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ScreenNC, a Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the Virus That Causes COVID-19

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ClinicalTrials.gov Identifier: NCT04367740
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19

Condition or disease Intervention/treatment
Asymptomatic Condition Infection Viral Coronavirus Infections Severe Acute Respiratory Syndrome Coronavirus 2 Coronaviridae Infections RNA Virus Infections Virus Diseases Communicable Disease Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2

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 .

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Serum Antibodies
Blood samples to be obtained assess for IgG antibodies against SARS-CoV2
Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2
Swabs will be collected to assess for COVID-19 if PPE supplies allow.
Other Names:
  • Nasopharyngeal Swab
  • Oropharyngeal Swab




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. [ Time Frame: at enrollment ]
    swab for presence of SARS-CoV-2 virus


Biospecimen Retention:   Samples Without DNA
Blood; virus from nasal or oral swab


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at UNC Outpatient clinics who are asymptomatic for COVID-19 infection
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any individual arriving at any participating UNC Healthcare clinic for diagnosis or treatment of respiratory symptoms meeting the following COVID-19 clinical evaluation criteria:

    1. Developed non-allergy respiratory symptoms of cough or shortness of breath in the past 7 days

      AND

    2. 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
      • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367740


Locations
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United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: David B Peden, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04367740    
Other Study ID Numbers: 20-0937
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
COVID-19
Pandemic
COVID-19 virus testing
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
RNA Virus Infections
Coronaviridae Infections
Asymptomatic Diseases
Nidovirales Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Antibodies
Immunologic Factors
Physiological Effects of Drugs