NCT07374991

Clinical and Molecular Effects of N-Acetylcysteine Treatment in COVID-19-Related Acute Respiratory Distress Syndrome

Clinical and Molecular Effects of N-Acetylcysteine Treatment in COVID-19-Related Acute Respiratory Distress Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Gaziantep · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	N-Acetylcysteine (NAC)	Intravenous N-acetylcysteine administered at 150 mg/kg on day 1 followed by 50 mg/kg/day on days 2 and 3, in addition to standard of care.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-06-10
• Completion: 2022-10-10
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: Turkey (Türkiye)