An observational study in Hypertension and COVID-19, sponsored by Medical Practice Prof D. Ivanov. Completed at 1 site in Ukraine. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Medical Practice Prof D. Ivanov · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 112 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Medical Practice Prof D. Ivanov as lead sponsor.
Counted across the registry records on this site, refreshed daily.
patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at the onset and COVID-19 course during 3 weeks
Exclusion Criteria:
Hypertensive patients with COVID-19 who received ARBs
Drug: Angiotensin Receptor Blockers
Hypertensive patients with COVID-19 who received ACEis
Drug: Angiotensin converting enzyme inhibitor
Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis)
Drug: Direct renin inhibitor
routine drug intake
Also known as: no other drug as RAS inhibitor
routine drug intake
Also known as: no other drug as RAS inhibitor
routine drug intake
Also known as: no other drug as RAS inhibitor
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
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
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
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
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
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
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
| Milestone | Group 1: ARB Group | Group 2: iACE Group | Group 3: DRI Group |
|---|---|---|---|
| Started | 37 | 44 | 31 |
| Completed | 35 | 42 | 31 |
| Not completed | 2 | 2 | 0 |
| Withdrew: Death | 2 | 2 | 0 |
BP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset
| mm Hg | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| Systolic BP | 136 ± 1.1 | 138 ± 1.1 | 34 ± 1.4 |
| Diastolic BP | 82 ± 1.2 | 83 ± 1.2 | 82 ± 1.2 |
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
| Participants | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| Number of Patients With Fever Above 37.2 on COVID-19 Course | 32 | 39 | 30 |
the absolute number of patients with hypertension on RASi who have had a cough at 2, 4 and 12 weeks from COVID-19 onset
| Participants | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| Number of Patients With Cough in COVID-19 Course | 29 | 30 | 28 |
the number of patients with hypertension on RASi with throat pain at 2, 4 and 12 weeks follow-up
| Participants | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| Number of Patients With Throat Pain in COVID-19 Course | 19 | 21 | 16 |
the number of patients with hypertension on RASi with diarrhoea at 2, 4 and 12 weeks of follow-up
| Participants | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| Number of Patients With Diarrhea Inf COVID-19 Course | 3 | 4 | 1 |
the number of patients with hypertension on RASi who need hospital and intensive care unit at 2, 4 and 12 weeks of follow-up
| Participants | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| Number of Patients Who Need to Apply to Hospital in COVID-19 Course | 2 | 2 | 0 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARB Group | 2/35 (5.7%) | 2/35 (5.7%) | 0/35 (0%) |
| ACEi Group | 2/42 (4.8%) | 16/42 (38.1%) | 0/42 (0%) |
| DRi Group | 0/31 (0%) | 7/31 (22.6%) | 0/31 (0%) |
| Event | ARB Group | ACEi Group | DRi Group |
|---|---|---|---|
| hypotensionVascular disorders | 2/35 | 16/42 | 7/31 |
| Age, Categorical(Participants) | ARB Group | ACEi Group | DRi Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 36 | 30 | 97 |
| >=65 years | 4 | 6 | 1 | 11 |
| Age, Continuous(years) | ARB Group | ACEi Group | DRi Group | Total |
|---|---|---|---|---|
| Mean | 59 ± 1.8 | 55 ± 1.7 | 49 ± 1.4 | 55 ± 1.1 |
| Sex: Female, Male(Participants) | ARB Group | ACEi Group | DRi Group | Total |
|---|---|---|---|---|
| Female | 17 | 22 | 9 | 48 |
| Male | 18 | 20 | 22 | 60 |
| Race and Ethnicity Not Collected(Participants) | ARB Group | ACEi Group | DRi Group | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | ARB Group | ACEi Group | DRi Group | Total |
|---|---|---|---|---|
| Ukraine | 35 | 42 | 31 | 108 |
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