ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study

Assistance Publique - Hôpitaux de Paris1 site in 1 country44 target enrollmentApril 9, 2020

ConditionsHistory of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection

Drugs1: discontinuation of RAS blocker therapy 2: continuation of RAS blocker therapy

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 44
Locations: 1
Primary Endpoint: Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19.

Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.

Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19.

It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.

Registry

clinicaltrials.gov

Start Date

April 9, 2020

End Date

January 9, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old.
•Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month).
•Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method.
•Patients hospitalized in a non-intensive care unit.
•Pregnancy test at inclusion visit for women of childbearing potential.
•Women of childbearing potential must agree to use adequate contraception according to recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG).

Exclusion Criteria

•Shock requiring vasoactive agents.
•Acute respiratory distress syndrome requiring invasive mechanical ventilation.
•Circulatory assistance.
•History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension.
•Uncontrolled blood pressure despite the use of five antihypertensive drugs.
•History of nephrotic syndrome.
•History of hospitalization for hemorrhagic stroke in the past 3 months.
•RAS blockers therapy previously stopped \> 48h.
•No affiliation to the French Health Care System "Sécurité Sociale".
•Inability to obtain informed consent.

Outcomes

Primary Outcomes

Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)

Time Frame: from day 0 to day 28 or hospital discharge

Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first)

Secondary Outcomes

Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28(at day 28)
Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28.(at days 7, 14 and 28)
Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28(at day28)
Number of days alive free of oxygen.(from day 0 to day 28 or hospital discharge)
Number of days alive outside hospital until day28(at day28)
Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28(at day28)
Rate of cardiovascular death at day 28(at day 28)
Number of days alive free of ICU admission until day28(at day28)
Rate of all-cause mortality at day 28(at day 28)
Number of days alive free of acute kidney injury until hospital discharge(at day 28 to hospital discharge)