The Use of Angiotensin Converting Enzyme Inhibitors and I... | NCT04322786

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

NCT04322786

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Nov 13, 2020Actual

Enrollment

1,302,508Actual

Phase

Not provided

Conditions

Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom

Interventions

ACE inhibitor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1998Actual

Primary Completion Date

May 31, 2016Actual

Completion Date

Mar 31, 2021Estimated

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,302,508Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACEI user		Individuals with an ACEI prescription in the study population.	Drug: ACE inhibitor
Matched controls		Individuals without an ACEI prescription, and matched to the users by sex and 10-year age categories.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACE inhibitor	Drug	Any prescription of ACE inhibitor	ACEI user

Measure	Description	Time Frame
Incidence of influenza		Jan 1st 1998 - May 31st 2016

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D018352	Coronavirus Infections
D007251	Influenza, Human

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D009976	Orthomyxoviridae Infections

ID	Term
D011480	Protease Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses