Renin-Angiotensin System Inhibitors and COVID-19

NCT04331574 | Unknown DMC

• 1 other identifier: SARS-RAS
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Hypertension; Cardiovascular Diseases

Keywords

risk factors; SARS; ACE Inibitors; ARB

Outcome Measures

Primary Outcomes (2)

• Numbers of COVID-19 patients enrolled that use ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents

  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.

  3 months

• 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

  This study want to observe whether the assumption of antihypertensive ACE inhibitors or ARB increases the severity of the clinical manifestation of COVID19

  3 months

Secondary Outcomes (1)

• Number and type of anthropometric and clinical parameters that associate with COVID19 and COVID-19 severity

  3 months

Study Arms (1)

covid-19 patients

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients affected by COVID19 referring to italian outpatient clinics or hospitals

Sponsors & Collaborators

• Societa Italiana dell'Ipertensione Arteriosa: lead

Study Sites (1)

Spedali Civili di Brescia

Brescia, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 34055928 DERIVED

• 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.

  PMID: 33022004 DERIVED

• 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.

  PMID: 32564693 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19; Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases

Study Officials

• Guido Iaccarino, MD

  Federico II University

  STUDY CHAIR

• Guido Grassi, MD

  Inversity of Milan, BICOCCA

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Iaccarino, MD, PhD

CONTACT

+390817464717; guiaccar@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: March 10, 2020
• Primary Completion: April 10, 2020
• Study Completion: April 30, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)