COVIDCOVIDARNCT04437901
COVIDAR - Arrhythmias in COVID-19
An observational study of COVID and Arrhythmia, run by Hospital Clinic of Barcelona at 5 sites in 5 countries.
Trial summary
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID, Arrhythmia, Torsades de Pointe Caused by Drug
- How many people
- 10,000 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jun 2020to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.
Who may be able to join
- Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.
Who cannot join
- Formal opposition by the patient to data collection.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Belgium1 site
Antwerp University Hospital
Antwerp
Hein Heidbuchel, MD, PhD, hein.heidbuchel@uantwerpen.be
Hein Heidbuchel, MD, PhD
Italy1 site
Istituto Auxologico Italiano, IRCCS
Milan, 20149
Lia Crotti, MD, PhD, +39 02 6191 12374, l.crotti@auxologico.it
Lia Crotti, MD, PhD
Netherlands1 site
Amsterdam UMC
Amsterdam, AZ, 1105 AZ
Arthur A Wilde, MD, PhD, a.a.wilde@amsterdamumc.nl
Arthur A Wilde, MD, PhD
Spain1 site
Hospital Clinic of Barcelona
Barcelona, 08036
Elena Arbelo, MD, PhD, MSc, +34 93 227 5551, EARBELO@clinic.cat
Elena Arbelo, MD, PhD, MSc
United Kingdom1 site
St. Georges University Hospitals
London, SW17 0QT
Elijah Behr, MD, PhD, +44 20 8725 4571, ebehr@sgul.ac.uk
Elijah Behr, MD, PhD
About this study
Official title: COVIDAR - International Registry on Arrhythmias in COVID-19
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population.
MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection.
Read more
STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected.
STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.
Read the detailed description
The COVIDAR Registry is an international longitudinal multicentre observational study worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the context of SARS-CoV2 infection, also providing relevant information on events/management and major cardiovascular outcomes. During the course of the registry patients will be followed up according to the usual practice of the centres. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the treating physicians.
The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.
The registry will include all patients and collect data at the following timepoints:
- Admission: evaluation before SARS-CoV2 infection treatment initiation
- On-treatment: evaluation 24-28h after treatment initiation
- At any adverse event: evaluation if any adverse event occurs
- At discharge: evaluation of clinical status at the end of the admission period.
- Conditions
- COVID, Arrhythmia, Torsades de Pointe Caused by Drug, Qt Interval, Variation in, Atrioventricular Block, Atrial Fibrillation
- Medical subject headings
- Arrhythmias, Cardiac, Atrioventricular Block, Atrial Fibrillation, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia
Any arrhythmic event occurring in COVID-19 patients during hospital admission:
- Monomorphic ventricular tachycardia
- Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained)
- Ventricular fibrillation
- AV-block
- Severe bradycardia, symptomatic and/or requiring treatment
- New-onset atrial fibrillation
- Other
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (9)
Electrocardiographic changes - Underlying rhythm
Categorical variable collecting the patient's underlying rhythm at baseline, on treatment and in case of arrhythmic adverse events): sinus rhythm, atrial fibrillation/flutter, other
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - Atrioventricular conduction
Collected as a categorical (normal, 1st-, 2nd- or 3rd degree AV block) and a continuous (PR duration in ms) at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - QRS duration
Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - presence of Brugada QRS pattern
Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - QTc duration
Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - electrolyte misbalance
Kalium, magnesium and calcium collected as continuous variables at baseline, on treatment and in case of arrhythmic adverse events). Will be reported as a categorical variable (presence/absence) of electrolyte misbalance
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - cardiac biomarkers
Cardiac CK, troponin T and/or troponin I (where available) collected as a continuous variable at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - renal function
Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - liver function
Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events)
Measured: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Istituto Auxologico Italiano, St George's University Hospitals NHS Foundation Trust, University Hospital, Antwerp, European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART), European Society of Cardiology
- Responsible party
- Sponsor
- Investigators
- Elena Arbelo, MD, PhD, MSc, Study chair, Hospital Clinic of BarcelonaArthur A Wilde, MD, PhD, Study director, Amsterdam UMCLia Crotti, MD, PhD, Study director, Istituto Auxologico Italiano, IRCCSElijah Behr, MD, PhD, Study director, St George's University Hospitals NHS Foundation TrustHein Heidbuchel, MD, PhD, Study director, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437901
- Sponsor's protocol ID
- HCB/2020/0333
- Acronym
- COVIDAR
- Status last verified
- Jun 2020
- First submitted
- 28 May 2020
- Last updated
- 18 Jun 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVIDAR - International Registry on Arrhythmias in COVID-19
- ClinicalTrials.gov ID
- NCT04437901
- Acronym / sponsor ID
- COVIDAR / HCB/2020/0333
- Conditions
- COVID, Arrhythmia, Torsades de Pointe Caused by Drug, Qt Interval, Variation in, Atrioventricular Block, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Istituto Auxologico Italiano, St George's University Hospitals NHS Foundation Trust, University Hospital, Antwerp, European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART), European Society of Cardiology
- Study start
- Jun 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jun 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.
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population.
MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection.
STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected.
STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.
Detailed description
The COVIDAR Registry is an international longitudinal multicentre observational study worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the context of SARS-CoV2 infection, also providing relevant information on events/management and major cardiovascular outcomes. During the course of the registry patients will be followed up according to the usual practice of the centres. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the treating physicians.
The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.
The registry will include all patients and collect data at the following timepoints:
- Admission: evaluation before SARS-CoV2 infection treatment initiation
- On-treatment: evaluation 24-28h after treatment initiation
- At any adverse event: evaluation if any adverse event occurs
- At discharge: evaluation of clinical status at the end of the admission period.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | –Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.
Key inclusion criteria (1 listed)
- Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.
Key exclusion criteria (1 listed)
- Formal opposition by the patient to data collection.
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
Arrhythmia
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Any arrhythmic event occurring in COVID-19 patients during hospital admission: * Monomorphic ventricular tachycardia * Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained) * Ventricular fibrillation * AV-block * Severe bradycardia, symptomatic and/or requiring treatment * New-onset atrial fibrillation * Other
9 secondary outcomes
Electrocardiographic changes - Underlying rhythm
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - Atrioventricular conduction
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - QRS duration
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - presence of Brugada QRS pattern
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - QTc duration
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - electrolyte misbalance
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - cardiac biomarkers
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - renal function
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - liver function
Time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- 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.
Elena Arbelo, MD, PhD, MSc study chair
Hospital Clinic of Barcelona
Arthur A Wilde, MD, PhD study director
Amsterdam UMC
Lia Crotti, MD, PhD study director
Istituto Auxologico Italiano, IRCCS
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Arrhythmia, run by Hospital Clinic of Barcelona at 5 sites in 5 countries.
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 1 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 18 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 5 sites in Belgium, Italy, Netherlands, Spain, United Kingdom. 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 Elena Arbelo, MD, PhD (+34 93 227 5551, EARBELO@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia (time frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months). 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 18 Jun 2020.