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    The EU Clinical Trials Register currently displays   40665   clinical trials with a EudraCT protocol, of which   6637   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2020-003505-58
    Sponsor's Protocol Code Number:INCIPIT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-06
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003505-58
    A.3Full title of the trial
    A proof-of-concept study of the use of Inhaled liposomal -Cyclosporin-A in the treatment of moderate COVID-19-related pneumonia: a two-step phase II clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Inhaled liposomal -Cyclosporin-A in the treatment of moderate COVID-19-related pneumonia: a two-step phase II clinical trial
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberINCIPIT
    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.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 supportBreath Therapeutics
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Policlinico San Matteo
    B.5.2Functional name of contact pointPneumologia
    B.5.3 Address:
    B.5.3.1Street Addressviale Golgi 19
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    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 No
    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 nameCiclosporina A liposomiale
    D.3.2Product code [L-CSA]
    D.3.4Pharmaceutical form Powder for nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor codeL-CSA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate COVID-19-related pneumonia
    Polmonite COVID-19-correlata di grado moderato
    E.1.1.1Medical condition in easily understood language
    Moderate COVID-19-related pneumonia
    Polmonite COVID-19-correlata di grado moderato
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    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
    The safety and a proof of concept of efficacy of the treatment
    Sicurezza ed efficacia di risposta al trattamento
    E.2.2Secondary objectives of the trial
    • Survival rate within 8 and 28 days
    • > than 40% decrease in PaO2/FiO2 ratio
    • Peripheral capillary oxygen saturation (SpO2) at day 1,2,3,4,5,6,7,14 and 28
    • PaO2 at day 1,2,4,6,7 and 10
    • Admission to the ICU
    • Length of hospital stay
    • Re-admission within 28 days
    • The cumulative incidence and severity of adverse events
    1. sopravvivenza a 8 e 28 giorni;
    2. % di pazienti con riduzione > 40% di PaO2/FiO2
    3. Saturazione periferica di Ossigeno (SpO2) ai giorni 1,2,3,4,5,6,7,14 and 28
    4. PaO2 ai giorni 1,2,4,6,7 e 10.
    5. % Ricoveri in terapia intensiva;
    6. durata del ricovero;
    7. re-ospedalizzazione a 28 giorni;
    8. incidenza cumulativa e severità di eventi avversi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ability to obtain informed patient consent noting the limitations of existing knowledge regarding Inhaled Liposomal CSA efficacy and the labeled warning and precautions as the proposed use is outside the approved indication.
    • Informed Consent as documented by signature
    • Adult patients aged 18-74 years-old
    • Bilateral infiltrates at chest radiography
    • =48 hours from admission
    • Positive Nasal Swab at PCR assay specific for SARS-CoV-2
    • Moderate acute respiratory syndrome (SARS)-CoV-2 pneumonia PaO2/FiO2 between 300-200 in FiO2 </=60%)
    • Ability to perform 8-13 min aerosolization
    • Evidence of clear hyperinflammatory state (CRP >5mg/dl, IL6 levels >40 pg/ml)
    • Exclusion of coinfection by PTCI < than 0.5 ng/ml
    E.4Principal exclusion criteria
    • Patients aged < 18 years old and = 75 years old
    • Concomitant and documented bacterial infection or PCTI > 0.5 ng/ml
    • Lymphopenia less than 200/mmc
    • Hemoglobin < 8 g/dl
    • Absolute neutrophil count < 1 x 109 cells/L
    • PaO2/FiO2 not included in the following interval 300-200 need of a FiO2 support > than 60%
    • Treatment with CPAP and /or inability to perform a 10 min aerosolization course
    • Sudden clinical deterioration requiring ICU access or palliative care
    • Known hypersensitivity or allergy to CSA
    • Creatinine clearance < 30 mL/min;
    • Severe hepatic impairment
    • Pregnant or breast-feeding
    • Active tuberculosis
    • Evidence of active HBV (HbsAg positive) or with detectable HCV-RNA, HIV
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be safety and response to treatment. A patient is considered responder in the absence of oxygenation impairment (>than 40% decrease in PaO2/FiO2 ratio) within 7 days from enrolment.
    Numero di pazienti che tollerano la somministrazione per inalazione senza eventi avversi maggiori (almeno 80% per passare da fase IIa (di safety) a Fase IIb (di efficacia) il cui obiettivo è oltre alla sicurezza la valutazione di risposta al trattamento definita come miglioramento dell’ossigenazione ovvero assenza di peggioramento > 40% del ratio di PaO2/FiO2 entro 7 giorni dall’arruolamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    7 giorni
    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. 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E. description
    terapia antivirale e di supporto
    antiviral and supportive therapy
    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
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 31
    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)
    Subjects will be treated according to the best clinical practice of the centre
    I soggetti saranno trattati in accordo allo standard del centro
    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 Decision2020-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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