Clinical and Molecular Effects of N-Acetylcysteine Treatment in COVID-19-Related Acute Respiratory Distress Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Change in inflammatory and thromboinflammatory biomarkers
研究概览
简要总结
Prospective, randomized, double-blind, placebo-controlled clinical trial evaluating the clinical and molecular effects of intravenous N-acetylcysteine (NAC) in patients with COVID-19-associated acute respiratory distress syndrome (ARDS) treated in the intensive care unit. The study assessed inflammatory and thromboinflammatory biomarkers, hypoxia-related gene expression (HIF-1α, ACE2, CD147), and clinical outcomes including mortality and length of ICU stay.
详细描述
This single-center, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted in adult patients with PCR-confirmed COVID-19 and acute respiratory distress syndrome (ARDS) admitted to the intensive care unit. Eligible patients were randomly assigned in a 1:1 ratio to receive intravenous N-acetylcysteine (NAC) or placebo in addition to standard care. NAC was administered at a dose of 150 mg/kg on day 1 followed by 50 mg/kg/day on days 2 and 3.
The primary objectives were to evaluate the effects of NAC on inflammatory and thromboinflammatory biomarkers and hypoxia-related molecular pathways. Biochemical parameters including C-reactive protein, D-dimer, ferritin, zinc levels, and PaO₂/FiO₂ ratio were measured at ICU admission and on day 4. Gene expression levels of HIF-1α, ACE2, and CD147 were analyzed in peripheral blood using RT-qPCR.
Secondary objectives included assessment of clinical outcomes such as mortality, length of intensive care unit stay, and need for mechanical ventilation. The study was approved by the institutional ethics committee, and written informed consent was obtained from patients or their legal representatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Double-blind (participant, care provider, investigator, outcomes assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •PCR-confirmed SARS-CoV-2 infection
- •Diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin criteria
- •Admission to the intensive care unit
- •Written informed consent obtained from the patient or legal representative -
排除标准
- •Expected mortality within 48 hours of ICU admission
- •Prior chronic oxygen therapy
- •Previous COVID-19 treatment initiated at another center
- •Pregnancy or breastfeeding
- •Use of antioxidant or anti-inflammatory drugs within 30 days prior to enrollment
- •Known hypersensitivity to N-acetylcysteine
- •Use of medications affecting glutathione metabolism
研究组 & 干预措施
N-Acetylcysteine (NAC) Group
Participants received intravenous N-acetylcysteine (150 mg/kg on day 1, followed by 50 mg/kg/day on days 2 and 3) in addition to standard of care.
干预措施: N-Acetylcysteine (NAC) (Diagnostic Test)
Plasebo
Participants received intravenous 0.9% sodium chloride (placebo) administered at the same volume and duration as the intervention group, in addition to standard of care.
干预措施: N-Acetylcysteine (NAC) (Diagnostic Test)
结局指标
主要结局
Change in inflammatory and thromboinflammatory biomarkers
时间窗: Baseline (ICU admission) to Day 4
Change in C-reactive protein (CRP) and D-dimer levels from baseline (ICU admission) to day 4 of treatment.
次要结局
未报告次要终点
研究者
Gülseren
prof
University of Gaziantep