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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression

    Summary
    EudraCT number
    		 2022-002741-18
    Trial protocol
    		 FR   HU   ES   BG   IT  
    Global end of trial date
    07 Nov 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Feb 2025
    First version publication date
    13 Nov 2024
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    To update analysis population description and result values for outcome measure no 3 "Percentage of Participants Experiencing Laboratory Abnormalities"

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-611-6273
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05603143
    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
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@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
    07 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The goal of this clinical study was to test how well the study drug, obeldesivir (GS-5245), worked and how safe it was in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB 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
    05 Nov 2022
    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
    Singapore: 1
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Bulgaria: 196
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Romania: 53
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    Türkiye: 2
    Country: Number of subjects enrolled
    Taiwan: 40
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Mexico: 48
    Country: Number of subjects enrolled
    South Africa: 31
    Worldwide total number of subjects
    468
    EEA total number of subjects
    304
    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)
    332
    From 65 to 84 years
    130
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the South America, Europe, North America, Africa and Asia.

    Pre-assignment
    Screening details
    		 515 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
    		 Obeldesivir
    Arm description
    		 Participants received obeldesivir 350 mg orally twice daily for 5 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obeldesivir
    Investigational medicinal product code
    Other name
    GS-5245
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered orally without regard to food.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo-to-match obeldesivir orally twice daily for 5 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets administered orally without regard to food.

    Number of subjects in period 1
    		Obeldesivir Placebo
    Started
    233
    235
    Completed
    224
    227
    Not completed
    9
    8
         Adverse event, non-fatal
    2
    -
         Death
    -
    1
         Withdrew consent
    6
    2
         Investigator's discretion
    1
    -
         Randomized but never treated
    -
    3
         Lost to follow-up
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Obeldesivir
    Reporting group description
    		 Participants received obeldesivir 350 mg orally twice daily for 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo-to-match obeldesivir orally twice daily for 5 days.

    Reporting group values
    		 Obeldesivir Placebo Total
    Number of subjects
    		 233 235 468
    Age categorical
    Units: Subjects
        Adults (18 – 64 Years)
    		 159 173 332
        Geriatrics (65 – 84 Years)
    		 71 59 130
        Geriatrics (85 Years and Over)
    		 3 3 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ( 14.9 ) 53 ( 16.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 147 117 264
        Male
    		 86 118 204
    Race
    Units: Subjects
        White
    		 178 168 346
        Asian
    		 24 32 56
        American Indian or Alaska Native
    		 21 19 40
        Black or African American
    		 9 10 19
        Other or More Than One Race
    		 1 4 5
        Native Hawaiian or Other Pacific Islander
    		 0 2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 36 43 79
        Not Hispanic or Latino
    		 197 192 389
        Unknown or Not Reported
    		 0 0 0
    Baseline Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load
    The Safety Analysis Set included all participants who received at least 1 dose of study drug with data available were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this baseline measure. For obeldesivir arm N=218, placebo arm N=215.
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    		 6.15 ( 1.629 ) 6.15 ( 1.622 ) -

    End points

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    End points reporting groups
    Reporting group title
    Obeldesivir
    Reporting group description
    		 Participants received obeldesivir 350 mg orally twice daily for 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo-to-match obeldesivir orally twice daily for 5 days.

    Primary: Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29

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    End point title
    		 Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29
    End point description
    COVID-19–related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Full Analysis Positive Set included all randomized participants who received at least 1 dose of study drug and were SARS-CoV-2 positive at baseline as confirmed by cepheid’s xpert xpress coronavirus-2/flu/respiratory syncytial virus plus test or SARS-CoV-2 reverse transcriptase quantitative polymerase chain reaction test from the central laboratory.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    211
    207
    Units: percentage of participants
        number (not applicable)
    0
    0.5
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3161 [1]
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - PLACEHOLDER1

    Secondary: Percentage of Participants With Treatment-Emergent Adverse Events

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    End point title
    		 Percentage of Participants With Treatment-Emergent Adverse Events
    End point description
    TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug. Any AEs leading to premature discontinuation of study drug. Percentages were rounded off. Analysis Population Description: The Safety Analysis Set included all participants who received at least 1 dose of study drug. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this endpoint
    End point type
    Secondary
    End point timeframe
    First dose date up to 5 Days plus 30 Days
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    233 [2]
    231
    Units: percentage of participants
        number (not applicable)
    22.2
    20.8
    Notes
    [2] - N=234, one participant in placebo group received obeldesivir and was counted in obeldesivir group.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Laboratory Abnormalities

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    End point title
    		 Percentage of Participants Experiencing Laboratory Abnormalities
    End point description
    Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off. Analysis Population Description: Participants from the Safety Analysis Set who had available post baseline data were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this outcome measure.
    End point type
    Secondary
    End point timeframe
    First dose date up to 5 Days plus 30 Days
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    230
    227
    Units: percentage of participants
    number (not applicable)
        Any grade
    56.1
    61.7
        Grade 3 or 4
    6.5
    4.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation

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    End point title
    		 Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
    End point description
    A treatment emergent AE is defined as an AE that occurs or worsens in severity on or after the date of the first dose of study drug but no later than 30 days after the permanent discontinuation of study drug or an AE leading to discontinuation of study drug. A SAE is defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. Percentages were rounded off. Analysis Population Description: Participants in the Safety Analysis Set were analyzed. One participant randomized to placebo arm received obeldesivir and was counted in obeldesivir group for the analysis of this endpoint.
    End point type
    Secondary
    End point timeframe
    First dose date up to 5 Days plus 30 Days
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    233 [3]
    231
    Units: percentage of participants
    number (not applicable)
        AEs Leading to Study Drug Discontinuation
    1.7
    0.9
        SAEs Leading to Study Drug Discontinuation
    0.9
    0.9
    Notes
    [3] - One participant randomized to placebo arm received ODV and was counted in ODV group for the analysis
    No statistical analyses for this end point

    Secondary: Percentage of Participants With All-Cause Hospitalization by Day 29

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    End point title
    		 Percentage of Participants With All-Cause Hospitalization by Day 29
    End point description
    All-cause hospitalization was defined as ≥ 24 hours of acute care, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This includes specialized acute medical care units within an assisted living facility or nursing home. This does not include hospitalization for the purposes of public health and/or clinical study execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization is related to COVID-19) were recorded. Percentages were rounded off. Analysis Population Description: Participants in the Full Analysis Positive Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    211
    207
    Units: percentage of participants
        number (not applicable)
    0.5
    0
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3219
    Method
    		 Logrank
    Confidence interval

    Secondary: Percentage of Participants With COVID-19–Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29

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    End point title
    		 Percentage of Participants With COVID-19–Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29
    End point description
    Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. Analysis Population Description: Participants in the Full Analysis Positive Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    211
    207
    Units: percentage of participants
        number (not applicable)
    1.0
    1.0
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6568 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.496
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 8.952
    Notes
    [4] - Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.

    Secondary: Percentage of Participants With COVID-19–Related MAVs by Day 29

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    End point title
    		 Percentage of Participants With COVID-19–Related MAVs by Day 29
    End point description
    Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. Analysis Population Description: Participants in the Full Analysis Positive Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    211
    207
    Units: percentage of participants
        number (not applicable)
    1
    0.5
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.319 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.311
         upper limit
    		 28.74
    Notes
    [5] - Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.

    Secondary: Percentage of Participants With All-cause Death by Day 29

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    End point title
    		 Percentage of Participants With All-cause Death by Day 29
    End point description
    Percentages were rounded off. Analysis Population Description: Participants in the Full Analysis Positive Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    211
    207
    Units: percentage of participants
        number (not applicable)
    0
    0.5
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3161
    Method
    		 Logrank
    Confidence interval

