Renin-Angiotensin-Aldosterone System Inhibitors, Hypertension, and COVID-19

NCT04374695 | Unknown DMC

• 1 other identifier: P20/11_COVHYP
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Because ACE2 may be modulated by RAAS inhibitors, such as angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEi and ARBs may be at higher risk for COVID-19 infection and severity. Aim. To analyze the associations between COVID-19 and hypertension, and treatments with ACEi and ARBs. Methods. In this retrospective observational study, consecutive patients hospitalized for suspected COVID-19 pneumonia will be divided into 2 groups, whether or not COVID-19 is confirmed. The two groups will be compared for baseline characteristics, mainly prior treatment with ACEi and ARBs, and clinical outcome at 1-month follow-up. The main hypothesis is that ACEi and ARBs, which interact differently with ACE2, may have different relationships with COVID-19 infection or severity.

Conditions

COVID-19

Keywords

COVID-19; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Blockers; Renin-Angiotensin System; Hypertension; Observational Study

Outcome Measures

Primary Outcomes (2)

• Prior treatment by ACEi

  Prevalence of a previous treatment by angiotensin converting enzyme inhibitors in patients with and without confirmed Covid-19 pneumonia.

  at admission to hospital

• Prior treatment by ARB

  Prevalence of a previous treatment by angiotensin II type 1-receptor blockers in patients with and without confirmed Covid-19 pneumonia.

  at admission to hospital

Secondary Outcomes (2)

• Baseline characteristics and comorbidities

  at admission to hospital

• Major Clinical Adverse Events

  One month follow-up

Study Arms (2)

patients with COVID-19

Patients with positive RT-PCR for SARS-CoV-2, and patients with négative RT-PCR for SARS-CoV-2 but clinical presentation highly suggestive of COVID-19, and typical COVID-19 abnormalities on chest CT-Scan.

patients without COVID-19

Patients with négative RT-PCR for SARS-CoV-2 and chest CT-Scan or chest X-ray not suggestive of COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients presenting to the Centre hospitalier de Versailles emergency department from 2020 March 10th to April, 15th with clinical symptoms suggestive of COVID-19, who fulfilled the inclusion criteria.

You may qualify if:

• Age equal or more than 18;
• Symptoms suggestive of Covid-19 pneumonia. At least : fever \> 38°C or influenza-like illness (asthenia, myalgia, chills, muscular aches, …) AND cough or dyspnea;
• Hospitalization required on clinical criteria including: oxygen saturation \<96% without oxygen support, respiratory frequency \> 25 per minute, hemodynamic instability, medical history or comorbidities known at high risk for Covid-19 (chronic heart disease, congestive heart failure, chronic bronchopulmonary disease, diabetes mellitus, age\>70, history of cancer, immunosuppression, …);
• Covid-19 confirmation test performed (RT-PCR).

You may not qualify if:

• Age \< 18
• Refusal to participate in the study
• detainee or prisoner
• Protected adult uncapable to consent

Sponsors & Collaborators

• Versailles Hospital: lead
• Bernard LIVAREK, MD, Cardiology department, Versailles Hospital: collaborator
• Jean-Paul BERESSI, MD, Department of diabetology, Versailles Hospital: collaborator
• Mehrsa KOUKABI FRADELIZZI, MD, Emergency department, Versailles Hospital: collaborator
• Floriane GILLES, MD, Cardiology department, Versailles Hospital: collaborator
• Alisson BERTRAND, Cardiology department, Versailles Hospital: collaborator
• Marie DE TOURNEMIRE, Cardiology department, Versailles Hospital: collaborator
• Victorien MONGUILLON, Cardiology department, Versailles Hospital: collaborator
• Maeva PASQUALINI, Cardiology department, Versailles Hospital: collaborator
• Alix PREVOT, Cardiology department, Versailles Hospital: collaborator
• Guillaume ROGER, Cardiology department, Versailles Hospital: collaborator
• Joseph SABA, Cardiology department, Versailles Hospital: collaborator
• Joséphine SOLTANI, Cardiology department, Versailles Hospital: collaborator
• Jean-François PROST, Cardiology department, Versailles Hospital: collaborator
• Cécile LAUREANA, Department of medical information, Versailles Hospital: collaborator

MeSH Terms

Conditions

COVID-19; Hypertension

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; Cardiovascular Diseases

Central Study Contacts

Jean-Louis GEORGES, MD, MPH

CONTACT

33+139638870; jgeorges@ch-versailles.fr

Jean-Baptiste AZOWA

CONTACT

33+139638355; jbazowa@ch-versailles.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, FESC

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 5, 2020
• Study Start: May 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05