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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine (NAC) Group | Experimental | 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. |
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| Plasebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine (NAC) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory and thromboinflammatory biomarkers | Change in C-reactive protein (CRP) and D-dimer levels from baseline (ICU admission) to day 4 of treatment. | Baseline (ICU admission) to Day 4 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziantep üniversity | Gaziantep | 27 | Turkey (Türkiye) |
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Double-blind (participant, care provider, investigator, outcomes assessor)
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