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

Hypertension Clinical Trial

— BIRCOV  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364984
• Other study ID #: COVID20
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Medical Practice Prof D. Ivanov
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 1, 2021
• Est. primary completion date: July 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Hypertensive person, stage 1-2

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19
• Hypertension

Intervention

Drug:
• Angiotensin converting enzyme inhibitor
routine drug intake
• Angiotensin Receptor Blockers
routine drug intake
• Direct renin inhibitor
routine drug intake

Locations

Country	Name	City	State
Ukraine	Medical Practice Prof D.Ivanov	Kiev	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Medical Practice Prof D. Ivanov

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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