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
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.
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 →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.
One or more of the following:
Exclusion Criteria:
Subjects with recent history of COVID-19 infection randomized to receive N-Acetylcysteine.
Drug: N-Acetylcysteine
Subjects with recent history of COVID-19 infection randomized to receive placebo.
Drug: Placebo
N-Acetylcysteine in 600mg tablets
Placebo in 600mg tablets
DLco
Change in percent predicted DLco at week 12 compared to baseline
Time frame: Week 12
DLco
Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12
Time frame: Week 12
St. George's Respiratory Questionnaire (SGRQ)
Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline to week 12.
Time frame: Week 12
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
Change in Leicester Cough Questionnaire (LCQ)
Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12.
Time frame: Week 12
Forced Vital Capacity (FVC)
Change in FVC (L) from baseline to week 12.
Time frame: Week 12
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
Quantitative Lung Fibrosis
Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12.
Time frame: Week 12
Plan to share: No
No publications or documents are linked to this record.
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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Fondazione Policlinico Universitario Agostino Gemelli IRCCS