Covid19
Conditions
Keywords
COVID-19, Mass vaccination
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.
Interventions
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
CoronaVac COVID-19 vaccine
DRUGChAdOx1 nCoV-19 Covid-19 Vaccine
ChAdOx1 nCoV-19 Covid-19 Vaccine
DRUGAd26.COV2.S COVID-19 Vaccine
Ad26.COV2.S COVID-19 Vaccine
Sponsors
Universidade Federal do Paraná
Pfizer
Inova Medical
Hospital Moinhos de Vento
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Odds of symptomatic SARS-CoV-2 infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern | 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 |
| Duration of COVID-19 symptoms | within 180 days from enrollment | Length of COVID-19-related symptoms |
| Incidence of hospitalization due to COVID-19 | Within 30 days from enrollment | Incidence of hospital admission due to COVID-19 |
| Incidence of ICU admission | Within 30 days from enrollment | Incidence of ICU admission |
| Incidence of mechanical ventilation | Within 30 days from enrollment | Incidence of invasive mechanical ventilation |
| Odds of symptomatic SARS-CoV-2 infection due to Gamma variant | 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 |
| Utility score of health-related quality of life at 3 months | 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 \[no problems at all\]) |
| Prevalence of long COVID-19 symptoms at 6 months | 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) |
| Incidence of new symptomatic COVID-19 infection | 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 |
| Incidence of any vaccine-related adverse event | 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 |
| Incidence of vaccine-related severe adverse event | 365 days from enrollment | Incidence of any adverse event that result in death, hospitalization or prolongation of hospitalization, and persistent or significant disability |
| Mortality due to COVID-19 | Within 90 days from enrollment | Incidence of COVID-19-related mortality |
Countries
Brazil
Outcome results
None listed