CClinicalTrials.gg
Status unknownNCT05736887NACoVUpdated Feb 21, 2023

Exploratory Efficacy of N-Acetylcysteine in Patients With History of COVID-19

A Phase 2 interventional study of N-Acetylcysteine and Placebo in COVID-19, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2022, registered Feb 2023).
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

A randomized, double-blind, parallel-arm, phase II, explorative study investigating the efficacy and safety of orally administered N-Acetylcysteine (NAC) versus placebo in patients with history of SARS-Cov-2 infection and residual respiratory impairment.

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 and ≤90 years.
  2. History of hospitalization for COVID-19 pneumonia, as documented by positive RT/PCR testing for SARS-Cov-2 infection (nasopharyngeal swab) and suggestive radiological findings at the chest CT scan.
  3. Resolution of SARS-CoV-2 infection as defined by negative RT/PCR testing (nasopharyngeal swab).
  4. Evidence of residual interstitial lung abnormalities (including any of the following: ground glass, reticulation, or consolidation with overall extent ≥5% of total lung volume) on chest high resolution CT scan (performed during screening or within 30 days from screening visit) AND

One or more of the following:

  • DLco ≤ 70 % of predicted value at screening
  • Oxygen desaturation at 6-minute walk test (6MWT) ≥4% from baseline value at screening.
  • Total Lung Capacity ≤ 80 % of predicted value at spirometry performed at screening
  • Exertional dyspnea at screening, as defined by MMRC ≥1

Exclusion criteria

Exclusion Criteria:

  1. Evidence of resting respiratory failure, as defined by PaO2 ≤60 mmHg (FiO2 21%) at blood gas analysis at screening.
  2. History of interstitial lung disease, or evidence of interstitial lung disease at screening that suggests any of the following: idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases (Other than SARS-Cov-2 infection) and connective tissue diseases.
  3. History of other types of respiratory diseases, including disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study.
  4. Any other known disease, medical conditions or blood test abnormalities that in the opinion of the Investigator may put the patient at risk because of participation, interfere with study procedures or cause concern regarding the patient inability to participate in the study.
  5. Concomitant treatment with oral corticosteroids and/or other immunosuppressive drugs.
  6. Pregnancy status.
  7. Incapacity of providing valid informed consent.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    N-Acetylcysteine arm

    Subjects with recent history of COVID-19 infection randomized to receive N-Acetylcysteine.

    Drug: N-Acetylcysteine

  • Placebo comparator
    Placebo arm

    Subjects with recent history of COVID-19 infection randomized to receive placebo.

    Drug: Placebo

Interventions

  • DrugN-Acetylcysteine

    N-Acetylcysteine in 600mg tablets

  • DrugPlacebo

    Placebo in 600mg tablets

06

What researchers measure

Primary outcomes

  1. DLco

    Change in percent predicted DLco at week 12 compared to baseline

    Time frame: Week 12

Secondary outcomes

  1. DLco

    Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12

    Time frame: Week 12

  2. St. George's Respiratory Questionnaire (SGRQ)

    Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline to week 12.

    Time frame: Week 12

  3. Shortness of Breath Questionnaire (UCSD-SOBQ)

    Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) score from baseline to week 12.

    Time frame: Week 12

  4. Change in Leicester Cough Questionnaire (LCQ)

    Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12.

    Time frame: Week 12

  5. Forced Vital Capacity (FVC)

    Change in FVC (L) from baseline to week 12.

    Time frame: Week 12

  6. High-resolution computed tomography (HRCT)

    Proportion of patients with improvement of interstitial changes on chest high-resolution computed tomography at 12 weeks, as defined by central radiological review.

    Time frame: Week 12

  7. Quantitative Lung Fibrosis

    Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12.

    Time frame: Week 12

07

Study locations

1 site
  • Fondazione Policlinico Agostino Gemelli IRCCS
    Rome, Roma 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05736887
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
RICHELDI LUCA (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Feb 21, 2023
Start date
May 24, 2022
Primary completion
Jan 16, 2023
Completion
Jun 2023 (estimated)
Last update
Feb 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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