HypertensionBIRCOVNCT04364984
ARB, ACEi, DRi Effects on COVID-19 Course Disease
An observational study of Hypertension and COVID-19, run by Medical Practice Prof D. Ivanov at 1 site in Ukraine.
Trial summary
It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, COVID-19
- What is being tested?
- Angiotensin converting enzyme inhibitor, Angiotensin Receptor Blockers and Direct renin inhibitor
- How many people
- 112 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Apr 2020to 1 Aug 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at the onset and COVID-19 course during 3 weeks
Who may be able to join
- Hypertensive person, stage 1-2
Who cannot join
- Hypertensive subjects, stage 3, HF (NYHA) 3-4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of RAS Inhibitors (ARB, ACEi, DRI) in People With Hypertension 1-2 Stages on the Course of COVID-19 (BIRCOV Trial: ARB, ACEI, DRi Effects on COVID-19)
It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.
Read the detailed description
POEM (Patient-Oriented Evidence that Matters) intervention is performed as an open prospective randomized two medical centres trial in subjects suffering from COVID-19 who have been receiving iRAS, either ACEi, ARB or DRi as basic antihypertensive therapy.
COVID-19 is confirmed by a PCR test, the disease follow-up is divided into 2 periods: up to 12 weeks and up to 24 weeks.
Primary Outcome Measure: BP was known one week before COVID-19 and is tested during the disease onset on weeks 2, 4, 12, 24. Secondary Outcome Measures are clinical features. Subanalysis in patients with CKD is additionally performed for those who have CKD.
- Conditions
- Hypertension, COVID-19
- Being tested
- Angiotensin converting enzyme inhibitor, Angiotensin Receptor Blockers, Direct renin inhibitor
- Keywords
- ACEi, ARB, DRI, Clinical features, CKD
- Medical subject headings
- Hypertension, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin converting enzyme inhibitorDrug
Also called no other drug as RAS inhibitor
routine drug intake
Angiotensin Receptor BlockersDrug
Also called no other drug as RAS inhibitor
routine drug intake
Direct renin inhibitorDrug
Also called no other drug as RAS inhibitor
routine drug intake
| Study group | Role | What they receive |
|---|---|---|
| ARB group | Hypertensive patients with COVID-19 who received ARBs Receives: Drug: Angiotensin Receptor Blockers | |
| ACEi group | Hypertensive patients with COVID-19 who received ACEis Receives: Drug: Angiotensin converting enzyme inhibitor | |
| DRi group | Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis) Receives: Drug: Direct renin inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of BP in mm Hg
BP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset
Measured: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported
Secondary outcomes (5)
Number of Patients With Fever Above 37.2 on COVID-19 Course
the number of patients with hypertension who received RASi and has a fever (above 37.2C) separately on 2, 4 and 12 weeks follow-up
Measured: estimated at 2, 4, 12 weeks after the COVID-19 onset
Number of Patients With Cough in COVID-19 Course
the absolute number of patients with hypertension on RASi who have had a cough at 2, 4 and 12 weeks from COVID-19 onset
Measured: on 2,4 and 12 week from COVID-19 onset
Number of Patients With Throat Pain in COVID-19 Course
the number of patients with hypertension on RASi with throat pain at 2, 4 and 12 weeks follow-up
Measured: estimated at 2, 4, 12 weeks after the COVID-19 onset
Number of Patients With Diarrhea Inf COVID-19 Course
the number of patients with hypertension on RASi with diarrhoea at 2, 4 and 12 weeks of follow-up
Measured: estimated at 2, 4, 12 weeks after the COVID-19 onset
Number of Patients Who Need to Apply to Hospital in COVID-19 Course
the number of patients with hypertension on RASi who need hospital and intensive care unit at 2, 4 and 12 weeks of follow-up
Measured: estimated at 2, 4, 12 weeks after the COVID-19 onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2020
- Primary completion24 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Medical Practice Prof D. Ivanov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iryna Zavalna, MD, Study chair, Nephrology clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364984
- Sponsor's protocol ID
- COVID20
- Acronym
- BIRCOV
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2020
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of RAS Inhibitors (ARB, ACEi, DRI) in People With Hypertension 1-2 Stages on the Course of COVID-19 (BIRCOV Trial: ARB, ACEI, DRi Effects on COVID-19)
- ClinicalTrials.gov ID
- NCT04364984
- Acronym / sponsor ID
- BIRCOV / COVID20
- Conditions
- Hypertension, COVID-19
- Keywords
- ACEi, ARB, DRI, Clinical features, CKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical Practice Prof D. IvanovUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 18 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.
Detailed description
POEM (Patient-Oriented Evidence that Matters) intervention is performed as an open prospective randomized two medical centres trial in subjects suffering from COVID-19 who have been receiving iRAS, either ACEi, ARB or DRi as basic antihypertensive therapy.
COVID-19 is confirmed by a PCR test, the disease follow-up is divided into 2 periods: up to 12 weeks and up to 24 weeks.
Primary Outcome Measure: BP was known one week before COVID-19 and is tested during the disease onset on weeks 2, 4, 12, 24. Secondary Outcome Measures are clinical features. Subanalysis in patients with CKD is additionally performed for those who have CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARB group | – | Drug: Angiotensin Receptor BlockersHypertensive patients with COVID-19 who received ARBs |
| ACEi group | – | Drug: Angiotensin converting enzyme inhibitorHypertensive patients with COVID-19 who received ACEis |
| DRi group | – | Drug: Direct renin inhibitorHypertensive patients with COVID-19 who received direct renin inhibitor (DRis) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at the onset and COVID-19 course during 3 weeks
Key inclusion criteria (1 listed)
- Hypertensive person, stage 1-2
Key exclusion criteria (1 listed)
- Hypertensive subjects, stage 3, HF (NYHA) 3-4
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 |
|---|---|---|
| Angiotensin converting enzyme inhibitorAlso: no other drug as RAS inhibitorroutine drug intake | Drug | ACEi group |
| Angiotensin Receptor BlockersAlso: no other drug as RAS inhibitorroutine drug intake | Drug | ARB group |
| Direct renin inhibitorAlso: no other drug as RAS inhibitorroutine drug intake | Drug | DRi group |
Primary outcome
Level of BP in mm Hg
Time frame: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported
BP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset
5 secondary outcomes
Number of Patients With Fever Above 37.2 on COVID-19 Course
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
Number of Patients With Cough in COVID-19 Course
Time frame: on 2,4 and 12 week from COVID-19 onset
Number of Patients With Throat Pain in COVID-19 Course
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
Number of Patients With Diarrhea Inf COVID-19 Course
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
Number of Patients Who Need to Apply to Hospital in COVID-19 Course
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Iryna Zavalna, MD study chair
Nephrology clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and COVID-19, run by Medical Practice Prof D. Ivanov at 1 site in Ukraine.
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: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Level of BP in mm Hg (time frame: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported). 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 21 Mar 2023.