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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Hypertension, COVID-19

Intervention / Treatment
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* Drug: Angiotensin converting enzyme inhibitor
* Drug: Angiotensin Receptor Blockers
* Drug: Direct renin inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertensive person, stage 1-2 Exclusion Criteria: Hypertensive subjects, stage 3, HF (NYHA) 3-4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACEi, ARB, DRI, Clinical features, CKD