Monitoring the course of the COVID-19 epidemic in Estonia

ISRCTN ISRCTN10182320
DOI https://doi.org/10.1186/ISRCTN10182320
Submission date
14/03/2021
Registration date
16/03/2021
Last edited
21/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. The ongoing pandemic is an unprecedented global emergency. Epidemic risk management is a highly complex task in which sets of measures need to be put in place and coordinated at local, national, and international levels to minimize health and economic consequences. This complex and monumental task is highly knowledge/evidence-dependent.
There are many unanswered questions on the novel SARS-Cov-2 virus including the immune response and pathogenesis at the individual level. However, the answers to very similar questions at the population level (scale of exposure/infection in the population, the effect of community mitigation measures implemented) are crucial for an effective response to the pandemic and to inform future strategies.
The main aim of this study is to estimate the prevalence of symptomatic and asymptomatic COVID-19 in the general population and how this varies over time.

Who can participate?
People selected at random from the Estonian population registry will be invited for participation

What does the study involve?
Participants will be asked to visit a national covid testing center and fill in a web-based questionnaire and undergo nasopharyngeal swabbing (collected from the back of the nose and throat).

What are the possible benefits and risks of participating?
The possible benefits are that participants will get results from tests for SARS-CoV-2. The main disadvantage of taking part is the time and inconvenience of nasopharyngeal swabbing.

Where is the study run from?
University of Tartu (Estonia), and delivered by Kantar-Emor AS, OÜ Medicum Eriarstiabi, and SYNLAB Eesti OÜ (Estonia)

When is the study starting and how long is it expected to run for?
March 2020 to December 2023

Who is funding the study?
Ministry of Education and Research (Estonia)

Who is the main contact?
Unfortunately, this study is not recruiting public volunteers.

Study website

Contact information

Prof Ruth Kalda
Scientific

Ravila 19
Tartu
50411
Estonia

Phone +372 (0)731 9210
Email ruth.kalda@ut.ee

Study information

Study designSurveillance study based on repeated cross-sectional surveys of the general population (recruited via stratified random sampling)
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleCOVID-19 active monitoring program in Estonia
Study acronymCOVEST
Study objectivesThe main aim of this observational study is to estimate the prevalence of symptomatic and asymptomatic SARS-CoV-2 infection in the general population and how this varies over time.
Ethics approval(s)Approved 13/04/2020, Research Ethics Committee of the University of Tartu (Grant Office, University of Tartu, Raekoja plats 9, 51004 Tartu, Estonia; +372 (0)737 6215; eetikakomitee@ut.ee), ref: 310/T-1
Health condition(s) or problem(s) studiedCOVID-19 (SARS-CoV-2 infection)
InterventionRandomly selected consenting adults are asked to visit national testing centers for a nasopharyngeal swab and fill out a web-based questionnaire.
Intervention typeOther
Primary outcome measureSARS-CoV-2 prevalence measured using SARS-CoV-2 RNA RT-PCR at each of the cross-sectional study rounds (every month in 2020, six times a year in 2021, 2022/23 to be decided)
Secondary outcome measuresThe proportion of symptomatic cases among people testing positive for SARS-CoV-2, measured using a web-based questionnaire at each of the cross-sectional study rounds (every month in 2020, six times a year in 2021, 2022/23 to be decided)
Overall study start date17/03/2020
Completion date30/12/2023

Eligibility

Participant type(s)All
Age groupAdult
SexBoth
Target number of participants2000 in one cross-sectional study
Key inclusion criteria1. Adult, male or female
2. Willing and able to give informed consent for participation in the study
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment23/04/2020
Date of final enrolment30/11/2023

Locations

Countries of recruitment

  • Estonia

Study participating centre

University of Tartu
Ravila 19
Tartu
50411
Estonia

Sponsor information

University of Tartu
University/education

Ülikooli 18
Tartu
50090
Estonia

Phone +372 (0)737 5100
Email info@ut.ee
Website http://www.ut.ee/et
ROR logo "ROR" https://ror.org/03z77qz90

Funders

Funder type

Government

Ministry of Education and Research (Estonia)

No information available

Results and Publications

Intention to publish date31/01/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination plan1. Publication of positivity rates and behavioural characteristics after each recruitment round to the funding agency and the Estonian governmental task group on COVID-19
2. Planned publications in high-impact peer-reviewed journals
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 06/04/2021 No No
Preprint results non-peer reviewed 1st year results 13/09/2021 21/09/2021 No No

Additional files

ISRCTN10182320_PROTOCOL.pdf
Uploaded 06/04/2021

Editorial Notes

21/09/2021: Preprint reference added.
06/04/2021: Uploaded protocol (not peer reviewed).
16/03/2021: Trial's existence confirmed by the Research Ethics Committee of the University of Tartu.