    Secondary: Time to COVID-19 Symptom Alleviation by Day 15

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    End point title
    		 Time to COVID-19 Symptom Alleviation by Day 15
    End point description
    Time to COVID-19 symptom alleviation was calculated as symptom alleviation date/time minus the first dose date/time. Symptom alleviation was evaluated for the 15 targeted symptoms using symptoms of infection with coronavirus-19 (SIC) questionnaire. The SIC questionnaire assessed all targeted symptoms, alleviation was defined as the SIC rating of 0, or at least 3 points decrease in rating from baseline, or an answer “No” to the question for at least 48 consecutive hours. Analysis Population Description: Participants in the Full Analysis Positive Set with Covid19 symptoms who completed Symptoms of Infection With Coronavirus-19 at baseline were analyzed. 1111: Upper limit of CI did not reach due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Up to Day 15
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    84
    78
    Units: Days
        median (confidence interval 95%)
    7.3 (5.4 to 9.4)
    9.3 (6.5 to 1111)
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0859 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.425
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.961
         upper limit
    		 2.112
    Notes
    [6] - P-value was based on stratified Log-rank test with randomization stratification factors as the strata.

    Secondary: Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5

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    End point title
    		 Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
    End point description
    The mixed model for repeated measures (MMRM) was used for analysis.. Analysis Population Description: Virology Analysis Set included all randomized participants who received at least 1 dose of study drug and had baseline SARS-CoV-2 viral load greater than or equal to lower limit of quantitation.
    End point type
    Secondary
    End point timeframe
    Day 5
    End point values
    		 Obeldesivir Placebo
    Number of subjects analysed
    193
    192
    Units: log10 copies/mL
        least squares mean (standard error)
    -2.80 ( 0.092 )
    -2.22 ( 0.092 )
    Statistical analysis title
    		 Statistical Analysis Obeldesivir vs Placebo
    Comparison groups
    Obeldesivir v Placebo
    Number of subjects included in analysis
    385
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.0001
    Method
    		 Mixed Models Analysis
    Parameter type
    		 Treatment Difference (vs Placebo)
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 -0.33
    Notes
    [7] - Least-squares mean (SE), 95% CI and P value were from MMRM with baseline viral load and randomization strata as covariates.

    Secondary: Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)

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    End point title
    		 Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) [8]
    End point description
    Pharmacokinetic Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least 1 non missing concentration value reported by the PK laboratory with available data were analyzed .
    End point type
    Secondary
    End point timeframe
    Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Obeldesivir
    Number of subjects analysed
    224
    Units: ng/mL
    arithmetic mean (standard deviation)
        D 1, 0.75 h N=216
    2330.42 ( 1709.560 )
        D 1, 2 h N=95
    2535.84 ( 1370.131 )
        D 5, Predose N=170
    1116.81 ( 1101.371 )
        D 5, 0.75 h N=174
    3089.09 ( 1839.992 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All-cause mortality, AE's: First dose date up to 5 Days plus 30 Days
    Adverse event reporting additional description
    All-cause mortality: All Randomized Analysis Set; Adverse events: Safety Analysis Set. 1 participant randomized to placebo arm accidentally received obeldesivir and was counted in obeldesivir arm for the analysis of all-cause mortality and adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Obeldesivir
    Reporting group description
    		 Patients who received ODV

    Reporting group title
    Placebo
    Reporting group description
    		 Patients who received Placebo

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The participants did not experience any non-serious adverse events.
    Serious adverse events
    		 Obeldesivir Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 234 (0.85%)
    2 / 231 (0.87%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 234 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 234 (0.00%)
    1 / 231 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 231 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Obeldesivir Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 231 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Mar 2023
    Key changes included in Amendment 1 were the addition and modification of risk factors and targeted signs and symptoms of COVID-19 to the inclusion criteria, aligning with the Centers for Disease Control and Prevention. Additional relevant nonclinical toxicology, pharmacology, and PK language were included based on Phase 1 drug-drug interactions and radiolabeled ADME. Consequently, restrictions on the coadministration of acid-reducing agents were removed, hormonal contraceptive measures were amended, and phototoxicity results demonstrating that GS-5245 was not considered a photosafety risk were incorporated. Updates to secondary and exploratory objectives and endpoints were made to capture omissions (PK) and reflect additional analyses (PROs, viral titer, and coinfections)..

    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.
    None reported
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