Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001550-22
    Sponsor's Protocol Code Number:AMY-101_SAVE
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-31
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-001550-22
    A.3Full title of the trial
    A Phase 2 Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor, AMY-101, in patients with Acute Respiratory Distress Syndrome (ARDS) due to Covid-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of the investigational drug AMY-101 to treat patients with lung disease cased by corona virus infection (Covid-19).
    A.4.1Sponsor's protocol code numberAMY-101_SAVE
    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 SponsorAmyndas Pharmaceuticals S.A.
    B.1.3.4CountryGreece
    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 supportAmyndas Pharmaceuticals S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Ulm
    B.5.2Functional name of contact pointMarkus Huber-Lang
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Einstein-Allee 23
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89081
    B.5.3.4CountryGermany
    B.5.4Telephone number+491733462132
    B.5.6E-mailmarkus.huber-lang@uniklinik-ulm.de
    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 nameAMY-101 acetate (also known as Cp40 and Cp-14 in the scientific literature/ documentation)
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available yet
    D.3.9.1CAS number 1427001-89-5
    D.3.9.2Current sponsor codeAMY-101 acetate
    D.3.9.3Other descriptive nameS3,S13-CYCLO(D-TYROLSYL-L-ISOLEUCYL-L-CYSTEINYL-L-VALYL-1-METHYL-L-TRYPTOPHYL-L-GLUTAMINYL-L-ASPARTYL-L-TRYPTOPHYL-N-METHYL-L-GLYCYL-L-ALANYL-L-HISTIDYL-L-ARGINYL-L-CYSTEINYL-N-METHYL-L-ISOLEUCINAMIDE) ACETATE
    D.3.9.4EV Substance CodeSUB208608
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Respiratory Distress Syndrome (ARDS) due to SARS-CoV-2 infection.
    E.1.1.1Medical condition in easily understood language
    Lung disease caused by corona virus infection.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the impact of AMY-101 on the time needed for clinical improvement of the patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety, further measures of clinical efficacy and PK/PD of AMY-101 in patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Hospitalized adult (age ≥ 18), of any gender, with confirmed SARSCoV-2 infection with an oxygen saturation (SaO2) of 94% or less while they were breathing ambient air, or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) of less than
    300 mm Hg.
    2.Diagnosed with SARS-CoV-2 infection, according to the following
    criteria:
    −Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swap or bronchio-alveolar lavage (BAL) (the test that will be used for SARSCoV-2 RNAemia is certified with the CE mark and will be used within
    the scope of its intended purpose)
    −Pneumonia confirmed by chest imaging (ultrasound, X-ray, CT, etc.)
    3.Dated and signed informed consent from patient.
    E.4Principal exclusion criteria
    1.Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or procalcitonin ≥0.25 μg/L)
    2.Demonstrated local extrapulmonary abscess
    3.Chemotherapy for less than 3 months
    4.Use of other investigational drug within 4 weeks or a period of 5 half-lives duration prior to Day1 (whichever is longer)
    5.Ongoing participation in any other therapeutic clinical trial XML File Identifier: UMHQJ2DEWA4np0qWjAkTqsbNM4k=
    Page 8/15 01/08/2020
    6.Hypersensitivity to the active substance or any of the ingredients of
    the IMP or placebo
    7.Pregnancy
    8.Age <18.
    E.5 End points
    E.5.1Primary end point(s)
    The time to clinical improvement, defined as the time from randomization to an improvement of two points or more (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first:
    Seven-category ordinal scale („Cao-Scale" in accordance to Cao B et al.
    NEJM 2020):
    −1: not hospitalized with resumption of normal activities;
    −2: not hospitalized, but unable to resume normal activities;
    −3: hospitalized, not requiring supplemental oxygen;
    −4: hospitalized, requiring supplemental oxygen;
    −5: hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both;
    −6: hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and
    −7: death
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily evaluation
    E.5.2Secondary end point(s)
    Secondary endpoints will include data regarding safety, tolerability, efficacy and PK of AMY-101.
    Specifically, the following assessments will be made:
    o Efficacy:
    −Rate of patients surviving on day 28.
    −Rate of patients requiring invasive mechanical ventilation due to worsening of ARDS within 14 days after inclusion in the study
    −Rate of patients requiring non-invasive mechanical ventilation (NIV) due to worsening of ARDS within 14 days after inclusion in the study
    −Changes in PaO2 and PaO2/FIO2 from day 1 to day 7
    −Changes in respiratory rate from day 1 to day 7
    −Changes in quick Sequential Organ Failure Assessment Score (qSOFA: respiratory rate, systolic blood pressure, Glasgow Coma Scale (GCS) per day (up to day 14 or up to the day of discharge, in case of discharge earlier than day 14).
    −Changes in maximal and minimal cardiovascular parameters (RR, HR) per day
    −Changes in biomarkers of inflammation (CBC, CRP, Ferritin, Procalcitonin, etc) on day 1, 2, 3, 4, 5, 7, 10, 14 or up to the day of discharge, in case of discharge earlier than day 14.
    −Length of stay in ICU
    −Duration of hospitalization
    o Safety:
    −All severe adverse events
    −All adverse events
    −All infectious events
    −Anti-drug antibodies on day 0 and 14 (or on day 0 and on day of discharge, in case of discharge earlier than day 14)
    o PK/PD (on day 1, 2, 3, 4, 5, 7, 10, 14 or up to day of discharge, in case of discharge earlier than day 14):
    −AMY-101 plasma level
    −Biomarkers of complement activity (C3, C3a, C5a, sC5b-9
    −Biomarkers of cytokine release syndrome (e.g., IL-1, IL-6, IL-12)
    −Biomarkers of lung damage (Club Cell protein CC16).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily evaluation (or as indicated for each specific endpoint).
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.3Single blind Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state100
    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)
    If the subject has ended participation, he/she will be referred to a qualified practitioner or his/her personal physician for continued care.
    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 Decision2020-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 19:34:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA