There is one clinical trial.
The coronavirus disease 2019 (COVID-19) outbreak, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan in December 2019 and has spread globally, representing a serious threat to public health. While waiting for highly effective treatments or the development of an effective vaccine, it is necessary to reactivate key economic activities that are related to leisure and culture in an environment that is safest for the participants. The use of a rapid screening test for SARS-CoV-2 viral antigens with high sensitivity could be a useful tool to detect asymptomatic SARS-CoV-2 infected people, and thus be able to carry out events related to leisure in a safe environment. The aim of this study is to make a mass screening of asymptomatic infection of an (i) experimental group (public attending a massive mass musical show) and (ii) a control group (they will not enter the event) prior to entering to the event. Randomization 1: 1 by random blocks of the participants with a negative antigen test in the experimental group (attending the event) and the control group (they will not enter the event). Control with a new Polymerase Chain Reaction (PCR) test 8 days after the event (D8) in the participants of both randomized groups Control of the appearance of symptoms through a questionnaire 10 days after the event (D10), in the participants of both groups with a negative result on day 8. Validation of a rapid antigen detection test by comparison with the PCR technique. The indoor activity will include an array of measures designed to reducing the contagion risk, including: mandatory wearing a mask during the event, restricted outdoor areas of bar and smoking, enhanced ventilation of the whole indoor area, and avoiding queues. All subjects will have downloaded an app in their smart phones to help contact and place tracing during the event, to trace potential transmissions. This app will remain active for 8 days, until the last virologic control. The inclusion criteria will allow only subjects with an age <60 years, without comorbidities, and who do not live with old adults in their homes, to further reduce the risk of potential complications and transmission to at risk individuals.
Description: Incidence rate of people infected with SARS-CoV-2 8 days after randomization, detected by PCR in nasopharyngeal aspirate, on the experimental and the control group.Measure: Incidence rate of people infected with SARS-CoV-2 8 days after randomization Time: At 8 days
Description: Nasopharyngeal swab samples will be stored in case SARS-CoV-2 infections are documented for sequencing purposes to assess the possibility of spreading clusters during the event. Data will be matched with a Global Positioning System (GPS) smart phone tracking localization during the concert.Measure: SARS-CoV-2 genome sequence Time: At 8 days
Description: Incidence rate of appearance of symptoms compatible with COVID 19 in those attending the event after 10 days (D10).Measure: Incidence rate of appearance of symptoms compatible with COVID 19 Time: At 10 days
Description: Time spent in testing the total number of participants in the study.Measure: Time spent in testing the total number of participants in the study. Time: At day 0
Description: We will compare the diagnostic sensitivity of rapid antigen tests for SARS-CoV-2 compared to PCR in asymptomatic subjects.Measure: Comparison of the diagnostic sensitivity of rapid antigen tests for SARS-CoV-2 compared to PCR in asymptomatic subjects. Time: At day 0
Description: We will compare the diagnostic sensitivity of rapid antigen tests for SARS-CoV-2 using a nasopharyngeal swab sample compared to sample obtained trough saliva, in positive cases by this technique.Measure: Comparison of the diagnostic sensitivity of rapid antigen tests for SARS-CoV-2 using a nasopharyngeal swab sample compared to sample obtained trough saliva Time: At day 0
Description: Presence of viable SARS-CoV-2 from cell culture in all cases with negative Ag and positive PCR.Measure: Presence of viable SARS-CoV-2 from cell culture Time: At day 0
Description: Assessment of the results obtained on satisfaction in relation to the test procedure of those attending the event through a questionnaire. Questions: I have had all the necessary prior information to participate in this study I have felt properly cared for by the health personnel I have felt properly cared for by the room staff I have behaved naturally without feeling conditioned by the measures of the protocol during the event I have been able to enjoy the performance in a satisfactory way I will attend other leisure events in closed spaces following this same protocol It can be answered with a scale from 0 to 10 (0 not satisfied at all, 10 extremely satisfied)Measure: Satisfaction in relation to the test procedure Time: At 10 days
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports