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    Clinical Trial Results:
    Efficacy of Oscillococcinum® in the treatment of Influenza-like-illness symptoms: a national, multicentre, randomized, controlled trial

    Summary
    EudraCT number
    		 2020-002972-11
    Trial protocol
    		 FR   BE  
    Global end of trial date
    29 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2025
    First version publication date
    29 May 2025
    Other versions
    Summary report(s)
    		 CSR Gosci Summary V1.0 01/AUG/2024

    Trial information

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    Trial identification
    Sponsor protocol code
    BRN-C-2019-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BOIRON
    Sponsor organisation address
    2 Av. de l'Ouest Lyonnais, Messimy, France, 69510
    Public contact
    Projects management desk , KAPPA SANTE, 33 01 44 82 74 74, gosci@kappasante.com
    Scientific contact
    Projects management desk , KAPPA SANTE, 33 01 44 82 74 74, gosci@kappasante.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Oct 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.
    Protection of trial subjects
    Oscillococcinum® is a well-known and long-used medicine with no expected side effects. Non inclusion criteria : (For France) 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. (For Belgium) Adult patient deprived of liberty or incapable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 675
    Worldwide total number of subjects
    680
    EEA total number of subjects
    680
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    649
    From 65 to 84 years
    30
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Investigators ensure all criteria for inclusion and non-inclusion are checked. They inform each eligible patient in detail about the study, as required by the GCP guideline and specified in the patient information sheet (PIS). Each patient is given the PIS and the opportunity to ask questions. After study consent, the study procedures start.

    Pre-assignment
    Screening details
    		 Investigators (PIs) are invited to sensitise eligible patients to the study and to the monitoring of ILI symptoms occurrence. Those patients are invited to quickly contact the PIs to be enrolled in the study within 12 hours after ILI symptoms start ideally and up to 24 hours. Information is posted inmedical offices of PIs and through flyers.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The investigational drug blind was maintained using the IWRS. The investigator used the IWRS to randomise the patient into the study. He/she provided the necessary patient-identifying information, including the patient number assigned at screening. The medication identification (ID) number of the investigational drug to be dispensed was assigned by the IWRS.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo group
    Arm description
    		 Placebo contained 0.85 g sucrose plus 0.15 g lactose; it was not possible to differentiate it from Oscillococcinum® by its appearance and taste.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pillules in single-dose container
    Routes of administration
    Sublingual use
    Dosage and administration details
    Oscillococcinum® and placebo will be taken with 3 doses per day over 3 days. Each dose is to be taken orally. The entire content of a dose should be left melted under the tongue. The time of intake of the first dose during Initial Visit will be documented in the investigator CRF. From then onwards, the intake of each dose of study medication is to be documented in the diary as ‘taken dose’ or ‘missed dose’. Patients will be instructed to take all 9 doses as scheduled even if they are free of symptoms.

    Arm title
    		 Oscillococcinum®
    Arm description
    		 Oscillococcinum® will contain the extract from Anas barbariae, hepatis and cordis 200K plus 0.85 g sucrose plus 0.15 g lactose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oscillococcinum
    Investigational medicinal product code
    PRD4449039
    Other name
    Pharmaceutical forms
    Pillules in single-dose container
    Routes of administration
    Sublingual use
    Dosage and administration details
    The dosage of Oscillococcinum® in the study has been chosen based on the literature and on the approved dosage and notice used in countries participating to the study. Oscillococcinum® and placebo will be taken with 3 doses per day over 3 days. Each dose is to be taken orally. The entire content of a dose should be left melted under the tongue. The time of intake of the first dose during Initial Visit will be documented in the investigator CRF. From then onwards, the intake of each dose of study medication is to be documented in the diary as ‘taken dose’ or ‘missed dose’. Patients will be instructed to take all 9 doses as scheduled even if they are free of symptoms. The doses are to be taken 3 times each day, every 6 hours as compatible with the patient’s daily routine. The suggested schedule for intake is: · first dose in the morning defined as 12.01 am to 12pm · second dose at noon defined as 12.01pm to 06pm · third dose in the evening defined as 06.01pm to 12 am

    Number of subjects in period 1
    		Placebo group Oscillococcinum®
    Started
    338
    342
    Completed
    331
    333
    Not completed
    7
    9
         Protocol deviation
    7
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo contained 0.85 g sucrose plus 0.15 g lactose; it was not possible to differentiate it from Oscillococcinum® by its appearance and taste.

    Reporting group title
    Oscillococcinum®
    Reporting group description
    		 Oscillococcinum® will contain the extract from Anas barbariae, hepatis and cordis 200K plus 0.85 g sucrose plus 0.15 g lactose.

    Reporting group values
    		 Placebo group Oscillococcinum® Total
    Number of subjects
    		 338 342 680
    Age categorical
    Units: Subjects
        Adults <30 years
    		 107 107 214
        Adults ≥30 years
    		 231 235 466
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 36.5 (27 to 48) 36.5 (27 to 50) -
    Gender categorical
    Units: Subjects
        Male
    		 91 83 174
        Female
    		 247 259 506
    BMI (kg/m²) (classes)
    Units: Subjects
        Underweight (<18.5)
    		 19 14 33
        Healthy weight [18.5-25[
    		 167 186 353
        Overweight [25-30[
    		 84 94 178
        Obesity ≥30
    		 68 47 115
        Missing
    		 0 1 1
    Seasonal influenza vaccination
    Units: Subjects
        Yes
    		 36 38 74
        No
    		 302 304 606
    SARS-CoV2 vaccination
    Units: Subjects
        Yes
    		 200 205 405
        No
    		 64 56 120
        Missing
    		 74 81 155
    BMI
    Units: kg/m²
        median (inter-quartile range (Q1-Q3))
    		 24.5 (21.8 to 28) 24 (21.6 to 27.7) -
    Height
    Units: meters
        median (inter-quartile range (Q1-Q3))
    		 1.67 (1.61 to 1.73) 1.67 (1.61 to 1.73) -
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 70 (60 to 82) 68 (60 to 78) -
    Subject analysis sets

    Subject analysis set title
    Oscillococcinum® - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study medication. It would include any patient who accidently received study medication, but was not randomised in this study.

    Subject analysis set title
    Oscillococcinum® - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Defined according to the intention-to-treat principle, to consider all randomised patients who received at least one dose of study medication. NB: - The reason for exclusion from analyses will be reviewed and discussed during data review. - Despite the exclusion of patients who took no study medication, all patients will be analysed in the group to which they were initially assigned; the decision of whether or not to begin treatment could not be influenced by knowledge of the assigned treatment.

    Subject analysis set title
    Oscillococcinum® - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the full analysis set excluding patients with major protocol deviations*. *The classification of major and minor protocol deviations and the resulting definition of analysis sets will be performed prior to unblinding and will be approved by the Sponsor at the data review meeting.

    Subject analysis set title
    Placebo - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study medication. It would include any patient who accidently received study medication, but was not randomised in this study.

    Subject analysis set title
    Placebo - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Defined according to the intention-to-treat principle, to consider all randomised patients who received at least one dose of study medication. NB: - The reason for exclusion from analyses will be reviewed and discussed during data review. - Despite the exclusion of patients who took no study medication, all patients will be analysed in the group to which they were initially assigned; the decision of whether or not to begin treatment could not be influenced by knowledge of the assigned treatment.

    Subject analysis set title
    Placebo - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the full analysis set excluding patients with major protocol deviations*. *The classification of major and minor protocol deviations and the resulting definition of analysis sets will be performed prior to unblinding and will be approved by the Sponsor at the data review meeting.

    Subject analysis sets values
    		 Oscillococcinum® - SAF Oscillococcinum® - FAS Oscillococcinum® - PP Placebo - SAF Placebo - FAS Placebo - PP
    Number of subjects
    342
    342
    333
    338
    338
    331
    Age categorical
    Units: Subjects
        Adults <30 years
    107
    107
    107
    107
    107
    106
        Adults ≥30 years
    235
    235
    226
    231
    231
    225
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    36.5 (27 to 48)
    36.5 (27 to 48)
    36 (27 to 48)
    36.5 (27 to 50)
    36.5 (27 to 50)
    36 (27 to 50)
    Gender categorical
    Units: Subjects
        Male
    83
    83
    79
    91
    91
    88
        Female
    259
    259
    254
    247
    247
    243
    BMI (kg/m²) (classes)
    Units: Subjects
        Underweight (<18.5)
    14
    14
    14
    19
    19
    19
        Healthy weight [18.5-25[
    186
    186
    181
    167
    167
    164
        Overweight [25-30[
    94
    94
    90
    84
    84
    83
        Obesity ≥30
    47
    47
    47
    68
    68
    65
        Missing
    1
    1
    1
    0
    0
    0
    Seasonal influenza vaccination
    Units: Subjects
        Yes
    38
    38
    36
    36
    36
    34
        No
    304
    304
    297
    302
    302
    297
    SARS-CoV2 vaccination
    Units: Subjects
        Yes
    205
    205
    203
    200
    200
    198
        No
    56
    56
    56
    64
    64
    64
        Missing
    81
    81
    74
    74
    74
    69
    BMI
    Units: kg/m²
        median (inter-quartile range (Q1-Q3))
    24 (21.6 to 27.7)
    24 (21.6 to 27.7)
    24 (21.5 to 27.7)
    24.5 (21.8 to 28)
    24.5 (21.8 to 28)
    24.5 (21.7 to 27.9)
    Height
    Units: meters
        median (inter-quartile range (Q1-Q3))
    1.67 (1.61 to 1.73)
    1.67 (1.61 to 1.73)
    1.67 (1.61 to 1.73)
    1.67 (1.61 to 1.73)
    1.67 (1.61 to 1.73)
    1.67 (1.61 to 1.73)
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    68 (60 to 78)
    68 (60 to 78)
    68 (60 to 78)
    70 (60 to 82)
    70 (60 to 82)
    70 (60 to 82)

    End points

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    End points reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 Placebo contained 0.85 g sucrose plus 0.15 g lactose; it was not possible to differentiate it from Oscillococcinum® by its appearance and taste.

    Reporting group title
    Oscillococcinum®
    Reporting group description
    		 Oscillococcinum® will contain the extract from Anas barbariae, hepatis and cordis 200K plus 0.85 g sucrose plus 0.15 g lactose.

    Subject analysis set title
    Oscillococcinum® - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study medication. It would include any patient who accidently received study medication, but was not randomised in this study.

    Subject analysis set title
    Oscillococcinum® - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Defined according to the intention-to-treat principle, to consider all randomised patients who received at least one dose of study medication. NB: - The reason for exclusion from analyses will be reviewed and discussed during data review. - Despite the exclusion of patients who took no study medication, all patients will be analysed in the group to which they were initially assigned; the decision of whether or not to begin treatment could not be influenced by knowledge of the assigned treatment.

    Subject analysis set title
    Oscillococcinum® - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the full analysis set excluding patients with major protocol deviations*. *The classification of major and minor protocol deviations and the resulting definition of analysis sets will be performed prior to unblinding and will be approved by the Sponsor at the data review meeting.

    Subject analysis set title
    Placebo - SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one dose of study medication. It would include any patient who accidently received study medication, but was not randomised in this study.

    Subject analysis set title
    Placebo - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Defined according to the intention-to-treat principle, to consider all randomised patients who received at least one dose of study medication. NB: - The reason for exclusion from analyses will be reviewed and discussed during data review. - Despite the exclusion of patients who took no study medication, all patients will be analysed in the group to which they were initially assigned; the decision of whether or not to begin treatment could not be influenced by knowledge of the assigned treatment.

    Subject analysis set title
    Placebo - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the full analysis set excluding patients with major protocol deviations*. *The classification of major and minor protocol deviations and the resulting definition of analysis sets will be performed prior to unblinding and will be approved by the Sponsor at the data review meeting.

    Primary: Alleviation of all symptoms at 72h - FAS

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    End point title
    		 Alleviation of all symptoms at 72h - FAS
    End point description
    *155 patients without PRO measurement at 72h.
    End point type
    Primary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    93
    77
        No
    173
    182
        Missing
    76
    79
    Statistical analysis title
    		 Alleviation of all symptoms at 72h
    Comparison groups
    Placebo - FAS v Oscillococcinum® - FAS
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.45

    Primary: Alleviation of all symptoms at 72 - PP

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    End point title
    		 Alleviation of all symptoms at 72 - PP
    End point description
    End point type
    Primary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - PP Placebo - PP
    Number of subjects analysed
    333
    331
    Units: Subject
        Yes
    86
    77
        No
    171
    176
        Missing
    76
    78
    Statistical analysis title
    		 Efficacy endpoints in the PP population
    Statistical analysis description
    Mutivariable model adjusted for Global symptoms severity at baseline(Mild, Moderate, Severe), Use of paracetamol (Yes, No), Time of onser of ILI symptoms at inclusion (>12h, [12h - 24h]
    Comparison groups
    Oscillococcinum® - PP v Placebo - PP
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.36

    Secondary: Time to alleviation of symptoms of ILI - FAS

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    End point title
    		 Time to alleviation of symptoms of ILI - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    317 [1]
    317 [2]
    Units: days
        arithmetic mean (standard deviation)
    7.7 ( 3 )
    7.5 ( 3.2 )
    Notes
    [1] - 25 missing data
    [2] - 21 missing data
    Statistical analysis title
    		 Survival analysis - Oscillococcinum® - FAS
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    634
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31
    Method
    		 Logrank
    Parameter type
    		 Median survival
    Point estimate
    9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.1
         upper limit
    		 9.2
    Statistical analysis title
    		 Survival analysis - Placebo - FAS
    Comparison groups
    Placebo - FAS v Oscillococcinum® - FAS
    Number of subjects included in analysis
    634
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31
    Method
    		 Logrank
    Parameter type
    		 Median survival
    Point estimate
    9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.1
         upper limit
    		 9.2

    Secondary: Alleviation of all symptoms at 72h maintained over at least 24h - FAS

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    End point title
    		 Alleviation of all symptoms at 72h maintained over at least 24h - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    12
    12
        No
    81
    65
        Missing
    249
    261
    Statistical analysis title
    		 Alleviation of all symptoms at 72h maintained over
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.83
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.54

    Secondary: Alleviation of all symptoms at 48h - FAS

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    End point title
    		 Alleviation of all symptoms at 48h - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    62
    61
        No
    206
    216
        Missing
    74
    61
    Attachments
    		 Result of multivariate logistic model
    Statistical analysis title
    		 Alleviation of all symptoms at 48h
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.38
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.36

    Secondary: Time to return to usual daily activities - FAS

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    End point title
    		 Time to return to usual daily activities - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    247 [3]
    249 [4]
    Units: days
        arithmetic mean (standard deviation)
    1.7 ( 3.8 )
    1.8 ( 1.9 )
    Notes
    [3] - 95 missing data
    [4] - 89 missing data
    No statistical analyses for this end point

    Secondary: Alleviation of global and each other symptom at 72h - Fatigue - FAS

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    End point title
    		 Alleviation of global and each other symptom at 72h - Fatigue - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subbject
        Yes
    153
    158
        No
    104
    95
        Missing
    85
    85
    Statistical analysis title
    		 Alleviation of fatigue at 72h
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.07

    Secondary: Alleviation of global and each other symptom at 72h - Nasal congestion - FAS

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    End point title
    		 Alleviation of global and each other symptom at 72h - Nasal congestion - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    113
    116
        No
    143
    137
        Missing
    86
    85
    Statistical analysis title
    		 Alleviation of nasal congestion at 72h
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.96
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.13

    Secondary: Alleviation of global and each other symptom at 72h - Gastro-intestinal disturbances - FAS

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    End point title
    		 Alleviation of global and each other symptom at 72h - Gastro-intestinal disturbances - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    64
    59
        No
    191
    194
        Missing
    87
    85
    Statistical analysis title
    		 Alleviation of gastro-intestinal disturbances 72h
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    680
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Chi-squared
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.39

    Secondary: At least one secondary complication of ILI between D1 and D10 - FAS

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    End point title
    		 At least one secondary complication of ILI between D1 and D10 - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    17
    12
        No
    314
    314
        Missing
    11
    12
    No statistical analyses for this end point

    Secondary: Compliant regarding the use of treatment (according to Physician’s assessment) - FAS

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    End point title
    		 Compliant regarding the use of treatment (according to Physician’s assessment) - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    244
    236
        No
    42
    53
        Missing
    56
    49
    No statistical analyses for this end point

    Secondary: Satisfaction with the treatment according to patient - FAS

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    End point title
    		 Satisfaction with the treatment according to patient - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Satisfied/very satisfied
    175
    171
        Fairly satisfied
    34
    39
        Unsatisfied
    20
    23
        Missing
    113
    105
    No statistical analyses for this end point

    Secondary: Satisfaction with the treatment according to physician - FAS

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    End point title
    		 Satisfaction with the treatment according to physician - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    342
    338
    Units: Subject
        Satisfied/very satisfied
    274
    274
        Fairly satisfied
    51
    40
        Unsatisfied
    6
    12
        Missing
    11
    12
    No statistical analyses for this end point

    Secondary: Change in sleep quality compared to baseline - FAS

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    End point title
    		 Change in sleep quality compared to baseline - FAS
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - FAS Placebo - FAS
    Number of subjects analysed
    234 [5]
    231 [6]
    Units: VAS
        arithmetic mean (standard deviation)
    3.2 ( 2.7 )
    3 ( 2.6 )
    Notes
    [5] - 108 missing data
    [6] - 107 missing data
    Statistical analysis title
    		 Sleep quality (MMRM) Oscillococcinum® vs Placebo
    Comparison groups
    Oscillococcinum® - FAS v Placebo - FAS
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.069
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Other pre-specified: Patients with at least one Adverse Event - SAF

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    End point title
    		 Patients with at least one Adverse Event - SAF
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Overall
    End point values
    		 Oscillococcinum® - SAF Placebo - SAF
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    13
    16
        No
    329
    322
    No statistical analyses for this end point

    Other pre-specified: Patients with at least oneTreatment related AE (TRAE) - SAF

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    End point title
    		 Patients with at least oneTreatment related AE (TRAE) - SAF
    End point description
    Yes = reasonable possibility
    End point type
    Other pre-specified
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - SAF Placebo - SAF
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    1
    1
        No
    341
    337
    No statistical analyses for this end point

    Other pre-specified: Patients with at least one: Serious Adverse Event (SAE)

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    End point title
    		 Patients with at least one: Serious Adverse Event (SAE)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Overall study
    End point values
    		 Oscillococcinum® - SAF Placebo - SAF
    Number of subjects analysed
    342
    338
    Units: Subject
        Yes
    0
    0
        No
    342
    338
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Oscillococcinum®
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Oscillococcinum® Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 342 (0.00%)
    0 / 338 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Oscillococcinum® Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 342 (3.80%)
    16 / 338 (4.73%)
    Nervous system disorders
    Myalgia
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 342 (0.29%)
    1 / 338 (0.30%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 342 (0.29%)
    1 / 338 (0.30%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 338 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 342 (0.58%)
    2 / 338 (0.59%)
         occurrences all number
    2
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 342 (0.29%)
    1 / 338 (0.30%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 342 (0.58%)
    2 / 338 (0.59%)
         occurrences all number
    2
    2
    Epistaxis
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Pharyngeal erythema
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 338 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    3 / 342 (0.88%)
    3 / 338 (0.89%)
         occurrences all number
    3
    3
    Bronchitis
         subjects affected / exposed
    2 / 342 (0.58%)
    1 / 338 (0.30%)
         occurrences all number
    2
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 342 (0.29%)
    1 / 338 (0.30%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 342 (0.29%)
    0 / 338 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Pyelonephritis
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 342 (0.00%)
    1 / 338 (0.30%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2021
    Clarification of the management of patients suspected of being infected with SARS-CoV-2.
    08 Jul 2021
    Study extended in Belgium + paper PRO (in addition to the original electronic format), mandatory email to patient, inclusion period extended to September 2022
    23 Jul 2021
    Minor update following feedback from the Belgian EC
    21 Jun 2022
    Inclusion period extended to december 2022 in France and Belgium
    02 Dec 2022
    Inclusion period extended to April 2023 only in France
    05 Apr 2023
    Amendment of §5.4 Study Rational + §11.1 Determination of Sample Size + §11.4.1 Primary Efficacy Endpoint

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Data collected from patients'diary: not reflect the reality of symptoms intensity + a significant number of missing data (about 23%). Study during 3 winter seasons, several winter & epidemic diseses other than ILI occurs (especially Covid-19)
    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.

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