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    Summary
    EudraCT Number:2020-001498-63
    Sponsor's Protocol Code Number:BIO101-CL05
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-001498-63
    A.3Full title of the trial
    Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testing the Efficacy and Safety of BIO101, for the Prevention of Respiratory Deterioration, in Patients with COVID-19 Pneumonia (COVA study)
    A.4.1Sponsor's protocol code numberBIO101-CL05
    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 SponsorBiophytis S.A.
    B.1.3.4CountryFrance
    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 supportBiophytis S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiophytis S.A.
    B.5.2Functional name of contact pointMounia Chabane De Saint Aubin
    B.5.3 Address:
    B.5.3.1Street Address14 Avenue de l' Opéra
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75001
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)144 27 23 87
    B.5.6E-mailmounia.chabane@biophytis.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 nameBIO101
    D.3.2Product code BIO101
    D.3.4Pharmaceutical form Capsule
    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 INNNA
    D.3.9.1CAS number 5289-74-7
    D.3.9.2Current sponsor codeBIO101
    D.3.9.3Other descriptive name20-hydroxyecdysone
    D.3.9.4EV Substance CodeSUB193629
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Confirmed infection with SARS-CoV-2 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Corona virus (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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10047465
    E.1.2Term Viral infections NEC
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    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
    Part 1
    • Ascertain the safety and tolerability of BIO101, in order to begin recruitment to part 2
    • Obtain preliminary indication of activity of BIO101, in preventing respiratory deterioration in the target population

    Part 2
    • Re-assess the sample size that is needed for the confirmatory part of the study
    • Provide confirmation on the benefit of BIO101 in the target population
    • Identify and assess potential biomarkers for further understanding of the effect of BIO101 in the target population
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 45 and older.
    2. A confirmed diagnosis of COVID-19 infection, within the last 14 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used.
    3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration >=3 days
    4. With evidence of pneumonia based on all of the following:
    a. Clinical findings on a physical examination
    b. Respiratory symptoms developed within the past 7 days
    5. With evidence of respiratory decompensation that started not more than 4 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff:
    a. Tachypnea: ≥25 breaths per minute
    b. Arterial oxygen saturation ≤92%
    c. A special note should be made if there is suspicion of COVID-19-related myocarditis or pericarditis, as the presence of these is a stratification criterion
    6. Without a significant deterioration in liver function tests:
    a. ALT and AST ≤ 5x upper limit of normal (ULN)
    b. Gamma-glutamyl transferase (GGT) ≤ 5x ULN
    c. Total bilirubin ≤ 5×ULN
    7. Willing to participate and able to sign an informed consent form (ICF).Or, when relevant, a legally authorized representative (LAR) might sign the ICF on behalf of the study participant
    8. Female participants should be:
    at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile;
    OR
    a. Have a negative urine pregnancy test at screening
    b. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose.
    9. Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product;
    Note: medically acceptable methods of contraception that may be used by the participant and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy.
    10. Female participant who are lactating must agree not to breastfeed during the study and up to 14 days after the intervention.
    11. Male participants must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product;
    12. For France only: Being affiliated with a European Social Security.
    E.4Principal exclusion criteria
    1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication)
    2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions
    3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow-Oxygen*
    4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water).
    5. Disallowed concomitant medication:
    a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents)
    6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101
    7. Renal disease requiring dialysis, or known renal insufficiency (eGFR≤30 mL/min/1.73 m2, based on Cockroft & Gault formula)
    8. In France:
    o Non-affiliation to compulsory French social security scheme (beneficiary or right-holder)
    o Being under tutelage or legal guardianship
    * High-flow oxygen is defined as deliverey of oxygen at a flow ≥of 16L/min
    E.5 End points
    E.5.1Primary end point(s)
    For end-of-part-1 interim analysis:

    For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:

    Safety and tolerability to BIO101:

    • SUSARs, SAEs, AESIs, AEs
    • Vital signs
    • Safety labs (including testicular biomarkers)
    • ECGs

    For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:

    Primary:

    • Proportion of participants with ‘negative’ events, of either of the following:
    o All-cause mortality
    o Respiratory failure, defined as any of the following:
    - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
    - Requiring ECMO
    - Requiring high-flow oxygen

    Secondary:

    • SpO2/FiO2
    • Inflammatory markers including:
    o IL 6
    o TNF╬▒
    o D-dimer
    • RAS / MAS biomarkers:
    o Angiotensin 2
    o Angiotensin-converting enzyme (ACE) levels

    For part-2 sample size interim analysis:

    For sample size re-assessment for part 2, time frame – up to 28 days:

    • Proportion of participants with ‘negative’ events, of either of the following:
    o All-cause mortality
    o Respiratory failure, defined as any of the following:
    - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
    - Requiring ECMO
    - Requiring high-flow oxygen

    For the final analysis:

    Primary, time frame – up to 28 days:

    • Proportion of participants with ‘negative’ events, of either of the following:
    o All-cause mortality
    o Respiratory failure, defined as any of the following:
    - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
    - Requiring ECMO
    - Requiring high-flow oxygen
    E.5.1.1Timepoint(s) of evaluation of this end point
    For end-of-part-1 interim analysis:
    For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:

    For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:

    For part-2 sample size interim analysis:
    For sample size re-assessment for part 2, time frame – up to 28 days:

    For the final analysis:
    Primary, time frame – up to 28 days:
    E.5.2Secondary end point(s)
    Key secondary:
    • Proportion of participants with events of respiratory failure, defined as any of the following:
    o Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
    o Requiring ECMO
    o Requiring high-flow oxygen
    • Proportion of participants with ‘positive’ events:
    o official discharge from hospital care by the department due to improvement in participant condition (self-discharge by particpant is not considered a positive event)
    • Proportion of participants with events of all-cause mortality


    Additional secondary endpoints:
    • SpO2/FiO2
    • Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2)
    • Time to events, of either of the following:
    o All-cause mortality
    o Respiratory failure, defined as any of the following:
    - Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)
    - Requiring ECMO
    - Requiring high-flow oxygen
    • Time to event: official discharge from hospital care due to improvement
    • The National Early Warning Score 2 (NewS2)
    • Proportion of participants with CPAP/BiPAP events, defined as requiring CPAP/BiPAP in participants entering the study on low flow oxygen)
    • For participants who experienced a ‘positive’ event: proportion of participants with sustained positive outcome (to assess durability of effect after those participants discontinued study medication)
    • Population-PK study (pop-PK)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the trial
    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 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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    placebo-controlled, group sequential and adaptive
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    France
    United Kingdom
    United States
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 465
    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)
    see protocol
    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 Decision2020-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
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