ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic (ACORES-2)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

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

Treatments

Drug: 1: discontinuation of RAS blocker therapy

Drug: 2: continuation of RAS blocker therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04329195

APHP200409

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.