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SARS-CoV-2RESTARTNCT04839094

Dry Versus Wet Nasopharyngeal Rapid Test for the Detection of COVID-19.

An observational study of SARS-CoV-2, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2
What is being tested?
rapid antigen testing versus RT-PCR
How many people
58 participants
Where
1 siteSwitzerland
Study dates
10 Dec 2020to 1 Feb 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: All hospitalized patients with a confirmed SARS-CoV-2 infection will be screened for inclusion criteria.

Who may be able to join

  • Hospitalized patients aged above 18 years with confirmed SARS-CoV-2 infection by RT-PCR assay.
  • Provide informed consent.

Who cannot join

  • Patient's refusal to participate in the study.
  • Patients with negative RT-PCR if already performed for patient's follow up as part of standard care.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud

Other trials in Switzerland

About this study

Official title: Dry Nasopharyngeal Swab Versus Transported in Viral Transport Media Rapid Antigen Test Comparison for the Detection of SARS-CoV-2: a Comparative Trial (RESTART).

Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study the investigators compare antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples. The investigators conducted a prospective observational study among COVID-19 hospitalized patients between 10th December 2020 and 1st February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland).

Read the detailed description

In response to the growing SARS-CoV-2 pandemic and shortages of laboratory based rapid molecular testing capacity and reagents on a worldwide scale, multiple manufacturers have developed rapid testing kits to use out of laboratory settings. These simple kits are based either on detection of proteins from the SARS-CoV-2 virus on respiratory samples (e.g. nasopharyngeal or throat swabs), or detection, in blood or serum, of human antibodies generated in response to infection.

On 28 October 2020 the Swiss Federal Council decided that as of 2 November 2020, in addition to polymerase chain reaction (PCR) tests, which are considered the "Gold standard" for SARS-CoV-2 diagnosis, it would be possible to conduct nasopharyngeal rapid antigen tests all over Switzerland, also outside licensed laboratories. In a hospital care setting rapid tests are intended to help physicians on prompt clinical management of cases with COVID-19 compatible symptoms upon admission and facilitate patient triage and flow, notably in a period marked of transition to higher incidence rates and enormous pressure on health system. This strategy was subsequently adopted by the University Hospital of Lausanne as well.

Roche's SARS-CoV-2 Rapid Antigen Test (which is the actual test employed by our institution) is a rapid chromatographic immunoassay intended for the qualitative detection of a specific antigen of SARS-CoV-2 present in human nasopharynx. This test is performed using a nasopharyngeal swab collected from a patient with a result available after 10-15 minutes. While the manufacturer reports very good diagnostic performances of the test, literature shows high variability of sensitivity and specificity.Rapid antigen test's diagnostic performances can be high enough to detect cases with high viral load (i.e. pre-symptomatic and early symptomatic cases up to five days from symptom onset. Because of the intense but short-lived nature of SARS-CoV-2 shedding form the upper respiratory tract, the clinical use of rapid antigen testing requires great attention to the timing of infection because testing late in the course of infection will cause an apparently low clinical sensitivity. There is a significant decline of the viral load after 5-7 days of symptoms. In order to account for this possible drawback and compensate the loss of rapid antigen test's diagnostic performance on late infection, a confirmatory RT-PCR is systematically performed by the microbiology laboratory of Lausanne University Hospital. So as to avoid multiple sampling of the same patient and accelerate time-to-final-results, a single nasopharyngeal swab is performed on each patient and soaked on a viral transport medium. From this transport medium both tests are performed (rapid antigen test and RT-PCR). This procedure, introduces a pre-dilution step (in contrast to the usual rapid antigen testing procedure using a dry nasopharyngeal swab) but is in accordance to the specifications of the manufacturers' instructions. While current literature advocates against a significant decrease of tests' analytical performances due to this strategy, there is no strong consensus regarding the influence of transport medium on viral load stability and on test's analytical and clinical sensitivity

Conditions
SARS-CoV-2
Being tested
rapid antigen testing versus RT-PCR
Keywords
SARS-CoV-2 diagnosis, RT-PCR, rapid antigen testing, saliva, viral transport medium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rapid antigen testing versus RT-PCRDiagnostic test

    Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic assessment

    Comparison of diagnostic performances (sensitivity, specificity, positive and negative predictive value) of the different strategies on patients hospitalised with a SARS-CoV-2 infection.

    Measured: On the day of inclusion

Secondary outcomes (1)
  1. Limit of detection determination.

    • Define the limit of detection viral load and lowest dilution with the highest positivity rate of both strategies.

    Measured: On the day of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start10 Dec 2020
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2021

Resources

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
Prospective
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04839094
Sponsor's protocol ID
Q2059
Acronym
RESTART
Status last verified
Apr 2021
First submitted
6 Apr 2021
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 2 inclusion and 2 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 Switzerland. 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?

Diagnostic assessment (time frame: On the day of inclusion). 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; AzTrials last refreshed its copy on 7 Nov 2026.

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