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

NCT05386407 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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.

Sponsors & Collaborators

  • Teststation Praxis Dr. med Bielecki

    lead OTHER

Principal Investigators

  • Christian V Eisenring, MD · Teststation Praxis Dr. med Bielecki

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2023-10-30
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386407 on ClinicalTrials.gov