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OpenTrials
Completed

NCT Number: NCT04364984

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

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.

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Key information

Conditions

Hypertension COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Practice Prof D.Ivanov

Kiev, Please Select, 01014, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypertensive person, stage 1-2

Exclusion criteria

  • Hypertensive subjects, stage 3, HF (NYHA) 3-4

Treatment and study plan

Angiotensin Converting Enzyme Inhibitor

Drug

routine drug intake

Other names: no other drug as RAS inhibitor

Angiotensin Receptor Blockers

Drug

routine drug intake

Other names: no other drug as RAS inhibitor

Direct renin inhibitor

Drug

routine drug intake

Other names: no other drug as RAS inhibitor

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. Number of Patients With Cough in COVID-19 Course

    Time frame: on 2,4 and 12 week from COVID-19 onset

    the absolute number of patients with hypertension on RASi who have had a cough at 2, 4 and 12 weeks from COVID-19 onset

  3. Number of Patients With Throat Pain in COVID-19 Course

    Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset

    the number of patients with hypertension on RASi with throat pain at 2, 4 and 12 weeks follow-up

  4. Number of Patients With Diarrhea Inf COVID-19 Course

    Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset

    the number of patients with hypertension on RASi with diarrhoea at 2, 4 and 12 weeks of follow-up

  5. 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

    the number of patients with hypertension on RASi who need hospital and intensive care unit at 2, 4 and 12 weeks of follow-up

Sponsors and collaborators

Lead sponsor

Medical Practice Prof D. Ivanov

Other

Registry information

Official study 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)

Acronym: BIRCOV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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