drugset / Trial / NCT04330300

Coronavirus (COVID-19) ACEi/ARB Investigation

NCT04330300

Phase 4 Suspended 2414 enrolled National University of Ireland, Galway, Ireland
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2020-04-30
Primary completion
2021-07-31
Completion
2021-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified
Comparator Benazepril Unknown
Subject Bendroflumethiazide Small molecule
Comparator Candesartan Unknown
Comparator Captopril Small molecule
Subject Chlorothiazide Small molecule
Subject Chlorthalidone Other / unclassified
Subject Diltiazem Small molecule
Comparator Enalapril Other / unclassified
Comparator Eprosartan Small molecule
Subject Felodipine Small molecule
Comparator Fosinopril Small molecule
Subject Hydrochlorothiazide Unknown
Subject Indapamide Small molecule
Comparator Irbesartan Small molecule
Comparator LISINOPRIL ANHYDROUS Small molecule
Comparator Losartan Other / unclassified
Subject Metolazone Small molecule
Subject Nicardipine Small molecule
Subject Nifedipine Other / unclassified
Subject Nimodipine Small molecule
Subject Nitrendipine Small molecule
Comparator Olmesartan Other / unclassified
Comparator Perindopril Small molecule
Comparator Quinapril Small molecule
Comparator Ramipril Small molecule
Comparator Telmisartan Other / unclassified
Comparator Valsartan Small molecule
Subject Verapamil Other / unclassified
Comparator trandolapril Small molecule