COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs... | NCT04703140

Studies
COVIDISC: Rapid Diagnostic Tests on Nasopharyngeal Swabs for the Detection of COVID-19

NCT04703140

Sponsor

CMC Ambroise Paré

Status

Terminated

Last Update Posted

Jun 15, 2022Actual

Enrollment

192Actual

Phase

Not Applicable

Conditions

COVID-19
SARS-CoV-2

Interventions

Rapid Diagnostic Test vs PCR

Countries

France

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Non-significant intemedial analysis

Expanded Access Info

Start Date

Jan 27, 2021Actual

Primary Completion Date

May 4, 2021Actual

Completion Date

May 4, 2021Actual

First Submitted Date

Nov 30, 2020

First Submission Date that Met QC Criteria

Jan 8, 2021

First Posted Date

Jan 11, 2021Actual

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

Jun 13, 2022

Last Update Posted Date

Jun 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 Covid-19 pandemic requires a reliable diagnosis of patients in order to take care of them in the best conditions and in the appropriate services. Moreover, the current diagnostic reference is reverse transcription by polymerase chain reaction (RT-PCR) on a nasopharyngeal sample taken by swab. This technique is expensive (54€) and its production time is several hours.

Alternative methods are in progress, including, rapid diagnostic tests. The MEMS microfluids and nanostructures (MMN) laboratory, in partnership with the Institut Chimie Biologie Innovation (CBI) (Paris, 75005), have developed a portable test "COVIDISC", low-cost (10 €), fast (1 hour), including extraction, elution and amplification in solid medium isothermal, reverse amplification loop mediated transcription (RT-LAMP).

The "lab" version has received an analytical validation on human nasopharyngeal samples with performance comparable to classic RT-PCR (sensitivity of 7 copies per μl, specificity 100%).

The objective of this study is to validate the in vitro diagnostic medical device, COVIDISC, with the standard nasopharyngeal RT-PCR test.

Detailed Description

All outpatients and hospitalized patients (intensive care unit, internal medicine service and emergency service) will be proposed to participate to the study after assessment of eligibility criteria by the investigator. The investigator will collect a written consent of the patient or from the support person or a familiar if, the patient is not in condition to consent. Patient's participation will be notified in his medical record.

After inclusion of patient, the nurse will collect general and clinical data and 2 nasopharyngeal swabs will be taken. One sample to test the prototype of the RT-LAMP and the second one to carry out the classic RT-PCR. The results will be collected and compared in a second step.

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

192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nasopharyngeal swabs	Experimental	One patient will have 2 nasopharyngeal for PCR and COVIDISC	Diagnostic Test: Rapid Diagnostic Test vs PCR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapid Diagnostic Test vs PCR	Diagnostic Test	2 nasopharyngeal swabs taken for PCR and COVIDISC	nasopharyngeal swabs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparaison of the performance of the diagnostic performance (sensitivity, sensibility) of RT-LAMP test using the RT-PCR test as a reference.	Calculate sensitivity, Specificity, Positive predictive value, Negative predictive value, Positive and negative likelihood report COVIDISC fast, antigenic test compared to RT-PCR Covid-19 reference test conducted in the laboratory	Day 0

Secondary Outcomes

Measure	Description	Time Frame
Compare the diagnostic performances of RT-LAMP to clinical diagnosis.	The result of RT-LAMP test versus clinical evaluation defined by the clinical symptoms of the patients at the time of nasopharyngeal swab.	Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing nasopharyngeal SARS CoV2 RT-PCR testing

Exclusion Criteria:

< 18 years old
Having signed a written informed consent form,
Affiliation to the social security system.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ROSSI Benjamin, MD	Hopital Robert Ballanger	Principal Investigator
NGUYEN Lee, MD	CMC Ambroise Paré	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHI Robert Ballanger		Aulnay-sous-Bois			France

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided