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    Clinical Trial Results:
    A Multicenter, Observational, 6-Month Follow-up Study of Patients With COVID-19 Previously Enrolled in a RO7496998 (AT-527) Study

    Summary
    EudraCT number
    2021-000627-12
    Trial protocol
    BE   PT   DK   DE   IT   RO  
    Global end of trial date
    16 Mar 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Sep 2022
    First version publication date
    25 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CV43140
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05059080
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002963-PIP01-21
    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
    16 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study evaluated the long-term sequelae of COVID-19 in subjects diagnosed with COVID-19 who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study 2020-005759-18 [CV43043]), for approximately 6 months after the end of the parent study.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jun 2021
    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
    Argentina: 1
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Brazil: 5
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Mexico: 15
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Turkey: 19
    Country: Number of subjects enrolled
    Ukraine: 17
    Worldwide total number of subjects
    72
    EEA total number of subjects
    14
    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)
    1
    Adults (18-64 years)
    69
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled into the study at 27 investigational sites in 10 countries: Mexico, Ukraine, Turkey, Brazil, Belgium, Denmark, Argentina, Germany, Romania, and Switzerland.

    Pre-assignment
    Screening details
    Participants diagnosed with COVID-19, who previously enrolled in a RO7496998 (AT-527) study (i.e. parent study 2020-005759-18 [CV43043]), were enrolled in this study after the end of the parent study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    All Participants
    Arm description
    Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study 2020-005759-18 [CV43043]).
    Arm type
    No intervention

    Investigational medicinal product name
    AT-527
    Investigational medicinal product code
    Other name
    RO7496998
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the parent study participants were randomized 1:2 to receive either placebo or AT-527 550 milligrams (mg). AT-527 (RO7496998) was administered twice daily (BID) for 5 days. No study drug was administered in this follow-up study.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the parent study participants were randomized 1:2 to receive either placebo or AT-527 550 milligrams (mg). The dose and regimen of the placebo matched that of AT-527 (RO7496998). No placebo was administered in this follow-up study.

    Number of subjects in period 1
    All Participants
    Started
    72
    Completed
    5
    Not completed
    67
         Consent withdrawn by subject
    3
         Study Ended by Sponsor
    64

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Participants
    Reporting group description
    Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study 2020-005759-18 [CV43043]).

    Reporting group values
    All Participants Total
    Number of subjects
    72 72
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    40.4 ( 13.4 ) -
    Sex: Female, Male
    Units:
        Female
    43 43
        Male
    29 29

    End points

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    End points reporting groups
    Reporting group title
    All Participants
    Reporting group description
    Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study 2020-005759-18 [CV43043]).

    Primary: Percentage of Participants With COVID-19 Symptoms Assessed through the COVID-19 Symptom Diary from Baseline up to Month 6

