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

University of Gaziantep

Status: Completed

Conditions: COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS)

Treatments: Diagnostic Test: N-Acetylcysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07374991

TF.20.26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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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Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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59 participants in 2 patient groups, including a placebo group

N-Acetylcysteine (NAC) Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: N-Acetylcysteine (NAC)

Plasebo

Placebo Comparator group

Description:

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.

Treatment:

Diagnostic Test: N-Acetylcysteine (NAC)