RT Journal Article
SR Electronic
T1 Protocol for a 30-day randomised, parallel-group, non-inferiority, controlled trial investigating the effects of discontinuing renin-angiotensin system inhibitors in patients with and without COVID-19: the RASCOVID-19 trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e062895
DO 10.1136/bmjopen-2022-062895
VO 12
IS 11
A1 Kliim-Hansen, Vivian
A1 Gasbjerg, Lærke Smidt
A1 Ellegaard, Anne-Marie
A1 Lorentsson, Hans Johan Niklas
A1 Lynggaard, Mads Bank
A1 Hagemann, Christoffer Andersen
A1 Legart, Christian
A1 Mathiesen, David Siersbæk
A1 Sivapalan, Pradeesh
A1 Jensen, Jens-Ulrik Stæhr
A1 Vilsbøll, Tina
A1 Christensen, Mikkel Bring
A1 Knop, Filip Krag
YR 2022
UL http://bmjopen.bmj.com/content/12/11/e062895.abstract
AB Introduction The COVID-19 pandemic caused by the virus SARS-CoV has spread rapidly and caused damage worldwide. Data suggest a major overrepresentation of hypertension and diabetes among patients experiencing severe courses of COVID-19 including COVID-19-related deaths. Many of these patients receive renin-angiotensin system (RAS) inhibiting therapy, and evidence suggests that treatment with angiotensin II receptor blockers (ARBs) could attenuate SARS-CoV-induced acute respiratory distress syndrome, and ACE inhibitors and ARBs have been suggested to alleviate COVID-19 pulmonary manifestations. This randomised clinical trial will address whether RAS inhibiting therapy should be continued or discontinued in hospitalised patients with COVID-19.Methods and analysis This trial is a 30-day randomised parallel-group non-inferiority clinical trial with an embedded mechanistic substudy. In the main trial, 215 patients treated with a RAS inhibitor will be included. The participants will be randomly assigned in a 1:1 ratio to either discontinue or continue their RAS inhibiting therapy in addition to standard care. The patients are included during hospitalisation and followed for a period of 30 days. The primary end point is number of days alive and out of hospital within 14 days after recruitment. In a mechanistic substudy, 40 patients treated with RAS inhibition, who are not in hospital and not infected with COVID-19 will be randomly assigned to discontinue or continue their RAS inhibiting therapy with the primary end point of serum ACE2 activity.Ethics and dissemination This trial has been approved by the Scientific-Ethical Committee of the Capital Region of Denmark (identification no. H-20026484), the Danish Medicines Agency (identification no. 2020040883) and by the Danish Data Protection Agency (P-2020-366). The results of this project will be compiled into one or more manuscripts for publication in international peer-reviewed scientific journals.Trial registration number 2020-001544-26; NCT04351581.The data that support the findings of this study are available from the corresponding author, VK-H, upon reasonable request.