NCT04487691终止不适用
Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Spirometry-FVC and FEV1/FVC tests
研究概览
简要总结
To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
详细描述
This is a double-blind, randomized, placebo controlled single-center study using nebulized platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-COVID-19 ARDS syndrome.
20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily for eight weeks.
Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months
Goals for this study are as follows:
- Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early treatment timepoint.
- Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final treatment timepoint.
- Investigate, compare, and monitor long term function and quality of life through 6-months for treatment arm compared to control.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signature of the IRB approved Informed Consent
- •At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48 hours in the ICU
- •Patient is stable enough to have been discharged home
- •Male or female ages 18-85
- •Two weeks to 1-year post hospital discharge
- •Ongoing activity intolerance due to dyspnea related to ARDS
- •Is independent, ambulatory, and can comply with all post-operative evaluations and visits
- •6-minute walk test distance of < 450 M
- •SF-36 physical component score < 60
- •ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body test
- •Normal to mild post-ARDS reactive airway disease
排除标准
- •Oxygen dependent on nasal canula greater than 2-L per minute
- •Dependent on inhaled corticosteroid at the discretion of the physician
- •Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
- •Active known secondary bacterial or viral infection
- •Active moderate or severe post-ARDS reactive airway disease at the discretion of the physician
- •Pre-morbid COPD
- •Medication list will be reviewed on a case by case basis to allow for flexibility as post-COVID-19 patients' medication list may vary
- •Other medical comorbidities/conditions that may preclude participation in the study
结局指标
主要结局
Spirometry-FVC and FEV1/FVC tests
时间窗: 4 weeks; 8 weeks
Changes in pre and post treatment spirometry measures
次要结局
- 6 Minute Walk Distance test (6MWD)(4 weeks; 8 weeks; 3 months; 6 months)
- San Diego Shortness of Breath Questionnaire (SOBQ)(4 weeks; 8 weeks; 3 months; 6 months)
- Short Form-36 (SF-36)(4 weeks; 8 weeks; 3 months; 6 months)
- Spirometry-FVC and FEV1/FVC tests(3 months, 6 months)
- Distance-desaturation product from 6MWD(4 weeks; 8 weeks; 3 months; 6 months)
- Modified Single Assessment Numeric Evaluation (SANE)(4 weeks; 8 weeks; 3 months; 6 months)
- Medications(4 weeks; 8 weeks; 3 months; 6 months)
- Incidence of adverse events(4 weeks; 8 weeks; 3 months; 6 months)
- Incidence of surgical/other treatment interventions(4 weeks; 8 weeks; 3 months; 6 months)
研究者
研究点 (2)
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