Discontinuation of ACE inhibitors in patients with COVID-19 infectio

Phase 1

• Conditions: The study will investigate infections with the new SARS-CoV2 virus. Current studies show that the SARS-CoV2 virus penetrates human cells via the angiotensin converting enzyme II (ACE2) receptor 2. Experimental studies show that ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) can increase the expression of ACE2 and thus could facilitate virus uptake. This study will investigate the effect of stopping chronic ACEI or ARB therapy in patients with proven SARS-CoV2 infection.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001206-35-DE
• Lead Sponsor: Medizinische Universität Innsbruck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 798

Inclusion Criteria

1. Written, signed and dated informed consent form to participate in the clinical trial after prior written and oral information
2. Male and female patients = 18 years capable of making decisions
3. Confirmed symptomatic SARS-CoV2 infection (throat swab) = 5 days
4. Chronic (=1 month) pretreatment with medicinal products from the ATC groups C09A, C09B, C09C, C09D due to arterial hypertension, diabetes mellitus, heart failure or coronary heart disease.
5. Stable circulatory conditions with not more than four antihypertensive drugs, which allow discontinuation of the therapy with a medicinal product from the ATC groups C09A, C09B, C09C, C09D (systolic arterial blood pressure =180mmHg).
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 638

Exclusion Criteria

1. Women of childbearing potential including pregnant women and breastfeeding mothers
2. Participation in another interventional study
3. At the time of study inclusion oral medication is not possible
4. Acute coronary syndrome =3 months
5. Heart failure in stages NYHA III and IV
6. Restriction of left ventricular ejection fraction <30% or NTproBNP increase =600pg/mL in the case of clinical signs of heart failure
7. Hospitalization due to cardiac decompensation =3 months
8. Lung failure requiring intubation
9. Severe arterial hypertension with maximum antihypertensive therapy (taking >4 antihypertensive drugs)
10. Therapy-refractory arterial hypertension (systolic arterial blood pressure >180mmHg despite multiple therapy)
11. Patients who cannot be switched to alternative therapy.
12. Patients who cannot perform a blood pressure self-measurement under ambulant conditions

Study & Design

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