ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic

• Status: Terminated
• Trial end date: 2021-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Groupe Hospitalier Pitié-Salpêtrière
• Treatments: Angiotensin-Converting Enzyme Inhibitors

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.