跳至主要内容
临床试验/NCT04946162
NCT04946162撤回4 期

The Use of Tadalafil in Confirmed COVID-19 Pneumonia.

Santa Barbara Cottage Hospital0 个研究点开始时间: 2020年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
主要终点
Improvement in oxygen saturation

研究概览

简要总结

Our goal is to assess the effects of Tadalafil in the setting of confirmed COVID-19 pneumonia. In particular we plan to assess its effects on oxygen saturation, P:F ratio, and mixed central venous oxygen

We plan to recruit all hospitalized patients at Santa Barbara Cottage Hospital with a confirmed COVID19 pneumonia (positive PCR + clinical signs/symptoms of lower respiratory disease) who meet the Berlin definition of ARDS and have access to measure a mixed venous oxygen saturation. For the purposes of obtaining mixed central venous oxygen, all participating patients will already have an internal jugular central venous catheter in place for inclusion in this study. Since all patients will be intubated, their Legally Authorized Representative (LAR) will be approached to discuss the study and asked to participate in the study by an ICU physician, either the attending physician or a medical resident.

Informed consent will be obtained from the LAR by an ICU attending physician or resident involved in the study prior to participation. Patients who meet the above eligibility criteria will have baseline levels of mixed central venous oxygen, oxygen saturation, P:F ratio, blood pressure and PaO2 recorded.

Each patient will then receive Tadalafil 40mg once. The above listed parameters will be monitored again 30 minutes after drug administration and 4 hours after drug administration. No other medication or ventilator changes will be made during this time period outside of emergent changes in the setting of patient deterioration. We will continue to analyze the data in the event of emergent ventilator changes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients at SBCH with confirmed COVID19 pneumonia (PCR + clinical signs/symptoms of lower respiratory disease)
  • Patients currently on a ventilator
  • Patients who meet the Berlin definition of ARDS
  • Patients who have access to measure a mixed venous oxygen saturation (i.e., patients with an internal jugular central venous catheter)
  • Patient and/or Legally Authorized Representative is willing/able to provide informed consent

排除标准

  • As tadalafil is currently a FDA Class B1 medication, indicating that little information is available, pregnant women along with women who are actively breastfeeding will be excluded from this series.
  • All patients under 18
  • Patients who are routinely taking nitrate medications
  • All patients using Tadalafil daily for pulmonary arterial hypertension (Note: patients using Tadalafil intermittently for erectile dysfunction may still participate in the study)

研究组 & 干预措施

Tadalafil Group

Experimental

Each patient will be given tadalafil 40 mg one time

干预措施: Tadalafil Pill (Drug)

结局指标

主要结局

Improvement in oxygen saturation

时间窗: Pre-medication, 30 minutes post medication, 4 hours post-medication

Change in oxyhemoglobin as noted on an arterial blood gas sample after medication administration

Improvement in partial pressure of oxygen in the bloodstream

时间窗: Pre-medication, 30 minutes post medication, 4 hours post-medication

Change in oxygen partial pressure (aka PaO2) as noted on an arterial blood gas sample after medication administration

Improvement in P:F ratio

时间窗: Pre-medication, 30 minutes post medication, 4 hours post-medication

Change in a patient's P:F ratio after medication administration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验