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Renin-Angiotensin System Inhibitors and COVID-19 (SARS-RAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331574
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Societa Italiana dell'Ipertensione Arteriosa

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

Condition or disease
COVID-19 Hypertension Cardiovascular Diseases

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: Phase IV Observational Study to Associate Hypertension and Hypertensinon Treatment to COVID19
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : April 10, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
covid-19 patients
Patients with certified diagnosis of COVID-19 recruited in Italian hospitals



Primary Outcome Measures :
  1. Numbers of COVID-19 patients enrolled that use ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents [ Time Frame: 3 months ]
    Using anamnestic data collected from the health record of the hospital or of the general practitioner, we will count the number of COVID-19 patients enrolled that were treated with ACE Inhibitors or ARB.

  2. Numbers of COVID-19 patients enrolled with no symptoms, with moderate symptoms or with severe symptoms of pneumoni based on the WHO specification for ARDS that also used ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents [ Time Frame: 3 months ]
    This study want to observe whether the assumption of antihypertensive ACE inhibitors or ARB increases the severity of the clinical manifestation of COVID19


Secondary Outcome Measures :
  1. Number and type of anthropometric and clinical parameters that associate with COVID19 and COVID-19 severity [ Time Frame: 3 months ]
    Collecting selected data from the health record and hospital charts of the patients we will assess whether among the recorded parameters there are any that can predict COVID19 prevalence and severity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
COVID-19 patients enrolled in infectious disease and resuscitation centers in Italy or in home isolation and health surveillance
Criteria

Inclusion Criteria:

Patients affected by COVID19 referring to italian outpatient clinics or hospitals

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331574


Contacts
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Contact: Guido Iaccarino, MD, PhD +390817464717 guiaccar@unina.it

Locations
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Italy
Spedali Civili di Brescia Recruiting
Brescia, Italy
Contact: Marialorenza Muiesan         
Sponsors and Collaborators
Societa Italiana dell'Ipertensione Arteriosa
Investigators
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Study Chair: Guido Iaccarino, MD Federico II University
Study Director: Guido Grassi, MD Inversity of Milan, BICOCCA
Principal Investigator: MariaLorenza Muiesan, MD Università degli Studi di Brescia
Principal Investigator: Claudio Borghi, MD University of Bologna
Principal Investigator: Claudio Ferri, MD University of L'Aquila
Principal Investigator: MASSIMO VOLPE, MD Univerity of Rome "La Sapienza"
Principal Investigator: Leonardo Sechi University of Udine
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Societa Italiana dell'Ipertensione Arteriosa
ClinicalTrials.gov Identifier: NCT04331574    
Other Study ID Numbers: SARS-RAS
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Societa Italiana dell'Ipertensione Arteriosa:
risk factors
SARS
ACE Inibitors
ARB
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases