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    Clinical Trial Results:
    A SINGLE-BLINDED RANDOMIZED, PLACEBO-CONTROLLED PHASE II TRIAL OF PROPHYLACTIC TREATMENT WITH ORAL AZITHROMYCIN VERSUS PLACEBO IN CANCER PATIENTS UNDERGOING ANTINEOPLASTIC TREATMENT DURING THE COVID-19 PANDEMIC

    Summary
    EudraCT number
    		 2020-001327-13
    Trial protocol
    		 AT  
    Global end of trial date
    14 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Nov 2022
    First version publication date
    05 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OnCoVID19Trial
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04369365
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedUniWien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Marika Rosner, Med. Univ. Wien, +43 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Matthias Preusser, Med. Univ. Wien, +43 14040044450, mattias.preusser@meduniwien.ac.at
    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
    30 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cumulative number of SARS-COV-2 infections as verified by PCR from routine nasal swabs performed every 28 days (symptomatic or asymptomatic) at week 12 after initiation of therapy
    Protection of trial subjects
    no protection needed for this IMP
    Background therapy
    		 no background therapy needed for this IMP
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 2020
    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
    Austria: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    39
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited through the outpatient clinic, the daily clinic, and the inpatient ward of the Department of Internal Medicine I.

    Pre-assignment
    Screening details
    		 The screening was done on the basis of the screening criteria.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Azithromycin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1500mg azithromycin once a week

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1500mg placebo once a week

    Number of subjects in period 1
    		Azithromycin Placebo
    Started
    32
    31
    Completed
    24
    25
    Not completed
    8
    6
         Consent withdrawn by subject
    8
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 63 63
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 39 39
        From 65-84 years
    		 24 24
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 59 (19 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 24 24
    Subject analysis sets

    Subject analysis set title
    cumulative number of SARS-CoV-2 infections (both symptomatic a
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Kaplan-Meier plots, log-rank Tests

    Subject analysis sets values
    		 cumulative number of SARS-CoV-2 infections (both symptomatic a
    Number of subjects
    63
    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)
    39
        From 65-84 years
    24
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    59 (19 to 82)
    Gender categorical
    Units: Subjects
        Female
    39
        Male
    24

    End points

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    End points reporting groups
    Reporting group title
    Azithromycin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    cumulative number of SARS-CoV-2 infections (both symptomatic a
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Kaplan-Meier plots, log-rank Tests

    Primary: Cumulative number of SARS-CoV-2 infections (both symptomatic and asymptomatic)

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    End point title
    		 Cumulative number of SARS-CoV-2 infections (both symptomatic and asymptomatic)
    End point description
    End point type
    Primary
    End point timeframe
    after 12 weeks
    End point values
    		 Azithromycin Placebo cumulative number of SARS-CoV-2 infections (both symptomatic a
    Number of subjects analysed
    32
    31
    63
    Units: 63
    32
    31
    63
    Statistical analysis title
    		 cumulative number of SARS-CoV-2 infections
    Comparison groups
    Placebo v Azithromycin
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: Cumulative number of SARS-CoV-2 infections (both symptomatic and asymptomatic)

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    End point title
    		 Cumulative number of SARS-CoV-2 infections (both symptomatic and asymptomatic)
    End point description
    End point type
    Primary
    End point timeframe
    after 12 weeks
    End point values
    		 Azithromycin Placebo cumulative number of SARS-CoV-2 infections (both symptomatic a
    Number of subjects analysed
    32
    31
    63
    Units: 63
    32
    31
    63
    Statistical analysis title
    		 cumulative number of SARS-CoV-2 infections
    Comparison groups
    Azithromycin v Placebo
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of signing the informed consent through to the end of study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Unspecific Adverse Events
    Reporting group description
    		 Toxicities were mainly mild and mostly unspecific.

    Serious adverse events
    		 Unspecific Adverse Events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Unspecific Adverse Events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 63 (44.44%)
    Cardiac disorders
    QTc prolongation
         subjects affected / exposed
    14 / 63 (22.22%)
         occurrences all number
    14
    Hypertension
         subjects affected / exposed
    2 / 63 (3.17%)
         occurrences all number
    2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 63 (1.59%)
         occurrences all number
    1
    Immune system disorders
    Fever
         subjects affected / exposed
    1 / 63 (1.59%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    6 / 63 (9.52%)
         occurrences all number
    6
    Abdominal cramps
         subjects affected / exposed
    2 / 63 (3.17%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    1 / 63 (1.59%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 63 (1.59%)
         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? 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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    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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