Prazosin to Prevent COVID-19 (PREVENT-COVID Trial) (PREVENT)

• ClinicalTrials.gov Identifier: NCT04365257
• Recruitment Status: Terminated
• First Posted: April 28, 2020
• Results First Posted: January 31, 2023
• Last Update Posted: January 31, 2023
• Sponsor: Johns Hopkins University
• Collaborator: Fast Grants
• Information provided by (Responsible Party): Johns Hopkins University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: COVID-19
• Interventions: Drug: Prazosin; Other: Standard of care
• Enrollment: 5

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Period Title: Overall Study
Started	3	2
Completed	1	1
Not Completed	2	1
Reason Not Completed
Physician Decision	1	0
Patient Noncompliance	1	0
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		Prazosin	Standard of Care	Total
Arm/Group Description		Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.	Total of all reporting groups
Overall Number of Baseline Participants		3	2	5
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	5 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	3 100.0%	0 0.0%	3 60.0%
	>=65 years	0 0.0%	2 100.0%	2 40.0%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	3 participants	2 participants	5 participants
		53.3; (47 to 57)	71; (71 to 71)	60.4; (47 to 71)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	5 participants
	Female	1 33.3%	2 100.0%	3 60.0%
	Male	2 66.7%	0 0.0%	2 40.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	2 participants	5 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 33.3%	2 100.0%	3 60.0%
	White	1 33.3%	0 0.0%	1 20.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 33.3%	0 0.0%	1 20.0%

Outcome Measures

1. Primary Outcome

Title	Death
Description	Number of participants in each arm who expire.
Time Frame	up to day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description:	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Overall Number of Participants Analyzed	3	2
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

2. Primary Outcome

Title	Hospitalized, Requiring Mechanical Ventilation and/or High Flow Nasal Cannula and/or ICU/CCU Admission (or Equivalent) and/or ECMO
Description	Number 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.
Time Frame	up to day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description:	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Overall Number of Participants Analyzed	3	2
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 50.0%

3. Primary Outcome

Title	Hospitalized, Requiring Supplemental Oxygen, Not Requiring ICU/CCU Level Care (or Interventions Listed Under Outcome 2)
Description	Number of participants in each arm who are hospitalized and requiring supplemental oxygen, not requiring ICU/CCU level care (or interventions listed under Outcome 2).
Time Frame	up to day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description:	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Overall Number of Participants Analyzed	3	2
Measure Type: Count of Participants; Unit of Measure: Participants
	2 66.7%	1 50.0%

4. Primary Outcome

Title	Cumulative Incidence of Grade 3 and 4 Adverse Events
Description	Number of participants in each arm who develop grade 3 and 4 adverse events during the study period.
Time Frame	up to day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description:	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Overall Number of Participants Analyzed	3	2
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

5. Primary Outcome

Title	Number of Participants With Serious Adverse Events
Description	Number of participants in each arm who develop serious adverse events during the study period.
Time Frame	up to day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description:	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Overall Number of Participants Analyzed	3	2
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

6. Primary Outcome

Title	Incidence of Symptomatic Hypotension or Hypotension Requiring Cessation of Prazosin
Description	Number of participants in each arm who develop symptomatic hypotension (systolic blood pressure <90 mmHg) or hypotension requiring cessation of prazosin.
Time Frame	up to day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prazosin	Standard of Care
Arm/Group Description:	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.	Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
Overall Number of Participants Analyzed	3	2
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

7. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Peripheral Blood
Description	Number 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.
Time Frame	up to day 60

Outcome Measure Data Not Reported

8. Secondary Outcome

Title	Duration of Laboratory Abnormalities in Peripheral Blood
Description	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.
Time Frame	up to day 60

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Plasma
Description	Number of participants with laboratory abnormalities in fractionated plasma catecholamines and plasma metanephrines.
Time Frame	up to day 60

Outcome Measure Data Not Reported

10. Secondary Outcome

Title	Duration of Laboratory Abnormalities in Plasma
Description	Number of days with laboratory abnormalities in fractionated plasma catecholamines and plasma metanephrines.
Time Frame	up to day 60

Outcome Measure Data Not Reported

Adverse Events

Time Frame	60 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Prazosin		Standard of Care
Arm/Group Description	Prazosin 1mg given to observe if medication is tolerated or if signs or symptoms of hypotension develop (e.g. dizziness, lightheadedness).; If the patient remains asymptomatic and BP >110/60 mmHg, prazosin is continued at 1mg every 8 hours (q8h).; Day 3: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 2mg q8h.; Day 6: If the patient remains asymptomatic and BP >110/60 mmHg, increase dose to 5mg q8h.; 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.; 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.		Subjects randomized to this arm will receive standard of care. Standard of care: Participants in this arm will receive standard of care.
All-Cause Mortality
	Prazosin		Standard of Care
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/3 (0.00%)		0/2 (0.00%)
Serious Adverse Events
	Prazosin		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0.00%)		0/2 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Prazosin		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.33%)		1/2 (50.00%)
Cardiac disorders
Hypotension †	1/3 (33.33%)	1	0/2 (0.00%)	0
Gastrointestinal disorders
Constipation †	0/3 (0.00%)	0	1/2 (50.00%)	1
General disorders
dizziness †	0/3 (0.00%)	0	1/2 (50.00%)	1
Hypoxia during the night †	1/3 (33.33%)	1	0/2 (0.00%)	0
Musculoskeletal and connective tissue disorders
back pain †	0/3 (0.00%)	0	1/2 (50.00%)	1
Renal and urinary disorders
urinary urgency †	0/3 (0.00%)	0	1/2 (50.00%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Chetan Bettegowda
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Phone: 4109558620
• EMail: cbetteg1@jhmi.edu

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04365257
• Other Study ID Numbers: IRB00246659; COV2001 ( Other Identifier: Johns Hopkins University )
• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Results First Submitted: November 30, 2022
• Results First Posted: January 31, 2023
• Last Update Posted: January 31, 2023