Hypertension, COVID-19
Conditions
Keywords
ACEi, ARB, DRI, Clinical features, CKD
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.
Interventions
routine drug intake
routine drug intake
DRUGDirect renin inhibitor
routine drug intake
Sponsors
Medical Practice Prof D. Ivanov
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Hypertensive person, stage 1-2
Exclusion criteria
* Hypertensive subjects, stage 3, HF (NYHA) 3-4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
Ukraine
Participant flow
Recruitment details
120 people with stage 1-2 hypertension have been screened. Study Population: patients with proved COVID-19 and preliminary stage 1-2 hypertension receiving iRAS at the onset of COVID-19. Minimum Age:18 Years, Maximum Age: 90 Years, Sex: All Inclusion Criteria: Hypertension, stage 1-2 with COVID-19. Exclusion Criteria: Hypertension, stage 3, HF (NYHA) 3-4
Participants by arm
| Arm | Count |
|---|---|
| ARB Group Hypertensive patients with COVID-19 who received ARBs (valsartan 160-320 mg q.d. or olmesartan 20-40 mg q.d. or irbesartan 150-300 mg q.d. or candesartan 4-16 mg q.d.or losartan 50-100 mg q.d. in individual dosage) before and during COVID-19 for treatment of hypertension | 35 |
| ACEi Group Hypertensive patients with COVID-19 who received ACEis (enalapril 10-20 mg q.d. or ramipril 5-10 mg q.d. or lisinopril 10-20 mg q.d. or perindopril 5-10 mg q.d. in individual regime) before and during COVID-19 for treatment of hypertension | 42 |
| DRi Group Hypertensive patients with COVID-19 who received DRis (direct renin inhibitor rasilez in dosage 150-300 mg per day) before and during COVID-19 for treatment of hypertension | 31 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | ACEi Group | DRi Group | ARB Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 1 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 30 Participants | 31 Participants | 97 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 1.7 | 49 years STANDARD_DEVIATION 1.4 | 59 years STANDARD_DEVIATION 1.8 | 55 years STANDARD_DEVIATION 1.1 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Ukraine | 42 participants | 31 participants | 35 participants | 108 participants |
| Sex: Female, Male Female | 22 Participants | 9 Participants | 17 Participants | 48 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 18 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 35 | 2 / 42 | 0 / 31 |
| other Total, other adverse events | 0 / 35 | 0 / 42 | 0 / 31 |
| serious Total, serious adverse events | 2 / 35 | 16 / 42 | 7 / 31 |
Outcome results
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
Time frame: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARB Group | Level of BP in mm Hg | Systolic BP | 136 mm Hg | Standard Error 1.1 |
| ARB Group | Level of BP in mm Hg | Diastolic BP | 82 mm Hg | Standard Error 1.2 |
| ACEi Group | Level of BP in mm Hg | Systolic BP | 138 mm Hg | Standard Error 1.1 |
| ACEi Group | Level of BP in mm Hg | Diastolic BP | 83 mm Hg | Standard Error 1.2 |
| DRi Group | Level of BP in mm Hg | Systolic BP | 34 mm Hg | Standard Error 1.4 |
| DRi Group | Level of BP in mm Hg | Diastolic BP | 82 mm Hg | Standard Error 1.2 |
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
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARB Group | Number of Patients Who Need to Apply to Hospital in COVID-19 Course | 2 Participants |
| ACEi Group | Number of Patients Who Need to Apply to Hospital in COVID-19 Course | 2 Participants |
| DRi Group | Number of Patients Who Need to Apply to Hospital in COVID-19 Course | 0 Participants |
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
Time frame: on 2,4 and 12 week from COVID-19 onset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARB Group | Number of Patients With Cough in COVID-19 Course | 29 Participants |
| ACEi Group | Number of Patients With Cough in COVID-19 Course | 30 Participants |
| DRi Group | Number of Patients With Cough in COVID-19 Course | 28 Participants |
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
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARB Group | Number of Patients With Diarrhea Inf COVID-19 Course | 3 Participants |
| ACEi Group | Number of Patients With Diarrhea Inf COVID-19 Course | 4 Participants |
| DRi Group | Number of Patients With Diarrhea Inf COVID-19 Course | 1 Participants |
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
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
Population: in the report, we document how many patients have a temperature above 37.2 on control data: 2, 4 and 12 weeks from COVID-19 onset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARB Group | Number of Patients With Fever Above 37.2 on COVID-19 Course | 32 Participants |
| ACEi Group | Number of Patients With Fever Above 37.2 on COVID-19 Course | 39 Participants |
| DRi Group | Number of Patients With Fever Above 37.2 on COVID-19 Course | 30 Participants |
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
Time frame: estimated at 2, 4, 12 weeks after the COVID-19 onset
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARB Group | Number of Patients With Throat Pain in COVID-19 Course | 19 Participants |
| ACEi Group | Number of Patients With Throat Pain in COVID-19 Course | 21 Participants |
| DRi Group | Number of Patients With Throat Pain in COVID-19 Course | 16 Participants |