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   43857   clinical trials with a EudraCT protocol, of which   7284   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:2020-001671-32
    Sponsor's Protocol Code Number:STS-BDB001-04
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-001671-32
    A.3Full title of the trial
    A multi-center, open-label, randomized parallel controlled evaluation on the efficacy and safety of BDB-001 injection in the treatment of progressive severe COVID-19 in phase II
    Evaluación de fase II, multicéntrica, abierta, aleatorizada y controlada con grupos paralelos de la eficacia y la seguridad del BDB-001 inyectable en el tratamiento de la COVID-19 severa progresiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the efficacy and safety of a new compound for the treatment of COVID-19, called BDB-001. Patients in the trial will be randomly allocated to either the new treatment or the conventional treatment and will be aware of which treatment they are receiving
    A.4.1Sponsor's protocol code numberSTS-BDB001-04
    A.5.4Other Identifiers
    Name:NMPANumber:020L00003
    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 SponsorStaidson (Beijing) Biopharmaceutical Co., Ltd. and Beijing Defengrui Biological Technology Co., Ltd.
    B.1.3.4CountryChina
    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 supportStaidson (Beijing) Biopharmaceutical Co., Ltd. and Beijing Defengrui Biological Technology Co., Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStaidson Biopharma Inc.
    B.5.2Functional name of contact pointLixin Jiang
    B.5.3 Address:
    B.5.3.1Street Address2600 Hilltop Drive, Building E
    B.5.3.2Town/ cityRichnond, CA
    B.5.3.3Post code94806
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16283002288
    B.5.5Fax number+15109570288
    B.5.6E-maillxjiang@staidsonbio.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 nameBDB-001
    D.3.2Product code BDB-001
    D.3.4Pharmaceutical form Solution for infusion in administration system
    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 INNnot available
    D.3.9.2Current sponsor codeBDB-001
    D.3.9.3Other descriptive nameAnti-C5AR1 IgG1 human monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    Hospitalized patients with COVID-19
    Pacientes hospitalizados con 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 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy and safety assessments of BDB-001 for infusion in treating patients with progressive severe COVID-19.
    Evaluación de la eficacia y la seguridad de BDB-001 para perfusión en el tratamiento de pacientes con COVID-19 severa progresiva
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 18-80 years old; Gender: male and/or female.
    2. Subject with confirmed severe COVID-19 in less than 5 days who meets any of the following criteria:
    a. Respiratory distress, RR ≥30 times/min
    b. In resting state, finger oxygen saturation ≤93%
    c. Oxygenation Index (PaO2/FiO2)≤300 mmHg (1 mmHg = 0.133kpa) in supine position
    d. Pulmonary imaging shows lesion progression >50% within 24 – 48 hours.
    3. The informed consent signed.
    1. Edad: 18-80 años; Sexo: varones y/o mujeres.
    2. Sujeto con COVID-19 severa confirmada en menos de 5 días que cumple cualquiera de los siguientes criterios:
    a. Dificultad respiratoria, frecuencia respiratoria ≥ 30 respiraciones por minuto
    b. Saturación de oxígeno periférica en reposo ≤ 93%
    c. Índice de oxigenación (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0,133 kpa) en decúbito supino
    d. Progresión de las lesiones en las pruebas de diagnóstico por imagen pulmonares >50% en un plazo de 24 a 48 horas.
    3. Firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Subjects already progressed into COVID-19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock.
    2. History of severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis; history of severe heart disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥grade 3 (NYHA Classification); history of severe liver diseases (e.g. Child-Pugh score ≥grade C); history of severe kidney diseases, such as renal insufficiency (GFR ≤15 mL/min/1.73m2); immune deficiencies or immune- related diseases : including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies.
    3. Clear diagnosis of combined bacterial, fungal infections which would disturb the study results according to the opinion of the investigator
    4. Subjects on current treatment with a complement inhibitor such as eculizumab.
    5. Subjects with a history of hypersensitivity to any ingredient contained in the study drug
    6. A subject has used the following drugs within 2 weeks prior to screening procedures:
    • Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
    • Immunosuppressant (e.g., everolimus, sirolimus, etc.)
    • Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
    7. Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include:
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    • Intrauterine device
    • Intrauterine hormone-releasing system
    • Bilateral tubal occlusion
    • Vasectomized partner
    8. Any other circumstances that the investigator considers inappropriate for the participation in this study.
    1. Sujetos que ya hayan progresado a COVID-19 severa crítica (con insuficiencia respiratoria que precise ventilación mecánica, o shock, o asociada a otra insuficiencia orgánica) o sepsis y shock séptico;
    2. Antecedentes de enfermedad pulmonar severa, como enfermedad pulmonar obstructiva crónica (EPOC) (moderada o severa), cáncer de pulmón, tuberculosis; antecedentes de cardiopatía severa: angina de pecho inestable, infarto de miocardio, cirugía cardiaca previa, clase funcional cardiaca de grado ≥ 3 (clasificación de la NYHA); antecedentes de hepatopatía severa(puntuación de Child Pugh de grado ≥ C); antecedentes de nefropatía severa, como insuficiencia renal (con tasa de filtración glomerular [TFG] ≤ 15 ml/min/1,73 m2); inmunodeficiencias o enfermedades del sistema inmunitario, tales como ciertas enfermedades autoinmunitarias, enfermedades relacionadas con IgG4, alveolitis alérgica, vasculitis; tumores malignos.
