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Covid19NCT05052307

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

An observational study of Covid19, run by Hospital Moinhos de Vento at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Covid19
What is being tested?
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine, CoronaVac COVID-19 vaccine and ChAdOx1 nCoV-19 Covid-19 Vaccine
Type of treatment
Vaccines
How many people
4,574 participants
Where
3 sitesBrazil
Study dates
3 Nov 2021to 20 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

  • Pronto Atendimento Municipal de Toledo

    Toledo, Paraná

  • Unidade Básica de Saúde Jardim Cosmos

    Toledo, Paraná

  • Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha

    Toledo, Paraná

Other trials in Brazil

About this study

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

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.

Conditions
Covid19
Being tested
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine, CoronaVac COVID-19 vaccine, ChAdOx1 nCoV-19 Covid-19 Vaccine, Ad26.COV2.S COVID-19 Vaccine
Keywords
COVID-19, Mass vaccination
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDrug

    Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

  • CoronaVac COVID-19 vaccineDrug

    CoronaVac COVID-19 vaccine

  • ChAdOx1 nCoV-19 Covid-19 VaccineDrug

    ChAdOx1 nCoV-19 Covid-19 Vaccine

  • Ad26.COV2.S COVID-19 VaccineDrug

    Ad26.COV2.S COVID-19 Vaccine

Study groups in NCT05052307
Study groupRoleWhat they receive
Fully vaccinated with BNT162b2 COVID-19 vaccineDefined as 2 doses of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. This group will serve as the 'exposed' group evaluated in the primary objective.
Receives: Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Ever vaccinated with BNT162b2 COVID-19 vaccinedefined as ≥1 dose of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
Receives: Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Partially vaccinated with BNT162b2 COVID-19 vaccineDefined as 1 dose (only) of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
Receives: Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Fully vaccinated with other available COVID-19 vaccinesDefined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations.
Receives: Drug: CoronaVac COVID-19 vaccine; Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine; Drug: Ad26.COV2.S COVID-19 Vaccine
Never vaccinatedDefined as never received any COVID-19 vaccine. This group will serve as the reference exposure group (i.e., 'unexposed' group) in all vaccine effectiveness analyses.
Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccineDefined as fully vaccinated with available COVID-19 vaccines according to the manufacturer recommendations plus booster dose of BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
Receives: Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine; Drug: CoronaVac COVID-19 vaccine; Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine; Drug: Ad26.COV2.S COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Odds of symptomatic SARS-CoV-2 infection

    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).

    Measured: At the moment of enrollment

Secondary outcomes (12)

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

    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

    Measured: At the moment of enrollment

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

    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

    Measured: At the moment of enrollment

  3. Duration of COVID-19 symptoms

    Length of COVID-19-related symptoms

    Measured: within 180 days from enrollment

  4. Incidence of hospitalization due to COVID-19

    Incidence of hospital admission due to COVID-19

    Measured: Within 30 days from enrollment

  5. Incidence of ICU admission

    Incidence of ICU admission

    Measured: Within 30 days from enrollment

  6. Incidence of mechanical ventilation

    Incidence of invasive mechanical ventilation

    Measured: Within 30 days from enrollment

  7. Mortality due to COVID-19

    Incidence of COVID-19-related mortality

    Measured: Within 90 days from enrollment

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

    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])

    Measured: 90 days after enrollment

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

    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)

    Measured: 180 days after enrollment

  10. Incidence of new symptomatic COVID-19 infection

    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

    Measured: 365 days from enrollment

  11. Incidence of any vaccine-related adverse event

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

    Measured: 365 days from enrollment

  12. Incidence of vaccine-related severe adverse event

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

    Measured: 365 days from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start3 Nov 2021
  3. Primary completion20 Jun 2022
  4. Study completion20 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
4,574 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05052307
Sponsor's protocol ID
BNT162b2 in Toledo, Brazil
Status last verified
Feb 2023
First submitted
17 Sep 2021
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36264905

  • 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.

    PubMed 37507274

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Hospital Moinhos de Vento at 3 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds of symptomatic SARS-CoV-2 infection (time frame: At the moment of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05052307, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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