Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04367740
Other study ID # 20-0937
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 28, 2020
Est. completion date February 28, 2022

Study information

Verified date January 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 .


Recruitment information / eligibility

Status Completed
Enrollment 6313
Est. completion date February 28, 2022
Est. primary completion date February 24, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Center for Environmental Medicine, Asthma and Lung Biology Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. Presence or absence of IgG antibodies to SARS-CoV2 at enrollment
Secondary Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. swab for presence of SARS-CoV-2 virus at enrollment
See also
  Status Clinical Trial Phase
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT04644484 - A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety Phase 3
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Completed NCT00734175 - Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine Phase 1
Completed NCT00516035 - Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults Phase 1
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly Phase 3
Recruiting NCT06113757 - Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease N/A
Completed NCT01991587 - Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults Phase 1/Phase 2
Completed NCT03294135 - The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine Phase 4
Active, not recruiting NCT02545517 - A Clinical Study to Evaluate Immune Responses to Rabies Vaccine in Adults Who Received Different Primary Rabies Vaccination Regimens Phase 3
Active, not recruiting NCT05619770 - Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects Phase 1
Not yet recruiting NCT01289301 - Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant Phase 4
Active, not recruiting NCT01055990 - Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients Phase 2
Completed NCT01842997 - Safety of H1N1 Influenza Vaccination in Pregnant Women Phase 4
Completed NCT00980447 - Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults Phase 2
Completed NCT00380237 - Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B) Phase 1
Completed NCT00219453 - Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination Phase 1
Completed NCT02548078 - A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children Phase 2