COVID-19 - ACORES-2 study: ACE inhibitors or ARBs discontinuation for Clinical Outcome Risk reduction in patients hospitalized for the Endemic Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infectio

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; Adult patients with a diagnosis of COVID-19 requiring hospitalization in a non-ICU and on prior therapy with RAS blockers

• Registration Number: EUCTR2020-001381-11-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-29
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for enrolment into the study:
1.Age = 18 year/old
2.Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration = 1 month))
3.Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method
4.Patients hospitalized in a non-ICU
5.Pregnancy test at inclusion visit for women of childbearing potential
6.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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 277
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 277

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
1.Shock requiring vasoactive agents
2.Acute respiratory distress syndrome requiring invasive mechanical ventilation
3.Circulatory assistance
4.History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension
5.Uncontrolled blood pressure despite the use of five antihypertensive drugs
6.History of nephrotic syndrome
7.History of hospitalization for hemorrhagic stroke in the past 3 months
8.RAS blockers therapy previously stopped > 48h
9.No affiliation to the French Health Care System Sécurité Sociale”
10.Inability to obtain informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified