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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARB group | Hypertensive patients with COVID-19 who received ARBs |
| |
| ACEi group | Hypertensive patients with COVID-19 who received ACEis |
| |
| DRi group | Hypertensive patients with COVID-19 who received direct renin inhibitor (DRis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin converting enzyme inhibitor | Drug | routine drug intake |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at the onset and COVID-19 course during 3 weeks
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| Name | Affiliation | Role |
|---|---|---|
| Iryna Zavalna, MD | Nephrology clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Practice Prof D.Ivanov | Kiev | Please Select | 01014 | Ukraine |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: ARB Group | 44 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension |
| FG001 | Group 2: iACE Group | 44 patients with COVID-19 and hypertension 1-2 stages, who received iACE as the main treatment for hypertensions |
| FG002 | Group 3: DRI Group | 31 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | mm Hg | estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARB Group | Hypertensive patients with COVID-19 who received ARBs | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypotension | Vascular disorders | SNOMED CT | Non-systematic Assessment | hypotension as less than 110 mm Hg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dmytro Ivanov | Medical Practice Prof D.Ivanov | 0504448788 | +38 | drivanovdd@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2022 | Feb 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D057911 | Angiotensin Receptor Antagonists |
| D000092502 | Renin Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Angiotensin Receptor Blockers | Drug | routine drug intake |
|
|
| Direct renin inhibitor | Drug | routine drug intake |
|
|
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 |
| 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | documents and records | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Hypertensive patients with COVID-19 who received DRis |
|
|
| 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 | 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 | Posted | Count of Participants | Participants | estimated at 2, 4, 12 weeks after the COVID-19 onset |
|
|
|
| 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 | Posted | Count of Participants | Participants | on 2,4 and 12 week from COVID-19 onset |
|
|
|
| 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 | Posted | Count of Participants | Participants | estimated at 2, 4, 12 weeks after the COVID-19 onset |
|
|
|
| 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 | Posted | Count of Participants | Participants | estimated at 2, 4, 12 weeks after the COVID-19 onset |
|
|
|
| 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 | Posted | Count of Participants | Participants | estimated at 2, 4, 12 weeks after the COVID-19 onset |
|
|
|
| 35 |
| 2 |
| 35 |
| 0 |
| 35 |
| EG001 | ACEi Group | Hypertensive patients with COVID-19 who received ACEis Angiotensin converting enzyme inhibitor: routine drug intake | 2 | 42 | 16 | 42 | 0 | 42 |
| EG002 | DRi Group | Hypertensive patients with COVID-19 who received DRis | 0 | 31 | 7 | 31 | 0 | 31 |
|
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| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020164 | Chemical Actions and Uses |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|