Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
Italy has been one of the most affected countries in Europe. The virus has posed an extremely difficult challenge for health units and health workers. Reliable and fast tests for diagnosis at the Emergency room level are of the highest importance. The aim of this study is to assess the performance of different tests for the diagnosis of COVID-19
Who can participate?
Adult patients with symptoms of COVID-19 who provide consent to participate in the study and to the donation of biological samples.
What does the study involve?
All patients presenting to the Emergency Room (ER) of the participating hospital with suspected COVID-19 will be given information about the study and asked for consent to participate. Participants who agree to participate will undergo several diagnostic tests for COVID-19 which involve blood withdrawal and a nose and throat swab.
What are the possible benefits and risks of participating?
Participants will receive standard care guided by the results of the validated test (PCR) used for the diagnosis of COVID-19. There are no additional direct benefits or risks. Adverse events are not expected.
Where is the study run from?
IRCCS Sacro Cuore Don Calabria hospital (Italy)
When is the study starting and how long is it expected to run for?
From March 2020 to May 2020
Who is funding the study?
Partially funded by the Italian Ministry of Health (Italy)
Who is the main contact?
Prof Zeno Bisoffi
zeno.bisoffi@sacrocuore.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Zeno Bisoffi
ORCID ID
http://orcid.org/0000-0001-9530-8742
Contact details
IRCCS Sacro Cuore don Calabria hospital
Via Sempreboni 5
Negrar
37024
Italy
+39 (0)456013326
zeno.bisoffi@sacrocuore.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Sensitivity, specificity and predictive values of molecular and serological tests for COVID-19: a longitudinal study in the emergency room
Acronym
Study hypothesis
To assess sensitivity, specificity and predictive values of different test methods for the diagnosis of SARS-CoV-2 infection used at the hospital emergency room: five IgG-IgM rapid diagnostic tests (RDT), an ELISA IgA-IgG test, and three Reverse Transcriptase-real-time PCR (RT-PCR) tests, with different gene targets, validated and widely used for diagnosis.
Ethics approval
Approved 02/04/2020, amendment approved 16/06/2020, Ethics Committee for the Clinical Trials (CESC) of Verona and Rovigo Provinces (AOUI di Verona, Servizio di Farmacia dell'Ospedale, Borgo Trento, P.le Stefani, 1, Verona 37126, Italy; +39 (0)45 8123236; comitatoetico.veronarovigo@aovr.veneto.it; comitatoetico.aovr@pecveneto.it), ref: 19408, amendment ref: 33102
Study design
Single-centre observational prospective diagnostic study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet (Italian)
Condition
COVID-19 (SARS-CoV-2 infection)
Intervention
Current interventions as of 25/06/2020:
Patients will be recruited at the participating centre emergency room. They will have nasopharyngeal swabs for PCR and blood taken for serological tests. The assessment will be carried out using the standard, RT-PCR used within the department as the gold standard and compared using the statistical technique of Latent Class Analysis. An exploratory analysis will also be carried out using a Composite Reference Standard (CRS). Participants will then be managed according to the results of the validated PCR (a few hours to have the results). All assessment will occur within the same emergency room visit. There will be no follow up, except for cases of uncertain classification, and for the final outcome that will be recorded for all patients admitted to hospital.
Previous interventions:
Patients will be recruited at the participating centre emergency room. They will have nasopharyngeal swabs for PCR and blood taken for serological tests. The assessment will be carried out using the standard, RT-PCR used within the department as the gold standard and compared using the statistical technique of Latent Class Analysis. An exploratory analysis will also be carried out using a Composite Reference Standard (CRS). Participants will then be managed according to the results of the validated PCR (a few hours to have the results). All assessment will occur within the same emergency room visit. There will be no follow up.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Current primary outcome measure as of 25/06/2020:
Test accuracy for the diagnosis of SARS-CoV-2 infection assessed through comparison against a patient classification made using all the molecular tests and selected clinical variables, using the statistical technique of Latent Class Analysis (LCA) and with clinical reassessment of uncertain cases; the standard molecular test is performed at baseline (upon patient recruitment), while the six serological and two additional molecular (Rt-PCR) tests will be performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment.
Previous primary outcome measure:
Test accuracy for the diagnosis of SARS-CoV-2 infection assessed through comparison against a patient classification using the standard molecular test, performed at baseline (upon patient recruitment) and with clinical reassessment of uncertain cases; and the six serological and three molecular (Rt-PCR) tests, performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment (within 1 h)
Secondary outcome measures
Current secondary outcome measures as of 25/06/2020:
Test accuracy of the six serological tests in the subset of patients reporting symptom duration ≥7 days assessed using the standard molecular test, performed at baseline (upon patient recruitment).
Previous secondary outcome measures:
Test accuracy in the subset of patients reporting symptom duration ≥7 days assessed using the standard molecular test, performed at baseline (upon patient recruitment); and the six serological and three molecular (Rt-PCR) tests, performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment (within 1 h)
Overall trial start date
26/02/2020
Overall trial end date
25/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years
2. Clinical suspicion of COVID-19
3. Consent to participate in the study and to the donation of biological samples given
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Missing or invalid samples
Recruitment start date
03/04/2020
Recruitment end date
09/05/2020
Locations
Countries of recruitment
Italy
Trial participating centre
IRCCS Sacro Cuore Don Calabria hospital
Via Sempreboni 5
Negrar
37024
Italy
Sponsor information
Organisation
IRCCS Sacro Cuore Don Calabria hospital
Sponsor details
Via Sempreboni 5
Negrar
37024
Italy
+39 (0)456014851
segreteriascientificairccs@sacrocuore.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Ministero della Salute
Alternative name(s)
Ministry of Health, Italy
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Italy
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository (Mendeley Data)
Intention to publish date
25/05/2021
Participant level data
Stored in repository
Basic results (scientific)
Publication list