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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19

    Summary
    EudraCT number
    		 2020-004743-83
    Trial protocol
    		 GB   BE   PT   FR   NL   IT   DE   RO   ES  
    Global end of trial date
    10 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2023
    First version publication date
    25 Feb 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SG018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04732949
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Synairgen Research Ltd
    Sponsor organisation address
    Tremona Road, Southampton, United Kingdom, SO16 6YD
    Public contact
    Brooke Clarke, Synairgen Research Ltd, 02 380512800, Brooke.Clarke@synairgen.com
    Scientific contact
    Brooke Clarke, Synairgen Research Ltd, 02 380512800, Brooke.Clarke@synairgen.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
    10 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate recovery in patients with moderate Coronavirus disease 2019 (COVID-19) after administration of SNG001 compared to placebo.
    Protection of trial subjects
    This trial was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, and other local applicable laws and regulations. After the trial had been fully explained and the patient had been given ample time to read the patient information sheet (PIS)/ICF, consider the trial, and discuss it in detail, informed consent was gained. The method of obtaining and documenting informed consent and the contents of the consent was discussed and agreed with the appropriate competent authorities. For this study, methods included both written and video consent with only sites in India implementing the audio-video process as per their local guidelines. Each method was discussed and approved by the, applicable IEC/IRB before the site obtained the first consent. Informed consent was always obtained from the patient before any trial related procedures were performed, irrespective of the method used. Patients were informed that their participation was voluntary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jan 2021
    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
    Netherlands: 11
    Country: Number of subjects enrolled
    Portugal: 26
    Country: Number of subjects enrolled
    Romania: 14
    Country: Number of subjects enrolled
    Spain: 35
    Country: Number of subjects enrolled
    United Kingdom: 176
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    France: 41
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Italy: 41
    Country: Number of subjects enrolled
    Brazil: 18
    Country: Number of subjects enrolled
    India: 72
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Mexico: 32
    Country: Number of subjects enrolled
    Serbia: 81
    Country: Number of subjects enrolled
    United States: 19
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Colombia: 9
    Worldwide total number of subjects
    623
    EEA total number of subjects
    201
    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)
    483
    From 65 to 84 years
    133
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was conducted at 112 centers which included 623 patients across 17 countries. The trial began on 12 January 2021 (first patient consented) and was completed on 10 Feb 2022.

    Pre-assignment
    Screening details
    		 The pre-treatment assessments were performed on Day 0 prior to the first dose preferably. All the study assessments were performed as per the schedule of assessments.

    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
    Blinding implementation details
    The patient and investigator-blinded with regard to SNG001 or placebo but not the dose.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SNG001
    Arm description
    		 Patients received SNG001 via inhalation using nebuliser, once a day for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    SNG001
    Investigational medicinal product code
    SNG001
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The SNG001 nebuliser (study medication) solution delivered using the nebuliser. The study medication was taken once daily at approximately the same time of day for 14 consecutive days. There was a gap of at least 8 hours between doses.

    Arm title
    		 Placebo
    Arm description
    		 Patients received Placebo via inhalation using nebuliser, once a day for 14 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The Placebo delivered using the nebuliser. The Placebo was taken once daily at approximately the same time of day for 14 consecutive days. There was a gap of at least 8 hours between doses.

    Number of subjects in period 1
    		SNG001 Placebo
    Started
    309
    314
    Completed
    233
    231
    Not completed
    76
    83
         Adverse event, serious fatal
    16
    18
         Consent withdrawn by subject
    23
    27
         Physician decision
    2
    1
         Adverse event, non-fatal
    2
    1
         Other
    6
    3
         Non-serious adverse event
    1
    3
         Non-compliance
    -
    2
         Lost to follow-up
    26
    27
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SNG001
    Reporting group description
    		 Patients received SNG001 via inhalation using nebuliser, once a day for 14 days

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo via inhalation using nebuliser, once a day for 14 days

    Reporting group values
    		 SNG001 Placebo Total
    Number of subjects
    		 309 314 623
    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)
    		 52 ± 15.19 53.7 ± 14.42 -
    Gender categorical
    Units: Subjects
        Female
    		 203 208 411
        Male
    		 106 106 212

    End points

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    End points reporting groups
    Reporting group title
    SNG001
    Reporting group description
    		 Patients received SNG001 via inhalation using nebuliser, once a day for 14 days

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo via inhalation using nebuliser, once a day for 14 days

    Primary: Time to Hospital Discharge

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    End point title
    		 Time to Hospital Discharge
    End point description
    The time to hospital discharge in patients with moderate COVID-19 after administration of SNG001 compared to placebo was evaluated. The Intent-to-Treat (ITT) analysis population consisted of all randomised patients.
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: day
        median (full range (min-max))
    7.0 (7.0 to 8.0)
    8.0 (7.0 to 9.0)
    Statistical analysis title
    		 SNG001 vs Placebo
    Statistical analysis description
    Hazard Ratio for time to hospital discharge
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.509
    Method
    		 Cox proportional hazard model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.27

    Primary: Time to Recovery

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    End point title
    		 Time to Recovery
    End point description
    Recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo by time to recovery was evaluated. The ITT analysis population consisted of all randomised patients. Here, the arbitrary value 9999.9999 indicates not calculable. The upper limit was not calculable due to Insufficient number of participants with events
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: day
        median (full range (min-max))
    25.0 (22.0 to 9999.9999)
    25.0 (22.0 to 9999.9999)
    Statistical analysis title
    		 SNG001 vs Placebo
    Statistical analysis description
    Hazard Ratio for time to OSCI recovery
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.888
    Method
    		 Cox proportional hazard model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.28

    Secondary: Number of Patients Who Progressed to Severe Disease or Death

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    End point title
    		 Number of Patients Who Progressed to Severe Disease or Death
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to severe disease or death was evaluated. Severe disease was defined by the Ordinal Scale for Clinical Improvement (OSCI) as a score between 5 and 7. Death was defined by an OSCI score of 8. The ITT analysis population consisted of all randomised patients. Here, the number of participants analyzed signifies the participants with available data that were analyzed for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Until Day 35
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    308
    312
    Units: participants
    33
    45
    Statistical analysis title
    		 SNG001 vs Placebo
    Statistical analysis description
    Odds Ratio for progression to severe disease or death
    Comparison groups
    Placebo v SNG001
    Number of subjects included in analysis
    620
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.161
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.15

    Secondary: Number of Patients Who Were Intubated or Who Died

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    End point title
    		 Number of Patients Who Were Intubated or Who Died
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing progression to intubation or death was evaluated. Intubation was defined by the OSCI as a score between 6 and 7. Death was defined by an OSCI score of 8. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Until Day 35
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
    20
    23
    Statistical analysis title
    		 SNG001 vs Placebo
    Statistical analysis description
    Odds Ratio for intubation or death
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.61
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.61

    Secondary: Number of Patients Who Died Within 35 Days of First Dose

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    End point title
    		 Number of Patients Who Died Within 35 Days of First Dose
    End point description
    Patients who died within 35 days of first dose of study intervention were calculated. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Until Day 35 of first dose
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
    14
    17
    Statistical analysis title
    		 SNG001 vs Placebo
    Statistical analysis description
    Odds Ratio for death
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.544
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.67

    Secondary: Cumulative Number of Patients Who Were Discharged From Hospital

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    End point title
    		 Cumulative Number of Patients Who Were Discharged From Hospital
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 was assessed by hospital dischargen on given days. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Days 7, 14, 21 and 28
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
        Day 7
    154
    141
        Day 14
    231
    223
        Day 21
    245
    249
        Day 28
    249
    255
    Statistical analysis title
    		 SNG001 vs Placebo (Day 7)
    Statistical analysis description
    Odds Ratio for hospital discharge (Day 7)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.323
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.64
    Statistical analysis title
    		 SNG001 vs Placebo (Day 14)
    Statistical analysis description
    Odds Ratio for hospital discharge (Day 14)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.406
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.7
    Statistical analysis title
    		 SNG001 vs Placebo (Day 21)
    Statistical analysis description
    Odds Ratio for hospital discharge (Day 21)
    Comparison groups
    Placebo v SNG001
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.828
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.43
    Statistical analysis title
    		 SNG001 vs Placebo (Day 28)
    Statistical analysis description
    Odds Ratio for hospital discharge (Day 28)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.706
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.4

    Secondary: Cumulative Number of Patients With Recovery

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    End point title
    		 Cumulative Number of Patients With Recovery
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing recovery was evaluated. Recovery is defined as no limitation of activities according to the Ordinal Scale of Clinical Improvement (OSCI), with no rebound at subsequent assessments. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Days 7, 14, 21 and 28
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
        Day 7
    28
    17
        Day 14
    75
    73
        Day 21
    117
    118
        Day 28
    145
    151
    Statistical analysis title
    		 SNG001 vs Placebo (Day 7)
    Statistical analysis description
    Odds Ratio for OSCI recovery (Day 7)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.101
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3.22
    Statistical analysis title
    		 SNG001 vs Placebo (Day 14)
    Statistical analysis description
    Odds Ratio for OSCI recovery (Day 14)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.942
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.45
    Statistical analysis title
    		 SNG001 vs Placebo (Day 21)
    Statistical analysis description
    Odds Ratio for OSCI recovery (Day 21)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.824
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.35
    Statistical analysis title
    		 SNG001 vs Placebo (Day 28)
    Statistical analysis description
    Odds Ratio for OSCI recovery (Day 28)
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.613
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.28

    Secondary: Improvement Based on Entire WHO OSCI Score

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    End point title
    		 Improvement Based on Entire WHO OSCI Score
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing improvement across the entire WHO OSCI were evaluated. Improvement in clinical status is based on the 9-point OSCI score. The score ranges from 0 to 8, where lower score of 0 represents no clinical or virological evidence of infection and higher score of 8 represents death. Higher scores indicated worse outcome. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Until Day 35
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
        Baseline, 0 = No clinical or virological evidence
    0
    0
        Baseline, 1 = No limitations of activities
    0
    0
        Baseline, 2 = Limitation of activities
    1
    0
        Baseline, 3 = Hospitalised - no oxygen therapy
    3
    8
        Baseline, 4 = Oxygen by mask, or nasal prongs
    304
    304
        Baseline, 5 = Non-invasive ventilation
    1
    2
        Baseline, 6 = Intubation & mechanical ventilation
    0
    0
        Baseline, 7 = Ventilation + organ support
    0
    0
        Baseline, 8 = Death
    0
    0
        Missing
    0
    0
        Day 7, 0 = No clinical or virological evidence
    20
    14
        Day 7, 1 = No limitations of activities
    18
    12
        Day 7, 2 = Limitation of activities
    115
    114
        Day 7, 3 = Hospitalised - no oxygen therapy
    42
    42
        Day 7, 4 = Oxygen by mask, or nasal prongs
    53
    69
        Day 7, 5 = Non-invasive ventilation
    18
    26
        Day 7, 6 = Intubation & mechanical ventilation
    2
    2
        Day 7, 7 = Ventilation + organ support
    3
    3
        Day 7, 8 = Death
    4
    0
        Day 7, Missing
    34
    32
        Day 14, 0 = No clinical or virological evidence
    62
    57
        Day 14, 1 = No limitations of activities
    24
    30
        Day 14, 2 = Limitation of activities
    135
    127
        Day 14, 3 = Hospitalised - no oxygen therapy
    11
    18
        Day 14, 4 = Oxygen by mask, or nasal prongs
    13
    15
        Day 14, 5 = Non-invasive ventilation
    2
    4
        Day 14, 6 = Intubation & mechanical ventilation
    3
    1
        Day 14, 7 = Ventilation + organ support
    3
    9
        Day 14, 8 = Death
    9
    7
        Day 14, Missing
    47
    46
        Day 21, 0 = No clinical or virological evidence
    89
    94
        Day 21, 1 = No limitations of activities
    32
    23
        Day 21, 2 = Limitation of activities
    109
    114
        Day 21, 3 = Hospitalised - no oxygen therapy
    3
    4
        Day 21, 4 = Oxygen by mask, or nasal prongs
    7
    4
        Day 21, 5 = Non-invasive ventilation
    1
    0
        Day 21, 6 = Intubation & mechanical ventilation
    2
    1
        Day 21, 7 = Ventilation + organ support
    2
    8
        Day 21, 8 = Death
    12
    9
        Day 21, Missing
    52
    57
        Day 28, 0 = No clinical or virological evidence
    123
    134
        Day 28, 1 = No limitations of activities
    23
    13
        Day 28, 2 = Limitation of activities
    85
    95
        Day 28, 3 = Hospitalised - no oxygen therapy
    0
    0
        Day 28, 4 = Oxygen by mask, or nasal prongs
    3
    2
        Day 28, 5 = Non-invasive ventilation
    4
    0
        Day 28, 6 = Intubation & mechanical ventilation
    0
    1
        Day 28, 7 = Ventilation + organ support
    1
    3
        Day 28, 8 = Death
    14
    14
        Day 28, Missing
    56
    52
        Day 35, 0 = No clinical or virological evidence
    147
    153
        Day 35, 1 = No limitations of activities
    10
    16
        Day 35, 2 = Limitation of activities
    71
    73
        Day 35, 3 = Hospitalised - no oxygen therapy
    0
    0
        Day 35, 4 = Oxygen by mask, or nasal prongs
    2
    1
        Day 35, 5 = Non-invasive ventilation
    1
    0
        Day 35, 6 = Intubation & mechanical ventilation
    2
    1
        Day 35, 7 = Ventilation + organ support
    1
    1
        Day 35, 8 = Death
    14
    17
        Day 35, Missing
    61
    52
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)

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    End point title
    		 Change From Baseline in Total Score According to the Breathlessness, Cough and Sputum Scale (BCSS)
    End point description
    The efficacy of SNG001 compared with placebo in patients with moderate COVID-19 by assessing changes in daily breathlessness, cough and sputum scores on a scale of 0 (no symptoms) up to 4 (severe symptoms) was evaluated. The BCSS is a daily patient-reported outcome measure that was designed as a daily diary in which patients were asked to record the severity of three symptoms: breathlessness, cough and sputum. Each symptom is represented by a single item which is evaluated on a 5-point scale ranging from 0-4, with higher scores indicating more severe symptoms. Breathing difficulty: 0=None, 1=Mild, 2=Moderate, 3=Marked, 4=Severe; Cough: 0=No cough, 2=Occasional, 3=Frequent, 4=Almost constant; Sputum: 0=None, 1=Mild, 2=Moderate, 3=Marked, 4=Severe. A mean decline of 1 point on the BCSS total scale signifies a substantial reduction in symptom severity. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 15
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: Score on a scale
        least squares mean (standard error)
    -2.1 ± 0.09
    -2.2 ± 0.09
    Statistical analysis title
    		 SNG001 vs Placebo
    Comparison groups
    SNG001 v Placebo
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.41
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12

    Secondary: Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period

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    End point title
    		 Change From Baseline in National Early Warning Score (NEWS2) During the Hospitalisation Period
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing changes in NEWS2 during hospitalisation period was evaluated. The NEWS2 is a tool which is used in detection and response to clinical deterioration in adult patients and is a key element of patient safety and improving patient outcomes. The NEWS2 score was calculated using Six physiological parameters such as: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion and temperature. Each parameter was assigned a score between 0 and 3 and the NEWS2 score was calculated as the sum of the individual parameter scores. NEWS2 score between 0 and 4: Low, Score of any individual parameter of 3: Low-medium, NEWS2 score of 5 or 6: Medium, NEWS2 score of 7 or more: High. Higher scores indicates high clinical risk. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Day 1 until Day 28
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    75
    87
    Units: Score on a scale
    least squares mean (standard error)
        Day 7 (n= 75, 87)
    -0.7 ± 3.08
    -0.7 ± 2.55
        Day 14 (n= 17, 30)
    0.2 ± 3.83
    -0.3 ± 3.32
        Day 21 (n= 10, 12)
    2.8 ± 3.16
    2.3 ± 3.62
        Day 28 (n= 4, 6)
    -0.5 ± 2.08
    4.5 ± 4.37
    No statistical analyses for this end point

    Secondary: Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment

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    End point title
    		 Number of Patients With Presence of COVID-19 Symptoms Based on Daily Assessment
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of COVID-19 symptoms was evaluated. The presence of COVID-19 symptoms were assessed. Individual symptoms related to COVID-19/SARS-CoV-2 infection such as fever, breathlessness, and fatigue were assessed. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Day 1 until Day 90
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
        Baseline (n= 309, 314)
    306
    310
        Day 7 (n= 264, 271)
    221
    234
        Day 14 (n= 247, 251)
    169
    162
        Day 21 (n= 243, 238)
    154
    139
        Day 28 (n= 236, 243)
    122
    117
        Day 35 (n= 164, 171)
    61
    69
        Day 60 (n= 166, 171)
    44
    57
        Day 90 (n= 176, 176)
    41
    51
    No statistical analyses for this end point

