Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566965
Status:
TERMINATED
Last Update Posted:
2021-12-22
First Post:
2020-09-24
Brief Title:
Serology to COVID-19 for Recording Exposures and Evaluating Needs
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Serology to Covid for Recording Exposures and Evaluating Needs SCREEN
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CARES and institutional funding ended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCREEN
Brief 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 Childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None