NCT04364984

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Medical Practice Prof D. Ivanov · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Angiotensin converting enzyme inhibitor	routine drug intake
DRUG	Angiotensin Receptor Blockers	routine drug intake
DRUG	Direct renin inhibitor	routine drug intake

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-07-24
• Completion: 2021-08-01
• First posted: 2020-04-28
• Last updated: 2023-03-21
• Results posted: 2022-02-18

Locations

1 site across 1 country: Ukraine

Regulatory

• FDA-regulated drug study