Ozone Therapy for Patients With COVID-19 Pneumonia: Preliminary Report of a Prospective Case-control Study
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
- 否
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
Marc Vives
Clinical Research Lead, MD, PhD, EDAIC
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta