Serology to COVID-19 for Recording Exposures and Evaluating Needs

Covid19 Clinical Trial

— SCREEN  

Official title:

Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04566965
• Other study ID #: SCREEN
• Status: Terminated
• Start date: August 18, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. As new residents and fellows arrive in July 2020 to Cincinnati Children's Hospital Medical Center (CCHMC), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. The investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection among trainees at CCHMC, including risk factors for transmission and immunological recovery. SCREEN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection within the cohort of CCHMC residents and fellows who have patient contact. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), the investigators will determine the prevalence and cumulative incidence of infection by SARS-CoV-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current full-time residents and fellows at CCHMC

• Cell phone that can be used for text messaging or web-based viewing of surveys

• Willing and able to provide informed consent

• Ability to comply with all study related evaluations and follow-up

Exclusion Criteria:

• Any condition or illness that makes study participation ill-advised

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Diagnostic Test:
• SARS-CoV-2
Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection. Testing monthly serum samples to document post-viral infection.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 12-month cumulative incidence of acquired COVID infection in the study cohort.	Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR.	Weekly for 12 months