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    Clinical Trial Results:
    A multi-center, randomized, placebo-controlled, double-blind, dose-finding clinical trial investigating the short-term relief of symptoms of acute pharyngitis such as throat soreness pain and difficulty to swallow by treatment with three different doses of MYRAMISTIN™ oromucosal spray

    Summary
    EudraCT number
    		 2018-002543-28
    Trial protocol
    		 DE   AT  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jan 2023
    First version publication date
    18 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MIRA1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04470089
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MEGAINPHARM GmbH
    Sponsor organisation address
    Wörthersee-Süduferstraße 163c5, Maria Wörth, Austria, 9082
    Public contact
    Evgeni Gorokhov, MEGAINPHARM GmbH, 0043 15134733, evgorokhov@megainpharm.com
    Scientific contact
    Dr. Andrew Leary, regenold GmbH , 0049 07632 8226-418, andrew.leary@regenold.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
    31 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the short-term efficacy of different MyramistinTM doses (0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute pharyngitis.
    Protection of trial subjects
    This clinical trial was designed and was implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including applicable European Directives, AMG and GCP-V), and with the ethical principles laid down in the Declaration of Helsinki. Every patient was informed verbally and also in writing, with a patient information leaflet explaining the nature of the study, its objectives, the study medication and potential risks, the rights and obligations of the participant and the fact that he was free to withdraw his consent at any time without giving any reason. Details of indemnity and insurance were also stated. All questions about the trial were answered to the satisfaction of the patient. Women of child bearing potential had to be informed that taking the IMP may involve unknown risks to the fetus if pregnancy occurred during the clinical trial and agree that in order to participate in the clinical trial, they must adhere to the contraception requirement for the duration of the clinical trial. Prior to the participation in the trial, a written informed consent form had to be signed and personally dated by the subject and by the person who conducted the informed consent. The patient’s information and informed consent form were available in the local language. The final trial protocol together with the patient information sheet, the informed consent form and the Investigator’s drug brochure were submitted to the involved Ethics Committees and were constituted to fulfil regulatory laws. The study was approved by all Ethics Committees before clinical trial start.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 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
    Germany: 169
    Worldwide total number of subjects
    169
    EEA total number of subjects
    169
    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)
    160
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All patients were recruited in Germany in practices of general practitioners and specialists for ear nose and throat. Recruitment started in February 2020 and was interrupted from March 2020 until September 2020 due to COVID. After restart recruitment was very slow.

    Pre-assignment
    Screening details
    		 Screening and first study medication application was possible the same day. Only one screening failure was identified during the study, who did not fulfil inclusion criteria and was not randomised.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    A randomisation list was created by an independent company containing the random numbers, code and treatment descriptions. It was sorted by random number. Based on this list MoNo chem-pharm Produkte GmbH filled in the different doses in a white opaque spray, which is delivered in a white, neutral outer carton. The packaging and labeling of the IMP was done in accordance with the applicable regulatory requirements of each participating country and under the responsibility of MoNo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Myramistin 0.005%
    Arm description
    		 0.005% Myramistin oromucosal spray containing 0.05 mg myramistin per 1 ml Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Myramistin 0.005%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Myramistin™ spray was applied to the back of the throat 3 times a day for 3 days with a minimum of 4 hours between two subsequent doses. Each application consisted of 3 puffs and each puff delivered 0.14 ml (i.e., a total of 0.42 ml per application). The first application was done at the study centre, whereas the following applications were administered at home. In total, Myramistin™ was to be applied 9-10 times during the trial.

    Arm title
    		 Myramistin 0.01%
    Arm description
    		 0.01% of Myramistin oromucosal spray containing 0.1 mg myramistin per 1 ml Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramisti/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Myramistin 0.01%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Myramistin™ spray was applied to the back of the throat 3 times a day for 3 days with a minimum of 4 hours between two subsequent doses. Each application consisted of 3 puffs and each puff delivered 0.14 ml (i.e., a total of 0.42 ml per application). The first application was done at the study centre, whereas the following applications were administered at home. In total, Myramistin™ was to be applied 9-10 times during the trial.

    Arm title
    		 Myramistin 0.02%
    Arm description
    		 0.02% of Myramistin oromucosal spray containing 0.2 mg myramistin per 1 ml, Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Myramistin 0.02%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Myramistin™ spray was applied to the back of the throat 3 times a day for 3 days with a minimum of 4 hours between two subsequent doses. Each application consisted of 3 puffs and each puff delivered 0.14 ml (i.e., a total of 0.42 ml per application). The first application was done at the study centre, whereas the following applications were administered at home. In total, Myramistin™ was to be applied 9-10 times during the trial.

    Arm title
    		 Placebo
    Arm description
    		 Placebo: matched control spray not containing myramistin. Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Placebo spray was applied to the back of the throat 3 times a day for 3 days with a minimum of 4 hours between two subsequent doses. Each application consisted of 3 puffs and each puff delivered 0.14 ml (i.e., a total of 0.42 ml per application). The first application was done at the study centre, whereas the following applications were administered at home. In total, Myramistin™ was to be applied 9-10 times during the trial.

    Number of subjects in period 1
    		Myramistin 0.005% Myramistin 0.01% Myramistin 0.02% Placebo
    Started
    40
    46
    40
    43
    Completed
    40
    46
    40
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Myramistin 0.005%
    Reporting group description
    		 0.005% Myramistin oromucosal spray containing 0.05 mg myramistin per 1 ml Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group title
    Myramistin 0.01%
    Reporting group description
    		 0.01% of Myramistin oromucosal spray containing 0.1 mg myramistin per 1 ml Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramisti/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group title
    Myramistin 0.02%
    Reporting group description
    		 0.02% of Myramistin oromucosal spray containing 0.2 mg myramistin per 1 ml, Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: matched control spray not containing myramistin. Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group values
    		 Myramistin 0.005% Myramistin 0.01% Myramistin 0.02% Placebo Total
    Number of subjects
    		 40 46 40 43 169
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 35 45 40 40 160
        From 65-84 years
    		 5 1 0 3 9
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 40.7 (19 to 68) 36.0 (18 to 68) 38.5 (18 to 64) 39.8 (18 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 29 28 28 28 113
        Male
    		 11 18 12 15 56
    Smoking History
    Units: Subjects
        Non smoker
    		 30 38 30 34 132
        Smoker
    		 9 8 7 9 33
        Ex smoker
    		 1 0 3 0 4
    Subject analysis sets

    Subject analysis set title
    Safety Evaluable Set (SES)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety and tolerability evaluations were done using the SES including all randomized patients with at least one dose of study medication and at least had one safety assessment performed.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Primary and secondary efficacy endpoints were evaluated using the FAS, defined as all randomized patients who received at least one dose of study medication and had at least one post-treatment efficacy assessment.

    Subject analysis sets values
    		 Safety Evaluable Set (SES) Full Analysis Set (FAS)
    Number of subjects
    169
    169
    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)
    160
    160
        From 65-84 years
    9
    9
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (full range (min-max))
    38,7 (18 to 69)
    38,7 (18 to 69)
    Gender categorical
    Units: Subjects
        Female
    113
    113
        Male
    56
    56
    Smoking History
    Units: Subjects
        Non smoker
    132
    132
        Smoker
    33
    33
        Ex smoker
    4
    4

    End points

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    End points reporting groups
    Reporting group title
    Myramistin 0.005%
    Reporting group description
    		 0.005% Myramistin oromucosal spray containing 0.05 mg myramistin per 1 ml Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group title
    Myramistin 0.01%
    Reporting group description
    		 0.01% of Myramistin oromucosal spray containing 0.1 mg myramistin per 1 ml Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramisti/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group title
    Myramistin 0.02%
    Reporting group description
    		 0.02% of Myramistin oromucosal spray containing 0.2 mg myramistin per 1 ml, Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: matched control spray not containing myramistin. Unit dose amounts to 0.42 ml per application (3 puffs of 0.14 ml, administered to the back of the throat) in all treatment arms. Myramistin/Placebo is administered 3 times per day with a minimum of 4 hours between two subsequent doses. The total amount applied per day is 1.26 ml.

    Subject analysis set title
    Safety Evaluable Set (SES)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety and tolerability evaluations were done using the SES including all randomized patients with at least one dose of study medication and at least had one safety assessment performed.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Primary and secondary efficacy endpoints were evaluated using the FAS, defined as all randomized patients who received at least one dose of study medication and had at least one post-treatment efficacy assessment.

    Primary: Summarized pain intensity differences (SPID-2Pain)

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    End point title
    		 Summarized pain intensity differences (SPID-2Pain)
    End point description
    The primary endpoint was SPID-2Pain, defined as pain intensity differences (PID) summarized over the time course of 2 hours after first application on Day 1 (Baseline). The sum was calculated over the time-weighted differences from each measured time point to Baseline using the 100 mm VAS Sore Throat Pain Intensity Scale (STPIS). The primary endpoint should show superiority of each of the individual active Myramistin doses (0.005%, 0.01% and 0.02%) versus Placebo.
    End point type
    Primary
    End point timeframe
    From baseline summarized over 2 hours (SPID-2Pain) after first IMP application.
    End point values
    		 Myramistin 0.005% Myramistin 0.01% Myramistin 0.02% Placebo
    Number of subjects analysed
    40
    46
    40
    43
    Units: Pain intensity on 100 mm VAS score
        number (confidence interval 60%)
    -1390.0 (-1521.68 to -1258.28)
    -925.5 (-1047.96 to -803.13)
    -1256.0 (-1387.90 to -1124.14)
    -1492.8 (-1619.69 to -1365.92)
    Statistical analysis title
    		 Mixed-Model Repeated Measurement (MMRM)
    Comparison groups
    Myramistin 0.005% v Myramistin 0.01% v Myramistin 0.02% v Placebo
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.2
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Visit 1 after signing informed consent onwards to Visit 4.
    Adverse event reporting additional description
    After the first IMP application patients were handed out a diary, which they had to complete twice daily. All adverse events were collected there and also through questioning the patient at visit 2. Lab values and vital signs were measured at each visit. Adverse events were assessed by the respective investigators.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Myramistin 0.005%
    Reporting group description
    		 Seventeen adverse events were reported in this group, but only one patient, in this group described feeling of drunkenness assessed as related to the IMP. This adverse event resolved within one day. All other events were assessed as not related. Two adverse events were graded as moderate all other events as mild.

    Reporting group title
    Myramistin 0.01%
    Reporting group description
    		 Seven adverse events were reported in this group. Only one of the adverse events in this group was assessed as related to the IMP. The patient reported about paresthesia in the tongue. All adverse events were graded as mild.

    Reporting group title
    Myramistin 0.02%
    Reporting group description
    		 None of the eight reported adverse events in this group was assessed to be related to the IMP. All adverse events were graded as mild.

    Reporting group title
    Placebo
    Reporting group description
    		 In total 10 adverse events were reported in this group. All adverse events were graded as mild. One patient reported about odynophagia, which was assessed as related to the IMP.

    Serious adverse events
    		 Myramistin 0.005% Myramistin 0.01% Myramistin 0.02% Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Myramistin 0.005% Myramistin 0.01% Myramistin 0.02% Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 40 (17.50%)
    4 / 46 (8.70%)
    3 / 40 (7.50%)
    6 / 43 (13.95%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 46 (4.35%)
    2 / 40 (5.00%)
    3 / 43 (6.98%)
         occurrences all number
    2
    2
    3
    3
    General disorders and administration site conditions
    Feeling drunk
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Gastrointestinal disorders
    Odynophagia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Paresthesia oral
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 46 (2.17%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    2
    0
    0
    1
    Epigastric discomfort
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 46 (4.35%)
    0 / 40 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    2
    0
    2
    Nasal congestion
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in jaw
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 46 (0.00%)
    1 / 40 (2.50%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
    Additional description: Worsening of pharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 46 (0.00%)
    0 / 40 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    1
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2020
    A substantial amendment was submitted to EC for restart after COVID in September 2020 but due to EC request a negative COVID test had to be added to the inclusion criteria. Furthermore, the study end was prolonged until end of second quarter of 2021.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    Due to the high risks identified that patients, study personal and other people might get infected due to study visits, and the fact that there are alternative treatments, including available over the counter, the risk to patients at the current time was assessed to be higher than the benefit of clinical trial participation. In addition, there were several governmental rules in place requiring people to not leave the home in order to reduce “social contacts”. This general societal aspect were also taken into consideration.
    07 Dec 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The results of the primary endpoint analysis indicate that Myramistin does not differentiate from placebo at any dose level. The same outcome was found for all secondary endpoints and all sensitivity analyses, and at all timepoints assessed.
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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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