Trial Outcomes & Findings for Prazosin to Prevent COVID-19 (PREVENT-COVID Trial) (NCT NCT04365257)
NCT ID: NCT04365257
Last Updated: 2023-04-10
Results Overview
Number of participants in each arm who expire.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
up to day 60
Results posted on
2023-04-10
Participant Flow
Participant milestones
| Measure |
Prazosin
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Prazosin
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Patient Noncompliance
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Prazosin to Prevent COVID-19 (PREVENT-COVID Trial)
Baseline characteristics by cohort
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
53.3 years
n=99 Participants
|
71 years
n=107 Participants
|
60.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to day 60Number of participants in each arm who expire.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to day 60Number of participants in each arm who are hospitalized and requiring mechanical ventilation and/or high flow nasal cannula and/or ICU/CCU admission (or equivalent) and/or ECMO.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Hospitalized, Requiring Mechanical Ventilation and/or High Flow Nasal Cannula and/or ICU/CCU Admission (or Equivalent) and/or ECMO
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: up to day 60Number of participants in each arm who are hospitalized and requiring supplemental oxygen, not requiring ICU/CCU level care (or interventions listed under Outcome 2).
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Hospitalized, Requiring Supplemental Oxygen, Not Requiring ICU/CCU Level Care (or Interventions Listed Under Outcome 2)
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: up to day 60Number of participants in each arm who develop grade 3 and 4 adverse events during the study period.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Cumulative Incidence of Grade 3 and 4 Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to day 60Number of participants in each arm who develop serious adverse events during the study period.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to day 60Number of participants in each arm who develop symptomatic hypotension (systolic blood pressure \<90 mmHg) or hypotension requiring cessation of prazosin.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Incidence of Symptomatic Hypotension or Hypotension Requiring Cessation of Prazosin
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to day 60Number of participants with laboratory abnormalities in peripheral blood (Lymphopenia, leukocytosis, anemia, thrombocytopenia, creatinine, AST/ALT, troponin I, pro-BNP, D-dimer, ferritin, interleukin (IL-6), soluble IL-2 receptor.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Peripheral Blood
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to day 60Population: Data was not collected because no participant had laboratory abnormalities in peripheral blood.
Number of days with laboratory abnormalities in peripheral blood (Lymphopenia, leukocytosis, anemia, thrombocytopenia, creatinine, AST/ALT, troponin I, pro-BNP, D-dimer, ferritin, interleukin (IL-6), soluble IL-2 receptor.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to day 60Number of participants with laboratory abnormalities in fractionated plasma catecholamines and plasma metanephrines.
Outcome measures
| Measure |
Prazosin
n=3 Participants
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 Participants
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Plasma
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to day 60Population: Data was not collected because no participant had laboratory abnormalities in plasma.
Number of days with laboratory abnormalities in fractionated plasma catecholamines and plasma metanephrines.
Outcome measures
Outcome data not reported
Adverse Events
Prazosin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prazosin
n=3 participants at risk
1. Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).
2. If the patient remains asymptomatic and BP \>110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).
3. Day 3: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 2mg q8h.
4. Day 6: If the patient remains asymptomatic and BP \>110/60 mmHg, increase dose to 5mg q8h.
5. If the BP is \<100/60 mmHg at any time, the next dose should be held, and patient continues with the highest previously tolerated dose 8 hours later.
6. If the patient did not tolerate dose escalation to 5mg q8h, one attempt is made to increase dose to 3mg q8h. If this is not tolerated, the patient continues with the highest previously tolerated dose 8 hours later.
If BP monitoring is not available, repeated occurrences of postural dizziness should trigger drug dose reduction or BP monitoring.
Prazosin: Participants in this arm will receive the study drug as outlined in the arm description.
|
Standard of Care
n=2 participants at risk
Subjects randomized to this arm will receive standard of care.
Standard of care: Participants in this arm will receive standard of care.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 60 days
|
50.0%
1/2 • Number of events 1 • 60 days
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/3 • 60 days
|
50.0%
1/2 • Number of events 1 • 60 days
|
|
General disorders
dizziness
|
0.00%
0/3 • 60 days
|
50.0%
1/2 • Number of events 1 • 60 days
|
|
Renal and urinary disorders
urinary urgency
|
0.00%
0/3 • 60 days
|
50.0%
1/2 • Number of events 1 • 60 days
|
|
Cardiac disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • 60 days
|
0.00%
0/2 • 60 days
|
|
General disorders
Hypoxia during the night
|
33.3%
1/3 • Number of events 1 • 60 days
|
0.00%
0/2 • 60 days
|
Additional Information
Chetan Bettegowda
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 4109558620
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place