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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04703140
Other study ID # 2020/09
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date May 4, 2021

Study information

Verified date June 2022
Source CMC Ambroise Paré
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 192
Est. completion date May 4, 2021
Est. primary completion date May 4, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Rapid Diagnostic Test vs PCR
2 nasopharyngeal swabs taken for PCR and COVIDISC

Locations

Country Name City State
France CHI Robert Ballanger Aulnay-sous-Bois

Sponsors (1)

Lead Sponsor Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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