NCT04330300

Coronavirus (COVID-19) ACEi/ARB Investigation

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

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,414 (estimated)
• Sponsor: National University of Ireland, Galway, Ireland · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• COVID-19

Interventions

Type	Name	Description
DRUG	Thiazide or Thiazide-like diuretics	Anti-hypertensive (Active Arm)
DRUG	Calcium Channel Blockers	Anti-hypertensive (Active Arm)
DRUG	ACE inhibitor	Anti-hypertensive (Control Arm)
DRUG	Angiotensin receptor blocker	Anti-hypertensive (Control Arm)

Timeline

• Start date: 2020-04-30
• Primary completion: 2021-07-31
• Completion: 2021-12-01
• First posted: 2020-04-01
• Last updated: 2020-06-30

Locations

1 site across 1 country: Ireland