COVID-19
Conditions
Interventions
This is an open clinical trial designed to evaluate the usability and ability to monitor viral spread of a self-test for the detection of SARS-CoV-2 virus in nasal samples (COVISTIX/COVIMARK). The tri
E02.900.950
E05.481
Sponsors
CAEP - Centro Avançado de Estudos e Pesquisas
CAEP - Centro Avançado de Estudos e Pesquisas
Synova Pesquisa Científica Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the subject's performance in carrying out the self-test with COVISTIX/COVIMARK through a usability questionnaire answered by the team member during the subject's supervision ;Assess the subject's ability to interpret the result (self-test result and other predetermined result);Evaluate the quality of instructions, ease of self-test execution and level of satisfaction with COVISTIX/COVIMARK, through a usability questionnaire answered by the subject | — |
Secondary
| Measure | Time frame |
|---|---|
| Semi-quantitative viral load obtained by RT-PCR (Ct value), collected by a trained professional, in which the self-test with COVISTIX/COVIMARK has a positive result during the period of isolation of subjects with COVID-19;Record of adverse events related to nasal swab collection by the subject and related to the use or handling of COVISTIX/COVIMARK;Registration of technical complaints related to COVISTIX/COVIMARK and reported by the subjects;Number of days (descriptive statistics), during the isolation of subjects with COVID-19, in which the SARS-CoV-2 virus was detected by self-test with COVISTIX/COVIMARK compared to the RT-PCR test performed with samples collected by a trained professional;Ratio of semi-quantitative viral load reduction by RT-PCR (Ct value), from beginning to the moment when the self-test with COVISTIX/COVIMARK is negative, during the period of isolation of subjects with COVID-19 | — |
Countries
Brazil
Contacts
Public ContactFernando Bastos Canton Pacheco
CAEP - Centro Avançado de Estudos e Pesquisas
Outcome results
None listed