Covid19SCREENNCT04566965
Serology to COVID-19 for Recording Exposures and Evaluating Needs
An observational study of Covid19 and Coronavirus, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Coronavirus, SARS-CoV Infection
- What is being tested?
- SARS-CoV-2
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult men and women who are CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties.
Who may be able to join
- 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
Who cannot join
- Any condition or illness that makes study participation ill-advised
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)
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.
- Conditions
- Covid19, Coronavirus, SARS-CoV Infection
- Being tested
- SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2Diagnostic test
- Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.
- Testing monthly serum samples to document post-viral infection.
| Study group | Role | What they receive |
|---|---|---|
| Full-Time CCHMC Employees | All CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties. Receives: Diagnostic Test: SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start18 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: CARES and institutional funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Russell Ware, MD, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiMary Allen Staat, MD, MPH, Principal investigator, Children's Hospital Medical Center, CincinnatiSue Poynter Wong, MD, MEd, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566965
- Sponsor's protocol ID
- SCREEN
- Acronym
- SCREEN
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serology to Covid for Recording Exposures and Evaluating Needs (SCREEN)
- ClinicalTrials.gov ID
- NCT04566965
- Acronym / sponsor ID
- SCREEN / SCREEN
- Conditions
- Covid19, Coronavirus, SARS-CoV Infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: CARES and institutional funding ended
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-Time CCHMC Employees | – | Diagnostic Test: SARS-CoV-2All CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult men and women who are CCHMC full-time residents and fellows who have some direct contact with patients and their families as part of normal workplace duties.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any condition or illness that makes study participation ill-advised
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-21. Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection. 2. Testing monthly serum samples to document post-viral infection. | Diagnostic test | Full-Time CCHMC Employees |
Primary outcome
The 12-month cumulative incidence of acquired COVID infection in the study cohort.
Time frame: Weekly for 12 months
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.
Results and safety
The study was stopped early (reason given: CARES and institutional funding ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Ware, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Mary Allen Staat, MD, MPH principal investigator
Children's Hospital Medical Center, Cincinnati
Sue Poynter Wong, MD, MEd principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Coronavirus, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: CARES and institutional funding ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 12-month cumulative incidence of acquired COVID infection in the study cohort. (time frame: Weekly for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.