ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19

COVID-19 Clinical Trial

— CODIV-ACE  

Official title:

ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318418
• Other study ID #: DEP_012020
• Status: Completed
• Start date: March 23, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background Very recent evidences support the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 coronavirus receptor ACE2 for gains entry into target cells. Angiotensin receptor-blocker (ARB) drugs, one of the most commonly used antihypertensive drug, typically increase ACE2 expression, often very markedly. With SARS-CoV-2 infection increased ACE2 expression very definitely would not be beneficial, and could be adverse. However, augmented ACE2 expression with ARB has been demonstrated in the kidneys and heart but has not been tested in the lungs. So, the hypothesis that using of ARB or ACE inhibitors (ACE-I) drugs during the COVID-19 may possibly be harmful is urgently to be verified in epidemiological studies.

Aim To retrospectively test whether 2019-nCoV patients treated with ARB or ACE-I, in comparison with patients who not, are at higher risk of having severe COVID-19 (coronavirus infection disease 2019), including death.

Population Hospitalized patients with confirmed COVID-19 infection (any type).

Outcome The project will retrospectively collect data on the most severe manifestation of COVID-19 occurred in 2019-nCoV infected patients during hospitalization. Severity will be classified as: hospital discharge with healing, asymptomatic, mild complications but not pneumonia, not severe pneumonia, severe pneumonia, acute respiratory distress syndrome (ARDS) and death. Classification of pneumonia will follow WHO (World Health Organization) criteria. Data on severity will be obtained from medical record at one-point time (at the moment of inclusion in the study).

Exposure Treatment for ARB or ACE-I. When available, type of drugs will be recorded.

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). Association between use of ACE-I or ARB and severity of COVID-19 will be assessed by using of multivariable logistic regression analysis. Data on potential confounders will be obtained by medical records: age, sex, time intervals from hospital admission to worse manifestation of COVID-19 and to eventual death or recovering, smoking, body mass index, history of myocardial infarction, diabetes, hypertension, cancer, respiratory disease, other morbidities, creatinine, insulin, glomerular filtration rate together with use of Tocilizumab, anti-aldosterone agents, diuretics, Kaletra, cortisone, Remdesivir, Hydroxychloroquine, Sacubitril or Valsartan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3400
• Est. completion date: June 30, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients hospitalized for COVID-19

Exclusion Criteria:

none

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Italy	IRCCS Neuromed, Department of Epidemiology and Prevention	Pozzilli

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe COVID-19	Severity pneumonia or acute respiratory distress syndrome by COVID-19	1 month
Secondary	Death	Death by COVID-19	1 month