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    End point title
    Percentage of Participants With COVID-19 Symptoms Assessed through the COVID-19 Symptom Diary from Baseline up to Month 6 [1]
    End point description
    COVID-19 symptoms were evaluated using the COVID-19 Symptom Diary. The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 were recorded on a 4-point Likert scale (i.e none/mild/moderate/severe). Items 13-14 were recorded on a 3-point Likert scale (i.e. same as usual/less than usual/no sense). Reported here is the percentage of participants with COVID-19 symptoms (mild/moderate/severe or less than usual/no sense) recorded during week 4 of each month following the baseline assessment. Here, n indicates the number of participants analyzed at each time point. BL=Baseline, M1=Month 1 -Week 4, M2=Month 2 - Week 4, M3=Month 3 - Week 4, M4=Month 4 - Week 4, M5=Month 5 - Week 4, M6=Month 6 - Week 4
    End point type
    Primary
    End point timeframe
    Baseline, Month 1 - Week 4, Month 2 - Week 4, Month 3 - Week 4, Month 4 - Week 4, Month 5 - Week 4, Month 6 - Week 4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary analysis was planned to be descriptive in nature and there were no plans for formal hypothesis testing in the analysis of the primary endpoint.
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
    number (not applicable)
        Nasal Congestion or Runny Nose: BL (n=69)
    17.4
        Nasal Congestion or Runny Nose: M1 (n=61)
    18.0
        Nasal Congestion or Runny Nose: M2 (n=64)
    17.2
        Nasal Congestion or Runny Nose: M3 (n=59)
    18.6
        Nasal Congestion or Runny Nose: M4 (n=32)
    15.6
        Nasal Congestion or Runny Nose: M5 (n=14)
    21.4
        Nasal Congestion or Runny Nose: M6 (n=3)
    0
        Sore Throat: BL (n=69)
    7.2
        Sore Throat: M1 (n=61)
    9.8
        Sore Throat: M2 (n=64)
    14.1
        Sore Throat: M3 (n=59)
    15.3
        Sore Throat: M4 (n=32)
    18.8
        Sore Throat: M5 (n=14)
    0
        Sore Throat: M6 (n=3)
    0
        Cough: BL (n=69)
    21.7
        Cough: M1 (n=61)
    16.4
        Cough: M2 (n=64)
    17.2
        Cough: M3 (n=59)
    16.9
        Cough: M4 (n=32)
    15.6
        Cough: M5 (n=14)
    7.1
        Cough: M6 (n=3)
    0
        Shortness of Breath: BL (n=69)
    5.8
        Shortness of Breath: M1 (n=61)
    11.5
        Shortness of Breath: M2 (n=64)
    12.5
        Shortness of Breath: M3 (n=59)
    18.6
        Shortness of Breath: M4 (n=32)
    12.5
        Shortness of Breath: M5 (n=14)
    7.1
        Shortness of Breath: M6 (n=3)
    0
        Muscle or Body Aches: BL (n=69)
    21.7
        Muscle or Body Aches: M1 (n=61)
    13.1
        Muscle or Body Aches: M2 (n=64)
    18.8
        Muscle or Body Aches: M3 (n=59)
    18.6
        Muscle or Body Aches: M4 (n=32)
    12.5
        Muscle or Body Aches: M5 (n=14)
    14.3
        Muscle or Body Aches: M6 (n=3)
    0
        Fatigue: BL (n=69)
    31.9
        Fatigue: M1 (n=61)
    27.9
        Fatigue: M2 (n=64)
    26.6
        Fatigue: M3 (n=59)
    35.6
        Fatigue: M4 (n=32)
    25.0
        Fatigue: M5 (n=14)
    28.6
        Fatigue: M6 (n=3)
    0
        Headache: BL (n=69)
    13.0
        Headache: M1 (n=61)
    6.6
        Headache: M2 (n=64)
    7.8
        Headache: M3 (n=59)
    20.3
        Headache: M4 (n=32)
    12.5
        Headache: M5 (n=14)
    0
        Headache: M6 (n=3)
    0
        Chills/Sweats: BL (n=69)
    5.8
        Chills/Sweats: M1 (n=61)
    0
        Chills/Sweats: M2 (n=64)
    7.8
        Chills/Sweats: M3 (n=59)
    6.8
        Chills/Sweats: M4 (n=32)
    6.3
        Chills/Sweats: M5 (n=14)
    0
        Chills/Sweats: M6 (n=3)
    0
        Feeling Hot or Feverish: BL (n=69)
    4.3
        Feeling Hot or Feverish: M1 (n=61)
    3.3
        Feeling Hot or Feverish: M2 (n=64)
    6.3
        Feeling Hot or Feverish: M3 (n=59)
    5.1
        Feeling Hot or Feverish: M4 (n=32)
    3.1
        Feeling Hot or Feverish: M5 (n=14)
    0
        Feeling Hot or Feverish: M6 (n=3)
    0
        Nausea: BL (n=69)
    4.3
        Nausea: M1 (n=61)
    0
        Nausea: M2 (n=64)
    6.3
        Nausea: M3 (n=59)
    10.2
        Nausea: M4 (n=32)
    6.3
        Nausea: M5 (n=14)
    0
        Nausea: M6 (n=3)
    0
        Vomiting: BL (n=69)
    0
        Vomiting: M1 (n=61)
    0
        Vomiting: M2 (n=64)
    1.6
        Vomiting: M3 (n=59)
    3.4
        Vomiting: M4 (n=32)
    0
        Vomiting: M5 (n=14)
    0
        Vomiting: M6 (n=3)
    0
        Diarrhea: BL (n=69)
    2.9
        Diarrhea: M1 (n=61)
    1.6
        Diarrhea: M2 (n=64)
    4.7
        Diarrhea: M3 (n=59)
    5.1
        Diarrhea: M4 (n=32)
    9.4
        Diarrhea: M5 (n=14)
    0
        Diarrhea: M6 (n=3)
    0
        Reduction or Loss of Sense of Smell: BL (n=69)
    23.2
        Reduction or Loss of Sense of Smell: M1 (n=61)
    18.0
        Reduction or Loss of Sense of Smell: M2 (n=64)
    18.8
        Reduction or Loss of Sense of Smell: M3 (n=59)
    18.6
        Reduction or Loss of Sense of Smell: M4 (n=32)
    15.6
        Reduction or Loss of Sense of Smell: M5 (n=14)
    21.4
        Reduction or Loss of Sense of Smell: M6 (n=3)
    0
        Reduction or Loss of Sense of Taste: BL (n=69)
    17.4
        Reduction or Loss of Sense of Taste: M1 (n=61)
    11.5
        Reduction or Loss of Sense of Taste: M2 (n=64)
    15.6
        Reduction or Loss of Sense of Taste: M3 (n=59)
    13.6
        Reduction or Loss of Sense of Taste: M4 (n=32)
    15.6
        Reduction or Loss of Sense of Taste: M5 (n=14)
    21.4
        Reduction or Loss of Sense of Taste: M6 (n=3)
    0
    No statistical analyses for this end point

    Secondary: Dyspnea Symptoms Assessment Score through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire

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    End point title
    Dyspnea Symptoms Assessment Score through the Patient Reported Outcomes Measurement Information System - Short Form (PROMIS-SF) - Dyspnea Questionnaire
    End point description
    The PROMIS-SF-Dyspnea Questionnaire is a 10-item questionnaire to evaluate the impact of dyspnea on specific activities. Participants self-assessed the severity of shortness of breath and difficulty of breathing in response to specific activities with a recall of the past 7 days. The PROMIS SF-Dyspnea Severity instrument is scored on a 4-point Likert scale, with an option to indicate that an activity had not been performed. Total score range is 0-30, where a higher score indicates a higher symptom severity of dyspnea.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=70)
    2.04 ( 3.62 )
        Month 1 (n=59)
    1.94 ( 3.49 )
        Month 2 (n=63)
    2.12 ( 3.69 )
        Month 3 (n=58)
    1.97 ( 2.97 )
        Month 4 (n=30)
    1.33 ( 2.95 )
        Month 5 (n=13)
    0.69 ( 1.70 )
        Month 6 (n=3)
    0.00 ( 0.00 )
    No statistical analyses for this end point

    Secondary: Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)

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    End point title
    Respiratory-specific Health-related Quality of Life Score as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
    End point description
    The SGRQ is a 50-item respiratory-specific health-related quality of life instrument that measures health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. Each scale is scored from 0 to 100, and the total score represents the weighted average of these three subscores. Higher scores correspond to worse quality of life. The SGRQ had a recall specification of 4 weeks. Here, n indicates the number of participants analyzed at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline (n=70)
    12.93 ( 16.57 )
        Month 1 (n=59)
    11.13 ( 16.27 )
        Month 2 (n=60)
    11.39 ( 16.35 )
        Month 3 (n=59)
    11.40 ( 16.27 )
        Month 4 (n=32)
    13.88 ( 23.91 )
        Month 5 (n=13)
    6.66 ( 14.70 )
        Month 6 (n=3)
    3.46 ( 4.11 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with COVID-19 Related Medically-Attended Visits

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    End point title
    Percentage of Participants with COVID-19 Related Medically-Attended Visits
    End point description
    COVID-19-related medically-attended visits were defined as hospitalization, ER visit, urgent care visit, physician’s office visit, or telemedicine visit with the primary reason for the visit being COVID-19 or COVID-19-related symptoms. The analysis population included all enrolled participants in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
        number (confidence interval 97.5%)
    2.8 (0.00 to 7.81)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Death Attributable to Progression of COVID-19

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    End point title
    Percentage of Participants with Death Attributable to Progression of COVID-19
    End point description
    The analysis population included all enrolled participants in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Re-Infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)

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    End point title
    Percentage of Participants Re-Infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
    End point description
    Reinfection was defined as any nasopharyngeal (NP) swab that was positive for SARS-CoV-2 infection via reverse-transcriptase polymerase chain reaction (RT-PCR), taken when clinically indicated based on symptoms. The analysis population included all enrolled participants in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with any Post-Treatment Infection

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    End point title
    Percentage of Participants with any Post-Treatment Infection
    End point description
    Post-treatment infections were defined as any adverse event with a primary system organ class of infections and infestations. The analysis population included all enrolled participants in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
        number (confidence interval 97.5%)
    8.3 (0.34 to 16.33)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with COVID-19-Related Complications

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    End point title
    Percentage of Participants with COVID-19-Related Complications
    End point description
    COVID-19 related complications included pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis and/or myocarditis, and cardiac failure. The analysis population included all enrolled participants in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
        number (confidence interval 97.5%)
    0 (0.00 to 0.69)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Events (AEs)

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    End point title
    Percentage of Participants with Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition not present at baseline or related to a protocol-mandated intervention. The safety population included all enrolled participants in the study.
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    All Participants
    Number of subjects analysed
    72
    Units: percentage of participants
        number (not applicable)
    26.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 months
    Adverse event reporting additional description
    All AEs/Serious AEs continuing/persisting from the parent study or any new AEs with an onset date on or after the first day of enrollment and during this follow-up study are displayed. The safety population included all participants enrolled in the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    All Participants
    Reporting group description
    Participants were previously enrolled in a RO7496998 (AT-527) study (i.e. parent study 2020-005759-18 [CV43043]).

    Serious adverse events
    All Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 72 (2.78%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Arterial occlusive disease
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    All Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 72 (23.61%)
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Muscle strain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    3
    Hyposmia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Taste disorder
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Hangover
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Vaccination site pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Sneezing
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Tenosynovitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Mar 2022
    Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.
    -

    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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    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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