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

Completed

• Conditions: Hypertension; COVID-19
• Interventions: Drug: Angiotensin Receptor Blockers; Drug: Angiotensin converting enzyme inhibitor; Drug: Direct renin inhibitor

• Registration Number: NCT04364984
• Lead Sponsor: Medical Practice Prof D. Ivanov

Brief 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.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Primary Completion: 2021-07-24
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Results First Submitted: 2021-08-27
• Results First Submitted QC: 2022-02-16
• Results First Posted: 2022-02-18
• Last Update Submitted: 2023-03-18
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Hypertensive person, stage 1-2

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARB group	Angiotensin Receptor Blockers	Hypertensive patients with COVID-19 who received ARBs
ACEi group	Angiotensin converting enzyme inhibitor	Hypertensive patients with COVID-19 who received ACEis
DRi group	Direct renin inhibitor	Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis)

Primary Outcome Measures

Name	Time	Method
Level of BP in mm Hg	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 Outcome Measures

Name	Time	Method
Number of Patients With Cough in COVID-19 Course	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
Number of Patients With Throat Pain in COVID-19 Course	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
Number of Patients With Fever Above 37.2 on COVID-19 Course	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
Number of Patients With Diarrhea Inf COVID-19 Course	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
Number of Patients Who Need to Apply to Hospital in COVID-19 Course	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

Trial Locations

Locations (1)

Medical Practice Prof D.Ivanov; 🇺🇦 Kiev, Please Select, Ukraine