Covid19NCT04480580
Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery
An observational study of Covid19 and Surgery, run by University of Cagliari at 1 site in Italy.
Trial summary
We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Surgery, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- SARS-CoV-2 Ab
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2020to 30 Jun 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients hospitalized in surgical department
Who may be able to join
- Patients hospitalized during pandemic spread
Who cannot join
- Incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this context.
- Conditions
- Covid19, Surgery, SARS (Severe Acute Respiratory Syndrome)
- Being tested
- SARS-CoV-2 Ab
- Keywords
- SARS-CoV-2, surgery
- Medical subject headings
- COVID-19, 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-2 AbDiagnostic test
Patient test for specific antibodies for SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | Not described Receives: Diagnostic Test: SARS-CoV-2 Ab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence of SARS-CoV-2
Positivity of specific IgM or IgG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start30 Mar 2020
- Primary completion30 Apr 2020
- Study completion30 Jun 2020
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 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
- NCT04480580
- Sponsor's protocol ID
- COVID-SURG
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 21 Jul 2020
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery
- ClinicalTrials.gov ID
- NCT04480580
- Acronym / sponsor ID
- COVID-SURG
- Conditions
- Covid19, Surgery, SARS (Severe Acute Respiratory Syndrome)
- Keywords
- SARS-CoV-2, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jul 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.
We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this context.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | Diagnostic Test: SARS-CoV-2 Ab |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in surgical department
Key inclusion criteria (1 listed)
- Patients hospitalized during pandemic spread
Key exclusion criteria (1 listed)
- Incomplete data
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-2 AbPatient test for specific antibodies for SARS-CoV-2 | Diagnostic test | Hospitalized patients |
Primary outcome
Seroprevalence of SARS-CoV-2
Time frame: 3 months
Positivity of specific IgM or IgG
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 21 Jul 2020.
- 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 Covid19 and Surgery, 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 21 Jul 2020. 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?
Seroprevalence of SARS-CoV-2 (time frame: 3 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 21 Jul 2020.