COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS)
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTN-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.
Sponsors
University of Gaziantep
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Masking description
Double-blind (participant, care provider, investigator, outcomes assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 -
Exclusion criteria
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory and thromboinflammatory biomarkers | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed