Prazosin to Prevent COVID-19 (PREVENT-COVID Trial)
Condition: COVID-19
MeSH terms: COVID-19; Respiratory Distress Syndrome
Intervention: Prazosin; Standard of care
Intervention description: Participants in this arm will receive the study drug as outlined in the arm description.; Participants in this arm will receive standard of care.
Intervention MeSH terms: Prazosin; Adrenergic alpha-1 Receptor Antagonists; Adrenergic Antagonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; Coronavirus disease 2019; COVID-19; Cytokine Storm Syndrome; Acute Respiratory Distress Syndrome; Prazosin; Alpha-1 receptor antagonist

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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)