A diagnostic study comparing different tests for the diagnosis of COVID-19
| ISRCTN | ISRCTN13990999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13990999 |
- Submission date
- 23/06/2020
- Registration date
- 24/06/2020
- Last edited
- 17/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
IRCCS Sacro Cuore don Calabria hospital
Via Sempreboni 5
Negrar
37024
Italy
 ORCID ID |
0000-0001-9530-8742 |
|---|---|
| Phone | +39 (0)456013326 |
| zeno.bisoffi@sacrocuore.it |
Study information
| Study design | Single-centre observational prospective diagnostic study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet (Italian) |
| Scientific title | Sensitivity, specificity and predictive values of molecular and serological tests for COVID-19: a longitudinal study in the emergency room |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 26/02/2020 |
| Completion date | 25/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 346 |
| Key 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 |
| Key exclusion criteria | 1. Missing or invalid samples |
| Date of first enrolment | 03/04/2020 |
| Date of final enrolment | 09/05/2020 |
Locations
Countries of recruitment
- Italy
Study participating centre
Negrar
37024
Italy
Sponsor information
Hospital/treatment centre
Via Sempreboni 5
Negrar
37024
Italy
| Phone | +39 (0)456014851 |
|---|---|
| segreteriascientificairccs@sacrocuore.it | |
| Website | www.sacrocuore.it |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Italian Ministry of Health, Italy Ministry of Health, Ministry of Health of Italy, Ministry of Health - Italy, Ministry of Health, Italy
- Location
- Italy
Results and Publications
| Intention to publish date | 25/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository (Mendeley Data) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/09/2020 | 17/03/2021 | Yes | No |
Editorial Notes
17/03/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
25/06/2020: The following changes were made to the trial record:
1. The interventions were changed.
2. The primary outcome measure was changed.
3. The secondary outcome measures were changed.
24/06/2020: Trial’s existence confirmed by Ethics Committee for the Clinical Trials (CESC) of Verona and Rovigo Provinces.
