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    Summary
    EudraCT Number:2022-001819-12
    Sponsor's Protocol Code Number:CIS-COV
    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:2022-06-24
    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 number2022-001819-12
    A.3Full title of the trial
    Cysteamine in association with standard therapy for the treatment of hospitalized patients with COVID-19 pneumonia: phase 2 study on safety of a new antiviral and direct therapy on the host
    Cisteamina in associazione alla terapia standard per il trattamento dei pazienti ospedalizzati con polmonite da COVID-19: studio di fase 2 sulla sicurezza di una nuova terapia antivirale e diretta sull’ospite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cysteamine in association with standard therapy for the treatment of hospitalized patients with COVID-19 pneumonia: phase 2 study on safety of a new antiviral and direct therapy on the host
    Cisteamina in associazione alla terapia standard per il trattamento dei pazienti ospedalizzati con polmonite da COVID-19: studio di fase 2 sulla sicurezza di una nuova terapia antivirale e diretta sull’ospite
    A.3.2Name or abbreviated title of the trial where available
    CIS-COV
    CIS-COV
    A.4.1Sponsor's protocol code numberCIS-COV
    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 SponsorISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    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 support5X1000
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.5.2Functional name of contact pointUOSD Ricerca Traslazionale
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number06551702906
    B.5.6E-maildelia.goletti@inmi.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 Cystagon
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe SARL
    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 nameCystagon
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMERCAPTAMINA
    D.3.9.1CAS number 156-57-0
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameCisteamina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1950
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Covid-19 infection
    Infezione da Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 Infection
    Infezione da Covid-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    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
    The study evaluate the safety of cysteamine in hospitalized patients with COVID-19 pneumonia not requiring high oxygen flows, previously vaccinated with anti-COVID-19 vaccines or not vaccinated by recording serious and non-serious adverse events.
    Therapeutic adherence and tolerability of the cysteamine administered orally in two different dosage regimens, 1050 mg / day and 1950 mg / day will be evaluated.
    Any adverse events may be correlated with blood levels of cysteamine
    Lo studio si propone di valutare la sicurezza della cisteamina in pazienti ospedalizzati con polmonite COVID-19 non richiedente alti flussi di ossigeno, vaccinati o meno in precedenza con vaccini anti–COVID-19 tramite la registrazione degli eventi avversi gravi e non gravi.
    Sarà valutata l’aderenza terapeutica e la tollerabilità del farmaco cisteamina somministrato per via orale in due differenti regimi posologici, 1050 mg/die e 1950 mg/die.
    Gli eventuali eventi avversi potranno essere correlati con i livelli ematici della cisteamina.
    E.2.2Secondary objectives of the trial
    The study perform an immunological characterization of the activity of cysteamine on the antibody and cellular response of patients treated using specific laboratory assays.
    Pharmacokinetics of cysteamine.
    The pharmacokinetics (PK) of cysteamine after taking Cystagon® are characterized by rapid absorption (highest C in short t) and a short half-life. The dosage of cysteamine will be done on day 6 using samples taken before the administration of the drug, and after 1 and 2 hours after the administration of the drug. The High-Performance Liquid Chromatography-UltraViolet (HPLC-UV) System will be used.
    Exploratory objectives:
    To investigate the potential efficacy of administering two different cysteamine dosing regimens, 1050 mg / day and 1950 mg / day, in addition to standard of care, in hospitalized patients with COVID-19 pneumonia not requiring high oxygen flows
    Lo studio si propone di eseguire una caratterizzazione immunologica dell’attività della cisteamina sulla risposta anticorpale e cellulare dei pazienti trattati tramite saggi di laboratorio specifici.
    Farmacocinetica della cisteamina
    La farmacocinetica (PK) della cisteamina dopo l'assunzione di Cystagon® è caratterizzata dal rapido assorbimento (Cmax più alta in tmax breve) e dalla breve emivita. Il dosaggio della cisteamina si farà al giorno 6 utilizzando prelievi eseguiti prima della somministrazione del farmaco, e dopo 1 e 2 ore la somministrazione del farmaco. Si utilizzerà il Sistema High-Performance Liquid Chromatography-UltraViolet (HPLC-UV).
    Obiettivi esplorativi:
    Indagare la potenziale efficacia della somministrazione di due differenti regimi posologici di cisteamina, 1050 mg/die e 1950 mg/die, in aggiunta allo standard di cura, in pazienti ospedalizzati con polmonite COVID-19 non richiedente alti flussi di ossigeno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=18 years
    • Positive nasopharyngeal swab for SARS-CoV-2 (antigen or molecular test)
    • COVID-19 symptoms onset = <10 days
    • Clinical signs and symptoms of COVID-19 pneumonia
    • Image examination (X-ray / echo / CT) of the chest compatible with COVID-19 pneumonia not requiring high oxygen flows
    • Low flow respiratory support with Venturi mask or goggles with pO2 / FiO2 ratio (index obtained from the ratio between the PaO2 detected through blood gas analysis, and the fraction of oxygen, FiO2 administered)> 200
    • Weight >= 50 kg
    • Ability to provide informed consent
    • Ability to adhere to control visits
    • Infertility condition (post-menopause, surgically induced sterility eg vasectomy with documented azoospermia for men or tubal closure for women) or in subjects of childbearing potential, negative urine pregnancy test (women), and consent to comply with following contraception requirements from 2 weeks prior to enrollment to 18 weeks after study drug administration (men and women):
    -Use of condom for male subjects or one of the following contraceptive methods by the partner:
    -Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal)
    -Hormonal progestin contraceptives associated with an ovulation inhibitor (oral, injectable, implantable)
    -Intrauterine devices
    -Bilateral tubal ligation
    -sexual abstinence (hetero)
    • Età >=18 anni
    • Tampone nasofaringeo positivo per SARS-CoV-2 (esame antigenico o molecolare)
    • Esordio dei sintomi COVID-19 relati = < 10 giorni
    • Segni e sintomi clinici di polmonite da COVID-19
    • Esame di immagine (Radiografia/eco/TC) del torace compatibile con polmonite da COVID-19 non richiedente alti flussi di ossigeno
    • Supporto respiratorio a bassi flussi con maschera di Venturi o occhialini con rapporto pO2/FiO2 (indice che si ricava dal rapporto tra la PaO2 rilevata attraverso l'emogasanalisi, e la frazione di ossigeno, FiO2 somministrata) > 200
    • Peso >= 50 kg
    • Capacità di fornire il consenso informato
    • Capacità di aderire alle visite di controllo
    • Condizione di infertilità (post-menopausa, sterilità indotta chirurgicamente es. vasectomia con documentata azoospermia per l’uomo o chiusura delle tube per la donna) oppure in soggetti potenzialmente fertili, test di gravidanza urinario negativo (donne), e consenso ad attenersi ai seguenti requisiti di contraccezione a partire da 2 settimane precedenti l’arruolamento a 18 settimane dopo la somministrazione del farmaco sperimentale (uomini e donne):
    -Utilizzo del condom per i soggetti di sesso maschile o uno dei seguenti metodi contraccettivi da parte della partner:
    -Contraccettivi ormonali combinati associati ad inibitori dell’ovulazione (orali, intravaginali, transdermici)
    -Contraccettivi ormonali progestinici associati ad un inibitore dell’ovulazione (orale, iniettabile, impiantabile)
    -Dispositivi intrauterini
    -Legatura tubarica bilaterale
    -Astinenza (etero) sessuale
    E.4Principal exclusion criteria
    Exclusion criteria
    • Age <18 years
    • pO2 / FiO2 ratio = < 200 mmHg
    • Need for high flow oxygen (CPAP / NIV / VM / ECMO)
    • Use of antiretroviral drugs
    • Hemoglobin concentration below 10 g / dl
    • Elevation of creatinine kinase at baseline more than three times the normal upper limit
    • Abnormal laboratory values at baseline (baseline alanine aminotransferase (ALT) concentration more than three times the upper limit of normal, serum creatinine concentration more than twice the upper limit of normal, serum total bilirubin level greater than twice the upper limit than normal, platelet count <100,000 / mm3, white blood cells (WBC) <2500 (mcL)
    • Pregnancy or breastfeeding
    • Silico-tuberculosis
    • Scheduled or current use of cyclosporine, tacrolimus, erythromycin or colchicine
    • Seropositivity for HIV, HCV, HBV (HBsAg positivity)
    • Hepatic insufficiency (Child A-C), Renal insufficiency (creatinine clearance <50 ml / min), heart failure (NYHA III-IV), decompensated diabetes mellitus, neoplasms, current neurological / psychiatric pathology (eg depression, psychotic crisis, suicide attempt), chronic inflammatory bowel disease or gastric / duodenal ulcer under treatment, autoimmune diseases
    • Hypersensitivity to cysteamine or penicillin
    • Drug / alcohol abuse
    • Inability to understand and sign informed consent
    Presence of any physical or psychological condition which, according to the study responsible, makes participation in the study not recommended
    Criteri di esclusione
    • Età <18 anni
    • Rapporto pO2/FiO2 =< 200 mmHg
    • Necessità di ossigeno ad alti flussi (CPAP/NIV/VM/ECMO)
    • Uso di farmaci antiretrovirali
    • Concentrazione di emoglobina inferiore a 10 g/dl
    • Elevazione della creatinina chinasi al basale più di tre volte il limite superiore del normale
