Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United KingdomNCT04322786
The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?
An observational study of Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom
- What is being tested?
- ACE inhibitor
- How many people
- 1,302,508 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1998to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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).
Who may be able to join
- We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.
Who cannot join
- We exclude individuals with a prior history of influenza and viral pneumonia before study entry.
About this study
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.
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.
- Being tested
- ACE inhibitor
- Medical subject headings
- COVID-19, Coronavirus Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE inhibitorDrug
Any prescription of ACE inhibitor
| Study group | Role | What they receive |
|---|---|---|
| ACEI user | Individuals with an ACEI prescription in the study population. Receives: Drug: ACE inhibitor | |
| Matched controls | Individuals without an ACEI prescription, and matched to the users by sex and 10-year age categories. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of influenza
Measured: Jan 1st 1998 - May 31st 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jan 1998
- Primary completion31 May 2016
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United KingdomStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,302,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322786
- Sponsor's protocol ID
- ISAC17_205R
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04322786
- Acronym / sponsor ID
- ISAC17_205R
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,302,508 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACEI user | – | Drug: ACE inhibitorIndividuals with an ACEI prescription in the study population. |
| Matched controls | – | –Individuals without an ACEI prescription, and matched to the users by sex and 10-year age categories. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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).
Key inclusion criteria (1 listed)
- We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.
Key exclusion criteria (1 listed)
- We exclude individuals with a prior history of influenza and viral pneumonia before study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE inhibitorAny prescription of ACE inhibitor | Drug | ACEI user |
Primary outcome
Incidence of influenza
Time frame: Jan 1st 1998 - May 31st 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of influenza (time frame: Jan 1st 1998 - May 31st 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.