NCT05736887进行中（未招募）2 期
Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- DLco
研究概览
简要总结
A randomized, double-blind, parallel-arm, phase II, explorative study investigating the efficacy and safety of orally administered N-Acetylcysteine (NAC) versus placebo in patients with history of SARS-Cov-2 infection and residual respiratory impairment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤90 years.
- •History of hospitalization for COVID-19 pneumonia, as documented by positive RT/PCR testing for SARS-Cov-2 infection (nasopharyngeal swab) and suggestive radiological findings at the chest CT scan.
- •Resolution of SARS-CoV-2 infection as defined by negative RT/PCR testing (nasopharyngeal swab).
- •Evidence of residual interstitial lung abnormalities (including any of the following: ground glass, reticulation, or consolidation with overall extent ≥5% of total lung volume) on chest high resolution CT scan (performed during screening or within 30 days from screening visit) AND
- •One or more of the following:
- •DLco ≤ 70 % of predicted value at screening
- •Oxygen desaturation at 6-minute walk test (6MWT) ≥4% from baseline value at screening.
- •Total Lung Capacity ≤ 80 % of predicted value at spirometry performed at screening
- •Exertional dyspnea at screening, as defined by MMRC ≥1
排除标准
- •Evidence of resting respiratory failure, as defined by PaO2 ≤60 mmHg (FiO2 21%) at blood gas analysis at screening.
- •History of interstitial lung disease, or evidence of interstitial lung disease at screening that suggests any of the following: idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (Other than SARS-Cov-2 infection) and connective tissue diseases.
- •History of other types of respiratory diseases, including disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study.
- •Any other known disease, medical conditions or blood test abnormalities that in the opinion of the Investigator may put the patient at risk because of participation, interfere with study procedures or cause concern regarding the patient inability to participate in the study.
- •Concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs.
- •Pregnancy status.
- •Incapacity of providing valid informed consent.
研究组 & 干预措施
N-Acetylcysteine arm
Experimental
Subjects with recent history of COVID-19 infection randomized to receive N-Acetylcysteine.
干预措施: N-Acetylcysteine (Drug)
Placebo arm
Placebo Comparator
Subjects with recent history of COVID-19 infection randomized to receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
DLco
时间窗: Week 12
Change in percent predicted DLco at week 12 compared to baseline
次要结局
- St. George's Respiratory Questionnaire (SGRQ)(Week 12)
- DLco(Week 12)
- Shortness of Breath Questionnaire (UCSD-SOBQ)(Week 12)
- Change in Leicester Cough Questionnaire (LCQ)(Week 12)
- High-resolution computed tomography (HRCT)(Week 12)
- Quantitative Lung Fibrosis(Week 12)
- Forced Vital Capacity (FVC)(Week 12)
研究者
RICHELDI LUCA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (1)
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