    • Valori di laboratorio anormali al basale (concentrazione basale di alanina aminotransferasi (ALT) più di tre volte il limite superiore del normale, concentrazione di creatinina sierica più del doppio del limite superiore del normale, livello di bilirubina totale sierica maggiore del doppio del limite superiore del normale, conta piastrinica < 100.000/mm3, globuli bianchi (WBC) <2500 (mcL)
    • Gravidanza o allattamento al seno
    • Silico-tubercolosi
    • Uso programmato o corrente di ciclosporina, tacrolimus, eritromicina o colchicina
    • Sieropositività per HIV, HCV, HBV (HBsAg positività)
    • Insufficienza epatica (Child A-C), Insufficienza renale (clearance della creatinina < 50 ml/min), insufficienza cardiaca (NYHA III-IV), diabete mellito scompensato, neoplasie, patologia neurologica/psichiatrica in atto (es. depressione, crisi psicotica, tentativo di suicidio), malattie infiammatorie croniche intestinali o ulcera gastrica/duodenale in trattamento, malattie autoimmuni
    • Ipersensibilità a cisteamina o penicillina
    • Abuso di droghe/alcol
    • Incapacità a comprendere e firmare il consenso informato
    Presenza di qualsiasi condizione fisica o psicologica che, secondo il responsabile dello studio, rende sconsigliata la partecipazione allo studio
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of patients with treatment-related AEs of grade =3 within 28 days and 90 days from the start of therapy
    • Percentage of patients with AE (all and those in serious conditions) of any degree and regardless of causality within 28 days and 90 days from the start of therapy
    • Percentage of patients who decide to stop therapy before day 10 or discharge
    • Difference between number of tablets taken and expected number of cysteamine tablets
    • Pharmacokinetic curve of cysteamine at day 6
    • Percentuale di pazienti con EA correlati al trattamento di grado =3 entro 28 giorni e 90 giorni dall’inizio della terapia
    • Percentuale di pazienti con EA (tutti e quelli in condizioni serie) di qualsiasi grado e indipendentemente dalla causalità entro 28 giorni e 90 giorni dall’inizio della terapia
    • Percentuale di pazienti che decidono di interrompere la terapia prima del giorno 10 o della dimissione
    • Differenza tra numero compresse assunte e numero compresse previste di cisteamina
    • Curva farmacocinetica di cisteamina al giorno 6
    E.5.1.1Timepoint(s) of evaluation of this end point
    • within 28 days and 90 days from the start of therapy
    • within 28 days and 90 days from the start of therapy
    • before day 10 or discharge
    • after day 10
    • at day 6
    • entro 28 giorni e 90 giorni dall’inizio della terapia
    • entro 28 giorni e 90 giorni dall’inizio della terapia
    • prima del giorno 10 o della dimissione
    • dopo il giorno 10
    • al giorno 6
    E.5.2Secondary end point(s)
    Secondary endpoints
    • Cytokines and blood biomarkers at baseline and on days 3, 7, 10 (or discharge if before day 10), 28.

    Exploratory endpoints
    • Number of days required for the SARS-COV-2 buffer to become negative.
    • Clinical status expressed by the 11 points of the WHO Clinical Progression Scale on days 7, 10 and 28.
    • Number of days until discharge from the hospital
    • Percentage of patients requiring high flow oxygen therapy within day 10
    • Percentage of patients transferred to the ICU or who died within day 28
    Endpoint secondari
    • Citochine e biomarcatori ematici al basale e ai giorni 3, 7, 10 (o dimissione se prima del 10° giorno), 28.

    Endpoint esplorativi
    • Numero dei giorni necessari alla negativizzazione del tampone per SARS-COV-2.
    • Stato clinico espresso mediante gli 11 punti della WHO Clinical Progression Scale al giorno 7, 10 e 28.
    • Numero di giorni alla dimissione dall’ospedale
    • Percentuale di pazienti che richiedono ossigenoterapia ad alti flussi entro il giorno 10
    • Percentuale di pazienti trasferiti in terapia intensiva o deceduti entro il giorno 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints
    • on days 3, 7, 10 (or discharge if before day 10), 28.

    Exploratory endpoints
    • Number of days required for the SARS-COV-2 buffer to become negative.
    • by the 11 points of the WHO Clinical Progression Scale on days 7, 10 and 28.
    • Number of days until discharge from the hospital
    • within day 10
    • within day 28
    Endpoint secondari
    • ai giorni 3, 7, 10 (o dimissione se prima del 10° giorno), 28.

    Endpoint esplorativi
    • Numero dei giorni necessari alla negativizzazione del tampone per SARS-COV-2.
    • al giorno 7, 10 e 28.
    • Numero di giorni alla dimissione dall’ospedale
    • entro il giorno 10
    • entro il giorno 28
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 and closure of clinical centers
    LVLS e chiusura dei centri clinici
    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 months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    At the end of the study, patients will be treated with the treatments required by normal clinical practice
    Al termine dello studio i pazienti saranno trattati con le cure previste dalla 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 Decision2022-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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