Status:
TERMINATED
Prazosin to Prevent COVID-19 (PREVENT-COVID Trial)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Fast Grants
Conditions:
COVID-19
Eligibility:
All Genders
45-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of prazosin to prevent cytokine storm syndrome and severe complications in hospitalized patients with Coronavirus disease 2019 (COVID-19)...
Detailed Description
In Coronavirus disease 2019 (COVID-19), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) elicits an exuberant local or systemic immune response ('hyperinflammation') in the lung and other ...
Eligibility Criteria
Inclusion
- Subjects must be 45 years of age or older
- Provision of informed consent
- Subjects who tested positive for SARS-CoV-2 AND have clinical symptoms of COVID-19\* AND have been hospitalized, but are not requiring more than 4 liters/minute of supplemental oxygen by nasal cannula and are not requiring ICU/CCU-level care at time of enrollment
- (\*)Acute respiratory tract infection (sudden onset of at least one of the following: fever, chills, sore throat, myalgia, diarrhea, cough, or shortness of breath) AND with no other etiology that fully explains the clinical presentation
Exclusion
- Female subjects who identify as pregnant, self-reported positive pregnancy testing, or who are breastfeeding during the study period
- Age \>85 years
- Known history of known orthostatic hypotension, unexplained history of syncope, postural orthostatic tachycardia syndrome (POTS), neurally-mediated hypotension, heart failure, myocardial infarction, stable or unstable angina, history of coronary artery bypass surgery, stroke, carotid artery disease, or moderate to severe mitral or aortic stenosis
- Current use of tocilizumab, sarilumab, siltuximab, lopinavir/ritonavir, remdesivir, favipiravir, alpha-blockers, combined alpha/beta blockers (carvedilol, labetalol), sotalol, clonidine, phosphodiesterase type 5 inhibitors, asenapine, or alpha-methyldopa
- Need for vasopressors, inotropes, or intra-aortic balloon pump at time of enrollment
- Allergy or intolerance to quinazolines (including prazosin)
- Requires oxygen supplementation beyond 4 liters of oxygen/minute per nasal cannula at time of enrollment (i.e. not requiring oxygenation by non-rebreather, high-flow nasal cannula, CPAP/BiPAP, or invasive mechanical ventilation)
- Patients who are in the custody of state or federal entities (prisoners)
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04365257
Start Date
May 13 2020
End Date
March 31 2022
Last Update
April 10 2023
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287