COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS)A ProspectiveNCT07374991
Clinical and Molecular Effects of N-Acetylcysteine Treatment in COVID-19-Related Acute Respiratory Distress Syndrome
A study testing N-Acetylcysteine (NAC) in people with COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS), run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- N-Acetylcysteine (NAC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Molecular Effects of N-Acetylcysteine Treatment in COVID-19-Related Acute Respiratory Distress Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
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.
Read the 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.
- Being tested
- N-Acetylcysteine (NAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC)Diagnostic test
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: N-Acetylcysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (ICU admission) to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Nov 2020
- Primary completion10 Jun 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülseren, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374991
- Sponsor's protocol ID
- TF.20.26
- Acronym
- A Prospective
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Effects of N-Acetylcysteine Treatment in COVID-19-Related Acute Respiratory Distress Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07374991
- Acronym / sponsor ID
- A Prospective / TF.20.26
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine (NAC) Group | Experimental | Diagnostic Test: N-Acetylcysteine (NAC)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. |
| Plasebo | Placebo comparator | Diagnostic Test: N-Acetylcysteine (NAC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetylcysteine (NAC)Also: NACIntravenous 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. | Diagnostic test | N-Acetylcysteine (NAC) Group, Plasebo |
Primary outcome
Change in inflammatory and thromboinflammatory biomarkers
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-Acetylcysteine (NAC) in people with COVID-19-Associated Acute Respiratory Distress Syndrome (ARDS), run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory and thromboinflammatory biomarkers (time frame: Baseline (ICU admission) to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.