Phase II Trial of Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 ARDS - A Multi-Site, Randomized, Double-blinded, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change Extravascular Lung Water Index
研究概览
简要总结
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.
详细描述
Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
- •Diagnosis of ARDS by the Berlin Criteria (2012):
- •Onset: < 7 days
- •Chest x-ray: Bilateral Patchy Opacities, Infiltrates
- •Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O
- •Pulmonary Edema: Not fully explained by cardiogenic etiology
- •Hypoxia: PaO2/FIO2 Ratio < 300, or O2Sat/FIO2 Ratio < 315
排除标准
- 未提供
研究组 & 干预措施
T3 Intervention
Participants in this arm will receive the experimental intervention.
干预措施: Instilled T3 (Drug)
Placebo Therapy
Participants in this arm will receive placebo therapy.
干预措施: Placebo Therapy (Other)
结局指标
主要结局
Change Extravascular Lung Water Index
时间窗: 1 hour
EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 1 hour post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.
次要结局
- New York Heart Association (NYHA) Functional Classification(30 days)
- Number of Ventilator-Free Days(30 days)
- Creatinine Concentration(4 days)
- Glomerular Filtration Rate(4 days)
- Length of ICU Stay(Baseline to ICU discharge up to 30 days)
- 30-day Survival(30 days)