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Completed

NCT Number: NCT05052307

A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pronto Atendimento Municipal de Toledo, Toledo, Paraná, Brazil

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Drug

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

CoronaVac COVID-19 vaccine

Drug

CoronaVac COVID-19 vaccine

ChAdOx1 nCoV-19 Covid-19 Vaccine

Drug

ChAdOx1 nCoV-19 Covid-19 Vaccine

Ad26.COV2.S COVID-19 Vaccine

Drug

Ad26.COV2.S COVID-19 Vaccine

Primary outcomes

  1. Odds of symptomatic SARS-CoV-2 infection

    Time frame: At the moment of enrollment

    Odds of symptomatic SARS-CoV-2 infection defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2. Symptoms suggestive of COVID-19 are defined as follows: 1) Acute respiratory illness 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).

Secondary outcomes

  1. Odds of symptomatic SARS-CoV-2 infection due to Gamma variant

    Time frame: At the moment of enrollment

    Odds of symptomatic SARS-CoV-2 infection due to Gamma variant defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2 Gamma variant

  2. Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern

    Time frame: At the moment of enrollment

    Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2 Alfa, Beta, or Delta variant

  3. Duration of COVID-19 symptoms

    Time frame: within 180 days from enrollment

    Length of COVID-19-related symptoms

  4. Incidence of hospitalization due to COVID-19

    Time frame: Within 30 days from enrollment

    Incidence of hospital admission due to COVID-19

  5. Incidence of ICU admission

    Time frame: Within 30 days from enrollment

    Incidence of ICU admission

  6. Incidence of mechanical ventilation

    Time frame: Within 30 days from enrollment

    Incidence of invasive mechanical ventilation

  7. Mortality due to COVID-19

    Time frame: Within 90 days from enrollment

    Incidence of COVID-19-related mortality

  8. Utility score of health-related quality of life at 3 months

    Time frame: 90 days after enrollment

    Utility score of health-related quality of life assessed with the EuroQol- 5 dimensions 3-level questionnaire. The utility score derived from the descriptive system for the Brazilian population ranges from -0.176 (indicating the worst health status [serious problems in all domains]) to 1.0 (indicating the best health status [no problems at all])

  9. Prevalence of long COVID-19 symptoms at 6 months

    Time frame: 180 days after enrollment

    Incidence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache, anxiety, and depression)

  10. Incidence of new symptomatic COVID-19 infection

    Time frame: 365 days from enrollment

    Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection

  11. Incidence of any vaccine-related adverse event

    Time frame: 365 days from enrollment

    Incidence of any vaccine-related adverse event including local pain, hyperemia or necrosis; fever; fatigue; headache; myalgia; arthralgia; vomiting; diarrhea; and other symptoms

  12. Incidence of vaccine-related severe adverse event

    Time frame: 365 days from enrollment

    Incidence of any adverse event that result in death, hospitalization or prolongation of hospitalization, and persistent or significant disability

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Inova Medical
  • Pfizer
  • Universidade Federal do Paraná

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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