sability evaluation of the rapid SARS-CoV-2 antigen detection self-test (COVISTIX/COVIMARK) by lay subjects

CAEP - Centro Avançado de Estudos e Pesquisas0 个研究点开始时间: 2022年5月27日最近更新: 2023年5月29日

试验速览

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•Cohort A - Adult subjects over 18 years old, of both sexes; be able to sign the ICF approved by the EC and to execute and understand all the procedures and instructions of the study; presenting suspected flu-like symptoms of COVID-19 with an onset of 5 days or less; or having had contact with a person infected with SARS-CoV-2 within 14 days; Cohort B - Adult subjects over 18 years of age, of both sexes; be able to sign the ICF approved by the EC and execute and understand all assay procedures and instructions; previous positive test for COVID-19 less than 2 days; if the subject is symptomatic for COVID-19, the symptoms are of mild to moderate intensity; be immunized with at least two doses of the COVID-19 vaccine; availability of maintaining isolation for up to 9 days from the signing of the ICF, to perform the self-test at home and home collection of RT-PCR for SARS-CoV-2 at the end of the study; be able to photograph the cassettes with the test result and sending the images to the research center, daily

•Cohort A - Present a diagnosis of COVID-19 with symptoms of severe acute respiratory syndrome; presence of nasal obstruction that prevents swab collection; participation in a clinical trial in the previous twelve months; any condition that, in the investigator's judgment, precludes participation for reasons of subject safety or data integrity; Cohort B - Having a negative result in the self-test with COVISTIX/COVIMARK during the selection visit; being immunocompromised or using an immunosuppressant; having chronic diseases such as diabetes, hypertension, asthma, chronic obstructive pulmonary disease, obesity; having a diagnosis of COVID-19 with symptoms of severe acute respiratory syndrome; presence of serious symptoms or symptoms that require hospital care; previous positive test for SARS-CoV-2 infection or confirmed diagnosis of COVID-19 more than 2 days; being hospitalized or requiring hospitalization; inability to maintain isolation for up to 9 days after signing the ICF, for conducting the self-test at home and collecting a nasal swab at home of RT-PCR for SARS-CoV-2 at the end of the study; inability to photograph cassettes with test results and send the images to the study center daily; presence of nasal obstruction that prevents swab collection; - participation in a clinical trial in the previous twelve months; any condition that, in the investigator’s judgment, precludes participation for reasons of subject safety or data integrity

发起方

CAEP - Centro Avançado de Estudos e Pesquisas