Trial Outcomes & Findings for Ramipril for the Treatment of COVID-19 (NCT NCT04366050)
NCT ID: NCT04366050
Last Updated: 2023-09-28
Results Overview
The major primary outcome to be evaluated is improving a composite outcome of mortality or need for ICU admission or ventilator use within a 14-day window.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
14 days
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Ramipril 2.5mg Orally Daily
Total 2.5 mg Ramipril per day once a day orally for 14 days
Intervention: Ramipril
Ramipril 2.5 MG Oral Capsule: Include description or ramipril from protocol
|
Placebo
Placebo in the form of a capsule, taken orally for 14 days
Placebo oral capsule: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
35
|
|
Overall Study
COMPLETED
|
68
|
32
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ramipril for the Treatment of COVID-19
Baseline characteristics by cohort
| Measure |
Ramipril 2.5mg Orally Daily
n=79 Participants
Total 2.5 mg Ramipril per day once a day orally for 14 days
Intervention: Ramipril
Ramipril 2.5 MG Oral Capsule: Include description or ramipril from protocol
|
Placebo
n=35 Participants
Placebo in the form of a capsule, taken orally for 14 days
Placebo oral capsule: Placebo
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 16 • n=99 Participants
|
46 years
STANDARD_DEVIATION 14 • n=107 Participants
|
45 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe major primary outcome to be evaluated is improving a composite outcome of mortality or need for ICU admission or ventilator use within a 14-day window.
Outcome measures
| Measure |
Ramipril 2.5mg Orally Daily
n=79 Participants
Total 2.5 mg Ramipril per day once a day orally for 14 days
Intervention: Ramipril
Ramipril 2.5 MG Oral Capsule: Include description or ramipril from protocol
|
Placebo
n=35 Participants
Placebo in the form of a capsule, taken orally for 14 days
Placebo oral capsule: Placebo
|
|---|---|---|
|
Composite of Mortality or Need for ICU Admission or Ventilator Use
|
2 Participants
|
0 Participants
|
Adverse Events
Ramipril 2.5mg Orally Daily
Serious events: 2 serious events
Other events: 37 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramipril 2.5mg Orally Daily
n=79 participants at risk
Total 2.5 mg Ramipril per day once a day orally for 14 days
Intervention: Ramipril
Ramipril 2.5 MG Oral Capsule: Include description or ramipril from protocol
|
Placebo
n=35 participants at risk
Placebo in the form of a capsule, taken orally for 14 days
Placebo oral capsule: Placebo
|
|---|---|---|
|
Cardiac disorders
Cardiopulmonary Failure
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
Cardiac disorders
Hypertension
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
Other adverse events
| Measure |
Ramipril 2.5mg Orally Daily
n=79 participants at risk
Total 2.5 mg Ramipril per day once a day orally for 14 days
Intervention: Ramipril
Ramipril 2.5 MG Oral Capsule: Include description or ramipril from protocol
|
Placebo
n=35 participants at risk
Placebo in the form of a capsule, taken orally for 14 days
Placebo oral capsule: Placebo
|
|---|---|---|
|
General disorders
Lightheadedness
|
2.5%
2/79 • Number of events 2 • 28 Days
|
17.1%
6/35 • Number of events 6 • 28 Days
|
|
Gastrointestinal disorders
Diarrhea/Vomiting
|
5.1%
4/79 • Number of events 4 • 28 Days
|
8.6%
3/35 • Number of events 3 • 28 Days
|
|
General disorders
Drenching Sweats
|
2.5%
2/79 • Number of events 2 • 28 Days
|
5.7%
2/35 • Number of events 2 • 28 Days
|
|
General disorders
Head or Body Pain
|
7.6%
6/79 • Number of events 6 • 28 Days
|
5.7%
2/35 • Number of events 2 • 28 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough/Shortness of Breath/Pulmonary embolus
|
7.6%
6/79 • Number of events 6 • 28 Days
|
5.7%
2/35 • Number of events 2 • 28 Days
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
General disorders
Loss of Smell
|
2.5%
2/79 • Number of events 2 • 28 Days
|
2.9%
1/35 • Number of events 1 • 28 Days
|
|
General disorders
Elevated Lab Markers
|
3.8%
3/79 • Number of events 3 • 28 Days
|
2.9%
1/35 • Number of events 1 • 28 Days
|
|
Cardiac disorders
Cardiovascular Issues
|
6.3%
5/79 • Number of events 5 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
General disorders
Rectal Hemorrhage
|
0.00%
0/79 • 28 Days
|
2.9%
1/35 • Number of events 1 • 28 Days
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/79 • 28 Days
|
2.9%
1/35 • Number of events 1 • 28 Days
|
|
Endocrine disorders
Steroid induced Diabetes
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
Gastrointestinal disorders
Worsening GERD
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
Endocrine disorders
Pancreatitis
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
Respiratory, thoracic and mediastinal disorders
Throat Swelling
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
|
General disorders
Jittery
|
1.3%
1/79 • Number of events 1 • 28 Days
|
0.00%
0/35 • 28 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place