<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437901</url>
  </required_header>
  <id_info>
    <org_study_id>HCB/2020/0333</org_study_id>
    <nct_id>NCT04437901</nct_id>
  </id_info>
  <brief_title>COVIDAR - Arrhythmias in COVID-19</brief_title>
  <acronym>COVIDAR</acronym>
  <official_title>COVIDAR - International Registry on Arrhythmias in COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istituto Auxologico Italiano</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St George's University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Society of Cardiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia&#xD;
      occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand,&#xD;
      treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and&#xD;
      pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging&#xD;
      drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the&#xD;
      occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify&#xD;
      potential modifiable predisposing factors to reduce their incidence and to inform the best&#xD;
      arrhythmia management options in this patient population.&#xD;
&#xD;
      MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the&#xD;
      SARS-CoV2 infection.&#xD;
&#xD;
      STUDY DESIGN: patient registry (observational). Patients will not undergo any additional&#xD;
      investigations. Only data that is generated during routine clinical care will be collected.&#xD;
&#xD;
      STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed&#xD;
      COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The COVIDAR Registry is an international longitudinal multicentre observational study&#xD;
      worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the&#xD;
      context of SARS-CoV2 infection, also providing relevant information on events/management and&#xD;
      major cardiovascular outcomes. During the course of the registry patients will be followed up&#xD;
      according to the usual practice of the centres. Drug prescriptions and indications to perform&#xD;
      diagnostic/therapeutic procedures will be completely left to the treating physicians.&#xD;
&#xD;
      The registry population will consist of patients presenting with a suspicion of SARS-CoV2&#xD;
      infection, who are hospitalised in a medical or surgical department of the participating&#xD;
      hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19&#xD;
      disease has formally been noted or confirmed in the patient's medical record.&#xD;
&#xD;
      The registry will include all patients and collect data at the following timepoints:&#xD;
&#xD;
        -  Admission: evaluation before SARS-CoV2 infection treatment initiation&#xD;
&#xD;
        -  On-treatment: evaluation 24-28h after treatment initiation&#xD;
&#xD;
        -  At any adverse event: evaluation if any adverse event occurs&#xD;
&#xD;
        -  At discharge: evaluation of clinical status at the end of the admission period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Arrhythmia</measure>
    <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</time_frame>
    <description>Any arrhythmic event occurring in COVID-19 patients during hospital admission:&#xD;
Monomorphic ventricular tachycardia&#xD;
Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained)&#xD;
Ventricular fibrillation&#xD;
AV-block&#xD;
Severe bradycardia, symptomatic and/or requiring treatment&#xD;
New-onset atrial fibrillation&#xD;
Other</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic changes - Underlying rhythm</measure>
    <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</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic changes - Atrioventricular conduction</measure>
    <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</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic changes - QRS duration</measure>
    <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</time_frame>
    <description>Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic changes - presence of Brugada QRS pattern</measure>
    <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</time_frame>
    <description>Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrocardiographic changes - QTc duration</measure>
    <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</time_frame>
    <description>Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory abnormalities - electrolyte misbalance</measure>
    <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</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory abnormalities - cardiac biomarkers</measure>
    <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</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory abnormalities - renal function</measure>
    <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</time_frame>
    <description>Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory abnormalities - liver function</measure>
    <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</time_frame>
    <description>Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>COVID</condition>
  <condition>Arrhythmia</condition>
  <condition>Torsades de Pointe Caused by Drug</condition>
  <condition>Qt Interval, Variation in</condition>
  <condition>Atrioventricular Block</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Bradyarrhythmia</condition>
  <condition>Ventricular Arrythmia</condition>
  <arm_group>
    <arm_group_label>COVID-19 patients</arm_group_label>
    <description>Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The registry population will consist of patients presenting with a suspicion of SARS-CoV2&#xD;
        infection, who are hospitalised in a medical or surgical department of the participating&#xD;
        hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19&#xD;
        disease has formally been noted or confirmed in the patient's medical record.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Formal opposition by the patient to data collection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Arbelo, MD, PhD, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arthur A Wilde, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lia Crotti, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Istituto Auxologico Italiano, IRCCS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elijah Behr, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>St George's University Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hein Heidbuchel, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elena Arbelo, MD, PhD</last_name>
    <phone>+34 93 227 5551</phone>
    <email>EARBELO@clinic.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Hein Heidbuchel, MD, PhD</last_name>
      <email>hein.heidbuchel@uantwerpen.be</email>
    </contact>
    <investigator>
      <last_name>Hein Heidbuchel, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Auxologico Italiano, IRCCS</name>
      <address>
        <city>Milan</city>
        <zip>20149</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Lia Crotti, MD, PhD</last_name>
      <phone>+39 02 6191 12374</phone>
      <email>l.crotti@auxologico.it</email>
    </contact>
    <investigator>
      <last_name>Lia Crotti, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <state>AZ</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <last_name>Arthur A Wilde, MD, PhD</last_name>
      <email>a.a.wilde@amsterdamumc.nl</email>
    </contact>
    <investigator>
      <last_name>Arthur A Wilde, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nynke Hoffman, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic of Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Elena Arbelo, MD, PhD, MSc</last_name>
      <phone>+34 93 227 5551</phone>
      <email>EARBELO@clinic.cat</email>
    </contact>
    <investigator>
      <last_name>Elena Arbelo, MD, PhD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marta Hernandez-Meneses, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alex Soriano, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Georges University Hospitals</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Elijah Behr, MD, PhD</last_name>
      <phone>+44 20 8725 4571</phone>
      <email>ebehr@sgul.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Elijah Behr, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Atrioventricular Block</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
    <mesh_term>Torsades de Pointes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437901
org study id: HCB/2020/0333
nct id: NCT04437901
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
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
description: 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
measure: 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
description: 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
measure: 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
description: 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)
measure: 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
description: Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
measure: 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
description: Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events)
measure: 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
description: Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
measure: 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
description: 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
measure: 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
description: 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)
measure: 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
description: Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events)
measure: 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
description: Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events)
arm group label: COVID-19 patients
description: Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Elena Arbelo, MD, PhD, MSc
role: Study Chair
affiliation: Hospital Clinic of Barcelona
last name: Arthur A Wilde, MD, PhD
role: Study Director
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Lia Crotti, MD, PhD
role: Study Director
affiliation: Istituto Auxologico Italiano, IRCCS
last name: Elijah Behr, MD, PhD
role: Study Director
affiliation: St George's University Hospitals NHS Foundation Trust
last name: Hein Heidbuchel, MD, PhD
role: Study Director
affiliation: University Hospital, Antwerp
last name: Elena Arbelo, MD, PhD
phone: +34 93 227 5551
email: EARBELO@clinic.cat
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
investigator: 
facility: 
contact: 
investigator: 
investigator: 
investigator: 
facility: 
contact: 
investigator: 
country: Belgium
country: Italy
country: Netherlands
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac
mesh term: Atrioventricular Block
mesh term: Bradycardia
mesh term: Torsades de Pointes
sharing ipd: Undecided