This trial is designed to generate point prevalence of infected (I) persons, independent of clinical symptoms. The susceptible (S) class is the number of COVID-19 tested by any FDA-approved NP swab test or a SARS-CoV2 IgG antibody test. At present FDA does not have approved SARS-CoV serology and such serology is not used for diagnosis of acute infection. The recovered (R) class is the number of positives. This information allows for modeling of the COVID-19 epidemic in NC. The investigation is not testing the effectiveness or safety of either of these testing modalities, though serology may be offered in the future by UNC Healthcare laboratories. The blood samples to be obtained assess development of host response to SARS-CoV2 infection.
ScreenNC will be implemented within the logistic and clinical limitations of the current outbreak. This is a single visit study. Since there is a shortage of PPE the investigators will rely on screening at locations different then the screening of presumed infected persons. Additionally, due to logistical considerations, volunteers may have a viral swab (nasopharyngeal or oropharyngeal) and/or a blood sample obtained. Thus, at recruitment, volunteers may be asked to give both samples or only one.
Viral load testing will be done at LabCorp and/or UNC labs using compatible assays (Roche, ThermoFischer , WHO). Confirmatory testing (other PCR, sequencing, culture) will be done at UNC. Blood samples will be tested at the McClendon Clinical Immunology laboratory for IgG antibodies against SARS-CoV2.
Because these patients are in the UNC Health Care system, The investigators will have access to their medical records, which will provide very granular information as to co-morbidities and other demographic factors which can be assessed in the context of SAR-CoV-2 (COVID-19) infection status. Future analyses of this cohort will employ statistical methods which allow us to account for sampling bias of this convenience sample to construct a representative sample of the state of NC .
- Conditions
- Asymptomatic Condition, Infection Viral, Coronavirus Infections, Severe Acute Respiratory Syndrome Coronavirus 2, Coronaviridae Infections, RNA Virus Infections
- Being tested
- To assess for development of IgG antibodies against SARS-CoV2
- Keywords
- COVID-19, Pandemic, COVID-19 virus testing
- Medical subject headings
- Asymptomatic Diseases, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, RNA Virus Infections, Communicable Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess for development of IgG antibodies against SARS-CoV2Diagnostic test
Also called Nasopharyngeal Swab, Oropharyngeal Swab
Swabs will be collected to assess for COVID-19 if PPE supplies allow.
| Study group | Role | What they receive |
|---|---|---|
| Serum Antibodies | Blood samples to be obtained assess for IgG antibodies against SARS-CoV2 Receives: Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection.
Presence or absence of IgG antibodies to SARS-CoV2
Measured: at enrollment
Secondary outcomes (1)
Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.
swab for presence of SARS-CoV-2 virus
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start28 Apr 2020
- Primary completion24 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic ConditionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B Peden, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367740
- Sponsor's protocol ID
- 20-0937
- Status last verified
- Jan 2022
- First submitted
- 27 Apr 2020
- Last updated
- 9 Jan 2023
- 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 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04367740
- Acronym / sponsor ID
- 20-0937
- Conditions
- Asymptomatic Condition, Infection Viral, Coronavirus Infections, Severe Acute Respiratory Syndrome Coronavirus 2, Coronaviridae Infections, RNA Virus Infections
- Keywords
- COVID-19, Pandemic, COVID-19 virus testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,313 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 29 Apr 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.
Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Detailed description
ScreenNC is design ed for comprehensive virus screening and serology to assess exposure to SAR-CoV2 in persons not-indicated for COVID-19 testing as per the CDC screening algorithm and implemented at UNC Health Care (at the time of activation). This trial is designed to generate point prevalence of infected (I) persons, independent of clinical symptoms. The susceptible (S) class is the number of COVID-19 tested by any FDA-approved NP swab test or a SARS-CoV2 IgG antibody test. At present FDA does not have approved SARS-CoV serology and such serology is not used for diagnosis of acute infection. The recovered (R) class is the number of positives. This information allows for modeling of the COVID-19 epidemic in NC. The investigation is not testing the effectiveness or safety of either of these testing modalities, though serology may be offered in the future by UNC Healthcare laboratories. The blood samples to be obtained assess development of host response to SARS-CoV2 infection.
ScreenNC will be implemented within the logistic and clinical limitations of the current outbreak. This is a single visit study. Since there is a shortage of PPE the investigators will rely on screening at locations different then the screening of presumed infected persons. Additionally, due to logistical considerations, volunteers may have a viral swab (nasopharyngeal or oropharyngeal) and/or a blood sample obtained. Thus, at recruitment, volunteers may be asked to give both samples or only one.
Viral load testing will be done at LabCorp and/or UNC labs using compatible assays (Roche, ThermoFischer , WHO). Confirmatory testing (other PCR, sequencing, culture) will be done at UNC. Blood samples will be tested at the McClendon Clinical Immunology laboratory for IgG antibodies against SARS-CoV2.
Because these patients are in the UNC Health Care system, The investigators will have access to their medical records, which will provide very granular information as to co-morbidities and other demographic factors which can be assessed in the context of SAR-CoV-2 (COVID-19) infection status. Future analyses of this cohort will employ statistical methods which allow us to account for sampling bias of this convenience sample to construct a representative sample of the state of NC .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum Antibodies | – | Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2Blood samples to be obtained assess for IgG antibodies against SARS-CoV2 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients seen at UNC Outpatient clinics who are asymptomatic for COVID-19 infection
Key inclusion criteria (2 listed)
- Individuals aged 18-99 who arrive at any participating UNC Healthcare clinic for care and who have a medical record in UNC EPIC.
- Patients may be included if they have completed the quarantine as recommended by the CDC and at least 4 weeks since the initial positive COVID-19 NP test.
Key exclusion criteria (18 listed)
- Any individual arriving at any participating UNC Healthcare clinic for diagnosis or treatment of respiratory symptoms meeting the following COVID-19 clinical evaluation criteria:
- AND
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 |
|---|---|---|
| To assess for development of IgG antibodies against SARS-CoV2Also: Nasopharyngeal Swab, Oropharyngeal SwabSwabs will be collected to assess for COVID-19 if PPE supplies allow. | Diagnostic test | Serum Antibodies |
Primary outcome
Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection.
Time frame: at enrollment
Presence or absence of IgG antibodies to SARS-CoV2
1 secondary outcome
Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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.
David B Peden, MD principal investigator
University of North Carolina, Chapel Hill
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 Asymptomatic Condition and Infection Viral, run by University of North Carolina, Chapel Hill 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 2 inclusion and 18 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: finished, as of the sponsor's last update on 9 Jan 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. (time frame: at enrollment). 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 9 Jan 2023.