SARS-CoV InfectionCOVID-19NCT04839913
Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study
An observational study of SARS-CoV Infection and Seroprevalence, run by University of Cagliari at 1 site in Italy.
Trial summary
The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV Infection, Seroprevalence, Covid19
- What is being tested?
- Antibodies testing
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 10 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: This is a cohort of elective surgical patients admitted to our unit in the 2020 fall period
Who may be able to join
- Patient admitted to our unit who had performed SARS-COV-2 serologic test
Who cannot join
- age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Update From an Unicentric, Regional Study
The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery.
- Conditions
- SARS-CoV Infection, Seroprevalence, Covid19
- Being tested
- Antibodies testing
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibodies testingDiagnostic test
Serologic test for both SARS-COV-2 IgG and IgM
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-COV-2 seroprevalence
SARS-COV-2 IgG and IgM seroprevalence between spring and fall period
Measured: 1St September - 10Th December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Sep 2020
- Primary completion10 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839913
- Sponsor's protocol ID
- COVID-SER
- Acronym
- COVID-19
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Update From an Unicentric, Regional Study
- ClinicalTrials.gov ID
- NCT04839913
- Acronym / sponsor ID
- COVID-19 / COVID-SER
- Conditions
- SARS-CoV Infection, Seroprevalence, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 9 Apr 2021 (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.
The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a cohort of elective surgical patients admitted to our unit in the 2020 fall period
Key inclusion criteria (1 listed)
- Patient admitted to our unit who had performed SARS-COV-2 serologic test
Key exclusion criteria (1 listed)
- age < 18
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 |
|---|---|---|
| Antibodies testingSerologic test for both SARS-COV-2 IgG and IgM | Diagnostic test | – |
Primary outcome
SARS-COV-2 seroprevalence
Time frame: 1St September - 10Th December 2020
SARS-COV-2 IgG and IgM seroprevalence between spring and fall period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SARS-CoV Infection and Seroprevalence, run by University of Cagliari at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 9 Apr 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SARS-COV-2 seroprevalence (time frame: 1St September - 10Th December 2020). 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 9 Apr 2021.