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

Outcome

Outcome not reported

Stopped (Business): “Challenges with funding and very low incidence of COVID-19 at Irish study site”

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 Unknown — —
Subject Verapamil Other / unclassified — —
Comparator trandolapril Small molecule — —