Doxazosin to Prevent Severe COVID-19 (CALM-COVID Trial)

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/09/036099
• Lead Sponsor: Johns Hopkins University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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 <90 mmHg or dizziness at time of enrollment

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified