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NCT04566965 · ClinicalTrials.gov registry record
Serology to COVID-19 for Recording Exposures and Evaluating Needs
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- 232
- Enrollment target
NCT04566965 is a clinical trial that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 232 participants.
The verdict
NCT04566965 was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- 232 participants
- Enrollment target
Study 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.
Interventions
- DIAGNOSTIC_TEST SARS-CoV-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2021-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04566965
The ClinicalTrials.gov registry entry for NCT04566965 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SARS-CoV-2 is the first listed.
NCT04566965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04566965 about?
NCT04566965 is a clinical study titled "Serology to COVID-19 for Recording Exposures and Evaluating Needs". 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-...
What is the current status of trial NCT04566965?
This trial is currently terminated. The enrollment target is 232 participants. The study started on 2020-08-18. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04566965?
The interventions under investigation include: SARS-CoV-2 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04566965?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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