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Coronavirus (COVID-19) ACEi/ARB Investigation (CORONACION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330300
Recruitment Status : Suspended (Challenges with funding and very low incidence of COVID-19 at Irish study site)
First Posted : April 1, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. John William McEvoy, National University of Ireland, Galway, Ireland

Tracking Information
First Submitted Date  ICMJE March 30, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE April 30, 2020
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV) [ Time Frame: 12 months ]
Time from randomization to the first occurrence of any of the clinical events above
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Number of Covid-19 positive participants who die [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Number of Covid-19 positive participants who require intubation in intensive care unit (ICU) [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV) [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Number of SARS-CoV-2 positive participants [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization [ Time Frame: 12 months ]
  • 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring [ Time Frame: 12 months ]
    Performed in a random sub-sample of the cohort (both study arms)
  • All-cause mortality [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Number of Covid-19 positive participants who die [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Number of Covid-19 positive participants who require intubation in intensive care unit (ICU) [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV) [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Number of SARS-CoV-2 positive participants [ Time Frame: 12 months ]
    Time from randomization to the first occurrence of above
  • Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization [ Time Frame: 12 months ]
  • 24 hour mean systolic BP (mmHg) on ambulatory BP monitoring [ Time Frame: 12 months ]
    Performed in a random sub-sample of the cohort (both study arms)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coronavirus (COVID-19) ACEi/ARB Investigation
Official Title  ICMJE The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial
Brief Summary Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hypertension
  • COVID-19
Intervention  ICMJE
  • Drug: Thiazide or Thiazide-like diuretics
    Anti-hypertensive (Active Arm)
    Other Name: Hydrochlorothiazide, metolazone, chlorthalidone, chlorothiazide, bendroflumethiazide, indapamide
  • Drug: Calcium Channel Blockers
    Anti-hypertensive (Active Arm)
    Other Name: Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil
  • Drug: ACE inhibitor
    Anti-hypertensive (Control Arm)
    Other Name: Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril
  • Drug: Angiotensin receptor blocker
    Anti-hypertensive (Control Arm)
    Other Name: Candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan
Study Arms  ICMJE
  • Experimental: Alternative anti-hypertensive medication
    Switch to an alternative BP medication (specifically a Calcium channel blocker [CCB] or Thiazide/Thiazide-like diuretic at an equipotent blood pressure lowering dose). The choice of either CCB or Thiazide/Thiazide-like anti-hypertensive provided as alternative therapy will be at the discretion of the patient's treating physician.
    Interventions:
    • Drug: Thiazide or Thiazide-like diuretics
    • Drug: Calcium Channel Blockers
  • Active Comparator: Continue ACEi/ARB antihypertensive
    Continue with either the ACEi (Angiotensin Converting Enzyme Inhibitor) or the Angiotensin Receptor Blocker (ARB) that had already been prescribed for the treatment of hypertension.
    Interventions:
    • Drug: ACE inhibitor
    • Drug: Angiotensin receptor blocker
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 30, 2020)
2414
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and non-pregnant women aged 60 or over
  • Known diagnosis of hypertension
  • Current use of ACEi or ARB for the treatment of hypertension
  • COVID-19 naïve (i.e. not known to be infected)
  • English speaker

Exclusion Criteria:

  • Known diabetic nephropathy
  • Known heart failure with reduced ejection fraction
  • Resistant hypertension (defined as blood pressure that remains above goal despite concurrent use of three anti-hypertensive agents of different classes, one of which should be a diuretic, or as blood pressure that is controlled with four or more medications)
  • Contraindications or allergies to CCB or Thiazide
  • Unconscious patients
  • Current psychiatric in-patients
  • Patients in an emergency medical setting
  • Inability to consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04330300
Other Study ID Numbers  ICMJE C.A. 2348
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 12-24 months
Access Criteria: To be determined
Responsible Party Prof. John William McEvoy, National University of Ireland, Galway, Ireland
Study Sponsor  ICMJE National University of Ireland, Galway, Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John William McEvoy, MBBCh MHS National University of Ireland, Galway, Ireland
PRS Account National University of Ireland, Galway, Ireland
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP