COVID-19ACOVIDNCT04395664
Arrhythmias in Patients With COVID-19
An observational study of COVID-19, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- C3+ Holter Monitor
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Apr 2020to 1 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In.patients from hospitals of the greater Copenhagen area
Who may be able to join
- All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 > 18 years of age.
Who cannot join
- Persons not able to cooperate
- Persons unable to understand and sign "informed consent"
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Herlev & Gentofte Hospital
Copenhagen, Hellerup, 2900
About this study
Official title: The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring
The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.
- Conditions
- COVID-19
- Being tested
- C3+ Holter Monitor
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C3+ Holter MonitorDevice
ECG monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis
Measured: 4 months
Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis
Measured: 4 months
Secondary outcomes (3)
Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis
Measured: 4 months
Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis
Measured: 4 months
Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start16 Apr 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Lamberts, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395664
- Sponsor's protocol ID
- H-20021500
- Acronym
- ACOVID
- Status last verified
- Sep 2020
- First submitted
- 19 May 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring
- ClinicalTrials.gov ID
- NCT04395664
- Acronym / sponsor ID
- ACOVID / H-20021500
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 20 May 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.
The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In.patients from hospitals of the greater Copenhagen area
Key inclusion criteria (1 listed)
- All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 > 18 years of age.
Key exclusion criteria (2 listed)
- Persons not able to cooperate
- Persons unable to understand and sign "informed consent"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C3+ Holter MonitorECG monitoring | Device | – |
Primary outcome
In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis
Time frame: 4 months
Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis
Time frame: 4 months
3 secondary outcomes
Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis
Time frame: 4 months
Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis
Time frame: 4 months
Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.