Clinical trial NCT05052307: A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil
Official title: Effectiveness of Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: a Real-world Evidence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
Mass vaccination
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Paraná
name: Pfizer
name: Inova Medical
First posted: 2021-09-22
Enrollment: 4574
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study population will be composed by individuals aged 12 years or older who seek the public healthcare system of Toledo city with symptoms suggestive COVID-19. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls.

Brief summary: The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences following a mass vaccination campaign in the city of Toledo in Southern Brazil.

Individuals aged 12 years or older who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of one year by means of structured telephone interviews.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 12 years old;
* Resident of Toledo city;
* Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
* Nasal sample for SARS-CoV-2 diagnosis obtained as standard of care.

Exclusion Criteria:

* SARS-CoV-2-directed antiviral treatment within the past 30 days;
* COVID-19 monoclonal antibody therapy within the past 90 days;
* COVID-19 convalescent serum therapy within the past 90 days;
* Lack of consent to participate.

Primary outcomes:
measure: Odds of symptomatic SARS-CoV-2 infection
timeFrame: At the moment of enrollment
Secondary outcomes:
measure: Odds of symptomatic SARS-CoV-2 infection due to Gamma variant
timeFrame: At the moment of enrollment
measure: Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern
timeFrame: At the moment of enrollment
measure: Duration of COVID-19 symptoms
timeFrame: within 180 days from enrollment
measure: Incidence of hospitalization due to COVID-19
timeFrame: Within 30 days from enrollment
measure: Incidence of ICU admission
timeFrame: Within 30 days from enrollment
measure: Incidence of mechanical ventilation
timeFrame: Within 30 days from enrollment
measure: Mortality due to COVID-19
timeFrame: Within 90 days from enrollment
measure: Utility score of health-related quality of life at 3 months
timeFrame: 90 days after enrollment
measure: Prevalence of long COVID-19 symptoms at 6 months
timeFrame: 180 days after enrollment
measure: Incidence of new symptomatic COVID-19 infection
timeFrame: 365 days from enrollment
measure: Incidence of any vaccine-related adverse event
timeFrame: 365 days from enrollment
measure: Incidence of vaccine-related severe adverse event
timeFrame: 365 days from enrollment
Other outcomes:
Locations:
city: Toledo
country: Brazil
facility: Pronto Atendimento Municipal de Toledo
state: Paraná
city: Toledo
country: Brazil
facility: Unidade Básica de Saúde Jardim Cosmos
state: PR
city: Toledo
country: Brazil
facility: Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha
state: PR
Study officials:
affiliation: Hospital Moinhos de Vento
name: Regis G Rosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Maicon Falavigna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goulart Rosa R, Spinardi J, Allen KE, Manfio J, de Araujo CLP, Cohen M, Robinson CC, Sganzerla D, Ferreira D, de Souza EM, de Oliveira JC, Gradia DF, Brandalize APC, Kucharski GA, Pedrotti F, Rodrigues CO, Kyaw MH, Castillo GDCM, Srivastava A, McLaughlin JM, Falavigna M. BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. PLoS One. 2022 Oct 20;17(10):e0276384. doi: 10.1371/journal.pone.0276384. eCollection 2022.
citation: Rosa RG, Falavigna M, Manfio JL, de Araujo CLP, Cohen M, do Valle Barbosa GRG, de Souza AP, Romeiro Silva FK, Sganzerla D, da Silva MMD, Ferreira D, de Oliveira Rodrigues C, de Souza EM, de Oliveira JC, Gradia DF, Brandalize APC, Royer CA, Luiz RM, Kucharski GA, Pedrotti F, Valluri SR, Srivastava A, Juliao VW, Melone OC, Allen KE, Kyaw MH, Spinardi J, Del Carmen Morales Castillo G, McLaughlin JM; Toledo BNT16b2 Study Group Investigators. BNT162b2 mRNA COVID-19 against symptomatic Omicron infection following a mass vaccination campaign in southern Brazil: A prospective test-negative design study. Vaccine. 2023 Aug 23;41(37):5461-5468. doi: 10.1016/j.vaccine.2023.07.038. Epub 2023 Jul 26.