Incidence of Colonization by Multidrug-resistant Organisms in Mechanically Ventilated Patients With Severe COVID-19
NCT05293418
Asymptomatic Diseases, Asymptomatic Infections
Milan, MI, Italy
View Trial DetailsNCT Number: NCT04355338
This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups. The study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. All participants will collect blood samples to get more details on the immune response.
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Observational
Universidade Federal do Ceará, Fortaleza, Ceará, Brazil
This is an observational longitudinal study to assess incidence of SARS-CoV-2 infection in Brazil. The study sample is stratified in nine age groups according decades of life, equally distributed in both sexes, with an expected incidence of 10%, at least, during the study period of 24 months. For the first age groups, (0-9, 10-19 and 20-29 years), sample was calculated with the minimum expected incidence of COVID-19 among infected, regardless severity, is 10%. For the latest age groups (30-39, 40-49, 50-59, 60-69, 70-79 and 80+), the sample was calculated with the expected minimum incidence of hospitalization due to COVID-19 according to estimates per age group reported by Verity R et al. https://doi.org/10.1016/S1473-3099(20)30243-7 After the consent procedure, all participants will have a short interview, a IgG/IgM SARS-CoV-2 rapid test and a blood withdrawal to obtain serum for neutralizing antibodies. These procedures will be repeated every four weeks until the end of the study. Individuals with symptoms compatible will be followed-up to confirm COVID-19 diagnosis as well as to assess severity, need for hospitalization and assisted ventilation, sequels, and eventual reinfection. Levels of neutralizing antibodies and other immune markers will be prospectively assessed in all infected participants, either asymptomatic and symptomatic.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months
Number of cases with serological/virological diagnosis for SARS-Co-2 infection
Time frame: 24 months
Number of cases of symptomatic SARS-CoV-2 infection
Time frame: 24 years
Number of cases of hospitalization due to symptomatic SARS-Co-2 infection
Time frame: 24 months
Level of neutralizing antibodies in participants with SARS-Co-2 infection
Time frame: 6 months
Positive serology for SARS-Co-2 infection at baseline
Time frame: 24 months
Number of a new SARS-CoV-2 infection in an individual with a proven previous infection
Time frame: 24 months
Number of COVID-19 cases requiring mechanical ventilation
Time frame: 24 months
Number of deaths due to COVID-19
Time frame: 24 months
Number and description of sequels attributed to COVID-19
Butantan Institute
Other Gov
Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil
Acronym: AVISA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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