Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Doxazosin mesylate: Doxazosin mesylate and standard of care
Doxazosin
Dose
Day 1 -1 mg
Day 2- 1 mg
Day 3 – 2 mg
Day 4 – 2 mg
Day 5 – 4 mg
Day 6- 4 mg
Day 7 – 4 mg
Day 8 – 6 mg
Day 9 –
Sponsors
Johns Hopkins University School of Medicine
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must be 45 years of age or older 2. Subjects have symptoms of COVID-19 and have Mild disease not requiring hospitalization 3. Subjects have an approved positive test for SARS-CoV-2 and symptom onset within 6 days of start of treatment 4. Subject must have indicated interest in participating in the clinical trial and provided informed consent to participate in the CALM-COVID trial specifically.
Exclusion criteria
Exclusion criteria: 1. Female subjects who identify as pregnant, self-reported positive pregnancy testing, or who are breastfeeding during the study period 2. Age >85 years 3. Subjects with COVID-19 and Moderate or Severe disease 4. Subjects receiving supplemental oxygen at baseline 5. Already receiving an effective therapy for early COVID-19 (monoclonal antibodies) at time of enrollment or enrolled in another clinical treatment trial for COVID-19 6. Subjects who have been administered one or more doses of any approved SARS-CoV-2 vaccine. 7. Known history of known orthostatic hypotension, unexplained history of syncope, postural orthostatic tachycardia syndrome (POTS), neurally-mediated hypotension (within the last year), heart failure (NYHA III or IV or exacerbation in past 2 months), myocardial infarction (within 6 months), stable or unstable angina, coronary artery bypass surgery (within 6 months), stroke (within 6 months), symptomatic carotid artery disease, or moderate to severe mitral or aortic stenosis, known moderate or severe hepatic impairment (Child-Pugh B and C) 8.Systolic blood pressure of 9. Systemic use of immunosuppressive medication (including corticosteroids and glucocorticoids), use of rituximab within 6 months prior to enrollment, use of alpha-1 adrenergic receptor antagonists, combined alpha-1/beta- adrenergic receptor antagonists, sotalol, clonidine, phosphodiesterase type 5 inhibitors, nitrates, asenapine, alpha-methyldopa 10.Allergy or intolerance to quinazolines (including doxazosin, prazosin, terazosin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of treatment with doxazosin (given for at least 2 doses) versus placebo to prevent deterioration of COVID-19 to Moderate/Severe disease in subjects testing positive for SARS-CoV-2 and presenting with Mild disease at the time of enrollment.Timepoint: After the treatment duration of 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessing shift in the ordinal scale of clinical status (scores 1-9) to less severe disease among those randomized to doxazosin plus standard of care as compared to placebo plus standard of care. The ordinal scale is an assessment of the clinical status at different time frames. 2.Time to meaningful recovery at 14 and 28 days. Clinical ordinal scale progression improved by one category and sustained for at least 2 consecutive days. 3.COVID-19 symptom severity (Daily Symptom Scale) on day 0, 14 or until hospitalization, 28 day. 4.Time to resolution of COVID-19 symptoms on day 0, 14 or until hospitalization, 28 day. 5.Frequency and severity of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) after 3 months and 6 monthsTimepoint: After the treatment duration of 14 days, 28 days, 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr Pallavi Ghana
Strand Life Sciences Private Limited
Outcome results
None listed