Renin-Angiotensin System Inhibitors and COVID-19

NCT ID: NCT04331574

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2020-04-30

Brief Summary

Multicentric non-profit observational study, in patients with COVID-19 hospitalized in Italy, conducted through a pseudonymised survey.

Detailed Description

The recent SARS-CoV-2 Coronavirus pandemic and subsequent spread of the disease called COVID-19 brought back to the discussion a topic already highlighted during the SARS-CoV-4 crown-related SARS epidemic of 2002. In particular, the angiotensin converting enzyme 2 (ACE2) has been identified as a functional receptor for coronaviruses, therefore including SARS-CoV-2. ACE2 is strongly expressed in the heart and lungs. SARS-CoV-2 mainly invades alveolar epithelial cells, resulting in respiratory symptoms. These symptoms could be made more severe in the presence of increased expression of ACE2. ACE2 levels can be increased by the use of renin-angiotensin system inhibitors (RAS). This therapeutic class is particularly widespread, as it represents the most important pharmacological protection for widespread diseases such as high blood pressure, heart failure and ischemic heart disease. It is therefore possible to hypothesize that pharmacological treatment with RAS inhibitors may be associated with a more severe symptomatology and clinic than COVID-19.

However, several observations from studies on SARSCoV, which are most likely also relevant for SARS-CoV-2 seem to suggest otherwise. Indeed, it has been shown that the binding of coronavirus to ACE2 leads to downregulation of ACE2, which in turn causes an ACE / ACE2 imbalance excessive production of angiotensin by the related ACE enzyme. Angiotensin II receptor 1 (AT1R) stimulated by angiotensin causes an increase in pulmonary vascular permeability, thereby mediating an increase in lung damage. Therefore, according to this hypothesis, the upregulation of ACE2, caused by the chronic intake of AT1R and ACE Inhibitors, could be protective through two mechanisms: the first, that of blocking in the AT1 receptor; second, increasing ACE2 levels decreases ACE production of angiotensin and increases ACE2 production of angiotensin 1-7.

The quickest approach to evaluating these two opposing hypotheses is to analyze the medical records of COVID-19 patients to determine whether patients on RAS antagonist therapy have a different disease outcome than patients without the above therapy.

This research aims to verify whether the chronic intake of RAS inhibitors modifies the prevalence and severity of the clinical manifestation of COVID-19.

Conditions

COVID-19; Hypertension; Cardiovascular Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

covid-19 patients

Patients with certified diagnosis of COVID-19 recruited in Italian hospitals

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Patients affected by COVID19 referring to italian outpatient clinics or hospitals

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana dell'Ipertensione Arteriosa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Iaccarino, MD

Role: STUDY_CHAIR

Federico II University

Guido Grassi, MD

Role: STUDY_DIRECTOR

Inversity of Milan, BICOCCA

MariaLorenza Muiesan, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Claudio Borghi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Claudio Ferri, MD

Role: PRINCIPAL_INVESTIGATOR

University of L'Aquila

MASSIMO VOLPE, MD

Role: PRINCIPAL_INVESTIGATOR

Univerity of Rome "La Sapienza"

Leonardo Sechi

Role: PRINCIPAL_INVESTIGATOR

University of Udine

Locations

Spedali Civili di Brescia

Brescia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Guido Iaccarino, MD, PhD

Role: CONTACT

guiaccar@unina.it

+390817464717

Facility Contacts

Marialorenza Muiesan

Role: primary

References

Iaccarino G, Grassi G, Borghi C, Grassi D, Mancusi C, Muiesan ML, Salvetti M, Volpe M, Ferri C. Preexisting Oral Anticoagulant Therapy Ameliorates Prognosis in Hospitalized COVID-19 Patients. Front Cardiovasc Med. 2021 May 13;8:633878. doi: 10.3389/fcvm.2021.633878. eCollection 2021.

Reference Type: DERIVED

PMID: 34055928 (View on PubMed)

Iaccarino G, Grassi G, Borghi C, Carugo S, Fallo F, Ferri C, Giannattasio C, Grassi D, Letizia C, Mancusi C, Minuz P, Perlini S, Pucci G, Rizzoni D, Salvetti M, Sarzani R, Sechi L, Veglio F, Volpe M, Muiesan ML; SARS-RAS Investigators. Gender differences in predictors of intensive care units admission among COVID-19 patients: The results of the SARS-RAS study of the Italian Society of Hypertension. PLoS One. 2020 Oct 6;15(10):e0237297. doi: 10.1371/journal.pone.0237297. eCollection 2020.

Reference Type: DERIVED

PMID: 33022004 (View on PubMed)

Iaccarino G, Grassi G, Borghi C, Ferri C, Salvetti M, Volpe M; SARS-RAS Investigators. Age and Multimorbidity Predict Death Among COVID-19 Patients: Results of the SARS-RAS Study of the Italian Society of Hypertension. Hypertension. 2020 Aug;76(2):366-372. doi: 10.1161/HYPERTENSIONAHA.120.15324. Epub 2020 Jun 22.

Reference Type: DERIVED

PMID: 32564693 (View on PubMed)

Related Links

https://siia.it/notizie-siia/inibitori-del-sistema-renina-angiotensina-e-sars-cov-2-lindagine-della-siia/

Related Info

Other Identifiers

SARS-RAS

Identifier Type: -

Identifier Source: org_study_id