Coronavirus InfectionNCT04370067
HUNgarian COronaVirus Disease-19 Epidemiological Research
An observational study of Coronavirus Infection, run by Semmelweis University Heart and Vascular Center at 4 sites in Hungary.
Trial summary
Hungarian CoronaVirus disease-19 Epidemiological Research Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection
- How many people
- 11,200 participants
- Where
- 4 sitesHungary
- Study dates
- 1 May 2020to 1 Aug 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hungarian male or female patients aged 14 and over who live in private households.
Who may be able to join
- Hungarian male or female patients aged 14 and over who live in private households
- Inactivated social security number does not infer the exclusion of the study
Who cannot join
- Patients under the age of 14
- Patients living in institutional households
Trial locations and contacts
4 sites in 1 country.
Hungary4 sites, 4 recruiting
- Recruiting
Semmelweis University - Heart and Vascular Center
Budapest, 1122
Béla Merkely, PhD,DSc, +36 20 825 8000, rektor@semmelweis-univ.hu
Annamaria Kosztin, MD,PhD, + 36 20 666 3236, kosztin.annamaria@gmail.com
- Recruiting
University of Debrecen
Debrecen, 4032
Ervin László Berényi, MD,PhD, ervin.berenyi@gmail.com
- Recruiting
University of Pecs
Pécs, 7622
Andor Sebestyén, MD,PhD, sebestyen.andor@pte.hu
- Recruiting
University of Szeged
Szeged, 6720
Csaba Lengyel, MD,PhD, +36-62-545-186, lecs.in1st@gmail.com
About this study
Official title: Hungarian CoronaVirus Disease-19 Epidemiological Research
Hungarian CoronaVirus disease-19 Epidemiological Research
Read the detailed description
The planned large-scale, cross-sectional, representative population screening can show the prevalence of COVID-19 and the degree of infection and trans-infection in Hungary after more than one month of strict restriction. In addition, it can have an impact on further actions, and we can track the impact of the decisions we make by repeating the screenings.
- Conditions
- Coronavirus Infection
- Keywords
- Coronavirus
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 rate
The rate of the infected patients, asymptomatic carrier and healed patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 May 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 11,200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University, Szeged University, University of Pecs, University of Debrecen
- Responsible party
- Sponsor
- Investigators
- Béla Merkely, PhD,DSc, Principal investigator, Semmelweis University Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370067
- Sponsor's protocol ID
- H-UNCOVER
- Status last verified
- Jun 2020
- First submitted
- 28 Apr 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Merkely B, Szabo AJ, Kosztin A, Berenyi E, Sebestyen A, Lengyel C, Merkely G, Karady J, Varkonyi I, Papp C, Miseta A, Betlehem J, Burian K, Csoka I, Vasarhelyi B, Ludwig E, Prinz G, Sinko J, Hanko B, Varga P, Fulop GA, Mag K, Voko Z; HUNgarian COronaVirus-19 Epidemiological Research (H-UNCOVER) investigators. Novel coronavirus epidemic in the Hungarian population, a cross-sectional nationwide survey to support the exit policy in Hungary. Geroscience. 2020 Aug;42(4):1063-1074. doi: 10.1007/s11357-020-00226-9. Epub 2020 Jul 17.
PubMed 32677025
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hungarian CoronaVirus Disease-19 Epidemiological Research
- ClinicalTrials.gov ID
- NCT04370067
- Acronym / sponsor ID
- H-UNCOVER
- Conditions
- Coronavirus Infection
- Keywords
- Coronavirus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,200 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- Semmelweis University, Szeged University, University of Pecs, University of Debrecen
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hungarian CoronaVirus disease-19 Epidemiological Research
Detailed description
The planned large-scale, cross-sectional, representative population screening can show the prevalence of COVID-19 and the degree of infection and trans-infection in Hungary after more than one month of strict restriction. In addition, it can have an impact on further actions, and we can track the impact of the decisions we make by repeating the screenings.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hungarian male or female patients aged 14 and over who live in private households.
Key inclusion criteria (2 listed)
- Hungarian male or female patients aged 14 and over who live in private households
- Inactivated social security number does not infer the exclusion of the study
Key exclusion criteria (2 listed)
- Patients under the age of 14
- Patients living in institutional households
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COVID-19 rate
Time frame: 1 year
The rate of the infected patients, asymptomatic carrier and healed patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 32677025Merkely B, Szabo AJ, Kosztin A, Berenyi E, Sebestyen A, Lengyel C, Merkely G, Karady J, Varkonyi I, Papp C, Miseta A, Betlehem J, Burian K, Csoka I, Vasarhelyi B, Ludwig E, Prinz G, Sinko J, Hanko B, Varga P, Fulop GA, Mag K, Voko Z; HUNgarian COronaVirus-19 Epidemiological Research (H-UNCOVER) investigators. Novel coronavirus epidemic in the Hungarian population, a cross-sectional nationwide survey to support the exit policy in Hungary. Geroscience. 2020 Aug;42(4):1063-1074. doi: 10.1007/s11357-020-00226-9. Epub 2020 Jul 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béla Merkely, PhD,DSc principal investigator
Semmelweis University Heart and Vascular Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Semmelweis University Heart and Vascular Center at 4 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Béla Merkely, PhD,DSc (+36 20 825 8000, rektor@semmelweis-univ.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.