跳至主要内容
临床试验/NCT04444531
NCT04444531已完成不适用

Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Time to clinical improvement

研究概览

简要总结

The objective is to determine whether the use of ozone autohemotherapy is associated with a decrease in time to clinical improvement

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

接受健康志愿者

入选标准

  • confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission)
  • severe pneumonia with baseline chest X-ray abnormalities;
  • Oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute.
  • Informed consent signed.

排除标准

  • Not willing to participate in the study.

结局指标

主要结局

Time to clinical improvement

时间窗: 28 days

Clinical improvement was defined as a two-point reduction (relative to the patient's status on hospital admission) on a six-point ordinal scale, or discharge alive from the hospital, whichever came first. The six-point scale was as follows: death (6 points); extracorporeal membrane oxygenation or mechanical ventilation (5 points); noninvasive ventilation or high-flow oxygen therapy (4 points); oxygen therapy without need for high-flow oxygen or non-invasive ventilation (3 points); hospital admission without need for oxygen therapy (2 points); and discharged from hospital or reached discharge criteria (1 point). Discharge criteria were as evidence of clinical recovery (normalization of pyrexia, respiratory rate \<24 per minute, oxygen saturation \>94% on room air, and absence of cough) for at least 72 hours.

次要结局

  • Time to a 2-fold decrease of ferritin from baseline(28 days)
  • Rate of patients with Clinical improvement at day 14(14 days)
  • Time to a 2-fold decrease of D-dimer from baseline(28 days)
  • Rate of patients with Clinical improvement at day 28(28 days)
  • Time to a 2-fold decrease of C-protein reactive from baseline(28 days)
  • Time to a 2-fold decrease of Lactate Dehydrogenase from baseline(28 days)

研究者

发起方
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Vives

Clinical Research Lead, MD, PhD, EDAIC

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

研究点 (1)

Loading locations...

相似试验