Performance of 3 Sampling Methods for the Detection of SA... | NCT04361448

Studies
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

NCT04361448

Sponsor

Jessa Hospital

Status

Terminated

Last Update Posted

Feb 15, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Covid-19
SARS-CoV-2
Diagnosis
Polymerase Chain Reaction

Interventions

samling of oropharynx and nasopharynx

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient sample number

Expanded Access Info

Start Date

Apr 20, 2020Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Apr 20, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2021

Last Update Posted Date

Feb 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.

Detailed Description

Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing.

For each volunteer, 3 swabs will be taken:

Flocked eSwab (Copan, Italy) of the oropharynx
Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx
Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene).

Performance of each method will be calculated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health Care Workers with Covid-19 symptoms	Other	3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer	Other: samling of oropharynx and nasopharynx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
samling of oropharynx and nasopharynx	Other	Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs	Health Care Workers with Covid-19 symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity	sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

health care workers with symptoms suspicious for Covid-19

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reinoud Cartuyvels	Jessa Hospital, Hasselt, Belgium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jessa Hospital		Hasselt		3500	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D004194	Disease

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided