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    Summary
    EudraCT Number:2020-002972-11
    Sponsor's Protocol Code Number:BRN-C-2019-02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002972-11
    A.3Full title of the trial
    Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms: a national, multicentre, randomized, controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms
    A.3.2Name or abbreviated title of the trial where available
    GOSCI
    A.4.1Sponsor's protocol code numberBRN-C-2019-02
    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 SponsorBOIRON
    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 supportBOIRON
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKAPPA SANTE
    B.5.2Functional name of contact pointProjects management desk
    B.5.3 Address:
    B.5.3.1Street Address4 rue de Cléry
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75002
    B.5.3.4CountryFrance
    B.5.4Telephone number3301 44 82 74 74
    B.5.5Fax number3301 44 82 74 75
    B.5.6E-mailgosci@kappasante.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 Yes
    D.2.1.1.1Trade name Oscillococcinum
    D.2.1.1.2Name of the Marketing Authorisation holderBOIRON
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameOscillococcinum
    D.3.4Pharmaceutical form Pillules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOscilllococcinum
    D.3.9.3Other descriptive nameAnas barbariae, hepatis et cordis extractum
    D.3.9.4EV Substance CodeSUB184507
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Yes
    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 placeboPillules
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza-like illness (ILI) symptoms
    E.1.1.1Medical condition in easily understood language
    Influenza-like illness (ILI) symptoms
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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
    To evaluate the efficacy of Oscillococcinum® in the alleviation of ILI symptoms within 72h following the beginning of the first intake of medication.
    E.2.2Secondary objectives of the trial
    •To assess the effects of Oscillococcinum® on:
    -The alleviation of ILI symptoms within the first 72 hours (primary objective) and maintained over at least 24 hours
    -The alleviation of ILI symptoms within the first 48 hours following the beginning of the treatment
    -The reduction of time to alleviation of symptoms
    -The improvement of the ability to perform daily activities

    •To describe the effects of Oscillococcinum® on :
    -The improvement of sleep quality
    -The alleviation of other symptoms (fatigue, nasal congestion, gastro-intestinal disturbances)
    -The decrease in the development of secondary outcomes

    •To describe the patient’s compliance regarding the use of Oscillococcinum

    •To evaluate the tolerability of Oscillococcinum

    •To evaluate the patients’ and physicians’ satisfaction regarding the efficacy of Oscillococcinum.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged ≥ 18
    - Patients accepting to participate in the study through signing informed consent;
    - Patients with ILI defined as sudden onset of symptoms and at least one of the following systemic symptoms: fever (≥37.8°C) or feverishness (feeling of fever or a chill), malaise headache, myalgia (= assessment mild, moderate or severe for at least one of these symptoms) and at least one of the following respiratory symptom: cough, sore throat, shortness of breath (= assessment mild, moderate or severe for at least one of these symptoms), of less than 24h hours duration.
    - Patients able to take the first dose of study medication within 24 hours following the first symptoms of ILI.
    E.4Principal exclusion criteria
    - Patients refusing to sign the informed consent,
    - Patients with unstable or uncontrolled renal, cardiac, pulmonary, vascular, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), or immunodeficiency disorders, cancer, hepatitis, cirrhosis, asthma or chronic obstructive pulmonary disease (COPD)
    - Participation in a clinical study with an investigational drug within 4 weeks prior to study entry
    - Patients who experienced a previous episode of acute upper respiratory tract infection (URTI), sinusitis, bronchitis, otitis or pneumonia within 4 weeks prior to the Initial Visit
    - Patients taking corticosteroids or immuno-suppressant therapies within 2 months prior to the Initial Visit
    - Patients with evidence/history of alcoholism, drug abuse, psychiatric disorders (including dementia or dementia like syndrome) or any other medical condition that could affect the study completion or data collection
    - Treatment within 2 weeks prior to the Initial Visit with antiviral drugs such as neuraminidase inhibitors (Tamiflu®, Relenza®, Inavir®), or amantadine (Symmetrel®)
    - Treatment within 1 week prior to Initial Visit with Oscillococcinum® or antibiotics related to respiratory tract infection
    - Treatment within 1 week prior to Initial Visit with antipyretics other than paracetamol, analgesics, decongestants
    - Treatment within 1 week prior to Initial Visit with homeopathic medicine related to ILI at baseline or any other herbal medicine product or dietary supplement known to affect immune and/or inflammatory response
    - Patients with any other disease that requires immediate start of antibiotic treatment related to respiratory tract
    - Pregnant or breast-feeding women
    - Patients with intolerance of fructose, malabsorption of glucose or galactose, sucrase/isomaltase deficit
    - Any other condition which according to the investigator’s judgement is not compatible with the principles of the study, e.g. inability to give informed consent, inability to complete the electronic diary
    - Unaffiliated or non-beneficiary of a social security system patient as well as deprived of liberty (article L1121-6 of Code de la Santé Publique) or protected (article L1121-8) adults
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the proportion of patients with alleviation of ILI symptoms recorded at baseline within 72 hours following the initiation of treatment at initial visit.

    Definition of ILI:
    According to the definition of the Official Journal of European Union (OJEU) (1) ILI is defined as:
    •A sudden apparition of symptoms
    •AND at least one of the three following respiratory symptoms: cough, sore throat, shortness of breath
    •AND at least one of the four following systemic symptoms: fever or feverishness, headache, malaise, myalgia.

    Fever is considered as body temperature ≥ 37.8 °C (2) .
    Feverishness is defined as the patient’s subjective symptom of feeling like they had a fever or chill.

    Assessment of ILI symptoms:
    Patients will assess each symptom of ILI difined above as none, mild, moderate or severe on a diary. Regarding fever, they will indicate their body temperature with a digital thermometer through oral route.

    The definitions of symptoms intensity are as follows:
    •None (0 point): symptom is not present
    •Mild (1 point): patient is aware of the symptom, but can tolerate it
    •Moderate (2 points): the discomfort resulting from the symptom leads to a reduction of the patient’s usual level of activity
    •Severe (3 points): patient experiences a significant impairment of functioning

    As for fever, it is considered mild from 37.8 to 38.4°C, moderate from 38.5° to 39.0°C, severe is from 39.1°C onwards.

    In order to measure the secondary efficacy endpoint that refers to symptom alleviation maintained over at least 24 hours, the investigators will instruct the patients to continue with completing the diaries as scheduled until the Final Visit, even if their symptoms have ceased.

    Definition of ILI symptoms alleviation:
    The proportion of patients with alleviation of symptoms within 72 hours will be calculated as the % of patients, 72h after the first intake of study medication, with:
    •Alleviation of all symptoms defined as the decrease of at least one stage of severity for each symptom recorded at inclusion, i.e.:
    - if recorded as ‘severe’ at inclusion  recorded as ‘moderate’, ‘mild’ or ‘none’ at 72h,
    - if recorded as ‘moderate’ at inclusion  recorded as ‘mild’ or ‘none’ at 72h,
    - or if recorded as ‘mild’ at inclusion recorded as ‘none’ at 72h).
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours following the initiation of treatment at initial visit
    E.5.2Secondary end point(s)
    •Alleviation of ILI symptoms within 72h according to the primary outcome and maintained over at least 24h. Reappearance or worsening of ILI symptoms will be assessed through daily reports of ILI symptoms by the patient until Final Visit.
    •Alleviation of ILI symptoms recorded at inclusion within 48h following the initiation of treatment

    •The reduction of time to alleviation of symptoms will bi assessed through several criteria:
    -Time to alleviation of symptoms of ILI, defined as the time needed for alleviation of systemic flu-like symptoms, including no fever (body temperature <37.8°C) or reduction of 0.5°C from baseline AND alleviation of respiratory flu-like symptoms.
    -Time to alleviation of systemic flu-like symptoms.
    -Time to alleviation of respiratory flu-like symptoms.
    -Time to alleviation of each symptom.

    •To evaluate the efficacy of Oscillococcinum in the improvement of the ability to perform daily activities”
    -Time to return to usual daily activities and perform these as normal. Usual daily activities will be captured by the patient once a day in the evening based on the following criteria ‘Activities you normally would have done today’. 'These activities will be accessessed as ‘not possible’, ‘possible but difficult’, or ‘can be done as normal’,
    -Number of days of absence from work/school (if applicable). These data will be captured by the patient during the Final Visit,
    - Number of days with sick certificate: the days covered by a sick certificate will be recorded by the patient during the Final Visit, as appropriate.
    •To descrive the improvement of sleep quality
    The improvement of sleep quality, recorded in a Visual Analogic Scale once a day (at morning).

    • To describe the alleviation of other symptoms
    Alleviation of other ILI symptoms such as fatigue, nasal congestion and gastro-intestinal disturbances will be described at 72h. These symptoms will be recorded as main ILI symptoms three times a day during the first 72h and then twice a day until Final Visit.

    • To describe the efficacy of Oscillococcinum® in the development of secondary complications
    Incidence of secondary complications of influenza-like illness such as sinusitis, bronchitis, otitis, pneumonia as well as unplanned additional visits and hospitalisations related to ILI will be described. Secondary complications will be captured by the investigator during the Final Visit.

    • To describe the patients’ and physicians’ satisfaction regarding the efficacy of Oscillococcinum®
    The patient and the investigator will be asked to assess their satisfaction with the study treatment efficacy during the Final Visit independently from each other using the following categories: ‘very good’, ‘good’, ‘neutral’, ‘poor’, ‘very poor’.

    • To describe patients’ compliance regarding the use of Oscillococcinum®
    Compliance will be assessed by two means:
    - through the patient diary (ePRO) : the patient will record each dose taken in the diary
    - by counting the unused doses at the Final Visit to obtain the number of doses used and to compare the number of doses actually used with the number of doses expected to be used. Patients will be considered as compliant if their actual dose consumption differs by not more than ± 1 dose from the number of doses expected to be used.

    • To evaluate the tolerability of Oscillococcinum®
    Occurrence of Adverse Events (AE), Serious Adverse Event (SAE) and AE/SAE related to treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From initial visit (day 0) to final visit (day 10)
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned80
    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 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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state800
    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)
    Treatment has to been taken only 3 days by episode of ILI. A follow-up of 7 days after the end of the treatment is included in the protocol of the study. After the end of the study, the care of the patient shoud be the same as the usual.
    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 Decision2020-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-09
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