    3. Diagnóstico claro de infecciones bacterianas o fúngicas asociadas que alterarían los resultados del estudio, a juicio del investigador;
    4. Sujetos en tratamiento con ihibidores del complemento tales como ecolizumab
    5. Sujectos con historia de hipersensibilidad a cualqueira de los ingredientes del farmaco de estudio
    6. Tratamiento con los siguientes medicamentos en las 2 semanas previas a los procedimientos de la selección:
    • Inhibidores de la calcineurina (p. ej., ciclosporina, tacrólimus, etc.)
    • Inmunosupresores (p. ej., everólimus, sirólimus, etc.)
    • Antimetabólicos (p. ej., micofenolato mofetilo, micofenolato, sulfato de purina, etc.)
    7. Mujer embarazada o en periodo de lactancia. Prueba de embarazo en suero positiva en el cribado en mujeres en edad fértil. Se considera que una mujer tiene un potencial de procreación, es decir, fértil, después de la menarquia (primer ciclo menstrual) y hasta volverse post menopáusica a menos que sea permanentemente estéril: los métodos de esterilización permanente incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral. Un estado post menopáusico se define como la ausencia de menstruaciones durante 12 meses sin una causa médica alternativa. Las mujeres en edad fértil deben abstenerse de tener relaciones sexuales o utilizar métodos anticonceptivos efectivos durante 1 mes después de que finalice su participación en el estudio. Los hombres con una pareja capaz de tener hijos deben abstenerse de tener relaciones sexuales o utilizar métodos anticonceptivos efectivos durante 3 meses después de que finalice su participación en el estudio. Entre estos métodos se incluyen:
    • Anticoncepción hormonal combinada (que contenga estrógeno y progestágeno) asociada a inhibición de la ovulación (oral, intravaginal, transdérmica)
    • Anticoncepción hormonal que únicamente contenga progestágeno asociada a inhibición de la ovulación (oral, inyectable, implantable)
    • Dispositivo intrauterino
    • Sistema intrauterino de liberación hormonal
    • Ligadura de trompas bilateral
    • Pareja sometida a vasectomía
    8. Cualquier otra circunstancia que el investigador considere inadecuada para la participación en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patient number (%) achieve recovery [Oxygenation index ≥300mmHg from baseline (day 1 prior to investigational drug administration), in supine position OR discharge from hospital].
    Porcentaje de pacientes (%) que logren la recuperación [Indice de oxigenación ≥300 mmHg desde el momento basal, (día 1 antes de la administración del fármaco en investigación] en decúbito supino o el alta hospitalaria].
    E.5.1.1Timepoint(s) of evaluation of this end point
    days 3, 7, 11, 14.
    dias 3, 7, 11, 14
    E.5.2Secondary end point(s)
    1. Time for oxygenation index recovery to normal (≥300mmHg) or discharge from hospital based on the record on day 3,7,11,14.
    2. Mean change in the oxygenation index
    3. Mechanical ventilation time
    4. Oxygen therapy
    5. Change in inflammation indicators (CRP or IL-6) from baseline.
    6. Improvement in body temperature
    7. 28-day all-cause mortality rate
    8. Mean change from baseline in the clinical improvement ordinal scale recommended by the WHO R&D Blueprint during treatment period.
    9. Improvement in the ordinal scale at D3, D7, D11 & D14
    1. Tiempo hasta la vuelta a la normalidad del índice de oxigenación (≥300 mmHg) o al alta hospitalaria según los registros de los días 3, 7, 11 y 14
    2. Cambio medio en el índice de oxigenación
    3. Tiempo de ventilación mecánica
    4. Oxigenoterapia
    5. Cambio de los indicadores de inflamación (proteína C-reactiva o IL-6) respecto al valor basal
    6. Mejoría de la temperatura corporal
    7. Tasa de mortalidad por cualquier causa a los 28 días
    8. Cambio medio desde el inicio en la escala ordinal de mejora clínica recomendada por la OMS durante el período de tratamiento.
    9. Mejoría en la escala ordinal los dias 3, 7, 11 y 14
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 3, 7, 11, 14 and at the end of the study
    dias 3, 7, 11, 14 y al final del estudio
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    conventional treatment
    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 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 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
    LPLV
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 35
    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 No
    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 2020-05-31. 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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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
    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 Decision2020-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-25
    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-Wed Apr 24 16:04:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA