COVID-19
Conditions
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 among children aged 5 to 11 years in the city of Toledo in Southern Brazil. Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of 3 months by means of structured telephone interviews.
Interventions
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
BIOLOGICALCoronaVac COVID-19 vaccine
CoronaVac 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
5 Years to 11 Years
Inclusion criteria
* Age between 5 and 11 years; * 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 or nasopharyngeal sample for SARS-CoV-2 test 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; * Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.
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 RT-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 RT-PCR test for SARS-CoV-2 variants of concern. |
| Duration of COVID-19 symptoms | within 90 days from enrollment | Length of COVID-19-related symptoms |
| Incidence of hospitalization due to COVID-19 | Within 90 days from enrollment | Incidence of hospital admission due to COVID-19 |
| Incidence of PICU admission | Within 90 days from enrollment | Incidence of Pediatric intensive care unit admission |
| Odds of symptomatic SARS-CoV-2 infection due to Omicron variant | At the moment of enrollment | Odds of symptomatic SARS-CoV-2 infection due to Omicron variant defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2 Omicron variant |
| Incidence of multisystem inflammatory syndrome | Within 90 days from enrollment | Incidence of multisystem inflammatory syndrome |
| Mortality due to COVID-19 | Within 90 days from enrollment | Incidence of COVID-19-related mortality |
| Prevalence of long COVID-19 symptoms at 3 months | Within 90 days from enrollment | Prevalence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache) |
| Incidence of invasive mechanical ventilation | Within 90 days from enrollment | Incidence of invasive mechanical ventilation |
Countries
Brazil
Outcome results
None listed