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    Summary
    EudraCT Number:2021-002825-10
    Sponsor's Protocol Code Number:NACoV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-002825-10
    A.3Full title of the trial
    Exploratory efficacy of N-Acetylcysteine in patients with history of COVID-19
    (NACoV)
    Efficacia esplorativa di N-acetilcisteina nei pazienti con storia di COVID-19 (NACoV).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploratory efficacy of N-Acetylcysteine in patients with history of COVID-19
    (NACoV)
    Efficacia esplorativa di N-acetilcisteina nei pazienti con storia di COVID-19 (NACoV).
    A.3.2Name or abbreviated title of the trial where available
    NACoV
    NACoV
    A.4.1Sponsor's protocol code numberNACoV
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZAMBON SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
    B.5.2Functional name of contact pointDIREZIONE SCIENTIFICA
    B.5.3 Address:
    B.5.3.1Street AddressLARGO A. GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fluimucil 600 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderZambon Nederland B.V.
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameN-Acetylcysteine
    D.3.2Product code [NAC]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLCYSTEINE
    D.3.9.1CAS number 616-91-1
    D.3.9.2Current sponsor code616-91-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with history of SARS-Cov-2 infection and residual respiratory impairment
    Pazienti con storia recente di polmonite COVID-19
    E.1.1.1Medical condition in easily understood language
    patients with history of SARS-Cov-2 infection and residual respiratory impairment
    Pazienti con storia recente di polmonite COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10058686
    E.1.2Term Bilateral pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    - Valutare l’efficacia di NAC in termini di variazione della capacità di diffusione del monossido di carbonio (DLCO) rispetto al placebo in pazienti con storia recente di polmonite COVID-19.
    E.2.2Secondary objectives of the trial
    • 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.
    - Stabilire l’efficiacia di NAC in termini di tolleranza all’esercizio fisico, funzionalità polmonare, alterazioni radiologiche, sintomi e qualità di vita.
    - Valutare la sicurezza e tollerabilità di NAC nella popolazione di studio.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    1. Età =18 e =90.
    2. Storia di ospedalizzazione per polmonite COVID-19
    3. Risoluzione dell’infezione definita dalla negatività al test RT/PCR per Sars-Cov-2 (tampone nasofaringeo).
    4. Evidenza di persistenti alterazioni interstiziali alla TC del torace ad alta risoluzione eseguita durante lo screening o entro 30 giorni dalla visita di screening.
    In aggiunta ad uno dei seguenti criteri:
    - DLCO =70% del valore predetto allo screening,
    - Desaturazione al test del cammino dei 6 minuti (6MWT) =4% allo screening,
    - TLC =80% del valore predetto allo screening,
    - Dispnea da sforzo allo screening (MMRC =1).
    E.4Principal 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.
    1. Evidenza di insufficienza respiratoria a riposo definita come PaO2 =60 mmHg (FiO2 21%) all’emogasanalisi arteriosa allo screening,
    2. Storia di fibrosi polmonare o evidenza di una tra le seguenti patologie respiratorie allo screening: polmonite interstiziale idiopatica o secondaria ad esposizione, a farmaci, granulomatosi, vasculiti, infezioni (non da SARS-Cov-2) e connettivopatie,
    3. Storia di altre patologie respiratorie,
    4. Qualsiasi altra condizione medica o valori di laboratorio alterati che all'opinione dello sperimentatore possono interferire con la capacità del paziente di partecipare allo studio
    5. Assunzione di farmaci steroidei o immunosoppressori,
    6. Stato di gravidanza,
    7. Incapacità a fornire il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    Change in percent predicted DLco from baseline to week 12
    Variazione del valore di DLCO in percentuale rispetto al predetto dal baseline a 12 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 week
    12 settimane
    E.5.2Secondary 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.
    - Variazione del valore di DLCO in assoluto (ml/min/mmHg) rispetto al predetto dal baseline a 12 settimane.
    - Proporzione di pazienti con desaturazione al test del cammino =4% dal baseline a 12 settimane.
    - Variazione del punteggio al questionario St. George’s Respiratory (SGRQ) dal baseline a 12 settimane.
    - Variazione del punteggio al questionario University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) dal baseline a 12 settimane.
    - Variazione del punteggio al questionario Leicester Cough Questionnaire (LCQ) dal baseline a 12 settimane.
    - Variazione della FVC (L) dal baseline a 12 settimane.
    - Proporzione di pazienti con miglioramento delle alterazioni interstiziali rilevabili alla TC del torace ad alta risoluzione (HRCT) dal baseline alla settimana 24 dopo revisione centrale.
    - Variazione del Quantitative Lung Fibrosis (QLF) volume dal baseline a 12 settimane.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 week
    12 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    BEST CLINICAL PRACTICE
    MIGLIOR PRATICA CLINICA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-04-26
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