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COVID-19 Vaccine Effectiveness in Albanian Health Workers (COVEAL)

I

Institute of Public Health, Albania

Status

Unknown

Conditions

Covid19

Treatments

Biological: COVID-19 vaccine

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04811391
COV-VE-0001

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of the COVID-19 vaccine in hospital based HWs in Albania. This will answer critical questions about the real-world performance of COVID-19 vaccines in one of the key target groups for vaccination.

Full description

This protocol describes a prospective one-year cohort study of hospital-based health workers in Albania to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID -19 disease.

The investigators will measure the effectiveness of COVID-19 vaccines against laboratory-confirmed SARS-CoV-2 infection in both symptomatic and asymptomatic hospital health workers.

SARS-CoV-2 infection will be diagnosed using symptom questionnaires and PCR testing. Additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.

Enrollment

1,500 estimated patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All Health Workers eligible to receive the COVID-19 vaccination according to the national guidelines of Institute of Public Health.
  • Health Workers working at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.
  • Health Workers who have already been vaccinated against COVID-19 as part of the early COVID-19 vaccine rollout can be included, as long as information can be collected about the date and type of the vaccine that was administered. However, priority will be given to enrolling Health Workers who have received their COVID vaccine no more than 4 days prior to the day of enrolment in the study.

Exclusion criteria

  • Health Workers who are not eligible for COVID-19 vaccination or have a contraindication to vaccination should not participate in the study.
  • Health Workers who do not work at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.

Trial design

1,500 participants in 2 patient groups

Vaccinated participants
Description:
Participants who have received 2 doses of the pfizer Covid-19 vaccine or 1 or dose of the Astra Zeneca Covid-19 Vaccine
Treatment:
Biological: COVID-19 vaccine
Unvaccinated participants
Description:
Have not received any doses of any form of COVID-19 vaccine

Trial contacts and locations

3

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Central trial contact

Iria Preza, MPH

Data sourced from clinicaltrials.gov

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