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    Clinical Trial Results:
    Favipiravir, lopinavir/ritonavir or combination therapy: a randomised, double blind, 2x2 factorial placebo-controlled trial of early antiviral therapy in COVID-19

    Summary
    EudraCT number
    		 2020-002106-68
    Trial protocol
    		 GB  
    Global end of trial date
    10 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2023
    First version publication date
    26 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CTU/2020/354
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04499677
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower Street,, London, United Kingdom, WC1E 6BT
    Public contact
    CCTU enquires, The Comprehensive Clinical Trials Unit, University College London , 44 0207907466, cctu.enquires@ucl.ac.uk
    Scientific contact
    CCTU enquires, The Comprehensive Clinical Trials Unit, University College London , 44 02079074669, cctu.enquires@ucl.ac.uk
    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
    03 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to assess whether early antiviral therapy with either favipiravir + LPV/r, LPV/r or favipiravir is associated with a decrease in viral load in the upper respiratory tract after 5 days of therapy, compared with placebo.
    Protection of trial subjects
    The trial was conducted in compliance with the approved protocol, the Declaration of Helsinki (2008),the principles of Good Clinical Practice (GCP) as laid down by the Commission Directive 2005/28/EC with implementation in national legislation in the UK by Statutory Instrument 2004/1031 and subsequent amendments, the Human Tissue (Quality and Safety for Human Application) Regulations 2007, the UK Data Protection Act, and the National Health Service (NHS) Research Governance Framework for Health and Social Care (RGF). Participants were provided trial treatment for a 7-day period , and remained on the trial for a total of 28 days. Averse Events were collected throughout the trial and treated accordingly. As participation was voluntary, participants were free to discontinue at any given time without giving reason and without it affecting their normal standard of care.
    Background therapy
    		 N/A
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 240
    Worldwide total number of subjects
    240
    EEA total number of subjects
    0
    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)
    236
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants aged between 18 and 70 years who had recently (within the last 5 days) developed symptoms of COVID-19, or who had tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were within 7 days of symptom onset, or who were asymptomatic but had tested positive by PCR within the previous 48 hours, were recruited in 2 UK sites.

    Pre-assignment
    Screening details
    		 A pre-screening visit (usually by telephone) briefly assessed eligibility and collected the following information: study site, age , sex, height and weight, symptomatic or asymptomatic, current smoking status, ethnicity, previous COVID-19 specific vaccination, and presence/absence of the following comorbidities

    Pre-assignment period milestones
    Number of subjects started
    		 1215 [1]
    Number of subjects completed
    		 240

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 637
    Reason: Number of subjects
    		 Ineligible: 338
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period is the screening phase on this trial. Patients are considered enrolled when they are randomised to a treatment after being deemed eligible..
    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Trial medication kits, prepared by RenaClinical, were coded to maintain double blinding (investigators and participants). Kits contained favipiravir or colour and size matched placebo 200-mg tablets supplied by Fujifilm Toyama Chemical Co. and lopinavir-ritonavir 200-mg/50-mg tablets (AbbVie) or colour and size matched placebos (RenaClinical).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Favipiravir+LPV/r
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    favipiravir and lopinavir/ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) at 400mg/100 mg twice daily on Day 1 followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.

    Arm title
    		 Favipiravir+Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    favipiravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral favipiravir, 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) matched placebo at 400mg/100 mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.

    Arm title
    		 LPV/r+Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    lopinavir/ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral favipiravir matched placebo 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) at 400mg/100 mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    favipiravir placebo and lopinavir/ritonavir placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral favipiravir matched placebo 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) matched placebo at 400mg/100 mg twice daily on Day 1 followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.

    Number of subjects in period 1
    		Favipiravir+LPV/r Favipiravir+Placebo LPV/r+Placebo Placebo
    Started
    61
    59
    60
    60
    Completed
    55
    56
    55
    58
    Not completed
    6
    3
    5
    2
         Consent withdrawn by subject
    -
    -
    1
    -
         Adverse event, non-fatal
    5
    2
    3
    -
         Missing primary outcome
    1
    1
    -
    1
         Lost to follow-up
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Favipiravir+LPV/r
    Reporting group description
    		 -

    Reporting group title
    Favipiravir+Placebo
    Reporting group description
    		 -

    Reporting group title
    LPV/r+Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Favipiravir+LPV/r Favipiravir+Placebo LPV/r+Placebo Placebo Total
    Number of subjects
    		 61 59 60 60 240
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.3 ( 13.1 ) 40.3 ( 12.1 ) 38.6 ( 11.5 ) 40.6 ( 12.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 27 31 29 117
        Male
    		 31 32 29 31 123
    Site
    Units: Subjects
        Royal Free
    		 56 55 55 55 221
        UCLH
    		 5 4 5 5 19
    Age
    Units: Subjects
        ≤ 55 years
    		 53 52 55 55 215
        > 55 years
    		 8 7 5 5 25
    Ethnicity
    Units: Subjects
        Caucasian
    		 50 49 49 49 197
        Other
    		 11 10 11 11 43
    BMI
    Units: Subjects
        <30
    		 51 49 50 50 200
        ≥30
    		 10 10 10 10 40
    Symptomatic disease
    Units: Subjects
        Yes
    		 61 59 60 59 239
        No
    		 0 0 0 1 1
    Current smoker
    Units: Subjects
        Yes
    		 6 7 7 7 27
        No
    		 55 52 53 53 213
    Vaccinated
    Units: Subjects
        Yes
    		 32 30 31 30 123
        No
    		 29 29 29 30 117
    Comorbidity
    Units: Subjects
        Present
    		 11 9 8 8 36
        Absent
    		 50 50 52 52 204

    End points

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    End points reporting groups
    Reporting group title
    Favipiravir+LPV/r
    Reporting group description
    		 -

    Reporting group title
    Favipiravir+Placebo
    Reporting group description
    		 -

    Reporting group title
    LPV/r+Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Viral load

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    End point title
    		 Viral load
    End point description
    End point type
    Primary
    End point timeframe
    Measured at baseline (Day 1) and at Day 5.
    End point values
    		 Favipiravir+LPV/r Favipiravir+Placebo LPV/r+Placebo Placebo
    Number of subjects analysed
    55
    56
    55
    58
    Units: log 10
        arithmetic mean (standard deviation)
    2.5 ( 2.1 )
    1.9 ( 2.0 )
    2.5 ( 2.0 )
    2.7 ( 2.2 )
    Statistical analysis title
    		 Primary outcome analysis
    Comparison groups
    Placebo v Favipiravir+Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 0.07
    Statistical analysis title
    		 Primary outcome analysis
    Comparison groups
    Placebo v LPV/r+Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 0.46
    Statistical analysis title
    		 Primary outcome analysis
    Comparison groups
    Placebo v Favipiravir+LPV/r
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 1.5

    Secondary: Undetected viral load

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    End point title
    		 Undetected viral load
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 5.
    End point values
    		 Favipiravir+LPV/r Favipiravir+Placebo LPV/r+Placebo Placebo
    Number of subjects analysed
    54
    51
    51
    51
    Units: Patients
        Yes
    20
    25
    17
    14
        No
    34
    26
    34
    37
    Statistical analysis title
    		 Secondary outcome analysis
    Comparison groups
    Placebo v Favipiravir+Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 5.65
    Statistical analysis title
    		 Secondary outcome analysis
    Comparison groups
    Placebo v LPV/r+Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 3
    Statistical analysis title
    		 Secondary outcome analysis
    Comparison groups
    Placebo v Favipiravir+LPV/r
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.66

    Other pre-specified: Viral load - adjusted for minimisation factors

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    End point title
    		 Viral load - adjusted for minimisation factors
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From Day 1 to Day 5.
    End point values
    		 Favipiravir+LPV/r Favipiravir+Placebo LPV/r+Placebo Placebo
    Number of subjects analysed
    56
    56
    55
    58
    Units: log 10
        arithmetic mean (standard deviation)
    2.6 ( 2.1 )
    1.9 ( 2.0 )
    2.5 ( 2.0 )
    2.7 ( 2.2 )
    Statistical analysis title
    		 Sensitivity analysis
    Comparison groups
    Placebo v Favipiravir+Placebo
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    -0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.16
         upper limit
    		 0.02
    Statistical analysis title
    		 Sensitivity analysis
    Comparison groups
    Placebo v LPV/r+Placebo
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Log risk ratio
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 0.45
    Statistical analysis title
    		 Sensitivity analysis
    Comparison groups
    Placebo v Favipiravir+LPV/r
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 1.46

    Other pre-specified: Viral load - mITT population

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    End point title
    		 Viral load - mITT population
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From Day 1 to Day 5.
    End point values
    		 Favipiravir+LPV/r Favipiravir+Placebo LPV/r+Placebo Placebo
    Number of subjects analysed
    54
    51
    51
    52
    Units: log 10
        arithmetic mean (standard deviation)
    2.6 ( 2.1 )
    2.1 ( 2.0 )
    2.7 ( 2.0 )
    3.0 ( 2.1 )
    Statistical analysis title
    		 Sensitivity analysis - mitt population
    Comparison groups
    Placebo v Favipiravir+Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.29
         upper limit
    		 0.11
    Statistical analysis title
    		 Sensitivity analysis - mitt population
    Comparison groups
    LPV/r+Placebo v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 0.51
    Statistical analysis title
    		 Sensitivity analysis - mitt population
    Comparison groups
    Favipiravir+LPV/r v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Slope
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 1.63

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 to Day 28.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Favipravir + LPV/r
    Reporting group description
    		 -

    Reporting group title
    Favipravir + Placebo
    Reporting group description
    		 -

    Reporting group title
    LPV/r + Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Favipravir + LPV/r Favipravir + Placebo LPV/r + Placebo Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia viral
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Favipravir + LPV/r Favipravir + Placebo LPV/r + Placebo Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 61 (90.16%)
    38 / 59 (64.41%)
    59 / 60 (98.33%)
    39 / 60 (65.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 61 (9.84%)
    1 / 59 (1.69%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    6
    1
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    4
    0
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 61 (9.84%)
    7 / 59 (11.86%)
    4 / 60 (6.67%)
    6 / 60 (10.00%)
         occurrences all number
    6
    7
    4
    6
    Anosmia
         subjects affected / exposed
    5 / 61 (8.20%)
    3 / 59 (5.08%)
    8 / 60 (13.33%)
    5 / 60 (8.33%)
         occurrences all number
    5
    3
    9
    5
    Dysgeusia
         subjects affected / exposed
    3 / 61 (4.92%)
    4 / 59 (6.78%)
    6 / 60 (10.00%)
    3 / 60 (5.00%)
         occurrences all number
    3
    4
    6
    3
    Dizziness
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 59 (1.69%)
    6 / 60 (10.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    1
    6
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 61 (6.56%)
    4 / 59 (6.78%)
    7 / 60 (11.67%)
    6 / 60 (10.00%)
         occurrences all number
    4
    4
    7
    7
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    4
    0
    1
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    38 / 61 (62.30%)
    8 / 59 (13.56%)
    44 / 60 (73.33%)
    10 / 60 (16.67%)
         occurrences all number
    41
    8
    47
    10
    Nausea
         subjects affected / exposed
    16 / 61 (26.23%)
    12 / 59 (20.34%)
    28 / 60 (46.67%)
    6 / 60 (10.00%)
         occurrences all number
    16
    13
    28
    6
    Vomiting
         subjects affected / exposed
    8 / 61 (13.11%)
    1 / 59 (1.69%)
    6 / 60 (10.00%)
    2 / 60 (3.33%)
         occurrences all number
    8
    1
    6
    2
    Abdominal pain
         subjects affected / exposed
    2 / 61 (3.28%)
    3 / 59 (5.08%)
    2 / 60 (3.33%)
    5 / 60 (8.33%)
         occurrences all number
    2
    3
    2
    5
    Dyspepsia
         subjects affected / exposed
    3 / 61 (4.92%)
    0 / 59 (0.00%)
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    5 / 61 (8.20%)
    6 / 59 (10.17%)
    7 / 60 (11.67%)
    6 / 60 (10.00%)
         occurrences all number
    5
    6
    7
    6
    Cough
         subjects affected / exposed
    2 / 61 (3.28%)
    4 / 59 (6.78%)
    4 / 60 (6.67%)
    5 / 60 (8.33%)
         occurrences all number
    2
    5
    4
    5
    Nasal congestion
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 59 (5.08%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    1
    3
    1
    2
    Rhinorrhea
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    2
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    2 / 61 (3.28%)
    4 / 59 (6.78%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    2
    4
    1
    2
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 61 (4.92%)
    2 / 59 (3.39%)
    1 / 60 (1.67%)
    3 / 60 (5.00%)
         occurrences all number
    3
    2
    1
    3
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 59 (1.69%)
    7 / 60 (11.67%)
    2 / 60 (3.33%)
         occurrences all number
    2
    1
    7
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2020
    Broadening the entry criteria from key workers and their household contacts to all adults aged 18-70 years as the population at risk has expanded. Specifying that participants can attend for recruitment visits in a designated area of the hospital site (with appropriate precautions), rather than only as a home visit. Specifying a maximum recommended paracetamol dose of 3g daily, as recommended by the manufacturers of favipiravir. Amending some details relating to the laboratory processing of samples for pharmacokinetic analysis specifying that sample inactivation should be with ethanol rather than heat, and that storage temperature can be at -20 C or below. Updating the statistical analysis methods with no changes to the participant numbers, endpoints or the running of the trial.
    26 Jan 2021
    • Change to the eligibility criteria to exclude participants who have received COVID-19 vaccination • Clarification that participants will not undergo safety blood tests at their Day 14 visit if no significantly abnormal results are observed for safety bloods tests taken at Day 7. This change is intended to limit the number of blood tests required of participants and therefore to facilitate an increase in the number of those consenting by removing one potential barrier (as venepuncture is often unpopular with trial participants). This change poses no increased risk to participant's safety. • Addition of flexibility windows to the trial visits in order to accommodate sites where the research staff do not work during weekends • Removal of collection of serum for storage and stool samples at Day 14 visit • Updated secondary outcomes to reflect changes at Day 14 visit • Addition of guidance for sites where unused trial medication cannot be destroyed or disposed by Pharmacy as part of the site local policy for COVID-19 trials. • Clarification regarding participants who start Day 1 of dosing but are deemed ineligible following results from safety bloods collected at Screening/Baseline visit. • Addition of guidance for sites contacting participants lost to follow-up • Clarification to when the participants will be considered as fully randomised

    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.
    13 participants withdrew from the trial and a further 28 discontinued medication but provided samples for analysis.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33685502
    http://www.ncbi.nlm.nih.gov/pubmed/36260627
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    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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