Session Type: ePosters
Session Title: ePosters
Authors(s): B. Revollo (1), I. Blanco (2), P. Soler (3), J. Toro (1), N. Izquierdo-Useros (4), J. Puig (1), X. Puig (5), V. Navarro (6), C. Casañ (2), L. Ruiz (4), D. Perez-Zsolt (7), S. Videla (8), B. Clotet (4), J.M. Llibre (1)
Authors Affiliations(s): (1) Division of Infectious diseases and Foundation for Fighting AIDS, Infectious Diseases and Promoting Health and Science,, Spain, (2) Metropolitana Nord Laboratory, Institut Català de la Salut, Badalona, Spain, Spain, (3) Primavera Sound Group, Barcelona, Spain, Spain, (4) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain., Spain, (5) Department of Statistics and Operations Research. Universitat Politècnica de Catalunya-BarcelonaTech, Barcelona, Spain., Spain, (6) Clinical Research Unit. Institut Català d'Oncologia, Spain, (7) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain. - Badalona (Spain), Spain, (8) Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital / Bellvitge Biomedical Research Institute (IDIBELL) / University of Barcelona, L'Hospitalet de Llobregat, Spain., Spain
Background:
Mass gathering events (MGEs) such as music concerts have been listed among the highest risk activities for coronavirus disease 2019 (COVID-19) transmission and have consequently been banned. We hypothesized that a live indoor concert performed under safe controlled conditions would not be associated with increased risk of SARS-CoV-2 infections.
Methods:This was an open-label randomized clinical. We performed a same-day antigen testing in nasopharyngeal swab (NPS) to all screened participants (18-59 years.) and a transcription mediated amplification (TMA) known thereafter. Real-time reverse transcriptase–polymerase chain reaction (RT-PCR) and cell viral cultures were performed in all TMA-positive samples. Eligible participants with a negative antigen test were randomly assigned (1:1) to go inside the concert (experimental group) or not (control group). A second SARS-CoV-2 TMA (and RT-PCR if positive) was repeated 8 days (D8) later. The primary endpoint was the number of participants with a positive for SARS-CoV-2 infection assessed by RT-PCR at day 8.
Safe controlled conditions inside the venue included an outdoor delimited place for smoking, a bar zone located in a supplementary room, and optimization of air flows and room ventilation. A N95 face mask wearing was mandatory during the entire event. No physical distancing was required and assistants could sing and dance
Results:All 1047 screened participants (81% males, median age 34 years) were randomized (523 experimental, 524 control group). Of them, 960 (465 experimental, 495 control) completed the D8 visit. None out of 465 participants in the experimental group became infected by SARS-CoV-2 (estimated incidence 0.14%; 95% credible-interval: 0.00%, 0.61%), versus 2 out of 495 in control group (0.31%; 95% credible-intervals: 0.04%, 0.73%). 28 subjects had a positive screening TMA test and two of them (one in every group) had a positive RT-PCR (cycle threshold 37 both). In vitro cell cultures were negative in all 28. Antigen test had a negative predictive value of 99.9% versus RT-PCR and 99.8% versus a viral cell culture.
Conclusions:Attendance to an indoor live concert performed under safety-controlled conditions, including same-day SARS-CoV-2 antigen screening, was not associated with an increased risk of SARS-CoV-2 infection. (ClinicalTrials.gov number, NCT04668625)
Keyword(s): SARS-CoV-2, mass events, superspreading events
COI Institutional Grants: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): B. Revollo (1), I. Blanco (2), P. Soler (3), J. Toro (1), N. Izquierdo-Useros (4), J. Puig (1), X. Puig (5), V. Navarro (6), C. Casañ (2), L. Ruiz (4), D. Perez-Zsolt (7), S. Videla (8), B. Clotet (4), J.M. Llibre (1)
Authors Affiliations(s): (1) Division of Infectious diseases and Foundation for Fighting AIDS, Infectious Diseases and Promoting Health and Science,, Spain, (2) Metropolitana Nord Laboratory, Institut Català de la Salut, Badalona, Spain, Spain, (3) Primavera Sound Group, Barcelona, Spain, Spain, (4) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain., Spain, (5) Department of Statistics and Operations Research. Universitat Politècnica de Catalunya-BarcelonaTech, Barcelona, Spain., Spain, (6) Clinical Research Unit. Institut Català d'Oncologia, Spain, (7) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain. - Badalona (Spain), Spain, (8) Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital / Bellvitge Biomedical Research Institute (IDIBELL) / University of Barcelona, L'Hospitalet de Llobregat, Spain., Spain
Background:
Mass gathering events (MGEs) such as music concerts have been listed among the highest risk activities for coronavirus disease 2019 (COVID-19) transmission and have consequently been banned. We hypothesized that a live indoor concert performed under safe controlled conditions would not be associated with increased risk of SARS-CoV-2 infections.
Methods:This was an open-label randomized clinical. We performed a same-day antigen testing in nasopharyngeal swab (NPS) to all screened participants (18-59 years.) and a transcription mediated amplification (TMA) known thereafter. Real-time reverse transcriptase–polymerase chain reaction (RT-PCR) and cell viral cultures were performed in all TMA-positive samples. Eligible participants with a negative antigen test were randomly assigned (1:1) to go inside the concert (experimental group) or not (control group). A second SARS-CoV-2 TMA (and RT-PCR if positive) was repeated 8 days (D8) later. The primary endpoint was the number of participants with a positive for SARS-CoV-2 infection assessed by RT-PCR at day 8.
Safe controlled conditions inside the venue included an outdoor delimited place for smoking, a bar zone located in a supplementary room, and optimization of air flows and room ventilation. A N95 face mask wearing was mandatory during the entire event. No physical distancing was required and assistants could sing and dance
Results:All 1047 screened participants (81% males, median age 34 years) were randomized (523 experimental, 524 control group). Of them, 960 (465 experimental, 495 control) completed the D8 visit. None out of 465 participants in the experimental group became infected by SARS-CoV-2 (estimated incidence 0.14%; 95% credible-interval: 0.00%, 0.61%), versus 2 out of 495 in control group (0.31%; 95% credible-intervals: 0.04%, 0.73%). 28 subjects had a positive screening TMA test and two of them (one in every group) had a positive RT-PCR (cycle threshold 37 both). In vitro cell cultures were negative in all 28. Antigen test had a negative predictive value of 99.9% versus RT-PCR and 99.8% versus a viral cell culture.
Conclusions:Attendance to an indoor live concert performed under safety-controlled conditions, including same-day SARS-CoV-2 antigen screening, was not associated with an increased risk of SARS-CoV-2 infection. (ClinicalTrials.gov number, NCT04668625)
Keyword(s): SARS-CoV-2, mass events, superspreading events
COI Institutional Grants: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): B. Revollo (1), I. Blanco (2), P. Soler (3), J. Toro (1), N. Izquierdo-Useros (4), J. Puig (1), X. Puig (5), V. Navarro (6), C. Casañ (2), L. Ruiz (4), D. Perez-Zsolt (7), S. Videla (8), B. Clotet (4), J.M. Llibre (1)
Authors Affiliations(s): (1) Division of Infectious diseases and Foundation for Fighting AIDS, Infectious Diseases and Promoting Health and Science,, Spain, (2) Metropolitana Nord Laboratory, Institut Català de la Salut, Badalona, Spain, Spain, (3) Primavera Sound Group, Barcelona, Spain, Spain, (4) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain., Spain, (5) Department of Statistics and Operations Research. Universitat Politècnica de Catalunya-BarcelonaTech, Barcelona, Spain., Spain, (6) Clinical Research Unit. Institut Català d'Oncologia, Spain, (7) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain. - Badalona (Spain), Spain, (8) Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital / Bellvitge Biomedical Research Institute (IDIBELL) / University of Barcelona, L'Hospitalet de Llobregat, Spain., Spain
Background:
Mass gathering events (MGEs) such as music concerts have been listed among the highest risk activities for coronavirus disease 2019 (COVID-19) transmission and have consequently been banned. We hypothesized that a live indoor concert performed under safe controlled conditions would not be associated with increased risk of SARS-CoV-2 infections.
Methods:This was an open-label randomized clinical. We performed a same-day antigen testing in nasopharyngeal swab (NPS) to all screened participants (18-59 years.) and a transcription mediated amplification (TMA) known thereafter. Real-time reverse transcriptase–polymerase chain reaction (RT-PCR) and cell viral cultures were performed in all TMA-positive samples. Eligible participants with a negative antigen test were randomly assigned (1:1) to go inside the concert (experimental group) or not (control group). A second SARS-CoV-2 TMA (and RT-PCR if positive) was repeated 8 days (D8) later. The primary endpoint was the number of participants with a positive for SARS-CoV-2 infection assessed by RT-PCR at day 8.
Safe controlled conditions inside the venue included an outdoor delimited place for smoking, a bar zone located in a supplementary room, and optimization of air flows and room ventilation. A N95 face mask wearing was mandatory during the entire event. No physical distancing was required and assistants could sing and dance
Results:All 1047 screened participants (81% males, median age 34 years) were randomized (523 experimental, 524 control group). Of them, 960 (465 experimental, 495 control) completed the D8 visit. None out of 465 participants in the experimental group became infected by SARS-CoV-2 (estimated incidence 0.14%; 95% credible-interval: 0.00%, 0.61%), versus 2 out of 495 in control group (0.31%; 95% credible-intervals: 0.04%, 0.73%). 28 subjects had a positive screening TMA test and two of them (one in every group) had a positive RT-PCR (cycle threshold 37 both). In vitro cell cultures were negative in all 28. Antigen test had a negative predictive value of 99.9% versus RT-PCR and 99.8% versus a viral cell culture.
Conclusions:Attendance to an indoor live concert performed under safety-controlled conditions, including same-day SARS-CoV-2 antigen screening, was not associated with an increased risk of SARS-CoV-2 infection. (ClinicalTrials.gov number, NCT04668625)
Keyword(s): SARS-CoV-2, mass events, superspreading events
COI Institutional Grants: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): B. Revollo (1), I. Blanco (2), P. Soler (3), J. Toro (1), N. Izquierdo-Useros (4), J. Puig (1), X. Puig (5), V. Navarro (6), C. Casañ (2), L. Ruiz (4), D. Perez-Zsolt (7), S. Videla (8), B. Clotet (4), J.M. Llibre (1)
Authors Affiliations(s): (1) Division of Infectious diseases and Foundation for Fighting AIDS, Infectious Diseases and Promoting Health and Science,, Spain, (2) Metropolitana Nord Laboratory, Institut Català de la Salut, Badalona, Spain, Spain, (3) Primavera Sound Group, Barcelona, Spain, Spain, (4) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain., Spain, (5) Department of Statistics and Operations Research. Universitat Politècnica de Catalunya-BarcelonaTech, Barcelona, Spain., Spain, (6) Clinical Research Unit. Institut Català d'Oncologia, Spain, (7) IrsiCaixa AIDS Research Institute, University Hospital Germans Trias i Pujol, Badalona, Spain. - Badalona (Spain), Spain, (8) Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital / Bellvitge Biomedical Research Institute (IDIBELL) / University of Barcelona, L'Hospitalet de Llobregat, Spain., Spain
Background:
Mass gathering events (MGEs) such as music concerts have been listed among the highest risk activities for coronavirus disease 2019 (COVID-19) transmission and have consequently been banned. We hypothesized that a live indoor concert performed under safe controlled conditions would not be associated with increased risk of SARS-CoV-2 infections.
Methods:This was an open-label randomized clinical. We performed a same-day antigen testing in nasopharyngeal swab (NPS) to all screened participants (18-59 years.) and a transcription mediated amplification (TMA) known thereafter. Real-time reverse transcriptase–polymerase chain reaction (RT-PCR) and cell viral cultures were performed in all TMA-positive samples. Eligible participants with a negative antigen test were randomly assigned (1:1) to go inside the concert (experimental group) or not (control group). A second SARS-CoV-2 TMA (and RT-PCR if positive) was repeated 8 days (D8) later. The primary endpoint was the number of participants with a positive for SARS-CoV-2 infection assessed by RT-PCR at day 8.
Safe controlled conditions inside the venue included an outdoor delimited place for smoking, a bar zone located in a supplementary room, and optimization of air flows and room ventilation. A N95 face mask wearing was mandatory during the entire event. No physical distancing was required and assistants could sing and dance
Results:All 1047 screened participants (81% males, median age 34 years) were randomized (523 experimental, 524 control group). Of them, 960 (465 experimental, 495 control) completed the D8 visit. None out of 465 participants in the experimental group became infected by SARS-CoV-2 (estimated incidence 0.14%; 95% credible-interval: 0.00%, 0.61%), versus 2 out of 495 in control group (0.31%; 95% credible-intervals: 0.04%, 0.73%). 28 subjects had a positive screening TMA test and two of them (one in every group) had a positive RT-PCR (cycle threshold 37 both). In vitro cell cultures were negative in all 28. Antigen test had a negative predictive value of 99.9% versus RT-PCR and 99.8% versus a viral cell culture.
Conclusions:Attendance to an indoor live concert performed under safety-controlled conditions, including same-day SARS-CoV-2 antigen screening, was not associated with an increased risk of SARS-CoV-2 infection. (ClinicalTrials.gov number, NCT04668625)
Keyword(s): SARS-CoV-2, mass events, superspreading events
COI Institutional Grants: Yes