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    Clinical Trial Results:
    Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study

    Summary
    EudraCT number
    		 2022-000641-33
    Trial protocol
    		 ES  
    Global end of trial date
    15 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2024
    First version publication date
    07 Sep 2024
    Other versions
    Summary report(s)
    		 Quality of life and laboratory Endpoints

    Trial information

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    Trial identification
    Sponsor protocol code
    PAX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05445674
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra les Infeccions
    Sponsor organisation address
    Carretera de Canyet s/n, Badalona, Spain, 08916
    Public contact
    ScienHub Research Support, Fundació Lluita contra les Infeccions, 34 934978414, info@scienhub.org
    Scientific contact
    ScienHub Research Support, Fundació Lluita contra les Infeccions, 34 934978414, info@scienhub.org
    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
    06 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) compared to sham plasma exchange (placebo).
    Protection of trial subjects
    Patients will discontinue participation in the study at the time they deem necessary. All study participants have the right to withdraw their consent at any time during the study. This event will be notified to the study monitor and duly documented both in the medical records and in the eCRF.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Sep 2022
    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
    Spain: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants have been recruited from the LONG COVID-19 unit at Hospital Universitari Germans Trias i Pujol.

    Pre-assignment
    Screening details
    		 Adult men and women with confirmed Post-Acute COVID-19 syndrome (PCC) diagnosis (Symptoms of persistent COVID-19 after 90 days of infection, not explainable by other causes and previous diagnosis of SARS-CoV-2 infection (WHO criteria), determined by PCR, validated antigen rapid diagnostic test and or positive serology test for COVID-19 (>90 days).

    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
    Masking of investigational products ensured that the investigator and the participant were blinded to the type of exchange procedure. Patients could not distinguish true from sham procedures at the end of the study. Each procedure will take approximately 2 hours to complete. In the sham procedure, the patients will also underwear 6 procedures lasting approximately 2 hours each. Blinding will be maintained throughout the study until after 3-month follow-up assessment of the last

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental Arm
    Arm description
    		 6 sessions of PE (Plasma Exchange) with human serum albumin. Plasma exchange sessions will occur on days 1, 3, 8, 10, 15 and 17.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plasma Exchange with human serum album
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Plasma exchanges will be performed with 5% albumin as the replacement fluid. The typical schedule prescribed will be an exchange of 1 volemia. Blood will be separated into cells and plasma; the cells will be combined with reconstituted 5% human serum albumin and reinfused into the patient with normal saline. Conventional fresh-frozen plasma will be used as replacement fluid (1/3 of the exchanged plasma volume) only in patients with a baseline coagulopathy (PT <50%). The fresh-frozen plasma to be used will be provided by the Blood and Tissues Bank from Hospital Universitari Germans Trias i Pujol.

    Investigational medicinal product name
    Human albumin 5%
    Investigational medicinal product code
    Other name
    Albutein 5% ®
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion , Intravenous use
    Dosage and administration details
    Human albumin 5% (Albutein 5% ®), solution for intravenous infusion. It will be used in bottles of 250mL or 500mL depending on availability. The administration volume will be adapted for each participant. Solution for infusion, clear, slightly viscous. Storage conditions: Keep at 25ºC maximum. Refrigeration is not necessary under these conditions. Protect from light. Do not freeze.

    Arm title
    		 Placebo Arm
    Arm description
    		 6 sessions with placebo (infusion of 200 to 250ml of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sterile saline solution 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    For sham plasma exchange procedures, a sound behind the curtain was performed imitating the sound of the cell processing platform, the participant wore headphones connected to a tablet with music. In these cases, only one infusion of 200 to 250ml of sterile saline solution 0.9% will be performed during the time established for all procedures. Albumin will not be necessary for those patients in the Sham plasma exchange arm.

    Number of subjects in period 1
    		Experimental Arm Placebo Arm
    Started
    25
    25
    Completed
    24
    25
    Not completed
    1
    0
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental Arm
    Reporting group description
    		 6 sessions of PE (Plasma Exchange) with human serum albumin. Plasma exchange sessions will occur on days 1, 3, 8, 10, 15 and 17.

    Reporting group title
    Placebo Arm
    Reporting group description
    		 6 sessions with placebo (infusion of 200 to 250ml of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.

