Coronavirus (COVID-19) ACEi/ARB Investigation

Hypertension Clinical Trial

— CORONACION  

Official title:

The CORONAvirus Disease 2019 Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker InvestigatiON (CORONACION) Randomized Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04330300
• Other study ID #: C.A. 2348
• Status: Suspended
• Phase: Phase 4
• Start date: April 30, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2020
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2414
• Est. completion date: December 1, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Hypertension

Intervention

Drug:
• Thiazide or Thiazide-like diuretics
Anti-hypertensive (Active Arm)
• Calcium Channel Blockers
Anti-hypertensive (Active Arm)
• ACE inhibitor
Anti-hypertensive (Control Arm)
• Angiotensin receptor blocker
Anti-hypertensive (Control Arm)

Locations

Country	Name	City	State
Ireland	University Hospital Galway	Galway

Sponsors (1)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV)	Time from randomization to the first occurrence of any of the clinical events above	12 months
Secondary	Number of Covid-19 positive participants who die	Time from randomization to the first occurrence of above	12 months
Secondary	Number of Covid-19 positive participants who require intubation in intensive care unit (ICU)	Time from randomization to the first occurrence of above	12 months
Secondary	Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV)	Time from randomization to the first occurrence of above	12 months
Secondary	Number of SARS-CoV-2 positive participants	Time from randomization to the first occurrence of above	12 months
Secondary	Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization		12 months
Secondary	24 hour mean systolic BP (mmHg) on ambulatory BP monitoring	Performed in a random sub-sample of the cohort (both study arms)	12 months
Secondary	All-cause mortality	Time from randomization to the first occurrence of above	12 months