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    Clinical Trial Results:
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Presatovir (GS-5806) in Healthy Volunteers Infected with Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)

    Summary
    EudraCT number
    		 2012-002413-19
    Trial protocol
    		 GB  
    Global end of trial date
    03 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2016
    First version publication date
    20 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-218-0103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01756482
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd , ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd , ClinicalTrialDisclosures@gilead.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
    03 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the antiviral effect of presatovir (GS-5806) in healthy adults infected with RSV-A Memphis 37b (RSV). 4 quarantines were enrolled at a 1:1 ratio to receive presatovir 50 mg on Day 1 and 25 mg on Days 2-5, or placebo to match. 3 adaptive quarantines were enrolled at a 4:1 ratio to receive presatovir (either 50 mg on Day 1 followed by 25 mg on Days 2-3; a single 100 mg dose on Day 1; or 10 mg on Day 1 followed by 5 mg on Days 2-5) or placebo to match; the adaptive quarantines were exploratory in nature and were included in the safety population, but not in the efficacy analyses.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC approval were submitted by the investigator to the IEC for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Nov 2012
    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
    United Kingdom: 143
    Worldwide total number of subjects
    143
    EEA total number of subjects
    143
    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)
    143
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at a single study site in the United Kingdom. The first participant was screened on 21 November 2012. The last study visit occurred on 03 August 2013.

    Pre-assignment
    Screening details
    		 372 participants were screened

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Presatovir
    Arm description
    		 Participants entered quarantine on Day -2 or -1, received presatovir for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Presatovir
    Investigational medicinal product code
    Other name
    GS-5806
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Presatovir was administered as either: 50 mg on Day 1, followed by 25 mg on Days 2 to 5; 50 mg on Day 1, followed by 25 mg on Days 2 to 3; 100 mg on Day 1 (single dose); or 10 mg on Day 1, followed by 5 mg on Days 2-5.

    Arm title
    		 Placebo
    Arm description
    		 Participants entered quarantine on Day -2 or -1, received presatovir placebo for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Presatovir Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Presatovir placebo was administered for up to 5 days.

    Number of subjects in period 1 [1]
    		Presatovir Placebo
    Started
    87
    53
    Completed
    87
    52
    Not completed
    0
    1
         Investigator's Discretion
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 3 participants who were enrolled but not treated are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Presatovir
    Reporting group description
    		 Participants entered quarantine on Day -2 or -1, received presatovir for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants entered quarantine on Day -2 or -1, received presatovir placebo for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.

    Reporting group values
    		 Presatovir Placebo Total
    Number of subjects
    		 87 53 140
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.4 ± 6.88 25.1 ± 3.7 -
    Gender categorical
    Units: Subjects
        Female
    		 22 13 35
        Male
    		 65 40 105
    Race
    Units: Subjects
        Asian
    		 5 1 6
        Black or African American
    		 5 4 9
        White
    		 74 46 120
        Other
    		 3 2 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 86 53 139

    End points

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    End points reporting groups
    Reporting group title
    Presatovir
    Reporting group description
    		 Participants entered quarantine on Day -2 or -1, received presatovir for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants entered quarantine on Day -2 or -1, received presatovir placebo for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.

    Primary: AUC of Viral Load Post Initial Dose through Study Day 12 by qRT-PCR

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    End point title
    		 AUC of Viral Load Post Initial Dose through Study Day 12 by qRT-PCR
    End point description
    Adjusted means (displayed as arithmetic mean) are generated from ANCOVA model with baseline viral load as a covariate. Data for participants in the Full Analysis Set receiving complete course of presatovir 50 mg on Day 1 followed by 25 mg on Days 2 to 5, and who had documented RSV infection prior to initiation of study drug are presented. AUC = viral load over time (area under the viral load versus time curve), measured in log10PFUe/mL × hour. qRT-PCR = quantitative reverse transcriptase-polymerase chain reaction. PFUe/mL = plaque-forming unit equivalents per milliliter.
    End point type
    Primary
    End point timeframe
    Baseline to Day 12
    End point values
    		 Presatovir Placebo
    Number of subjects analysed
    27
    27
    Units: (log10 PFUe/mL)*hour
        arithmetic mean (standard error)
    250.7 ± 31.36
    757.7 ± 64.28
    Statistical analysis title
    		 Difference in treatments
    Statistical analysis description
    The p-value, difference in treatments, and 95% confidence intervals (CIs) were generated using a parametric ANCOVA with corresponding baseline viral load as a covariate in the model and tested at the 2-sided 0.05 level.
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    506.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 361.8
         upper limit
    		 652.1

    Secondary: AUC of Viral Load Post Inoculation through Study Day 12 by qRT-PCR

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    End point title
    		 AUC of Viral Load Post Inoculation through Study Day 12 by qRT-PCR
    End point description
    Adjusted means (displayed as arithmetic mean) are generated from ANCOVA model with baseline viral load as a covariate. Data for participants in the Full Analysis Set receiving complete course of presatovir 50 mg on Day 1 followed by 25 mg on Days 2 to 5, and who had documented RSV infection prior to initiation of study drug are presented. AUC = viral load over time (area under the viral load versus time curve), measured in log10PFUe/mL × hour. qRT-PCR = quantitative reverse transcriptase-polymerase chain reaction. PFUe/mL = plaque-forming unit equivalents per milliliter.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 12
    End point values
    		 Presatovir Placebo
    Number of subjects analysed
    27
    27
    Units: (log10 PFUe/mL)*hour
        arithmetic mean (standard error)
    279.8 ± 40.64
    810.8 ± 71
    Statistical analysis title
    		 Difference in treatments
    Statistical analysis description
    The difference in treatments and 95% CIs were generated using an ANCOVA model with corresponding baseline value as a covariate.
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    531
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 365.3
         upper limit
    		 696.8

    Secondary: Total Weight of Mucus Post Initial Dose through Last Dose of Study Drug

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    End point title
    		 Total Weight of Mucus Post Initial Dose through Last Dose of Study Drug
    End point description
    The adjusted means (displayed as arithmetic mean) and pooled standard errors (SE) were generated from an ANOVA model. Data for participants in the Full Analysis Set receiving complete course of presatovir 50 mg on Day 1 followed by 25 mg on Days 2 to 5, and who had documented RSV infection prior to initiation of study drug are presented.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 12
    End point values
    		 Presatovir Placebo
    Number of subjects analysed
    27
    27
    Units: grams
        arithmetic mean (standard error)
    6.9 ± 2.56
    15.1 ± 2.56
    Statistical analysis title
    		 Difference in treatments
    Statistical analysis description
    The difference in treatments and 95% CIs were generated using an ANOVA model.
    Comparison groups
    Placebo v Presatovir
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 15.5

    Secondary: AUC of Total Symptom Scores Change from Baseline Post Initial Dose of Study Drug through Study Day 12

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    End point title
    		 AUC of Total Symptom Scores Change from Baseline Post Initial Dose of Study Drug through Study Day 12
    End point description
    Adjusted means (displayed as arithmetic mean) are generated from ANCOVA model with corresponding baseline symptom score as a covariate. Data for participants in the Full Analysis Set receiving complete course of presatovir 50 mg on Day 1 followed by 25 mg on Days 2 to 5, and who had documented RSV infection prior to initiation of study drug are presented. AUC = change in symptom score over time (area under the symptom score change versus time curve), measured in score × hour.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 12
    End point values
    		 Presatovir Placebo
    Number of subjects analysed
    27
    27
    Units: score*hour
        arithmetic mean (standard error)
    -20.2 ± 46.04
    204.9 ± 60.48
    Statistical analysis title
    		 Difference in treatments
    Statistical analysis description
    The difference in treatments and 95% CIs were generated using an ANCOVA model with corresponding baseline value as a covariate.
    Comparison groups
    Presatovir v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    225.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 72.2
         upper limit
    		 378

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 12 plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: Participants were randomized and received at least 1 dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Presatovir
    Reporting group description
    		 Participants entered quarantine on Day -2 or -1, received presatovir for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants entered quarantine on Day -2 or -1, received presatovir placebo for up to 5 days, were released from quarantine on Day 12, and had follow-up and end-of-study visits on Study Days 21 (± 3 days) and 26 (± 3 days), respectively.

    Serious adverse events
    		 Presatovir Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 53 (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: 5%
    Non-serious adverse events
    		 Presatovir Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 87 (39.08%)
    24 / 53 (45.28%)
    Investigations
    Pulmonary function test decreased
         subjects affected / exposed
    8 / 87 (9.20%)
    5 / 53 (9.43%)
         occurrences all number
    8
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 87 (3.45%)
    4 / 53 (7.55%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    20 / 87 (22.99%)
    13 / 53 (24.53%)
         occurrences all number
    23
    14
    Rhinorrhoea
         subjects affected / exposed
    2 / 87 (2.30%)
    7 / 53 (13.21%)
         occurrences all number
    2
    7
    Nasal congestion
         subjects affected / exposed
    4 / 87 (4.60%)
    4 / 53 (7.55%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    5 / 87 (5.75%)
    4 / 53 (7.55%)
         occurrences all number
    5
    4
    Rash
         subjects affected / exposed
    1 / 87 (1.15%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Sep 2012
    Documented history of allergy to sulfa drugs was added to the exclusion criteria; electrocardiogram (ECG) monitoring at Tmax, defined as approximately 3 hours postdose, from the day of first dose through 5 days of dosing was included; development of bronchospasm, regardless of causality, was included as a protocol-specific stopping rule; the time points used for determination of the ECG stopping rule were clarified.
    11 Jan 2013
    Quarantine 5 was allowed an adaptive design, 2 additional quarantines with an adaptive dosing regimen based on data obtained from the prespecified dosing quarantines (1-4) were added.

    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.
    There were no limitations affecting the analysis or results.
    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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