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The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?

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. Read our disclaimer for details. Identifier: NCT04322786
Recruitment Status : Active, not recruiting
First Posted : March 26, 2020
Last Update Posted : November 13, 2020
Information provided by (Responsible Party):
University College, London

Brief Summary:
The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.

Condition or disease Intervention/treatment
Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom Drug: ACE inhibitor

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Study Type : Observational
Actual Enrollment : 1302508 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective? An Analysis Using UK Based Electronic Health Records of 5.6 Million Individuals.
Actual Study Start Date : January 1, 1998
Actual Primary Completion Date : May 31, 2016
Estimated Study Completion Date : March 31, 2021

Group/Cohort Intervention/treatment
ACEI user
Individuals with an ACEI prescription in the study population.
Drug: ACE inhibitor
Any prescription of ACE inhibitor

Matched controls
Individuals without an ACEI prescription, and matched to the users by sex and 10-year age categories.

Primary Outcome Measures :
  1. Incidence of influenza [ Time Frame: Jan 1st 1998 - May 31st 2016 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The nested case-control study include cases who had an ACEI prescription during study follow-up. We randomly select one control per case from the study cohort of individuals without any documented ACEI use. Controls are matched to incident AF patients according to sex, age (10-year age strata).

Inclusion Criteria:

  • We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

  • We exclude individuals with a prior history of influenza and viral pneumonia before study entry.
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Responsible Party: University College, London Identifier: NCT04322786    
Other Study ID Numbers: ISAC17_205R
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiratory Tract Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action