NCT04322786

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,302,508

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
18.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

November 13, 2020

Status Verified

March 1, 2020

Enrollment Period

18.4 years

First QC Date

March 23, 2020

Last Update Submit

November 11, 2020

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Incidence of influenza

    Jan 1st 1998 - May 31st 2016

Study Arms (2)

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

ACE inhibitorDRUG

Any prescription of ACE inhibitor

ACEI user

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • We exclude individuals with a prior history of influenza and viral pneumonia before study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsInfluenza, Human

Interventions

Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 26, 2020

Study Start

January 1, 1998

Primary Completion

May 31, 2016

Study Completion

March 31, 2021

Last Updated

November 13, 2020

Record last verified: 2020-03