NCT04654442 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brengel-Pesce K, Morand P, Schmuck A, Bourgeat MJ, Buisson M, Barguès G, Bouzid M, Seigneurin JM
Routine use of real-time quantitative PCR for laboratory diagnosis of Epstein-Barr virus infections. J Med Virol. 2002 Mar;66(3):360-9.
Danis K, Epaulard O, Bénet T, Gaymard A, Campoy S, Botelho-Nevers E, Bouscambert-Duchamp M, Spaccaferri G, Ader F, Mailles A, Boudalaa Z, Tolsma V, Berra J, Vaux S, Forestier E, Landelle C, Fougere E, Thabuis A, Berthelot P, Veil R, Levy-Bruhl D, Chidiac C, Lina B, Coignard B, Saura C; Investigation Team
Cluster of Coronavirus Disease 2019 (COVID-19) in the French Alps, February 2020. Clin Infect Dis. 2020 Jul 28;71(15):825-832. doi: 10.1093/cid/ciaa424.
Le Maréchal M, Morand P, Epaulard O, Némoz B
COVID-19 in clinical practice: A narrative synthesis. Med Mal Infect. 2020 Nov;50(8):639-647. doi: 10.1016/j.medmal.2020.09.012. Epub 2020 Sep 29. Review.
Seo G, Lee G, Kim MJ, Baek SH, Choi M, Ku KB, Lee CS, Jun S, Park D, Kim HG, Kim SJ, Lee JO, Kim BT, Park EC, Kim SI
Rapid Detection of COVID-19 Causative Virus (SARS-CoV-2) in Human Nasopharyngeal Swab Specimens Using Field-Effect Transistor-Based Biosensor. ACS Nano. 2020 Apr 28;14(4):5135-5142. doi: 10.1021/acsnano.0c02823. Epub 2020 Apr 20. Erratum in: ACS Nano. 2020 Sep 22;14(9):12257-12258.
Wu Z, McGoogan JM
Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

Evaluation of the Feasibility and Analytic Performance of TestNPass (In Vitro Diagnosis Medical Device) for CoViD-19 Diagnosis on Saliva Sample. : a Pilot Study

Details for clinical trial NCT04654442

Clinical trial NCT04654442 - References