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    Summary
    EudraCT Number:2022-003703-16
    Sponsor's Protocol Code Number:GR-2021-12375001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-16
    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 number2022-003703-16
    A.3Full title of the trial
    The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol - SPHERE.
    L'effetto della phoSPHocreatina sui pazienti trattati dal team di emergenza medica (met): un protocollo di studio clinico randomizzato - SPHERE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of phosphocreatine, a substance in our body, on patients in inpatient wards
    Effetto della fosfocreatina, sostanza presente nel nostro organismo, che sui pazienti nei reparti di degenza
    A.3.2Name or abbreviated title of the trial where available
    SPHERE
    SPHERE
    A.4.1Sponsor's protocol code numberGR-2021-12375001
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointAnestesia e Rianimazione
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226436155
    B.5.5Fax number0126436152
    B.5.6E-maillandoni.giovanni@hsr.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 NEOTON
    D.2.1.1.2Name of the Marketing Authorisation holderAlfasigma S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    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 nameNEOTON
    D.3.2Product code [41/153/91-C/C]
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOSFOCREATINA SODICA
    D.3.9.1CAS number 922-32-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCreatine phosphate
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.3.11.13.1Other medicinal product typeDerivato amminoacidico
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with worsening clinical condition requiring MET intervention and in general ward
    Pazienti con peggioramento delle condizioni cliniche che richiedono l'intervento del MET e ricoverati in reparto di degenza
    E.1.1.1Medical condition in easily understood language
    Patients with severe respiratory, circulatory and consciousness impairment.
    Pazienti con severe alterazioni respiratorie del circolo e della coscienza.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10045240
    E.1.2Term Type I hypersensitivity
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083659
    E.1.2Term Hypotensive crisis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of phosphocreatine (PCr) on the number of Days alive and out of hospital at 30 days (DAOH30) in patients reviewed and treated by Medical Emergency Team (MET) in general wards.
    Valutare l'impatto della fosfocreatina (PCr) sul numero di giorni di vita e di dimissioni dall'ospedale a 30 giorni (DAOH30) nei pazienti visitati e trattati dal Medical Emergency Team (MET) nei reparti generali.
    E.2.2Secondary objectives of the trial
    To assess the impact of phosphocreatine (PCr) on:
    1. cognitive function at 30 days, by the mean of Cognitive Telephone Screening test (COGTEL) (Ihle 2017)
    2. the rate of arrhythmia needing treatment
    3. the rate of ICU admissions or criteria for ICU admission
    4. 30-days mortality
    Valutare l'impatto della fosfocreatina (PCr) su:
    1. la funzione cognitiva a 30 giorni, attraverso la media del Cognitive Telephone Screening test (COGTEL) (Ihle 2017)
    2. il tasso di aritmie da trattare
    3. il tasso di ricoveri in terapia intensiva o i criteri per il ricovero in terapia intensiva
    4. Mortalità a 30 giorni
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1.Threatened airways;
    2. Respiratory arrest;
    3. Respiratory rate <5 or >36 breaths per min;
    4. Pulse rate <40 or >140 beats per min;
    5. Systolic blood pressure < 90 mm Hg;
    6. Sudden fall in level of consciousness;
    7. Fall in Glasgow coma scale of > 2 points.
    8. Written informed consent from the patient him-/herself or the patient's next of kin or the legal representative as requested by the ethics committee.
    Criteri di inclusione:
    1. Alterazioni respiratorie;
    2. Arresto respiratorio;
    3. Frequenza respiratoria <5 o >36 respiri al minuto;
    4. Frequenza del polso <40 o >140 battiti al minuto;
    5. Pressione arteriosa sistolica < 90 mm Hg;
    6. Improvvisa caduta del livello di coscienza;
    7. Caduta della scala di coma di Glasgow di > 2 punti.
    8. Consenso informato firmato dal paziente o dal tutore legale, in conformità a quanto richiesto dal comitato etico
    E.4Principal exclusion criteria
    Exclusion criteria
    1.Age < 18 years;
    2. Ongoing cardiac massage;
    3. Current hospital admission from a care nursing facility;
    4. Planned discharge to a care nursing facility;
    5. Reasons for withdrawal of life-sustaining therapy;
    6. History of kidney transplantation;
    7. Solitary kidney (by any reason);
    8. Serum Creatinine > 2 mg/dl;
    9. Immediate need for ICU admission;
    10. Known allergy to PCr;
    11. Previous enrollment and randomization into this trial;
    13. Administration of PCr in the previous 30 day.
    14. Pregnancy
    Criteri di esclusione
    1. Età < 18 anni;
    2. Massaggio cardiaco in corso;
    3. Ricovero ospedaliero in corso da una struttura di cura;
    4. Dimissione programmata da una struttura di assistenza infermieristica;
    5. Motivi per la sospensione della terapia di sostegno vitale;
    6. Storia di trapianto di rene;
    7. Rene solitario (per qualsiasi motivo);
    8. Creatinina sierica > 2 mg/dl;
    9. Necessità immediata di ricovero in terapia intensiva;
    10. Allergia nota alla PCr;
    11. Precedenti arruolamenti e randomizzazioni in questo studio;
    12. Somministrazione di PCr nei 30 giorni precedenti
    13. Gravidanza
    E.5 End points
    E.5.1Primary end point(s)
    Number of Days alive and out of hospital
    Numero di giorni di vita; Riduzione della degenza ospedaliera.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 giorni
    E.5.2Secondary end point(s)
    Re-hospitalization rate, mortality; number of complications.Cognitive Telephone Screening test (COGTEL)
    Tasso di ri-ricovero, mortalità; numero di complicanze. Cognitive Telephone Screening test (COGTEL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 90 days and 1 year
    30 giorni, 90 giorni 1 e anno
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    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 Yes
    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 years3
    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 years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 2023-01-16. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who are unconscious and unable to give consent
    Pazienti incoscienti e incapaci di rilasciare il proprio consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    Standard clinical practice
    Normale 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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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