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

NCT07374991 | Completed

• 1 other identifier: TF.20.26
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Diagnostic Test: N-Acetylcysteine (NAC)

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.

Diagnostic Test: N-Acetylcysteine (NAC)

Interventions

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.

Also known as: NAC

N-Acetylcysteine (NAC) Group; Plasebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep üniversity

Gaziantep, 27, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Double-blind (participant, care provider, investigator, outcomes assessor)
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: November 1, 2020
• Primary Completion: June 10, 2022
• Study Completion: October 10, 2022
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)