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    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001745-40
    Sponsor's Protocol Code Number:COVID-SARI-001
    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:2020-06-24
    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 number2020-001745-40
    A.3Full title of the trial
    PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION
    PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION
    Studio pilota sull'utilizzo di sarilumab in pazienti con infezione da COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COVID-SARI-001
    COVID-SARI-001
    A.4.1Sponsor's protocol code numberCOVID-SARI-001
    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 SponsorASST FATEBENEFRATELLI SACCO
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASST Fatebenefratelli Sacco
    B.5.2Functional name of contact pointDipartimento di Scienze Cliniche -
    B.5.3 Address:
    B.5.3.1Street AddressVia G.B. Grassi 74
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.4Telephone number0239042451
    B.5.5Fax number0250319758
    B.5.6E-mailagostino.riva@unimi.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 Kevzara
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameKevzara
    D.3.2Product code [SAR153191]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSarilumab
    D.3.9.1CAS number 1189541-98-7
    D.3.9.2Current sponsor codeSAR153191
    D.3.9.4EV Substance CodeEU/17/1196/003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with COVID-19 infection
    Pazienti con infezione da COVID-19
    E.1.1.1Medical condition in easily understood language
    Patients with COVID-19 infection
    Pazienti con infezione da 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 22.1
    E.1.2Level LLT
    E.1.2Classification code 10048847
    E.1.2Term Lung infection NOS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as =30% decrease in oxygen requirement compared to baseline.
    Valutare la sicurezza e l'efficacia clinica di sarilumab nei pazienti adulti ricoverati in ospedale a causa di una polmonite Covid-19 grave sulla base della percentuale di pazienti che mostrano un miglioramento della funzione respiratoria, descritto come una riduzione =30% dell'ossigeno richiesto rispetto al basale.
    E.2.2Secondary objectives of the trial
    Potenziale efficacia di sarilumab nella polmonite Covid-19:
    • Nei pazienti con febbre al basale, valutazione del tempo alla risoluzione della febbre, definita come temperatura corporea =36,6 ° C axilla, =37,8 ° C rettale o timpanica per almeno 48 ore senza antipiretici;
    • Valutazione della carica virale, sangue ed espettorato per COVID-19 prima della somministrazione di sarilumab, 48 ore e 96 ore dopo la somministrazione;
    • Valutazione della concentrazione plasmatica di Il-6, TNF-a, Il-10 e GM-CSF pre-trattamento e 96 e 120 ore dopo il trattamento;
    • Valutazione del tasso di progressione della frazione WBC di granulociti immaturi - IG - (conteggi assoluti e%) e dei parametri morfologici-funzionali definiti da:
    - complessità citoplasmatica
    - intensità di fluorescenza
    - dimensioni
    - ampiezza di distribuzione degli eventi su entrambi gli assi del citogramma WDF.
    Further investigate the potential effectiveness of sarilumab in Covid-19 pneumonia by means of:
    • In patients with fever at baseline, evaluation of the time to resolution of fever, defined as body temperature =36.6°C axilla, =37.8°C rectal or tympanic for at least 48 hours without antipyretics;
    • Evaluation of the viral load on blood and sputum for COVID-19 before administration of sarilumab, 48 hours and 96 hours after administration;
    • Evaluation of the plasma concentration of Il-6, TNF-a, Il-10, and GM-CSF pre-treatment and 96 and 120 hours post-treatment;
    • Evaluation of the rate of progression of WBC fraction of immature granulocytes - IG - (absolute and % counts) and the morphological-functional parameters defined by:
    o cytoplasmic complexity
    o fluorescence intensity
    o size
    o distribution magnitude of events on both axes of the WDF cytogram.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age = 18 years and < 85 years.
    • Documented (chest X-Ray or TC scan), severe (BCRSS =3 and <4) interstitial pneumonia with respiratory failure (requiring supplemental oxygen) with positive Covid-19 swab testing.
    • Worsening of respiratory exchanges such as to require ventilation with Venturi mask >31% (6L/minute).
    • Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching = 1000 ng/mL.
    • Signed informed consent
    • Età = 18 anni e <85 anni.
    • Documentata (radiografia del torace o TC), polmonite interstiziale grave (BCRSS =3 e <4) con insufficienza respiratoria (che richiede ossigeno supplementare) con test di tampone Covid-19 positivo.
    • Necessità di una ventilazione con maschera Venturi> 31% (6L / minuto).
    • Livelli aumentati di D-dimero (> 1500 ng / mL) o D-dimero che aumentano progressivamente (oltre 3 misurazioni consecutive) e raggiungono = 1000 ng / mL.
    • Consenso informato firmato.
    E.4Principal exclusion criteria
    • Age < 18 years or = 85 years.
    • AST / ALT > 5x ULN.
    • Neutrophil count lower than 500 cells / mL.
    • PTL count lower than 50,000 cells / mL.
    • Documented sepsis due to infections other than Covid-19.
    • Presence of serious co-morbidities (such as COPD, diabetes, or cardiomyopathies) likely to cause, according to the clinical judgment, an unfavorable outcome.
    • Complicated diverticulitis or intestinal perforation.
    • Immunosuppressive therapy due to organ transplant.
    • Età <18 anni o = 85 anni.
    • AST / ALT> 5x ULN.
    • Conta dei neutrofili inferiore a 500 cellule / mL.
    • Conteggio PTL inferiore a 50.000 cellule / mL.
    • Sepsi documentata dovuta a infezioni diverse da Covid-19.
    • Presenza di gravi comorbilità (come BPCO, diabete o cardiomiopatie) che possono causare, secondo il giudizio clinico, un risultato sfavorevole.
    • Diverticolite complicata o perforazione intestinale.
    • Terapia immunosoppressiva dovuta al trapianto di organi.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who show an improvement of the respiratory function, described as =30% decrease in oxygen requirement compared to baseline.
    Percentuale di pazienti che mostrano un miglioramento della funzione respiratoria, descritto come una riduzione =30% dell'ossigeno richiesto rispetto al basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily until discharge
    Giornalmente fino a dimissione
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days42
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days42
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    unconscious patients may be included
    Potrebbero essere inclusi anche pazienti incoscienti
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Patients will be treated according to local clinical practice or guidelines on COVID-19 disease
    I pazienti saranno trattati in accordo alla pratica clinica locale o alle linee guida per la malattia COVID-19
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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