patients with history of SARS-Cov-2 infection and residual respiratory impairment MedDRA version: 23.0 Level: LLT Classification code 10058686 Term: Bilateral pneumonia System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Fluimucil 600 mg tablets
Product Name: N-Acetylcysteine
Product Code: [NAC]
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616-91-1
Current Sponsor code: 616-9
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of NAC in improving diffusion lung capacity of carbon monoxide (DLco) as compared to placebo in patients with recent history of COVID-19 infection.;Secondary Objective: •To assess efficacy of NAC on ameliorating tolerance to exercise, pulmonary function, radiological abnormalities, symptoms and quality of life in the selected study population. •To assess the safety and tolerability of NAC administration in the study population.;Primary end point(s): Change in percent predicted DLco from baseline to week 12;Timepoint(s) of evaluation of this end point: 12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in absolute (ml/min/mmHg) predicted DLco from baseline to week 12. - Proportion of patients with oxygen desaturation at 6MWT =4% from baseline value at week 12. - Change in St. George’s Respiratory Questionnaire (SGRQ) score from baseline to week 12. - Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) score from baseline to week 12. - Change in Leicester Cough Questionnaire (LCQ) from baseline to week 12. - Change in FVC (L) from baseline to week 12. - Proportion of patients with improvement of interstitial changes on chest high-resolution computed tomography at 12 weeks, as defined by central radiological review. - Change in Quantitative Lung Fibrosis (QLF) volume from baseline to week 12.;Timepoint(s) of evaluation of this end point: 12 week | — |
Countries
Italy
Contacts
Public ContactDIREZIONE SCIENTIFICA
FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
Outcome results
None listed