    Secondary: Number of Patients With Limitations of Usual Activities Based on Daily Assessment

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    End point title
    		 Number of Patients With Limitations of Usual Activities Based on Daily Assessment
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by daily assessment of limitation of usual activities was evaluated. The patients with limitations of usual activities were the patients who were unable to do usual activities (work, study, housework, family or leisure activities). The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Day 1 until Day 35
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    309
    314
    Units: participants
        Day 1 (n= 309, 314)
    0
    1
        Day 7 (n= 275, 283)
    115
    114
        Day 14 (n= 262, 268)
    135
    127
        Day 21 (n= 257, 257)
    109
    114
        Day 28 (n= 253, 262)
    85
    95
        Day 35 (n= 248, 262)
    71
    73
    No statistical analyses for this end point

    Secondary: Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)

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    End point title
    		 Quality of Life Measured Using EuroQol 5-dimension 5-level (EQ-5D-5L)
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by using EQ-5D-5L was evaluated. The EQ-5D-5L provides a simple descriptive profile and a single index value for health status. The EQ-5D-5L self-rated questionnaire includes a visual analogue scale, which records the respondent's self-rated health status on a graduated (0–100) scale, with higher scores for higher health-related quality of life. It also includes the EQ-5D-5L descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. Here, 100 means the best health and 0 means the worst health. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Day 0, Day 7, Day 15, Day 28, Day 60 and Day 90
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    302
    311
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 0 (n= 302, 311)
    56.4 ± 21.72
    56.9 ± 20.95
        Day 7 (n= 259, 264)
    72.6 ± 18.39
    71.1 ± 20.44
        Day 15 (n= 241, 251)
    79.5 ± 18.25
    79.0 ± 16.51
        Day 28 (n= 234, 242)
    83.3 ± 16.00
    83.5 ± 14.90
        Day 60 (n= 230, 232)
    88.9 ± 14.16
    88.0 ± 13.56
        Day 90 (n= 233, 229)
    90.3 ± 12.65
    89.9 ± 13.65
    No statistical analyses for this end point

    Secondary: General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score

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    End point title
    		 General Anxiety Disorder 7 Questionnaire (GAD-7) Total Score
    End point description
    The efficacy of SNG001 compared to placebo in patients with moderate COVID-19 by assessing long-COVID-19 symptoms was evaluated. Assessment of long-COVID-19 symptoms based on GAD-7 scale. GAD-7 scores seven individual item scales by assigning scores of 0, 1, 2, and 3, to the response categories of “not at all”, “several days”, “more than half the days”, and “nearly every day”, respectively. The GAD-7 total score is calculated by summing the individual item scales to give a total score between 0 and 21. Higher score indicates severe anxiety. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 28, Day 60 and Day 90
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    238
    249
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 15 (n=238, 249)
    3.3 ± 4.08
    3.5 ± 4.30
        Day 28 (n= 231, 240)
    2.2 ± 3.67
    1.9 ± 3.29
        Day 60 (n= 229, 231)
    1.4 ± 3.06
    1.7 ± 3.38
        Day 90 (n= 228, 227)
    1.0 ± 2.41
    1.6 ± 3.43
    No statistical analyses for this end point

    Secondary: Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score

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    End point title
    		 Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-FS [Version 4]) Total Score
    End point description
    Long-COVID-19 symptoms based on FACIT Fatigue Scale (Version 4) were evaluated. The FACIT Fatigue Scale (Version 4) included statements for patients such as: I feel fatigued; I feel weak all over; I feel listless (“washed out”); I feel tired; I have trouble starting things because I am tired; I have trouble finishing things because I am tired; I have energy; I am able to do my usual activities; I need to sleep during the day; I am too tired to eat; I need help doing my usual activities; and I am frustrated by being too tired to do the things I want to do. Based on responses on above statements, scoring was done and scores ranges from 0 to 4, where 0 represents not at all bothered by any of the above problems and 4 indicates very much bothered every day by any of the above problems. Total scores will be calculated as per the algorithm to give a total score on a scale between 0 and 52, where a higher total score indicates lower level of fatigue.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 28, Day 60 and Day 90
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    239
    248
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 15 (n= 239, 248)
    39.1 ± 9.79
    38.7 ± 10.31
        Day 28 (n= 233, 237)
    42.5 ± 10.19
    42.8 ± 8.98
        Day 60 (n= 228, 230)
    46.4 ± 8.22
    45.5 ± 7.96
        Day 90 (n= 230, 229)
    46.9 ± 8.01
    46.3 ± 7.78
    No statistical analyses for this end point

    Secondary: Patient Health Questionnaire-9 (PHQ-9) Total Score

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    End point title
    		 Patient Health Questionnaire-9 (PHQ-9) Total Score
    End point description
    Long-COVID-19 symptoms based on PHQ-9 were evaluated. Patient Health Questionnaire-9 (PHQ-9) scores nine individual item scales by assigning scores of 0, 1, 2, and 3, to the response categories of “not at all”, “several days”, “more than half the days”, and “nearly every day”, respectively. PHQ-9 total scores are calculated by summing the individual item scales to give a total score between 0 and 27. Higher scores indicated worse outcome. The ITT analysis population consisted of all randomised patients.
    End point type
    Secondary
    End point timeframe
    Day 15, Day 28, Day 60 and Day 90
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    237
    245
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 15 (n= 237, 245)
    4.6 ± 4.47
    5.0 ± 4.71
        Day 28 (n= 232, 238)
    3.2 ± 4.15
    3.1 ± 4.02
        Day 60 (n= 228, 229)
    1.7 ± 3.23
    2.1 ± 3.85
        Day 90 (n= 229, 228)
    1.5 ± 3.05
    2.0 ± 3.89
    No statistical analyses for this end point

    Secondary: Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores

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    End point title
    		 Overall Pain Severity as Measured by Brief Pain Inventory Composite Scores
    End point description
    Brief Pain Inventory Composite Scores is a self administered questionnaire that assesses pain interference. Overall pain severity score is calculated as the mean of questions of the brief pain inventory. The overall pain severity score is the average pain, on a scale from 0 to 10 of the worst pain, least pain and average pain in the last 24 hours and pain right now scores. Here, 0 indicates "No pain" and 10 indicates "Worst pain".
    End point type
    Secondary
    End point timeframe
    Day 15, Day 28, Day 60 and Day 90
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    50
    55
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Day 15 (n= 50, 55)
    3.4 ± 2.13
    3.3 ± 1.98
        Day 28 (n= 34, 38)
    3.2 ± 1.98
    3.2 ± 1.77
        Day 60 (n= 21, 20)
    4.1 ± 1.54
    3.3 ± 1.94
        Day 90 (n= 21, 21)
    4.5 ± 2.14
    3.5 ± 2.33
    No statistical analyses for this end point

    Secondary: Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    The general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19 by assessing number of patients with AEs was assessed. The Safety analysis population included all patients in the ITT population who receive at least one dose of study drug. LTD: leading to discontinuation
    End point type
    Secondary
    End point timeframe
    From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)
    End point values
    		 SNG001 Placebo
    Number of subjects analysed
    301
    303
    Units: participants
        Any Treatment-emergent adverse event (TEAE)
    251
    251
        Any serious TEAE
    38
    55
        Any serious related TEAE
    3
    3
        Any fatal TEAE
    16
    16
        Any fatal TEAE related to study treatment
    0
    0
        Any TEAE related to study treatment
    68
    77
        Any TEAE LTD of study treatment
    24
    23
        Any Adverse Events of Note
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the day informed consent is obtained until 28 days after the last administration of the study medication (Day 90)
    Adverse event reporting additional description
    There were two patients randomised to placebo, one of which was never dosed and the other was dosed but the fatal Adverse Event (AE) started before dosing (i.e. not treatment emergent). For adverse event reporting, safety population was used.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    SNG001
    Reporting group description
    		 Patients received SNG001 via inhalation using nebuliser, once a day for 14 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo via inhalation using nebuliser, once a day for 14 days.

