COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04365257

Chetan Bettegowda

not reported

2020-04-28

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

- 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)

2

Johns Hopkins University

45

85

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

5

Incidence of symptomatic hypotension or hypotension requiring cessation of prazosin;Hospitalized, requiring supplemental oxygen, not requiring ICU/CCU level care (or interventions listed under Outcome 2);Cumulative incidence of grade 3 and 4 adverse events;Number of participants with serious adverse events;Hospitalized, requiring mechanical ventilation and/or high flow nasal cannula and/or ICU/CCU admission (or equivalent) and/or ECMO;Death

None

Phase 2

[{"arm_notes": "", "treatment_id": 1019, "treatment_name": "Prazosin", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]