CTRI/2021/09/036099招募中2 期
Alpha-1 Adrenergic Receptor Antagonism to Prevent Cytokine Storm Syndrome and Severe COVID-19: A Pragmatic Randomized, Double-Blind Phase 2 Study Comparing the Efficacy of Doxazosin vs. Placebo for SARS-CoV-2 infection. - CALM-COVID Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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)
研究者
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