ARB, ACEi, DRi Effects on COVID-19 Course Disease (BIRCOV)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Hypertension
• Intervention / Treatment: Drug: Angiotensin Receptor Blockers; Drug: Angiotensin converting enzyme inhibitor; Drug: Direct renin inhibitor

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Ukraine
  • Please Select
    • Kiev, Please Select, Ukraine, 01014
      • Medical Practice Prof D.Ivanov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• Hypertensive person, stage 1-2

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARB group; Hypertensive patients with COVID-19 who received ARBs	Drug: Angiotensin Receptor Blockers; routine drug intake; Other Names: no other drug as RAS inhibitor
ACEi group; Hypertensive patients with COVID-19 who received ACEis	Drug: Angiotensin converting enzyme inhibitor; routine drug intake; Other Names: no other drug as RAS inhibitor
DRi group; Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis)	Drug: Direct renin inhibitor; routine drug intake; Other Names: no other drug as RAS inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	estimated at 2, 4, 12 weeks after the COVID-19 onset

Collaborators and Investigators

• Sponsor: Medical Practice Prof D. Ivanov
• Investigators: Study Chair: Iryna Zavalna, MD, Nephrology clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): July 24, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 18, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: CKD; Clinical features; ACEi, ARB, DRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Hypertension; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists
• Other Study ID Numbers: COVID20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No