Trial Outcomes & Findings for ARB, ACEi, DRi Effects on COVID-19 Course Disease (NCT NCT04364984)
NCT ID: NCT04364984
Last Updated: 2023-03-21
Results Overview
BP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset
Recruitment status
COMPLETED
Target enrollment
112 participants
Primary outcome timeframe
estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported
Results posted on
2023-03-21
Participant Flow
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
Participant milestones
| Measure |
Group 1: ARB Group
44 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension
|
Group 2: iACE Group
44 patients with COVID-19 and hypertension 1-2 stages, who received iACE as the main treatment for hypertensions
|
Group 3: DRI Group
31 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
44
|
31
|
|
Overall Study
COMPLETED
|
35
|
42
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1: ARB Group
44 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension
|
Group 2: iACE Group
44 patients with COVID-19 and hypertension 1-2 stages, who received iACE as the main treatment for hypertensions
|
Group 3: DRI Group
31 patients with COVID-19, hypertension 1-2 stages, who received ARB as main therapy for hypertension
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ARB Group
n=35 Participants
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
|
ACEi Group
n=42 Participants
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
|
DRi Group
n=31 Participants
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
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=108 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=35 Participants
|
36 Participants
n=42 Participants
|
30 Participants
n=31 Participants
|
97 Participants
n=108 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=35 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=31 Participants
|
11 Participants
n=108 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 1.8 • n=35 Participants
|
55 years
STANDARD_DEVIATION 1.7 • n=42 Participants
|
49 years
STANDARD_DEVIATION 1.4 • n=31 Participants
|
55 years
STANDARD_DEVIATION 1.1 • n=108 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=35 Participants
|
22 Participants
n=42 Participants
|
9 Participants
n=31 Participants
|
48 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=35 Participants
|
20 Participants
n=42 Participants
|
22 Participants
n=31 Participants
|
60 Participants
n=108 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Ukraine
|
35 participants
n=35 Participants
|
42 participants
n=42 Participants
|
31 participants
n=31 Participants
|
108 participants
n=108 Participants
|
PRIMARY outcome
Timeframe: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reportedBP in patients one week before COVID-19 infection and 2, 4, 12, 24 weeks follow-up after COVID-19 onset
Outcome measures
| Measure |
ARB Group
n=35 Participants
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 Participants
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 Participants
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Level of BP in mm Hg
Systolic BP
|
136 mm Hg
Standard Error 1.1
|
138 mm Hg
Standard Error 1.1
|
34 mm Hg
Standard Error 1.4
|
|
Level of BP in mm Hg
Diastolic BP
|
82 mm Hg
Standard Error 1.2
|
83 mm Hg
Standard Error 1.2
|
82 mm Hg
Standard Error 1.2
|
SECONDARY outcome
Timeframe: estimated at 2, 4, 12 weeks after the COVID-19 onsetPopulation: 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
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
Outcome measures
| Measure |
ARB Group
n=35 Participants
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 Participants
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 Participants
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Number of Patients With Fever Above 37.2 on COVID-19 Course
|
32 Participants
|
39 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: on 2,4 and 12 week from COVID-19 onsetthe absolute number of patients with hypertension on RASi who have had a cough at 2, 4 and 12 weeks from COVID-19 onset
Outcome measures
| Measure |
ARB Group
n=35 Participants
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 Participants
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 Participants
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Number of Patients With Cough in COVID-19 Course
|
29 Participants
|
30 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: estimated at 2, 4, 12 weeks after the COVID-19 onsetthe number of patients with hypertension on RASi with throat pain at 2, 4 and 12 weeks follow-up
Outcome measures
| Measure |
ARB Group
n=35 Participants
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 Participants
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 Participants
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Number of Patients With Throat Pain in COVID-19 Course
|
19 Participants
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: estimated at 2, 4, 12 weeks after the COVID-19 onsetthe number of patients with hypertension on RASi with diarrhoea at 2, 4 and 12 weeks of follow-up
Outcome measures
| Measure |
ARB Group
n=35 Participants
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 Participants
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 Participants
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Number of Patients With Diarrhea Inf COVID-19 Course
|
3 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: estimated at 2, 4, 12 weeks after the COVID-19 onsetthe number of patients with hypertension on RASi who need hospital and intensive care unit at 2, 4 and 12 weeks of follow-up
Outcome measures
| Measure |
ARB Group
n=35 Participants
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 Participants
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 Participants
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Number of Patients Who Need to Apply to Hospital in COVID-19 Course
|
2 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
ARB Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
ACEi Group
Serious events: 16 serious events
Other events: 0 other events
Deaths: 2 deaths
DRi Group
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARB Group
n=35 participants at risk
Hypertensive patients with COVID-19 who received ARBs
|
ACEi Group
n=42 participants at risk
Hypertensive patients with COVID-19 who received ACEis
Angiotensin converting enzyme inhibitor: routine drug intake
|
DRi Group
n=31 participants at risk
Hypertensive patients with COVID-19 who received DRis
|
|---|---|---|---|
|
Vascular disorders
hypotension
|
5.7%
2/35 • Number of events 35 • 6 months
|
38.1%
16/42 • Number of events 42 • 6 months
|
22.6%
7/31 • Number of events 31 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place