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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2021-006005-30
    Sponsor's Protocol Code Number:APG101_CD_018
    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:2022-11-18
    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 number2021-006005-30
    A.3Full title of the trial
    A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients with Moderate to Severe COVID-19 Disease
    Studio multicentrico, randomizzato, controllato con placebo, in doppio cieco, di fase III per valutare l'efficacia di Asunercept nel trattamento di pazienti ospedalizzati con malattia da COVID-19 da moderata a severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Asunercept for the treatment of patients with moderate to severe COVID-19 disease
    Asunercept per il trattamento di pazienti con malattia da COVID-19 da moderata a severa
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberAPG101_CD_018
    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 SponsorApogenix AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFederal Republic of Germany, represented by the Federal Ministry of Education and Research
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportApogenix AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApogenix AG
    B.5.2Functional name of contact pointSponsor's Medical Expert
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 584
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number004915115968284
    B.5.6E-maileike.buss@apogenix.com
    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 nameAsunercept
    D.3.2Product code [APG101]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNAsunercept
    D.3.9.1CAS number 1450882-18-4
    D.3.9.2Current sponsor codeAPG101
    D.3.9.4EV Substance CodeSUB31055
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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 placeboSolution for infusion in administration system
    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
    Moderate to Severe COVID-19 Disease
    Malattia COVID-19 da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe COVID-19 Disease
    Malattia COVID-19 da moderata a grave
    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
    To estimate the efficacy of Asunercept in the treatment of hospitalized patients with moderate to severe COVID-19 when given as add on to Standard of Care
    Stimare l'efficacia di Asunercept nel trattamento di pazienti ospedalizzati con malattia COVID-19 da moderata a grave, quando somministrato come aggiunta allo Standard of Care (SoC)
    E.2.2Secondary objectives of the trial
    To estimate the efficacy of Asunercept when given as add on to Standard of Care in reducing progression to more severe disease (i.e., invasive mechanical ventilation) or death
    Stimare l'efficacia di Asunercept quando somministrato come aggiunta allo SoC nel ridurre la progressione della gravità della malattia (ad esempio, necessità di ventilazione meccanica invasiva) o il decesso
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient or his/her legal authorized representative (in case the patient is unable to give consent due to his/her medical condition) has given informed consent to participate in the trial and to adhere to the procedures stated in the protocol
    2. The patient is a male or female adult aged =18 years at the time of giving informed consent
    3. The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 PCR test
    4. The patient has clinical symptoms indicative of moderate or severe illness (corresponding to score 5 [oxygen by mask or nasal prongs] or 6 [oxygen by non-invasive ventilation or high flow] on the WHO 10-point clinical progression scale) with COVID-19 prior to trial treatment on d1: Radiologically confirmed pneumonia due to COVID-19 and/ or clinical signs suggestive of moderate/severe illness with COVID-19
    5. The patient is willing to follow effective measures of contraception during the trial
    1.Il paziente o il suo rappresentante legale autorizzato (nel caso in cui il paziente non sia in grado di dare il consenso a causa della sua condizione medica) fornisce il consenso informato a partecipare allo studio e ad aderire alle procedure indicate nel protocollo
    2.Il paziente è di sesso maschile o femminile e ha un'età superiore o uguale a 18 anni al momento del consenso informato.
    3.Il paziente è ricoverato in ospedale (massimo 72 ore prima della randomizzazione) a causa di COVID-19 e ha un test positivo della reazione a catena della polimerasi (PCR) per SARS-CoV-2.
    4.Il paziente presenta sintomi clinici indicativi di malattia moderata o grave (corrispondenti a un punteggio di 5 [ossigeno tramite maschera o sondino nasale] o 6 [ossigeno tramite ventilazione non invasiva o ad alto flusso] sulla scala di progressione clinica a 10 punti dell'OMS) con COVID-19 prima del trattamento sperimentale al g1: Polmonite radiologicamente confermata dovuta a COVID-19 e/o segni clinici indicativi di malattia COVID-19 moderata/grave
    5.Il paziente è disposto a seguire misure contraccettive efficaci durante lo studio.
    E.4Principal exclusion criteria
    1. The patient is moribund or has an estimated life expectancy <1 month
    2. The patient is pregnant or breastfeeding
    3. The patient is anticipated to be discharged from hospital within 48 hrs
    4. The patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19. In addition, SoC comprises medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization)
    5. The patient requires invasive mechanical ventilation
    6. The patient is known to have active tuberculosis
    7. The patient is known to have hereditary fructose intolerance
    8. The patient is known to have co-infection with Influenza viruses or other viral respiratory infections
    9. The patient was or is currently participating in any investigational clinical study, other than observational, within 30 days prior to enrollment.
    1.Il paziente è moribondo o ha un'aspettativa di vita stimata <1 mese (per es. cancro terminale, ecc.).
    2.La paziente è in gravidanza o allattamento.
    3.Il paziente è previsto che venga dimesso dall'ospedale entro 48 ore.
    4.Il paziente necessita di farmaci antinfiammatori oltre i farmaci SoC (SoC sono farmaci approvati per il trattamento della malattia COVID-19. Inoltre, lo SoC comprende i farmaci che sono stati raccomandati nelle linee guida di trattamento delle autorità sanitarie nazionali e/o delle organizzazioni professionali).
    5. Il paziente necessita di ventilazione meccanica invasiva.
    6.È noto che il paziente è affetto da tubercolosi attiva.
    7.È noto che il paziente ha intolleranza ereditaria al fruttosio.
    8.È noto che il paziente è affetto da una coinfezione con virus influenzali o altre infezioni respiratorie virali (virus respiratorio sinciziale [RSV], virus parainfluenzali, adenovirus respiratori).
    9. Il paziente ha partecipato o sta partecipando a uno studio clinico sperimentale, esclusi studi osservazionali, nei 30 giorni precedenti l'arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    Time to sustained recovery, defined as sustained improvement (i.e.,without decrease) of >=2 points on the WHO 10-point clinical progression scale or discharge from hospital followed by being alive and at home for 14 consecutive days prior to day (d) 56, whichever occurs first
    Tempo di guarigione duraturo, definito come miglioramento prolungato (ossia senza diminuzione) di >=2 punti sulla scala di progressione clinica a 10 punti dell'OMS oppure dimissione dall'ospedale seguita dall’essere in vita e presso il proprio domicilio per 14 giorni consecutivi prima del giorno (g) 56, a seconda di quale delle due condizioni si verifichi per prima
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to 28, 35, 42, 49 & 56
    Giorno 1 al 28, 35, 42, 49 & 56
    E.5.2Secondary end point(s)
    All-cause mortality or progression to invasive mechanical ventilation
    (IMV) by d28
    Mortalità per tutte le cause o progressione alla ventilazione meccanica invasiva (IMV) entro il G28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to 28
    Giorno 1 a 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    India
    South Africa
    Austria
    France
    Poland
    Spain
    Germany
    Italy
    Georgia
    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
    the date of the last visit (Follow-up phone call) of the last patient in the trial
    la data dell'ultima visita (telefonata follow up) all'ultimo paziente nello studio
    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 months1
    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: 512
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who are not able to give consent on their own due to their medical condition
    Pazienti che non sono in grado di dare il proprio consenso a causa delle condizioni cliniche
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 640
    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)
    none
    nessuno
    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 Decision2023-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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