    Reporting group values
    		 Experimental Arm Placebo Arm Total
    Number of subjects
    		 25 25 50
    Age categorical
    Demographic, clinical profiles at baseline of all subjects analyzed are described in tables by study group. All categorical variables are described by the number of observations in each category and the percentage by study group. All continuous variables are described by number of cases, mean, median, 1st and 4th quartiles, standard deviation, and number of missing values.
    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)
    		 25 25 50
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Demographic, clinical profile at baseline of all subjects analyzed are described in tables by study group. All categorical variables are described by the number of observations in each category and the percentage by study group. All continuous variables are described by number of cases, mean, median, 1st and 4th quartiles, standard deviation, and number of missing values.
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 48.88 (45.00 to 53.00) 48.40 (40.00 to 57.00) -
    Gender categorical
    Demographic, clinical profile at baseline of all subjects analyzed are described in tables by study group. All categorical variables are described by the number of observations in each category and the percentage by study group. All continuous variables are described by number of cases, mean, median, 1st and 4th quartiles, standard deviation, and number of missing values.
    Units: Subjects
        Female
    		 16 17 33
        Male
    		 9 8 17

    End points

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    End points reporting groups
    Reporting group title
    Experimental Arm
    Reporting group description
    		 6 sessions of PE (Plasma Exchange) with human serum albumin. Plasma exchange sessions will occur on days 1, 3, 8, 10, 15 and 17.

    Reporting group title
    Placebo Arm
    Reporting group description
    		 6 sessions with placebo (infusion of 200 to 250ml of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.

    Primary: Proportion of adverse events (AEs) through day 90: all AEs

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    End point title
    		 Proportion of adverse events (AEs) through day 90: all AEs
    End point description
    In the primary analysis, the proportions of adverse events up to day 90 were described and compared between treatment arms using a Fisher’s exact test. The proportions of adverse events were also described graphically. This analysis was performed considering: all AEs, grade 3 and 4 AEs and AEs leading to study treatment discontinuation or study withdrawal. The causal relationships with the treatment were also described in this section.
    End point type
    Primary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [1]
    25 [2]
    Units: %
        number (not applicable)
    100
    100
    Notes
    [1] - Per Protocol
    [2] - Per Protocol
    Statistical analysis title
    		 Fisher's exact test
    Statistical analysis description
    In the primary analysis, the proportions of adverse events up to day 90 were described and compared between treatment arms using a Fisher’s exact test.
    Comparison groups
    Placebo Arm v Experimental Arm
    Number of subjects included in analysis
    49
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 > 0.9
    Method
    		 Fisher exact
    Confidence interval

    Primary: Proportion of adverse events (AEs) through day 90, considering: Grade 3 and 4 AEs

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    End point title
    		 Proportion of adverse events (AEs) through day 90, considering: Grade 3 and 4 AEs
    End point description
    In the primary analysis, the proportions of adverse events up to day 90 were described and compared between treatment arms using a Fisher’s exact test.
    End point type
    Primary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [3]
    25 [4]
    Units: Percentatge
        number (not applicable)
    4.2
    0
    Notes
    [3] - Per Protocol
    [4] - Per Protocol
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Experimental Arm v Placebo Arm
    Number of subjects included in analysis
    49
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.5
    Method
    		 Fisher exact
    Confidence interval

    Primary: Proportion of adverse events (AEs) through day 90: AEs leading to study withdrawal

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    End point title
    		 Proportion of adverse events (AEs) through day 90: AEs leading to study withdrawal
    End point description
    In the primary analysis, the proportions of adverse events up to day 90 were described and compared between treatment arms using a Fisher’s exact test.
    End point type
    Primary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [5]
    25 [6]
    Units: Percentatge
        number (not applicable)
    13
    4
    Notes
    [5] - Per Protocol
    [6] - Per Protocol
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Experimental Arm v Placebo Arm
    Number of subjects included in analysis
    49
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence [7]
    P-value
    		 = 0.3
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [7] - In the primary analysis, the proportions of adverse events up to day 90 were described and compared between treatment arms using a Fisher’s exact test.

    Secondary: Proportion of participants with an improvement in PCFS score to grades 1-2

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    End point title
    		 Proportion of participants with an improvement in PCFS score to grades 1-2
    End point description
    In the secondary analysis, the secondary endpoints were described through a table and graphically represented to evaluate its evolution over time. For the categorical endpoints sankey plots were used to describe the evolution of each category over time.
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [8]
    25 [9]
    Units: Percentatge
        number (not applicable)
    24
    40
    Notes
    [8] - Per Protocol
    [9] - Per Protocol
    No statistical analyses for this end point

    Secondary: Evaluation fatigue severity scale (FSS)

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    End point title
    		 Evaluation fatigue severity scale (FSS)
    End point description
    No changes were observed in the fatigue severity scale between the two groups during the study period.
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [10]
    25 [11]
    Units: Average score
        number (not applicable)
    57.16
    56.92
    Notes
    [10] - Per Protocol
    [11] - Per protocol
    No statistical analyses for this end point

    Secondary: Evolution of the mean score of the Can Ruti PCC symptoms scale in the two groups over time

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    End point title
    		 Evolution of the mean score of the Can Ruti PCC symptoms scale in the two groups over time
    End point description
    Symptom Assessment (Can Ruti Scale): No significant changes were found in the progression of the Can Ruti Symptom Assessment Scale throughout the trial in both groups.
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24
    25
    Units: Mean score
        number (not applicable)
    49.76
    49.76
    No statistical analyses for this end point

    Secondary: Evolution of the mean score of EuroQol-5D in the two groups over time - PP population

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    End point title
    		 Evolution of the mean score of EuroQol-5D in the two groups over time - PP population
    End point description
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [12]
    25 [13]
    Units: Mean
        number (not applicable)
    0.37
    0.42
    Notes
    [12] - Per Protocol
    [13] - Per Protocol
    No statistical analyses for this end point

    Secondary: Evolution of the physical health component of MOS-HIV in the two groups over time (Really good))

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    End point title
    		 Evolution of the physical health component of MOS-HIV in the two groups over time (Really good))
    End point description
    % of participants indicated "really good" in the health component of MOS-HIV at 90 days.
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [14]
    25 [15]
    Units: Percentatge
        number (not applicable)
    0
    4.2
    Notes
    [14] - Per Protocol
    [15] - Per Protocol
    No statistical analyses for this end point

    Secondary: Evolution of the mean score of Neu Screen in the two groups over time - PP population

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    End point title
    		 Evolution of the mean score of Neu Screen in the two groups over time - PP population
    End point description
    Evolution of the mean score of Neu Screen in the two groups over time - PP population (TMT-F+A+S)
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [16]
    25 [17]
    Units: score
        arithmetic mean (standard deviation)
    33.04 ( 11.75 )
    29.52 ( 8.85 )
    Notes
    [16] - PP population
    [17] - PP population
    No statistical analyses for this end point

    Secondary: Evolution of the mean score of the semantic fluency test in the two groups over time - PP population

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    End point title
    		 Evolution of the mean score of the semantic fluency test in the two groups over time - PP population
    End point description
    Evolution of the mean score of the semantic fluency test in the two groups over time - PP population
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [18]
    25 [19]
    Units: Mean
        arithmetic mean (standard deviation)
    18.71 ( 4.86 )
    16.88 ( 4.24 )
    Notes
    [18] - PP population
    [19] - PP population
    No statistical analyses for this end point

    Secondary: Evolution of the mean score of MEF-30 in the two groups over time - PP population

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    End point title
    		 Evolution of the mean score of MEF-30 in the two groups over time - PP population
    End point description
    Evolution of the mean score of MEF-30 in the two groups over time - PP population
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [20]
    25 [21]
    Units: Mean
        arithmetic mean (standard deviation)
    66.83 ( 25.54 )
    67.92 ( 22.20 )
    Notes
    [20] - Per Protocol
    [21] - Evolution of the mean score of MEF-30 in the two groups over time - PP population
    No statistical analyses for this end point

    Secondary: Evolution of the laboratory analysis profile of the two groups over time: FIBRINOGEN

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    End point title
    		 Evolution of the laboratory analysis profile of the two groups over time: FIBRINOGEN
    End point description
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24
    25
    Units: mg/dL
        median (inter-quartile range (Q1-Q3))
    361.50 (321.00 to 466.00)
    382.00 (343.00 to 410.00)
    No statistical analyses for this end point

    Secondary: Evolution of the laboratory analysis profile of the two groups over time: D-Dimer

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    End point title
    		 Evolution of the laboratory analysis profile of the two groups over time: D-Dimer
    End point description
    End point type
    Secondary
    End point timeframe
    At 90 days
    End point values
    		 Experimental Arm Placebo Arm
    Number of subjects analysed
    24 [22]
    25 [23]
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    240.50 (215.00 to 360.25)
    265.00 (231.00 to 358.00)
    Notes
    [22] - Per Protocol
    [23] - Per Protocol
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At 90 days
    Adverse event reporting additional description
    A safety analysis was also conducted, considering adverse events on both a per-subject basis and a per-event basis. Statistical analyses were performed with R software version 4.3.0 or higher and the most commonly used packages were gtsummary, ggplot2 and lme4.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 6 sessions of PE (Plasma Exchange) with human serum albumin. Plasma exchange sessions will occur on days 1, 3, 8, 10, 15 and 17.

    Reporting group title
    Control Group
    Reporting group description
    		 6 sessions with placebo (infusion of 200 to 250ml of sterile saline solution 0.9%) on days 1, 3, 8, 10, 15 and 17.

    Serious adverse events
    		 Experimental Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    22 / 25 (88.00%)
    General disorders and administration site conditions
    Site administration discomfort
         subjects affected / exposed
    25 / 25 (100.00%)
    22 / 25 (88.00%)
         occurrences all number
    41
    37
    Immune system disorders
    Allergic cough
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Reproductive tract disorder
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    12 / 25 (48.00%)
    6 / 25 (24.00%)
         occurrences all number
    12
    6
    Injury, poisoning and procedural complications
    Procedural complication
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 25 (12.00%)
         occurrences all number
    1
    3
    Cardiac disorders
    Cardiac dysfunction
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 25 (12.00%)
         occurrences all number
    5
    3
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    25 / 25 (100.00%)
    22 / 25 (88.00%)
         occurrences all number
    45
    31
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemias nonhaemolytic and marrow depression
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Eye disorders
    Eye disorder
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    25 / 25 (100.00%)
    22 / 25 (88.00%)
         occurrences all number
    39
    29
    Hepatobiliary disorders
    Hepatobiliary disease
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin disorders
         subjects affected / exposed
    5 / 25 (20.00%)
    7 / 25 (28.00%)
         occurrences all number
    5
    7
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 25 (8.00%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
         subjects affected / exposed
    25 / 25 (100.00%)
    13 / 25 (52.00%)
         occurrences all number
    31
    13
    Infections and infestations
    infections
         subjects affected / exposed
    14 / 25 (56.00%)
    17 / 25 (68.00%)
         occurrences all number
    14
    17
    Metabolism and nutrition disorders
    Metabolism disorders
         subjects affected / exposed
    5 / 25 (20.00%)
    4 / 25 (16.00%)
         occurrences all number
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2022
    To obtain the maximum information from participants diagnosed with Post-COVID-19 Syndrome (SPC), it is decided to add more parameters to be analyzed during the study, so the following documents are modified: - Protocol: New version 3.0, 06/22/2022 - Protocol Summary: New version 3.0, 06/22/2022 - HIP/CI: New version 4.0, 06/22/2022 - Annex IV: MOS-VIH (Annex IV (SF-36) is replaced by the MOS-VIH questionnaire. - Annex III: The version of the symptomatology questionnaire is updated. - Annex VI: The neurocognitive evaluation is added, based on the completion of 3 “Neuropsychological Assessment” questionnaires
    19 Dec 2022
    To obtain the maximum information from participants diagnosed with Post-COVID-19 Syndrome (PCS), it is decided to add an extra visit in case the participant presents re-infection by COVID-19, and it will be considered appropriate to carry out all the visits established by protocol, in case the participant has to prematurely discontinue the study treatment. Due to these changes, the following documentation is generated: - Protocol: New version 4.0, 12/19/2022 - Protocol Summary: New version 4.0, 12/19/2022 - HIP/CI: New version 5.0, 12/19/2022

    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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