NCT04547114

Brief Summary

Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 11, 2020

Last Update Submit

September 11, 2020

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

  • correct classification of SARS-CoV-2 infected and not infected subjects

    correct classification of SARS-CoV-2 infected and not infected subjects

    6 months

Study Arms (2)

SARS-CoV-2- infected

Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs

Diagnostic Test: Multicapillary column coupled ion mobility spectrometry

non infected

Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs

Diagnostic Test: Multicapillary column coupled ion mobility spectrometry

Interventions

Multicapillary column coupled ion mobility spectrometryDIAGNOSTIC_TEST

sampling of nasal air via a foam cuffed oxygen catheter

SARS-CoV-2- infectednon infected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult subjects of all genders and ages

You may qualify if:

  • hospital admission staff members

You may not qualify if:

  • too sick to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Bayreuth/ Bayreuth General Hospital

Bayreuth, 95445, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 14, 2020

Study Start

September 14, 2020

Primary Completion

December 31, 2020

Study Completion

April 30, 2021

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)