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    Clinical Trial Results:
    Hyperbaric Oxygen for Treatment of Long COVID syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial

    Summary
    EudraCT number
    		 2021-000764-30
    Trial protocol
    		 SE  
    Global end of trial date
    17 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2025
    First version publication date
    01 Nov 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HOT-LOCO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04842448
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Karolinska University hospital: K2021-1592, Karolinska Institutet: 4-621/2021
    Sponsors
    Sponsor organisation name
    Karolinska University Hospital
    Sponsor organisation address
    Eugeniavägen 3, Stockholm, Sweden, 17176
    Public contact
    Hyperbaric unit F3:76, Karolinska University Hospital, +46 8123 946 80, anders.kjellberg@regionstockholm.se
    Scientific contact
    Hyperbaric unit F3:76, Karolinska University Hospital, +46 8123 946 80, anders.kjellberg@regionstockholm.se
    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
    17 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if HBOT improves HRQoL (role limitations due to physical health and physical functioning) for patients with Long COVID compared to placebo (sham treatment).
    Protection of trial subjects
    Blood sampling may have negative impact on the subject as a large number of samples will be necessary for the clinical investigation and may be needed for other trials and therefore blood tests already collected were used as much as possible. The study was conducted in compliance with the protocol, regulatory requirements, Good Clinical Practice (GCP) and ethical principled of the latest version of the Declaration of Helsinki as adopted by the World medical Association.
    Background therapy
    		 Medications and treatments that were considered “best practice”was given to the subjects at the discretion of their attending physician/physiotherapist/phycologist. Subjects was discouraged to try new medications, treatments or remedies that were not evidence based during the course of the trial.
    Evidence for comparator
    		 The placebo protocol is previously well established and even experienced divers cannot differ between “sham treatment” and HBO2.
    Actual start date of recruitment
    20 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between Sept 15, 2021, and June 20, 2023, 80 subjects (65 women, 15 men) were enrolled (40 in each group). 80 subjects were randomized.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 129 [1]
    Intermediate milestone: Number of subjects
    Signed informed consent: 90
    Intermediate milestone: Number of subjects
    Screening visit 1: 83
    Number of subjects completed
    		 80

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Inclusion criteria: 3
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Reason: Number of subjects
    		 Declined participation: 6
    Reason: Number of subjects
    		 Exclusion criteria: 5
    Reason: Number of subjects
    		 Inclusion-/exclusion criteria: 13
    Reason: Number of subjects
    		 No response to written information: 20
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period (129 subjects) are all subjects that were pre-screened. The number of enrolled subjects are those that were found to eligible for inclusion and randomisation (80 subjects).
    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
    		 Investigator, Monitor, Subject
    Blinding implementation details
    Subjects and all study personell that participate in the asessement of sympoms and objective findings were blinded to the treatment. The placebo protocol is well established and even experienced divers cannot differ between “sham treatment” and HBO2 (Lansdorp and van Hulst, 2018). Pressure gauges that could seen by subjects were covered during the treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HBO2
    Arm description
    		 Hyperbaric Oxygen Therapy/Treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Conoxia
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicinal gas, cryogenic
    Routes of administration
    Inhalation use
    Dosage and administration details
    Hyperbaric oxygen 240 kPa for 90 minutes (with 10 min compression time, two air breakes and 10 minutes decompression time). The number and frequency of treatments and timing depended on the subject´s tolerance and available resources at the discretion of the attending physician, but the recommended interval was 2–5 treatments per week with a maximum of 10 treatments within 6 weeks from randomization. To satisfy the treatment compliance, a subject needed to complete at least 5 treatments.

    Arm title
    		 Placebo
    Arm description
    		 Placebo Air, compressed air medical grade
    Arm type
    		 Placebo

    Investigational medicinal product name
    Medicinal gas, compressed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Sham treatment with medical air was administered by increasing pressure to 1·34 ATA and then reduced to 1·2 ATA for 90 min with two five min air breaks (re-breather mask).

    Number of subjects in period 1
    		HBO2 Placebo
    Started
    40
    40
    Completed
    37
    32
    Not completed
    3
    8
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    1
    1
         Transferred to other arm/group
    1
    -
         Lost to follow-up
    -
    3
         Missing data
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HBO2
    Reporting group description
    		 Hyperbaric Oxygen Therapy/Treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Air, compressed air medical grade

    Reporting group values
    		 HBO2 Placebo Total
    Number of subjects
    		 40 40 80
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.1 ( 10.14 ) 41.4 ( 8.16 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 33 65
        Male
    		 8 7 15
    Tobacco, smoking
    Units: Subjects
        Never smoker
    		 28 31 59
        Ex-smoker
    		 12 9 21
    Tobacco, smokeless
    Units: Subjects
        Never used Swedish snus
    		 32 34 66
        Ex-user Swedish snus
    		 2 5 7
        Casual user Swedish snus
    		 2 0 2
        Daily user Swedish snus
    		 4 0 4
        Not recorded
    		 0 1 1
    Full time work/Study before COVID-19
    Units: Subjects
        Yes
    		 40 35 75
        No
    		 0 5 5
    Full time work/Study at baseline
    Units: Subjects
        Yes
    		 4 5 9
        No
    		 36 35 71
    Education (Diploma/University degree)
    Units: Subjects
        Yes
    		 31 34 65
        No
    		 9 6 15
    Fully vaccinated
    Units: Subjects
        Yes
    		 29 26 55
        No
    		 11 14 25
    Positive SARS-CoV-2 PCR
    Units: Subjects
        Yes
    		 16 14 30
        No
    		 24 26 50
    Positive SARS-CoV-2 antibodies
    Units: Subjects
        Yes
    		 23 18 41
        No
    		 17 22 39
    Body mass index (BMI)
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 24.4 ( 4.12 ) 24.3 ( 4.13 ) -
    Physical activity, exercise (min/week)
    Units: minute
        arithmetic mean (standard deviation)
    		 23.5 ( 54.6 ) 14.3 ( 30.8 ) -
    Time from COVID-19 onset
    Units: month
        arithmetic mean (standard deviation)
    		 26.2 ( 7.1 ) 25.1 ( 8.7 ) -
    RAND-36 domain Physical functioning (PF)
    Units: points
        arithmetic mean (standard deviation)
    		 39.8 ( 18.6 ) 37.9 ( 19.0 ) -
    RAND-36 domain Role-functioning physical (RP)
    Units: points
        arithmetic mean (standard deviation)
    		 0.6 ( 4.0 ) 0.0 ( 0.0 ) -
    RAND-36 domain General health (GH)
    Units: points
        arithmetic mean (standard deviation)
    		 28.8 ( 14.0 ) 25.0 ( 11.0 ) -
    RAND-36 domain Mental health (MH)
    Units: points
        arithmetic mean (standard deviation)
    		 61.1 ( 16.6 ) 60.0 ( 16.5 ) -
    RAND-36 domain Role emotional (RE)
    Units: points
        arithmetic mean (standard deviation)
    		 65.0 ( 45.3 ) 58.4 ( 45.2 ) -
    RANd-36 domain Social functioning (SF)
    Units: points
        arithmetic mean (standard deviation)
    		 21.4 ( 22.5 ) 22.4 ( 20.5 ) -
    RAND-36 domain Body pain (BP)
    Units: points
        arithmetic mean (standard deviation)
    		 51.6 ( 26.4 ) 51.6 ( 24.9 ) -
    RAND-36 domain Vitality (VT)
    Units: points
        arithmetic mean (standard deviation)
    		 19.1 ( 19.1 ) 14.8 ( 12.1 ) -
    EQ-5D (VAS)
    Units: points
        arithmetic mean (standard deviation)
    		 38.4 ( 15.1 ) 39.5 ( 16.8 ) -
    EQ-5D-5L (index)
    Units: points
        arithmetic mean (standard deviation)
    		 0.5 ( 0.2 ) 0.5 ( 0.2 ) -
    Reactive hyperemia index (RHI)
    Units: points
        arithmetic mean (standard deviation)
    		 2.1 ( 0.6 ) 2.0 ( 0.6 ) -
    Cardiac Index (Nexfin)
    Units: L/min/m2
        arithmetic mean (standard deviation)
    		 3.14 ( 0.84 ) 3.2 ( 0.76 ) -
    Chair standing test (CST 30s)
    Units: No/30s
        arithmetic mean (standard deviation)
    		 12.1 ( 4.4 ) 11.0 ( 4.1 ) -
    6 minute walk test (6MWT)
    Units: metre
        arithmetic mean (standard deviation)
    		 468.8 ( 129.6 ) 449.7 ( 141.8 ) -
    Subject analysis sets

    Subject analysis set title
    FAS analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) population includes all randomized subjects who were exposed at least once to the study intervention. FAS subjects were analysed according to their randomised/assigned treatment irrespective of which treatment they actually received.

    Subject analysis set title
    Safety analysis
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety (SAF) population includes all randomized subjects that have received at least one study treatment. SAF patients were analysed according to their actual treatment received.

    Subject analysis sets values
    		 FAS analysis Safety analysis
    Number of subjects
    80
    80
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.3 ( 9.15 )
    41.3 ( 9.15 )
    Gender categorical
    Units: Subjects
        Female
    65
    65
        Male
    15
    15
    Tobacco, smoking
    Units: Subjects
        Never smoker
    59
    59
        Ex-smoker
    21
    21
    Tobacco, smokeless
    Units: Subjects
        Never used Swedish snus
    66
    66
        Ex-user Swedish snus
    7
    7
        Casual user Swedish snus
    2
    2
        Daily user Swedish snus
    4
    4
        Not recorded
    1
    1
    Full time work/Study before COVID-19
    Units: Subjects
        Yes
    75
    75
        No
    5
    5
    Full time work/Study at baseline
    Units: Subjects
        Yes
    9
    9
        No
    71
    71
    Education (Diploma/University degree)
    Units: Subjects
        Yes
    65
    65
        No
    15
    15
    Fully vaccinated
    Units: Subjects
        Yes
    55
    55
        No
    25
    25
    Positive SARS-CoV-2 PCR
    Units: Subjects
        Yes
    30
    30
        No
    50
    50
    Positive SARS-CoV-2 antibodies
    Units: Subjects
        Yes
    41
    41
        No
    39
    39
    Body mass index (BMI)
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    24.4 ( 4.10 )
    24.4 ( 4.10 )
    Physical activity, exercise (min/week)
    Units: minute
        arithmetic mean (standard deviation)
    18.9 ( 44.3 )
    18.9 ( 44.3 )
    Time from COVID-19 onset
    Units: month
        arithmetic mean (standard deviation)
    25.6 ( 7.9 )
    25.6 ( 7.9 )
    RAND-36 domain Physical functioning (PF)
    Units: points
        arithmetic mean (standard deviation)
    38.8 ( 18.7 )
    38.8 ( 18.7 )
    RAND-36 domain Role-functioning physical (RP)
    Units: points
        arithmetic mean (standard deviation)
    0.3 ( 2.8 )
    0.3 ( 2.8 )
    RAND-36 domain General health (GH)
    Units: points
        arithmetic mean (standard deviation)
    25.0 ( 11.0 )
    25.0 ( 11.0 )
    RAND-36 domain Mental health (MH)
    Units: points
        arithmetic mean (standard deviation)
    60.6 ( 16.5 )
    60.6 ( 16.5 )
    RAND-36 domain Role emotional (RE)
    Units: points
        arithmetic mean (standard deviation)
    61.7 ( 45.1 )
    61.7 ( 45.1 )
    RANd-36 domain Social functioning (SF)
    Units: points
        arithmetic mean (standard deviation)
    21.9 ( 21.4 )
    21.9 ( 21.4 )
    RAND-36 domain Body pain (BP)
    Units: points
        arithmetic mean (standard deviation)
    51.6 ( 25.5 )
    51.6 ( 25.5 )
    RAND-36 domain Vitality (VT)
    Units: points
        arithmetic mean (standard deviation)
    16.9 ( 16.0 )
    16.9 ( 16.0 )
    EQ-5D (VAS)
    Units: points
        arithmetic mean (standard deviation)
    38.9 ( 15.9 )
    38.9 ( 15.9 )
    EQ-5D-5L (index)
    Units: points
        arithmetic mean (standard deviation)
    0.5 ( 0.2 )
    0.5 ( 0.2 )
    Reactive hyperemia index (RHI)
    Units: points
        arithmetic mean (standard deviation)
    2.0 ( 0.6 )
    2.0 ( 0.6 )
    Cardiac Index (Nexfin)
    Units: L/min/m2
        arithmetic mean (standard deviation)
    3.17 ( 0.80 )
    3.17 ( 0.80 )
    Chair standing test (CST 30s)
    Units: No/30s
        arithmetic mean (standard deviation)
    12.0 ( 4.2 )
    12.0 ( 4.2 )
    6 minute walk test (6MWT)
    Units: metre
        arithmetic mean (standard deviation)
    459.3 ( 135.4 )
    459.3 ( 135.4 )

    End points

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    End points reporting groups
    Reporting group title
    HBO2
    Reporting group description
    		 Hyperbaric Oxygen Therapy/Treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Air, compressed air medical grade

    Subject analysis set title
    FAS analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) population includes all randomized subjects who were exposed at least once to the study intervention. FAS subjects were analysed according to their randomised/assigned treatment irrespective of which treatment they actually received.

    Subject analysis set title
    Safety analysis
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety (SAF) population includes all randomized subjects that have received at least one study treatment. SAF patients were analysed according to their actual treatment received.

    Primary: Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical function (PF)

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    End point title
    		 Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical function (PF)
    End point description
    End point type
    Primary
    End point timeframe
    13 weeks after randomization
    End point values
    		 HBO2 Placebo
    Number of subjects analysed
    40
    39
    Units: RAND-36 score
        arithmetic mean (standard deviation)
    9 ( 18.68 )
    8.59 ( 16.02 )
    Statistical analysis title
    		 Primary endpoint (PF)
    Comparison groups
    HBO2 v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.87
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean difference
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.04
         upper limit
    		 8.29

    Primary: Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP).

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    End point title
    		 Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP).
    End point description
    End point type
    Primary
    End point timeframe
    13 weeks after randomization
    End point values
    		 HBO2 Placebo
    Number of subjects analysed
    40
    39
    Units: RAND-36 score
        arithmetic mean (standard deviation)
    6.25 ( 20.22 )
    3.85 ( 16.76 )
    Statistical analysis title
    		 Primary endpoint (RP)
    Comparison groups
    HBO2 v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.57
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean difference
    Point estimate
    2.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.95
         upper limit
    		 10.66

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from inclusion until visit 3. Only serious adverse events (SAEs) were collected outside the treatment period (visit 2). Ongoing AEs and SAEs at the end of visit 3 were followed up until end of trial for each subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    HBO2
    Reporting group description
    		 Hyperbaric Oxygen Therapy/Treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo Air, compressed air medical grade

    Serious adverse events
    		 HBO2 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Injury, poisoning and procedural complications
    Traumatic haemorrhage
         subjects affected / exposed
    0 / 39 (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 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HBO2 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 39 (48.72%)
    18 / 41 (43.90%)
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Bradycardia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Tachycardia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    3
    Dizziness
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Epilepsy with myoclonic-atonic seizures
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 39 (5.13%)
    5 / 41 (12.20%)
         occurrences all number
    2
    5
    Peripheral swelling
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    5 / 39 (12.82%)
    2 / 41 (4.88%)
         occurrences all number
    5
    2
    Vertigo
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Ear discomfort
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Hypoacusis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Subconjunctival haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    0 / 39 (0.00%)
    4 / 41 (9.76%)
         occurrences all number
    0
    4
    Dyspnoea
         subjects affected / exposed
    4 / 39 (10.26%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    13 / 39 (33.33%)
    6 / 41 (14.63%)
         occurrences all number
    13
    6
    Skin and subcutaneous tissue disorders
    Livedo reticularis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Paresthesia
    Additional description: Paresthesia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    Neck pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    2
    COVID-19
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2021
    Ver 2, 2021-06-30 Protocol updated based on comments from MPA
    30 Aug 2021
    Ver 3, 2021-08-30 Substantial amendment submitted to Ethical Review board

    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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