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NCT05386407

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

Status unknown NA Last updated 12 April 2023
What this trial tests

NA trial testing telemedically guided oropharyngeal + nasal (OP+N) self-sampling (GSS) and nasopharyngeal (NP) or OP+N sampling performed by health care professionals (HCP) in Telemedicine in 170 participants. Status unknown.

Timeline
14 April 2022
Primary endpoint
30 October 2023
31 December 2025

Quick facts

Lead sponsorTeststation Praxis Dr. med Bielecki
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposediagnostic
Enrollment170
Start date14 April 2022
Primary completion30 October 2023
Estimated completion31 December 2025
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Teststation Praxis Dr. med Bielecki

Who can join

18 and older, any sex, with Telemedicine or Pharynx. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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