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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled trial to evaluate the effect of Epstein-Barr virus suppression in chronic obstructive pulmonary disease (EViSCO trial).

    Summary
    EudraCT number
    		 2017-004686-28
    Trial protocol
    		 GB  
    Global end of trial date
    27 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2021
    First version publication date
    31 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14143JK-AS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03699904
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Belfast Health and Social Care Trust
    Sponsor organisation address
    A Floor, Belfast City Hospital, Lisburn Road, Belfast, United Kingdom, BT9 7AB
    Public contact
    Dr Joe Kidney, Belfast Health and Social Care Trust , 0044 (0)2895 047531, joe.kidney@belfasttrust.hscni.net
    Scientific contact
    Dr Joe Kidney, Belfast Health and Social Care Trust , 0044 (0)2895 047531, joe.kidney@belfasttrust.hscni.net
    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
    12 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Aim: To establish if an antiviral therapy (valaciclovir) used to treat other herpes viruses is safe in patients with COPD. To examine whether it is possible to supress EBV in the airways of patients with COPD and examine important outcome measures including lung function and markers of airway inflammation in the blood and sputum. Primary Objective: To evaluate the safety of valaciclovir (1 gram three times daily for 8 weeks) for the suppression of Epstein-Barr virus in patients with COPD. To suppress Epstein-Barr virus shedding in COPD.
    Protection of trial subjects
    The risks for the patients in the intervention group included the side effects of the study drug (valaciclovir) and included headache, nausea, diarrhoea, vomiting and photosensitivity reaction. Patients with documented history of allergy or intolerance of the study drug were excluded from the trial. Patients unable to produce sputum samples spontaneously were offered the opportunity to undergo sputum induction this can cause bronchospasm. Therefore, subjects requiring sputum induction received prior nebulised bronchodilator and had serial FEV1 monitoring to ensure no deterioration. An independent data monitoring and ethics committee was also convened for the trial.
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 The comparator was placebo.
    Actual start date of recruitment
    02 Nov 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    49
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place between 02/11/2018 and 12/03/2020 from a single site, the Mater Hospital Belfast. 85 patients out of the planned 88 patients were recruited during this period. Recruitment to the trial was terminated early (08/04/2020) due to the risks of ongoing recruitment of patients with COPD given the current Covid 19 pandemic.

    Pre-assignment
    Screening details
    		 Potentially eligible subjects with COPD were identified and screened by members of the direct care team based on the inclusion/exclusion criteria as specified in the study protocol. A total of 171 patients were screened, of which 85 patients were recruited.

    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, Assessor
    Blinding implementation details
    This study was a randomised double blind placebo controlled trial with an allocation ratio of 1 : 1. Randomisation was undertaken by the clinical trials unit using randomised permuted blocks All researchers were blinded to the treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 The intervention was valaciclovir 1 gram to be taken 3 times daily for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valaciclovir 500mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Valaciclovir 1 gram (2 x 500mg) orally three times daily for 8 weeks.

    Arm title
    		 Control
    Arm description
    		 The comparator was matched placebo to be taken 3 times daily for 8 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matched placebo (Avicel®PH)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matched placebo (Avicel®PH) orally three times daily for 8 weeks.

    Number of subjects in period 1 [1]
    		Intervention Control
    Started
    43
    41
    Completed
    41
    40
    Not completed
    2
    1
         Lost to follow-up
    2
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient was randomised to the trial, this patient subsequently withdrew prior to treatment allocation. 85 patients were randomised, 84 recieved an allocation to a treatment arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The intervention was valaciclovir 1 gram to be taken 3 times daily for 8 weeks.

    Reporting group title
    Control
    Reporting group description
    		 The comparator was matched placebo to be taken 3 times daily for 8 weeks.

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 43 41 84
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 23 26 49
        From 65-84 years
    		 20 15 35
        85 years and over
    		 0 0 0
    Age continuous
    Age at randomisation, years
    Units: years
        arithmetic mean (standard deviation)
    		 63.1 ( 8.1 ) 60.3 ( 9.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 26 55
        Male
    		 14 15 29
    Smoking Status
    Units: Subjects
        Current Smoker
    		 19 24 43
        Ex-Smoker
    		 24 17 41
        Never Smoked
    		 0 0 0
    Presence of EBV
    Units: Subjects
        Yes
    		 43 41 84
        No
    		 0 0 0
    Relevant co-morbidities
    Units: Subjects
        Yes
    		 38 36 74
        No
    		 5 5 10
    Pre-existing cardiovascular issues
    Units: Subjects
        Yes
    		 15 14 29
        No
    		 28 27 55
    Exacerbations in the last 12 months
    Units: Subjects
        Yes
    		 32 29 61
        No
    		 11 12 23
    Height
    Units: Metres
        arithmetic mean (standard deviation)
    		 1.7 ( 0.1 ) 1.7 ( 0.1 ) -
    Weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    		 77.2 ( 18.2 ) 75.4 ( 19.5 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.3 ( 5.3 ) 27.2 ( 6.2 ) -
    Transfer Factor
    Transfer Factor ((TLCO) as a percentage of the predicted value (%))
    Units: Percentage
        arithmetic mean (standard deviation)
    		 58.53 ( 16.30 ) 62.97 ( 19.28 ) -
    Forced Expiratory Volume
    Forced Expiratory Volume (FEV1 (L))
    Units: Litres
        arithmetic mean (standard deviation)
    		 1.60 ( 0.58 ) 1.57 ( 0.62 ) -
    Forced Vital Capacity
    Forced Vital Capacity (FVC (L))
    Units: Litres
        arithmetic mean (standard deviation)
    		 3.21 ( 0.92 ) 3.13 ( 0.94 ) -
    FEV1/FVC Ratio
    FEV1/FVC Ratio (%)
    Units: Percentage
        arithmetic mean (standard deviation)
    		 49.44 ( 9.67 ) 49.88 ( 10.23 ) -
    Mid Expiratory Flow
    Mid Expiratory Flow (MMEF 25-75% (L/s))
    Units: L/S
        arithmetic mean (standard deviation)
    		 0.59 ( 0.33 ) 0.67 ( 0.56 ) -
    Peak Expiratory Flow
    Peak Expiratory Flow (PEF (L/s))
    Units: L/S
        arithmetic mean (standard deviation)
    		 4.51 ( 1.68 ) 4.39 ( 1.60 ) -
    Pack Years
    Units: Years
        arithmetic mean (standard deviation)
    		 55.3 ( 36.7 ) 48.3 ( 25.9 ) -
    Quantitative PCR Titre
    Units: Copies
        median (inter-quartile range (Q1-Q3))
    		 91000 (15200 to 298000) 56400 (11500 to 315000) -

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The intervention was valaciclovir 1 gram to be taken 3 times daily for 8 weeks.

    Reporting group title
    Control
    Reporting group description
    		 The comparator was matched placebo to be taken 3 times daily for 8 weeks.

    Primary: Primary Efficacy Outcome (EBV Suppression)

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    End point title
    		 Primary Efficacy Outcome (EBV Suppression)
    End point description
    End point type
    Primary
    End point timeframe
    8 Weeks
    End point values
    		 Intervention Control
    Number of subjects analysed
    41
    40
    Units: n(%)
        Yes
    36
    17
        No
    5
    23
        Not Recorded
    0
    0
    Statistical analysis title
    		 Primary Efficacy ITT
    Statistical analysis description
    The primary efficacy outcome is suppression of Epstein-Barr virus in the sputum of subjects with COPD and was assessed using quantitative PCR at baseline and 8 weeks. EBV suppression is defined as a 90% reduction in the viral load.
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.2
         upper limit
    		 30

    Primary: Primary Safety Outcome (SARs)

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    End point title
    		 Primary Safety Outcome (SARs) [1]
    End point description
    The primary safety outcome is the incidence of serious adverse reactions (SARs).
    End point type
    Primary
    End point timeframe
    Week 8
    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: It was planned that the number of patients experiencing SAR in the two groups would be compared using Fisher’s exact test, reporting the relative risk and 95% confidence interval. There were no SARs reported and thus it was not possible to carry out the planned analysis.
    End point values
    		 Intervention Control
    Number of subjects analysed
    43
    41
    Units: n(%)
        Yes
    0
    0
        No
    43
    41
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AE reporting period for this trial begins on enrolment into the trial and ends 28 days following the administration of the study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 The intervention was valaciclovir 1 gram to be taken 3 times daily for 8 weeks.

    Reporting group title
    Control
    Reporting group description
    		 The comparator was matched placebo to be taken 3 times daily for 8 weeks.

    Serious adverse events
    		 Intervention Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 43 (60.47%)
    30 / 41 (73.17%)
    Vascular disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Chest Discomfort
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 41 (4.88%)
         occurrences all number
    1
    2
    Cough
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Haemoptysis
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Mucous plugging
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Pleuritic Pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Upper Respiratory Tract infection
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 41 (4.88%)
         occurrences all number
    2
    2
    Psychiatric disorders
    Depressed Mood
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Investigations
    Abnormal CT Scan
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Blood Creatinine
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Blood Potassium Increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Blood Urea Increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Culture Urine Positive
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Cystoscopy
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Endoscopy
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    International Normalised Ratio Increased
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Sputum Cuture Positive
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 41 (4.88%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 41 (4.88%)
         occurrences all number
    2
    2
    Eosinophilia
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Neutrophilia
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 41 (7.32%)
         occurrences all number
    3
    3
    Thrombocytopenia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye Pruitus
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Dry Eye
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    4 / 43 (9.30%)
    5 / 41 (12.20%)
         occurrences all number
    4
    5
    Dry Mouth
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Gastroesophageal Reflux Disease
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 41 (4.88%)
         occurrences all number
    4
    2
    Vomiting
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Pruritis
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Muscle Spasms
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    2
    Aspergillus Infection
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Oral Candidiasis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    White Blood Cell Count Increased
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Osteopenia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2019
    Substantial Amendment 1 (Amendment 3) was for the amendment of protocol version 2.0 (28/11/2018) to protocol version 3.0 (22/05/2019). The study sponsor requested that EBV quantitative PCR should be listed as a co-primary outcome as the study sample size was calculated based on this parameter. In addition the wording of the primary safety outcome was amended to: "The primary safety outcome is the incidence of serious adverse reactions (SARs)". This amendment was requested by the sponsor prior to recruitment commencing. Recruitment was permitted to commence and subsequently the amendment was submitted and approved by Ethics and MHRA.
    18 Mar 2020
    Substantial Amendment 2 (Amendment 7) was for the amendment of protocol version 3.0 (22/05/2019) to protocol version 4.0 (22/04/2020). This amendment was submitted in light of the Covid19 pandemic lockdown and detailed that study visits would be conducted virtually in order to protect study participants. This was actioned with immediate effect on urgent safety grounds.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Apr 2020
    The EVISCO trial was terminated early. A total of 85 patients out of the planned 88 patients were recruited. Recruitment to the trial was terminated early (08/04/2020) due to the risks of ongoing recruitment of patients with COPD during the Covid 19 pandemic.
    -

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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