Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine arm | Experimental | Subjects with recent history of COVID-19 infection randomized to receive N-Acetylcysteine. |
|
| Placebo arm | Placebo Comparator | Subjects with recent history of COVID-19 infection randomized to receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine | Drug | N-Acetylcysteine in 600mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| DLco | Change in percent predicted DLco at week 12 compared to baseline | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| DLco | Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12 | Week 12 |
| St. George's Respiratory Questionnaire (SGRQ) | Change in St. George's Respiratory Questionnaire (SGRQ) score from baseline to week 12. |
Not provided
Inclusion Criteria:
One or more of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli IRCCS | Rome | Roma | 00168 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo in 600mg tablets |
|
| 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. | Week 12 |
| Change in Leicester Cough Questionnaire (LCQ) | Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12. | Week 12 |
| Forced Vital Capacity (FVC) | Change in FVC (L) from baseline to week 12. | 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. | Week 12 |
| Quantitative Lung Fibrosis | Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12. | Week 12 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |