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    Clinical Trial Results:
    Coenzyme Q10 as treatment for Long Term COVID-19 (The QVID study)

    Summary
    EudraCT number
    		 2020-005961-16
    Trial protocol
    		 DK  
    Global end of trial date
    09 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2023
    First version publication date
    06 May 2023
    Other versions
    Summary report(s)
    		 Hansen KS et al. High-dose coenzyme Q10 versus placebo..pdf

    Trial information

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    Trial identification
    Sponsor protocol code
    QVID-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Blvd. 82, Aarhus N, Denmark, 8200
    Public contact
    Department of Infectious Diseases, Aarhus University Hospital, 0045 51513140, larsoest@rm.dk
    Scientific contact
    Department of Infectious Diseases, Aarhus University Hospital, 0045 51513140, larsoest@rm.dk
    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
    07 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of 6 weeks of CoQ10 treatment on the number and severity of self-reported symptoms in LTC patients
    Protection of trial subjects
    All trial visits conducted in hospital setting in outpatient clinic with appropriate discretion. All data collected stored at protected hospital servers. During data analysis, pseudonymised data was used and social security numbers were never transfered from safe servers. All patients provided written consent prior to any trial procedures or data collection.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 5 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 121
    Worldwide total number of subjects
    121
    EEA total number of subjects
    121
    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)
    119
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at the Department of Infectious Diseases at Aarhus University Hospital, Denmark. Participants were recruited from the PCC Outpatient Clinic at Aarhus University Hospital and Gødstrup Hospital, Denmark, directly or by letter invitation.

    Pre-assignment
    Screening details
    		 The following inclusion criteria were applied: >18 years of age; ability to give written informed consent; a history of SARS-CoV-2 infection based on either a PCR test or antibody test; and PCC-related symptoms that were diagnosed by a specialized infec- tious disease physician at the PCC Outpatient Clinic.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Proper concealment of randomization was obtained by the use of an external randomization service (Clinical Trial Unit, Department of Clinical Medicine, Aarhus University, Denmark), who created the computer-generated sequence. The allocation list was stored in an electronic database with a concealed de-identification code, in case premature blinding was needed. This process was logged and monitored. Allocation lists were obtained by the pharmaceutical supplier for preparation of the study medicin

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 In this cross-over setting Arm A receives Coenzym Q10 in first period
    Arm type
    		 Experimental

    Investigational medicinal product name
    Coenzyme Q10
    Investigational medicinal product code
    Other name
    Ubiquinone
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100mg five times / day to enhance gastroinstenal uptake. Total day dose = 500mg.

    Arm title
    		 Arm B
    Arm description
    		 In this cross-over setting Arm B receives placebo in first period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Soy oil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules administrated exactly like IMP: 1 capsule five times /day

    Number of subjects in period 1
    		Arm A Arm B
    Started
    59
    62
    Completed
    59
    60
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    2
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Proper concealment of randomization was obtained by the use of an external randomization service (Clinical Trial Unit, Department of Clinical Medicine, Aarhus University, Denmark), who created the computer-generated sequence. The allocation list was stored in an electronic database with a concealed de-identification code, in case premature blinding was needed. This process was logged and monitored. Allocation lists were obtained by the pharmaceutical supplier for preparation of the study medicin

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 In this cross-over setting arm A receives placebo in period 2
    Arm type
    		 Placebo

    Investigational medicinal product name
    Soy oil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule five times / day

    Arm title
    		 Arm B
    Arm description
    		 In this cross-over setting arm B receives Coenzyme Q10 in period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Coenzyme Q10
    Investigational medicinal product code
    Other name
    Ubiquinone
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100mg five times / day to enhance gastroinstenal uptake. Total day dose = 500mg.

    Number of subjects in period 2
    		Arm A Arm B
    Started
    59
    60
    Completed
    59
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 121 121
    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)
    		 119 119
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.95 ( 10.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 91 91
        Male
    		 30 30
    Smoking status
    Units: Subjects
        Never
    		 78 78
        Former
    		 36 36
        Current
    		 7 7
    Hospital admission during acute COVID
    Units: Subjects
        Yes
    		 18 18
        No
    		 103 103
    Charlson Comorbidity Index
    Units: Subjects
        Score 0
    		 62 62
        Score 1
    		 40 40
        Score 2
    		 16 16
        Score 3
    		 2 2
        Score 4
    		 1 1
    Vaccination status upon inclusion
    This categorical value refers to terms used at the time of the pandemic inclusion occured: "fully vaccinated" refers to having recieved first vaccination AND a booster and "partially vaccinated" to having recieved first vaccination, but no booster.
    Units: Subjects
        Fully vaccinated
    		 102 102
        Partially vaccinated
    		 13 13
        Not vaccinated
    		 6 6
    Interval between acute COVID-19 and inclusion
    Units: days
        arithmetic mean (standard deviation)
    		 287.76 ( 118.88 ) -
    Post COVID-19 condition symptom score at baseline
    Units: points
        arithmetic mean (standard deviation)
    		 43.06 ( 16.0 ) -
    EQ-5D-5L quality of life index at baseline
    Units: index
        arithmetic mean (standard deviation)
    		 0.66 ( 0.12 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.02 ( 5.75 ) -
    Subject analysis sets

    Subject analysis set title
    Coenzyme Q10 vs placebo PCC score
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    On average, the symptom scores were reduced by 5.18 points (95% CI: 3.40; 6.95) after the six-week treatment with CoQ10, compared to a reduction of 4.04 points (95% CI: 2.13; 5.96) after receiving placebo (Fig. 3A). After adjusting for sequence and period, the mean difference in the change in symptom scores be- tween CoQ10 and placebo was −1.18 (95% CI: −3.54; 1.17), indicating that on average the reduction in symptom score was 1.18 points larger after CoQ10 treatment compared to placebo; however, this difference was not significant (p = 0.32).

    Subject analysis set title
    Coenzyme Q10 vs placebo, EQ-5D-5L health index
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The estimated mean improvement in health index score was 0.04 (95% CI: 0.02; 0.06) and 0.03 (95% CI: 0.006; 0.05) after six weeks of CoQ10 treatment or placebo, respectively. After adjusting for period and sequence effect in the linear mixed-effects model, the estimated difference was 0.01 (95% CI: −0.02; 0.04), which was not statistically significant (p = 0.40).

    Subject analysis sets values
    		 Coenzyme Q10 vs placebo PCC score Coenzyme Q10 vs placebo, EQ-5D-5L health index
    Number of subjects
    119
    119
    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)
    117
    117
        From 65-84 years
    2
    2
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.97 ( 10.42 )
    47.97 ( 10.42 )
    Gender categorical
    Units: Subjects
        Female
    89
    89
        Male
    30
    30
    Smoking status
    Units: Subjects
        Never
    76
    76
        Former
    36
    36
        Current
    7
    7
    Hospital admission during acute COVID
    Units: Subjects
        Yes
    18
    18
        No
    101
    101
    Charlson Comorbidity Index
    Units: Subjects
        Score 0
    60
    60
        Score 1
    40
    40
        Score 2
    16
    16
        Score 3
    2
    2
        Score 4
    1
    1
    Vaccination status upon inclusion
    This categorical value refers to terms used at the time of the pandemic inclusion occured: "fully vaccinated" refers to having recieved first vaccination AND a booster and "partially vaccinated" to having recieved first vaccination, but no booster.
    Units: Subjects
        Fully vaccinated
    101
    101
        Partially vaccinated
    12
    12
        Not vaccinated
    6
    6
    Interval between acute COVID-19 and inclusion
    Units: days
        arithmetic mean (standard deviation)
    288.55 ( 119.7 )
    288.55 ( 119.7 )
    Post COVID-19 condition symptom score at baseline
    Units: points
        arithmetic mean (standard deviation)
    43.06 ( 15.9 )
    43.06 ( 15.9 )
    EQ-5D-5L quality of life index at baseline
    Units: index
        arithmetic mean (standard deviation)
    0.66 ( 0.1 )
    0.66 ( 0.1 )
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    28.08 ( 5.8 )
    28.08 ( 5.8 )

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 In this cross-over setting Arm A receives Coenzym Q10 in first period

    Reporting group title
    Arm B
    Reporting group description
    		 In this cross-over setting Arm B receives placebo in first period
    Reporting group title
    Arm A
    Reporting group description
    		 In this cross-over setting arm A receives placebo in period 2

    Reporting group title
    Arm B
    Reporting group description
    		 In this cross-over setting arm B receives Coenzyme Q10 in period 2

    Subject analysis set title
    Coenzyme Q10 vs placebo PCC score
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    On average, the symptom scores were reduced by 5.18 points (95% CI: 3.40; 6.95) after the six-week treatment with CoQ10, compared to a reduction of 4.04 points (95% CI: 2.13; 5.96) after receiving placebo (Fig. 3A). After adjusting for sequence and period, the mean difference in the change in symptom scores be- tween CoQ10 and placebo was −1.18 (95% CI: −3.54; 1.17), indicating that on average the reduction in symptom score was 1.18 points larger after CoQ10 treatment compared to placebo; however, this difference was not significant (p = 0.32).

    Subject analysis set title
    Coenzyme Q10 vs placebo, EQ-5D-5L health index
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The estimated mean improvement in health index score was 0.04 (95% CI: 0.02; 0.06) and 0.03 (95% CI: 0.006; 0.05) after six weeks of CoQ10 treatment or placebo, respectively. After adjusting for period and sequence effect in the linear mixed-effects model, the estimated difference was 0.01 (95% CI: −0.02; 0.04), which was not statistically significant (p = 0.40).

    Primary: Change in PCC symptom score

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    End point title
    		 Change in PCC symptom score
    End point description
    The study course of 20 weeks (for each individual) comprised 5 visits at time point 0, 6, 10, 16 and 20 weeks. From 0-6 weeks arm A recieved coenzym Q10 and arm B received placebo. From week 10-16 arm A received placebo and arm B received coenzym Q10. In this crossover setting, the PCC score was measured by questionnaire at each visit, providing a picture of symptom burden. Change in symptom score to baseline for each period was used to compare effect of coenzym Q10 vs placebo.
    End point type
    Primary
    End point timeframe
    6 weeks of treatment or placebo
    End point values
    		 Arm A Arm B Arm A Arm B Coenzyme Q10 vs placebo PCC score
    Number of subjects analysed
    59
    60
    59
    60
    119
    Units: PCC score
        arithmetic mean (confidence interval 95%)
    8.05 (5.73 to 10.37)
    7.02 (4.7 to 9.33)
    1.02 (-1.91 to 3.94)
    2.35 (-0.19 to 4.89)
    -1.18 (-3.54 to 1.17)
    Attachments
    		 Time course of PCC-specific symptom scores and EQ-
    Statistical analysis title
    		 Mixed-effects model linear regression
    Statistical analysis description
    To analyze the treatment effect of CoQ10 versus placebo and to quantify the period and sequence effects, we used a linear mixed-effects model with sequence, period, and treatment as two-level, fixed factors and participants as a random factor
    Comparison groups
    Arm A v Arm B v Arm A v Arm B
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Primary: Change in EQ-5D-5L health index

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    End point title
    		 Change in EQ-5D-5L health index
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks of treatment or placebo
    End point values
    		 Arm A Arm B Arm A Arm B Coenzyme Q10 vs placebo, EQ-5D-5L health index
    Number of subjects analysed
    59
    60
    59
    60
    119
    Units: index
        arithmetic mean (confidence interval 95%)
    0.05 (0.02 to 0.085)
    0.04 (0.001 to 0.07)
    0.02 (-0.006 to 0.04)
    0.03 (0.003 to 0.05)
    0.01 (-0.02 to 0.04)
    Statistical analysis title
    		 Mixed-effects model linear regression
    Comparison groups
    Arm A v Arm B v Arm A v Arm B v Coenzyme Q10 vs placebo, EQ-5D-5L health index
    Number of subjects included in analysis
    357
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose on day 1 of the study until 4 weeks after last dose (Coenzyme Q10 half-life is 48 hours).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 119 (1.68%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Skull X-ray
    Additional description: Participant admitted to emergency department due to fall and subsequent severe headache. Skull x-ray normal. Participants' serum ethanol was elevated.
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Suicidal behaviour
    Additional description: Admitted to hospital due to suicidal thoughts. Unrelated to study drug. Participant had pre-existing depression and the event was caused by social circumstances.
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 119 (10.92%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    2 / 119 (1.68%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 119 (1.68%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    9 / 119 (7.56%)
         occurrences all number
    9
    Heartburn
         subjects affected / exposed
    1 / 119 (0.84%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle pain
         subjects affected / exposed
    1 / 119 (0.84%)
         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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36337437
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