LBCTR2021014651尚未招募3 期
Managing Endothelial Dysfunction in COVID-19: A Randomized Clinical Trial at the Lebanese American University Medical Center- Rizk Hospital - MEDIC-LAUMCRH
AUMCRH0 个研究点目标入组 80 人开始时间: 2021年2月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA: Firstly, participants must be in-patient adults 18
- •years of age and above. Secondly, having PCR-confirmed COVID-19
- •classified as mild, moderate or severe disease as per the FDA and
- •admitted to the hospital for inpatient treatment as per the standard
- •of care, with mild being a positive testing by standard RT-PCR assay or
- •equivalent test and symptoms of mild illness with COVID-19 that
- •could include fever, cough, sore throat, malaise, headache, muscle
- •pain, gastrointestinal symptoms, without shortness of breath or
- •dyspnea. No clinical signs indicative of Moderate, Severe, or Critical
- •Severity. Moderate defined as positive testing by standard RT-PCR
- •assay or equivalent testing and symptoms of moderate illness which
- •could include any symptom of mild illness or shortness of breath with
- •exertion. Clinical signs suggestive of moderate illness with COVID-19
- •include respiratory rate = 20 breaths per minute, saturation of oxygen
- •(SpO2) > 93% on room air at sea level, heart rate = 90 beats per
- •minute without clinical signs indicative of Severe or Critical Illness
- •Severity. Severe symptoms could include any symptom of moderate
- •illness or shortness of breath at rest, or respiratory distress. Clinical
- •signs indicative of severe systemic illness with COVID-19 include
- •respiratory rate = 30 per minute, heart rate = 125 per minute, SpO2 =
- •93% on room air at sea level or PaO2/FiO2 < 300. No criteria for
- •Critical Severity.
排除标准
- •EXCLUSION CRITERIA:
- •Patients unable to tolerate oral
- •medications. Patients who are already on beta-blockers,
- •statins or Nicorandil, PDE5 inhibitors, Riociguat.. In addition to
- •those with shock as defined by SBP<90 for more than 30
- •minutes not responding to IV fluids with evidence of end organ
- •damage. Patients with severe bradycardia (<50 bpm) and heart
- •block greater than first-degree (except in patients with a
- •functioning artificial pacemaker) should be definitely excluded,
- •along with those who suffer from decompensated heart failure
- •and sick sinus syndrome (unless a permanent pacemaker is in
- •place). Severe hepatic impairment (Child-Pugh class C) or
- •active liver disease are absolute reasons not to be included
- •especially those with unexplained persistent elevations of
- •serum transaminases. Pregnancy or breastfeeding and
- •hypersensitivity to any of the medications are to be excluded
- •as well. Myocarditis. Acute pulmonary edema. Hypovolemia.
- •Patients enrolled in a different randomized study and/or
- •COVID interventional study.
研究者
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