ARB, ACEi, DRi Effects on COVID-19 Course Disease

NCT ID: NCT04364984

Last Updated: 2023-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARB group

Hypertensive patients with COVID-19 who received ARBs

Angiotensin Receptor Blockers

Intervention Type DRUG

routine drug intake

ACEi group

Hypertensive patients with COVID-19 who received ACEis

Angiotensin converting enzyme inhibitor

Intervention Type DRUG

routine drug intake

DRi group

Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis)

Direct renin inhibitor

Intervention Type DRUG

routine drug intake

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Angiotensin converting enzyme inhibitor

routine drug intake

Intervention Type DRUG

Angiotensin Receptor Blockers

routine drug intake

Intervention Type DRUG

Direct renin inhibitor

routine drug intake

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

no other drug as RAS inhibitor no other drug as RAS inhibitor no other drug as RAS inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hypertensive person, stage 1-2

Exclusion Criteria

* Hypertensive subjects, stage 3, HF (NYHA) 3-4
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Practice Prof D. Ivanov

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Iryna Zavalna, MD

Role: STUDY_CHAIR

Nephrology clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Practice Prof D.Ivanov

Kiev, Please Select, Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ukraine

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COVID20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The McGill RAAS-COVID-19 Trial
NCT04508985 COMPLETED NA
Essential Hypertension
NCT01264692 COMPLETED PHASE2