    Serious adverse events
    		 SNG001 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 301 (12.62%)
    55 / 303 (18.15%)
         number of deaths (all causes)
    16
    18
         number of deaths resulting from adverse events
    16
    16
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen consumption increased
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 301 (0.66%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 301 (0.33%)
    2 / 303 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Cardiac failure
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Myocardial ischaemia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dysaesthesia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood disorder
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    9 / 301 (2.99%)
    9 / 303 (2.97%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 9
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 301 (0.66%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Acute respiratory failure
         subjects affected / exposed
    1 / 301 (0.33%)
    7 / 303 (2.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 301 (0.00%)
    5 / 303 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 301 (0.00%)
    2 / 303 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary tract disorder
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 301 (1.00%)
    2 / 303 (0.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric decompensation
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    11 / 301 (3.65%)
    8 / 303 (2.64%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    5 / 5
    3 / 3
    COVID-19 pneumonia
         subjects affected / exposed
    8 / 301 (2.66%)
    8 / 303 (2.64%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    4 / 4
    2 / 2
    Pneumonia
         subjects affected / exposed
    3 / 301 (1.00%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 303 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia acinetobacter
         subjects affected / exposed
    1 / 301 (0.33%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 301 (0.00%)
    1 / 303 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SNG001 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    250 / 301 (83.06%)
    248 / 303 (81.85%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    71 / 301 (23.59%)
    61 / 303 (20.13%)
         occurrences all number
    84
    76
    Anosmia
         subjects affected / exposed
    18 / 301 (5.98%)
    20 / 303 (6.60%)
         occurrences all number
    18
    20
    Ageusia
         subjects affected / exposed
    13 / 301 (4.32%)
    18 / 303 (5.94%)
         occurrences all number
    13
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    39 / 301 (12.96%)
    40 / 303 (13.20%)
         occurrences all number
    40
    43
    Chest pain
         subjects affected / exposed
    36 / 301 (11.96%)
    52 / 303 (17.16%)
         occurrences all number
    37
    54
    Pyrexia
         subjects affected / exposed
    23 / 301 (7.64%)
    30 / 303 (9.90%)
         occurrences all number
    25
    34
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    25 / 301 (8.31%)
    9 / 303 (2.97%)
         occurrences all number
    26
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    22 / 301 (7.31%)
    26 / 303 (8.58%)
         occurrences all number
    23
    31
    Constipation
         subjects affected / exposed
    21 / 301 (6.98%)
    22 / 303 (7.26%)
         occurrences all number
    23
    27
    Vomiting
         subjects affected / exposed
    21 / 301 (6.98%)
    23 / 303 (7.59%)
         occurrences all number
    22
    26
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    70 / 301 (23.26%)
    72 / 303 (23.76%)
         occurrences all number
    78
    85
    Rhinorrhoea
         subjects affected / exposed
    58 / 301 (19.27%)
    54 / 303 (17.82%)
         occurrences all number
    62
    55
    Oropharyngeal pain
         subjects affected / exposed
    55 / 301 (18.27%)
    47 / 303 (15.51%)
         occurrences all number
    57
    50
    Wheezing
         subjects affected / exposed
    45 / 301 (14.95%)
    35 / 303 (11.55%)
         occurrences all number
    54
    45
    Cough
         subjects affected / exposed
    39 / 301 (12.96%)
    28 / 303 (9.24%)
         occurrences all number
    46
    32
    Dyspnoea
         subjects affected / exposed
    30 / 301 (9.97%)
    41 / 303 (13.53%)
         occurrences all number
    35
    46
    Haemoptysis
         subjects affected / exposed
    16 / 301 (5.32%)
    22 / 303 (7.26%)
         occurrences all number
    16
    22
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    60 / 301 (19.93%)
    60 / 303 (19.80%)
         occurrences all number
    62
    65
    Arthralgia
         subjects affected / exposed
    54 / 301 (17.94%)
    54 / 303 (17.82%)
         occurrences all number
    62
    62

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2020
    Amendment 2: Recruitment commenced on this version of the protocol. Changes were made following interactions with key regulatory agencies- Key secondary efficacy endpoint ‘Time to hospital discharge, defined by the OSCI score of 2 or below, with no rebound at subsequent assessments’ to a primary efficacy endpoint; Secondary efficacy endpoints ‘Progression to intubation or death, defined by the OSCI score of 6 or above within 28 days of first dose.’ and ‘death within 28 days of first dose.’ to key secondary efficacy endpoints; Addition of the following secondary endpoint: ‘daily assessment of COVID-19 symptoms and limitation of usual activities’.
    22 Feb 2021
    Amendment 4: Removed exclusion criteria number 12 that excluded patients who had received a prior SARS-CoV-2 vaccination; Included PK sampling schedule based on agreed FDA requirements

    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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