Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784403
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2020-12-21
Brief Title:
SCREENING AND SEROEPIDEMIOLOGY OF SARS-CoV-2 INFECTION AT THE UNIVERSITY OF BARCELONA A CROSS-SECTIONAL STUDY
Sponsor:
Dr Francisco Ciruela Alférez
Organization:
University of Barcelona
Study Overview
Official Title:
SCREENING AND SEROEPIDEMIOLOGY OF SARS-CoV-2 INFECTION AT THE UNIVERSITY OF BARCELONA A CROSS-SECTIONAL STUDY
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UB-GTMS-COVID
Brief Summary:
BACKGROUND On January 7 2020 the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2 whose genetic sequence was shared by Chinese authorities on January 12 taxonomy ID 2697049 On January 30 2020 the director general of the World Health Organization WHO following the advice of the Emergency Committee convened in accordance with the International Health Regulations 2005 declared that the COVID-19 outbreak started in Wuhan China in December 2019 being a public health emergency of international concern On March 11 the WHO declared the global SARS-CoV-2 pandemic
So far in the absence of effective vaccines or antiviral drugs efforts have focused on identifying cases and their contacts Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected
At the time of writing this new version of the protocol we are immersed in the second wave of the COVID-19 pandemic The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2 carried out at the end of the first wave made it possible to determine the feasibility of this second wave with the onset of cold from the autumn
Given this scenario the University of Barcelona together with the Gerencia Territorial del Área Metropolitana Sud has planned to carry out a study of seroprevalence and screnning of SARS-CoV-2 in the population of Universidad de Barcelona users
The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB in relation to its teaching and administrative activities In addition this cross-sectional study can serve as the base study for a future follow-up study
HYPOTHESIS The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population
MAIN OBJECTIVE
Estimate the incidence of SARS-CoV-2 infection in the UB community
Estimate the SARS-CoV-2 seroprevalence infection in the UB community
So far in the absence of effective vaccines or antiviral drugs efforts have focused on identifying cases and their contacts Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected
At the time of writing this new version of the protocol we are immersed in the second wave of the COVID-19 pandemic The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2 carried out at the end of the first wave made it possible to determine the feasibility of this second wave with the onset of cold from the autumn
Given this scenario the University of Barcelona together with the Gerencia Territorial del Área Metropolitana Sud has planned to carry out a study of seroprevalence and screnning of SARS-CoV-2 in the population of Universidad de Barcelona users
The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB in relation to its teaching and administrative activities In addition this cross-sectional study can serve as the base study for a future follow-up study
HYPOTHESIS The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population
MAIN OBJECTIVE
Estimate the incidence of SARS-CoV-2 infection in the UB community
Estimate the SARS-CoV-2 seroprevalence infection in the UB community
Detailed Description:
BACKGROUND On January 7 2020 the Chinese authorities identified as the agent responsible for the cases of atypical pneumonia of unknown etiology a new type of virus of the Coronaviridae family that has subsequently been named SARS-CoV-2 whose genetic sequence was shared by Chinese authorities on January 12 taxonomy ID 2697049
On January 30 2020 the director general of the World Health Organization WHO following the advice of the Emergency Committee convened in accordance with the International Health Regulations 2005 declared that the COVID-19 outbreak started in Wuhan China in December 2019 being a public health emergency of international concern On March 11 the WHO declared the global SARS-CoV-2 pandemic
So far in the absence of effective vaccines or antiviral drugs efforts have focused on identifying cases and their contacts Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected
At the level of microbiological clinical practice the diagnosis of SARS-CoV-2 infection can be made by
1 Detection of the presence of the target nucleic acid sequences in the RNA of SARS-CoV-2 RdRP gene of SARSCoV-2 and gene N and Orf1ab present in SARS and SARSCoV-2 gene E of SARS in the Patient specimen by reverse transcriptase polymerase chain reaction RT-PCR
2 Detection of antibodies total immunoglobulins and IgG
At the time of writing this new version of the protocol the country is immersed in the second wave of the COVID-19 pandemic The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2 carried out at the end of the first wave made it possible to determine the feasibility of this second wave with the onset of cold from the autumn Some of the factors that supported this hypothesis are
1 At the end of the first wave herd immunity against the virus was not reached The results of the ENE-COVID study published in the Lancet magazine in July this year indicated that in our environment only 6 have achieved immunity
2 Many respiratory viruses have a seasonal behavior and their circulation increases in the autumn and winter months This is why a similar behavior was assumed in this new SARS-CoV-2 virus experiencing greater transmissibility with the drop in temperature and increase in humidity typical of winter periods
3 Observing the evolution of the 1918 pandemic flu the first wave was in 1918 but this was followed by a second and third wave in 1919 and 1920 respectively However the second wave presented the peculiarity of being triggered in other areas where the first wave had not been so intense
Given this scenario the University of Barcelona together with the Gerencia Territorial del Área Metropolitana Sud has planned to carry out a study of seroprevalence and screnning of SARS-CoV-2 in the population of UB users The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB in relation to its teaching and administrative activities In addition this cross-sectional study can serve as the base study for a future follow-up study
HYPOTHESIS The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population
The seroprevalence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the seroprevalence of the general population
MAIN OBJECTIVE
Estimate the incidence of SARS-CoV-2 infection in the UB community
Estimate the SARS-CoV-2 seroprevalence infection in the UB community
SECONDARY OBJECTIVES
Clinical objectives
Estimate the factors associated with the incidence in the UB community
Estimate the factors associated with seroprevalence in the UB community
STUDY DESIGN Cross-sectional study with epidemiological information to determine the incidence and prevalence of SARS-CoV-2 infection in the UB population by PCR and serology tests to detect antibodies
On January 30 2020 the director general of the World Health Organization WHO following the advice of the Emergency Committee convened in accordance with the International Health Regulations 2005 declared that the COVID-19 outbreak started in Wuhan China in December 2019 being a public health emergency of international concern On March 11 the WHO declared the global SARS-CoV-2 pandemic
So far in the absence of effective vaccines or antiviral drugs efforts have focused on identifying cases and their contacts Both the cases and their contacts are isolated for about 14 days with the intention of minimizing the spread of this infection and avoiding an increase in the number of affected
At the level of microbiological clinical practice the diagnosis of SARS-CoV-2 infection can be made by
1 Detection of the presence of the target nucleic acid sequences in the RNA of SARS-CoV-2 RdRP gene of SARSCoV-2 and gene N and Orf1ab present in SARS and SARSCoV-2 gene E of SARS in the Patient specimen by reverse transcriptase polymerase chain reaction RT-PCR
2 Detection of antibodies total immunoglobulins and IgG
At the time of writing this new version of the protocol the country is immersed in the second wave of the COVID-19 pandemic The projections of the natural history of the disease and the estimates of possible infections by SARS-CoV-2 carried out at the end of the first wave made it possible to determine the feasibility of this second wave with the onset of cold from the autumn Some of the factors that supported this hypothesis are
1 At the end of the first wave herd immunity against the virus was not reached The results of the ENE-COVID study published in the Lancet magazine in July this year indicated that in our environment only 6 have achieved immunity
2 Many respiratory viruses have a seasonal behavior and their circulation increases in the autumn and winter months This is why a similar behavior was assumed in this new SARS-CoV-2 virus experiencing greater transmissibility with the drop in temperature and increase in humidity typical of winter periods
3 Observing the evolution of the 1918 pandemic flu the first wave was in 1918 but this was followed by a second and third wave in 1919 and 1920 respectively However the second wave presented the peculiarity of being triggered in other areas where the first wave had not been so intense
Given this scenario the University of Barcelona together with the Gerencia Territorial del Área Metropolitana Sud has planned to carry out a study of seroprevalence and screnning of SARS-CoV-2 in the population of UB users The results of this study will help to make preventive decisions in the face of SARS-CoV-2 infection at the UB in relation to its teaching and administrative activities In addition this cross-sectional study can serve as the base study for a future follow-up study
HYPOTHESIS The incidence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the incidence in the general population
The seroprevalence of SARS-CoV-2 infection in the group of students and workers at the University of Barcelona is similar to the seroprevalence of the general population
MAIN OBJECTIVE
Estimate the incidence of SARS-CoV-2 infection in the UB community
Estimate the SARS-CoV-2 seroprevalence infection in the UB community
SECONDARY OBJECTIVES
Clinical objectives
Estimate the factors associated with the incidence in the UB community
Estimate the factors associated with seroprevalence in the UB community
STUDY DESIGN Cross-sectional study with epidemiological information to determine the incidence and prevalence of SARS-CoV-2 infection in the UB population by PCR and serology tests to detect antibodies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None