Clinical trial NCT05282017: LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study
Official title: LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19, SARS-CoV-2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects older than 18y that are hospitalized due COVID-19 like symptoms

Brief summary: COVID-19 is the infectious disease caused by the novel coronavirus known as SARS-CoV-2, that appeared in 2019. The World Health Organisation (WHO) declared the novel coronavirus a pandemic on 11 March 2020. The evolution of the pandemic is varying across countries, affected in part by different containment strategies ranging from extreme lockdown to relative inaction. As a result, there are regional waves of the disease and pockets of vulnerable populations. Globally, governments have acknowledged that effective vaccines against COVID-19 are the only way to guarantee a safe and sustained exit strategy from repeated lockdowns.

The objective of this study is to estimate the vaccine effectiveness against hospitalizations due to circulating COVID-19 VoC among subjects eligible for vaccination with the AstraZeneca or any other COVID-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission.

The study design is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2

Detailed description: LatInamerican Vaccine Effectiveness against hospitalizations due to circulating COVID-19 VoC RWE study is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (TNCC) of hospitalized COVID-19 like cases undergoing testing for SARS-CoV-2 by RT-PCR or rapid antigen test with the participation of countries from six LatAm Marketing Companies (Argentina, Brazil, Colombia, Costa Rica, Mexico and Panama).

This study will generate new information regarding vaccine effectiveness (VE) in the RW setting for populations where evidence is still unavailable

Eligibility criteria: Inclusion Criteria:

* 18y and older
* Ever eligible for vaccination with the AstraZeneca or any other COVID-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission.
* Hospitalization due to COVID-19 like case
* Willing and able to provide informed consent (or by legal accepted representative if patient are not able to provide their signature by themselves)

Exclusion Criteria:

* Cannot be swabbed or other conditions that contra-indicate swabbing
* COVID-19 hospitalization within 3 months prior to the current admission. Hospital transfers are not considered as a prior hospitalization.

Primary outcomes:
measure: Number of hospitalized patients due COVID-19 like symptoms
timeFrame: From enrollment date until study completion, an average 1 year
Secondary outcomes:
measure: SARS-CoV-2 variants detection
timeFrame: Through study completion and data analysis, an average of 1.5 year
Other outcomes:
measure: Disease severity (based on WHO severity scale, ICU admission, need of hemodialysis, mechanical ventilation) (Exploratory outcome)
timeFrame: From date of randomization until hospital discharge or date of death from any cause, whichever came first assessed up to 6 months
Locations:
city: Brazil
country: Brazil
facility: Research Site
state: Rio De Janeiro
city: Brazil
country: Brazil
facility: Research Site
state: Salvador
city: Brazil
country: Brazil
facility: Research Site
state: Sao Paulo
city: Bogota
country: Colombia
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Merida
country: Mexico
facility: Research Site
state: Yucatan
city: Panama
country: Panama
facility: Research Site
Study officials:
References: