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临床试验/NCT04489446
NCT04489446已完成1 期

Sildenafil for Treating Patients With COVID-19 and Perfusion Mismatch: A Pilot Randomised Trial

Universidad Nacional Andres Bello1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Arterial Oxygenation

研究概览

简要总结

This randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with COVID19.

详细描述

Perfusion anomalies, namely hypoperfusion of healthy lung and vasoplegia with hyperperfusion of diseased lung areas, have been recently described amongst patients with COVID19. In this triple-blind pilot randomised trial, adult patients with high clinical suspicion of SARS-CoV2 infection and perfusion defects in a substraction computed tomography angiography will be randomised in a 1:1 ratio to receive sildenafil or placebo. Informed consent will be obtained from every included participant. Patients requiring mechanical ventilation at baseline will be excluded, as will those who present a contraindication to sildenafil, previous users of sildenafil, those requiring therapy with nitrates, patients in which an order to limit therapeutic efforts has been issued, pregnant or breastfeeding women and those who decline to participate in this study. The primary outcome for this trial wil be oxygenation changes in blood gas analyses. Secondary outcomes will include clinical deterioration requiring admission to an intensive care unit, requirement of high-flow nasal cannula or invasive mechanical ventilation and overall survival. Patients will be followed-up until hospital discharge or up to fifteen days after randomisation. Statistical analyses will be undertaken by a statistician unaware of treatment allocation under the intention-to-treat principle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Adult participant with high clinical suspicion of a SARS-CoV2 infection.
  • Hypoperfusion of healthy lung areas in a substraction computed tomography angiography within 24 hours of admission to the hospital.

排除标准

  • Requirement of therapy with nitrates of nitrites
  • Arterial hypotension at presentation
  • Recent diagnosis of coronary artery disease (<6 months)
  • Acute heart failure at presentation
  • Recent stroke (< 6 months)
  • Chronic respiratory failure with CO2 retention
  • Known hypersensitivity to sildenafil
  • Advanced liver disease (Child-Pugh class B or higher)
  • Users of cytochrome P450 3A4 inhibitors (Erythromycin, Ketoconazole, Itraconazole, Saquinavir)
  • Pulmonary hypertension
  • Chronic users of phosphodiesterase 5 inhibitors
  • Requirement of invasive mechanical ventilation at baseline
  • Decision to limit therapeutic efforts at baseline
  • Pregnancy or lactation
  • History of retinitis pigmentosa
  • Known obstruction to left-ventricular outflow tract
  • Unwillingness to participate in the trial

研究组 & 干预措施

Sildenafil

Experimental

Patients allocated to this arm will receive Sildenafil 25mg every 8 hours orally for up to seven consecutive days.

干预措施: Sildenafil (Drug)

Control

Placebo Comparator

Patients allocated to this arm will receive a placebo that will be similar in form to sildenafil pills in the interventional arm. These doses will be scheduled every 8 hours and wil be administered orally por up to seven consecutive days.

干预措施: Placebo (Drug)

结局指标

主要结局

Arterial Oxygenation

时间窗: Daily until the end of follow-up (up to 15 days after randomisation)

Mean difference in alveolar oxygen pressure to inspired oxygen fraction (Pa/Fi) ratios.

Alveolo-arterial gradient

时间窗: Daily until the end of follow-up (up to 15 days after randomisation)

Mean difference in the alveolo-arterial gradient between study groups.

次要结局

  • Intensive care unit admission(Up to two weeks after randomisation)
  • Survival(Up to two weeks after randomisation)
  • Noninvasive Mechanical Ventilation or Requirement of High-Flow Nasal Cannula(Up to two weeks after randomisation)
  • Invasive mechanical ventilation(Up to two weeks after randomisation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felipe Martinez Lomakin

Investigator

Universidad Nacional Andres Bello

研究点 (1)

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