ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19
CODIV-ACE
1 other identifier
observational
3,400
1 country
1
Brief Summary
Hypothesis Very recent evidences supports the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 (severe acute respiratory syndrome ) coronavirus receptor angiotensin converting enzyme 2 (ACE2) for entry into target cells. The epidemiological association between Angiotensin receptor-blocker (ARB) or ACE inhibitors (ACE-I) use and severe sequelae of 2109-nCoV infection disease COVID-19 has not been yet conclusively demonstrated, but may have important consequences for population health. Aim To retrospectively test whether 2019-nCoV patients treated with ACE-I or ARB, in comparison with patients who not, are at higher risk of having severe COVID-19 (including death). Population Hospitalized patients with confirmed COVID-19 infection (any type). Study design Patients will be divided in two groups, a) controls: individuals who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection) and b) cases: individuals who developed severe COVID-19 disease (including fatal events). Treatment with ACE-I or ARB, together with possible confounding will be assessed retrospectively. Exposure Treatment for ACE-I or ARB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2020
CompletedStudy Start
First participant enrolled
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedSeptember 16, 2020
September 1, 2020
2 months
March 19, 2020
September 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severe COVID-19
Severity pneumonia or acute respiratory distress syndrome by COVID-19
1 month
Secondary Outcomes (1)
Death
1 month
Study Arms (2)
Cases
Patients who developed severe COVID-19 disease (including fatal events)
Controls
Infected patients who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection)
Eligibility Criteria
Hospitalized patients with confirmed COVID-19 infection (any type), recruited in Italian hospital
You may qualify if:
- Patients hospitalized for COVID-19
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromed IRCCSlead
Study Sites (1)
IRCCS Neuromed, Department of Epidemiology and Prevention
Pozzilli, 86077, Italy
Related Publications (1)
COVID-19 RISk and Treatments (CORIST) Collaboration. RAAS inhibitors are not associated with mortality in COVID-19 patients: Findings from an observational multicenter study in Italy and a meta-analysis of 19 studies. Vascul Pharmacol. 2020 Dec;135:106805. doi: 10.1016/j.vph.2020.106805. Epub 2020 Sep 28.
PMID: 32992048DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Augusto Di Castelnuovo, MSc, PhD
IRCCS Neuromed
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, PhD
Study Record Dates
First Submitted
March 19, 2020
First Posted
March 24, 2020
Study Start
March 23, 2020
Primary Completion
May 10, 2020
Study Completion
June 30, 2020
Last Updated
September 16, 2020
Record last verified: 2020-09