Telemedically Assisted Sampling of COVID-19 Patients - Is the Sampling Quality Sufficient

NCT05386407 | Unknown

• 1 other identifier: 2021-02508
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) pandemic has resulted in more than 3.8 billion registered tests, 275 million positive cases, and 5 million deaths worldwide. Early and regular testing has been an important pillar of secondary prevention since the beginning. However, this pandemic has also fostered solutions in the form of e telemedicine with enormously increased applicability. The question of whether telemedically supervised testing with SARS-CoV-2 Rapid Antigen Tests is non-inferior to the same tests being carried out by trained personnel in test centers is still unanswered. With this study, the investigators aim to compare and evaluate the reliability and sampling quality of telemedically guided self-performed rapid tests for professional use compared to professional sampling by healthcare personnel. Our hypothesis is that, applying a strict standard operating procedure (SOP, attached), guided oropharyngeal + nasal (OP+N) self-sampling (GSS) is non-inferior to nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP), and that guided OP+N sampling is superior to unsupervised OP+N self-sampling (USS).

Conditions

Telemedicine; Pharynx; COVID-19

Keywords

Telemedicine; supervised testing; nasopharyngeal swab,; COVID-19; rapid diagnostic tests

Outcome Measures

Primary Outcomes (3)

• NP HCP vs OP+N HCP

  Concordance of positive/negative samples in antigen tests with nasopharyngeal sampling vs. oropharyngeal + nasal sampling, both performed by health care professionals

  5 months

• OP+N HCP vs OP+N GSS

  Concordance of positive/negative samples in antigen tests with oropharyngeal + nasal sampling performed by health care professionals vs. oropharyngeal + nasal sampling telemedically guided self-sampling

  5 months

• OP+N HCP vs OP+N USS

  Concordance of positive/negative samples in antigen tests with oropharyngeal + nasal sampling performed by health care professionals vs. unsupervised oropharyngeal + nasal self-sampling (USS)

  5 months

Secondary Outcomes (9)

• Housekeeping gene Ct comparison of oropharyngeal + nasal samples between guided self-sampling, unsupervised self-sampling, or sampling performed by health care professionals

  5 months

• ORF1ab/RdRp-, E-, N-, and S genes Ct value comparison based on sampling method between samples based on GSS, USS, or HCP

  5 months

• Qualitative analysis of perceived sampling accuracy

  5 months

• Detected SARS-CoV-2 variants of concern

  5 months

• CRF assessing basic demographics and variables of interests

  5 months

Study Arms (2)

telemedically assisted guided oropharyngeal + nasal (OP+N) self-sampling (GSS): OP+N GSS

EXPERIMENTAL

After performing the telemedically assisted OP+N GSS procedure, the patients will continue to be sampled by HCP OP+N and HCP NP.

Diagnostic Test: telemedically guided oropharyngeal + nasal (OP+N) self-sampling (GSS) and nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP)

unsupervised OP+N self-sampling (USS): OP+N USS

EXPERIMENTAL

Written instructions on how to perform a self-test will be provided, representing the instructions that come along with a commercially available rapid test set. An instructional online video tutorial or similar would also account as the latest state of the art.30 However, this has not yet been implemented comprehensively with all available test sets. After performing the OP+N USS procedure, the patients will continue to be sampled by HCP OP+N and HCP NP.

Diagnostic Test: telemedically guided oropharyngeal + nasal (OP+N) self-sampling (GSS) and nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP)

Interventions

telemedically guided oropharyngeal + nasal (OP+N) self-sampling (GSS) and nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP) DIAGNOSTIC_TEST

After giving informed consent by signing the consent form, patients will be randomized to either OP+N GSS - or to OP+N USS. After performing either procedure, they will continue to be sampled by HCP OP+N and HCP NP.

Also known as: oropharyngeal + nasal (OP+N) sampling performed by health care professionals (HCP)

telemedically assisted guided oropharyngeal + nasal (OP+N) self-sampling (GSS): OP+N GSS; unsupervised OP+N self-sampling (USS): OP+N USS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Patients visiting the test-station for a SARS-CoV-2 test
• Consent to comply with the study protocol
• Age of 18 or older

You may not qualify if:

• Refusal to comply with the study protocol
• Digital illiteracy (i.e. patients who would never use telemedicine as they do not feel competent enough to use the necessary tools)
• Not German or English speaking
• People trained in the use of rapid diagnostic tests (HCP, biologists) will be excluded to reduce bias

Sponsors & Collaborators

• Teststation Praxis Dr. med Bielecki: lead

Study Sites (1)

Teststation Praxis Dr. med Bielecki

Olten, Canton of Solothurn, 4600, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christian V Eisenring, MD

  Teststation Praxis Dr. med Bielecki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Our hypothesis is that, applying a strict standard operating procedure (SOP, attached), guided oropharyngeal + nasal (OP+N) self-sampling (GSS) is non-inferior to nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP), and that guided OP+N sampling is superior to unsupervised OP+N self-sampling (USS). After giving informed consent by signing the consent form, patients will be randomized to either OP+N GSS - or to OP+N USS. After performing either procedure, they will continue to be sampled by HCP OP+N and HCP NP. The outcome assessors and the investigators will be blinded to the randomization to either OP+N GSS - or to OP+N US
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: interventional randomized method comparison study

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 23, 2022
• Study Start: April 14, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)