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    Clinical Trial Results:
    Open label, monocentric pilot study to evaluate safety and efficacy of Bazedoxifene in addition to Standard of Care in hospitalized COVID-19 patients suffering from moderate to severe Pneumonia

    Summary
    EudraCT number
    		 2021-000320-35
    Trial protocol
    		 CZ  
    Global end of trial date
    06 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    Summary report(s)
    		 Synopsis_OB001

    Trial information

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    Trial identification
    Sponsor protocol code
    OB001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oxygen Biotech s.r.o.
    Sponsor organisation address
    Italská 2581/67, Prague 2 – Vinohrady, Czechia, 120 00
    Public contact
    Tomáš Pacák, Oxygen Biotech s.r.o., admin@oxygenbiotech.com
    Scientific contact
    Tomáš Pacák, Oxygen Biotech s.r.o., admin@oxygenbiotech.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
    27 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety of bazedoxifene in patients with COVID-19 disease assessed by incidence and spectrum of reported AEs, and laboratory and clinical findings.
    Protection of trial subjects
    When obtaining informed consent, the subject’s state of health was considered, and the investigator extensively informed each subject of the objectives, benefits, risks and requirements imposed by the study. The subject was provided with an information and consent form in clear, simple language. He/she was allowed ample time to inquire about details of the study and to decide whether or not to participate in the study. The subjects were aware of the possible risks of their participation in the clinical trial and the possibility at any time without consequences to terminate their participation in the clinical trial. The subjects were also informed about the measures that were taken for the protection of personal data and also the fact that in case of damage to health due to the conduct of the trial were in compliance with the legislation in force liability insurance for the investigator and sponsor through which is secured and any compensation to the trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2021
    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
    Czechia: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted in the Czech Republic (CR) in 1 centre of Thomayer University Hospital, Prague and 3 subjects were selected in total, all of them were included in CR, and all subjects completed the study. Study began on 07-04-2021 when the 1st patient signed ICF. The recruitment was stopped on 06-12-2021 based on strategic decision of sponsor.

    Pre-assignment
    Screening details
    		 The screening was initiated after subject's informed consent had been obtained. The screening visit was performed within 5 days prior to Day 1 (baseline, start of IMP administration). It could have happened in the same day as baseline (Day 1).

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Arm of treatment period
    Arm description
    		 Only one arm was designed for this study. All subjects were assigned to receive active treatment of Conbriza® (bazedoxifene) in addition to SoC in COVID-19 patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bazedoxifene
    Investigational medicinal product code
    Other name
    Conbriza, CONBRIZA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On Day 1: once daily 2 tablets of 20 mg (i.e., 40 mg of bazedoxifene once daily), regardless of food intake; From Day 2 to EoT: once daily 1 tablet of 20 mg, regardless of food intake. Note: Only in exceptional circumstances of subjects admitted to hospital in the evening, if the first dose of the IMP was administered at 6 PM and later, subject would have received only 1 tablet of Conbriza® 20 mg on Day 1 and continued with the next dose in the morning of the Day 2.

    Number of subjects in period 1
    		Arm of treatment period
    Started
    3
    Completed
    3
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Arm of follow-up period
    Arm description
    		 Only one arm was designed for this study, and all 3 enrolled subjects continued into the Follow-up period. In this period, no study treatment was administered to the subjects.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Arm of follow-up period
    Started
    3
    Completed
    3

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 3 3
    Age categorical
    The target population was adult patients aged between 18 and 75 with presence of COVID 19 pneumonia (clinical manifestations and Xray or CT evidence) who were admitted to hospital due to moderate to severe symptoms of pneumonia as per investigator opinion.
    Units: Subjects
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.3 ± 9.61 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 1 1
    Race
    Units: Subjects
        White
    		 3 3
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 3 3
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 89.67 ± 7.506 -
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 166.0 ± 8.54 -
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 32.80 ± 5.294 -
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters. Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.

    Subject analysis sets values
    		 Safety analysis set
    Number of subjects
    3
    Age categorical
    The target population was adult patients aged between 18 and 75 with presence of COVID 19 pneumonia (clinical manifestations and Xray or CT evidence) who were admitted to hospital due to moderate to severe symptoms of pneumonia as per investigator opinion.
    Units: Subjects
        Adults (18-64 years)
    2
        From 65-84 years
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.3 ± 9.61
    Gender categorical
    Units: Subjects
        Female
    2
        Male
    1
    Race
    Units: Subjects
        White
    3
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    3
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    89.67 ± 7.506
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    166.0 ± 8.54
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    32.80 ± 5.294

    End points

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    End points reporting groups
    Reporting group title
    Arm of treatment period
    Reporting group description
    		 Only one arm was designed for this study. All subjects were assigned to receive active treatment of Conbriza® (bazedoxifene) in addition to SoC in COVID-19 patients.
    Reporting group title
    Arm of follow-up period
    Reporting group description
    		 Only one arm was designed for this study, and all 3 enrolled subjects continued into the Follow-up period. In this period, no study treatment was administered to the subjects.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters. Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.

    Primary: Primary Objective - Incidence and spectrum of reported AEs, laboratory and clinical findings

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    End point title
    		 Primary Objective - Incidence and spectrum of reported AEs, laboratory and clinical findings
    End point description
    Safety of bazedoxifene in patients with COVID-19 disease was assessed by incidence and spectrum of reported AEs, and laboratory and clinical findings.
    End point type
    Primary
    End point timeframe
    Screening: Within 5 days prior to D1 (baseline). Treatment period: From D1 till D5 at minimum and till D14 at maximum as per investigator opinion. Follow up period: From EoT till D21 or up to D28. Allowed visit window for EoS was D21 to D28
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: number
        Number of AEs
    1
    1
    1
        Number of SAEs
    0
    0
    0
        Number of AEs related to study treatment
    0
    0
    0
        No of AEs leading to study treatment discontinuati
    0
    0
    0
        No of AEs leading to death
    0
    0
    0
        No of clinical significant findings - hematology
    1
    1
    1
        No of clinical significant findings - biochemistry
    0
    0
    0
        No of clinical significant findings - immunology
    0
    0
    0
        No of clinical significant findings - urinalysis
    0
    0
    0
    Attachments
    		 14.3.1.-13. Safety Data
    16.2.7.-8. Listings by patient
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [1] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Secondary: Secondary Objective - Changes in clinical status of subject

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    End point title
    		 Secondary Objective - Changes in clinical status of subject
    End point description
    Changes in clinical status of subject (using 7-point ordinal scale): on Day 0, Day 5 and Day 21 – 28. a. Death b. Hospitalized, on invasive mechanical ventilation or ECMO c. Hospitalized, on non-invasive ventilation or high flow oxygen devices d. Hospitalized, requiring supplemental oxygen e. Hospitalized, not requiring supplemental oxygen – requiring ongoing medical care (COVID-19 related or otherwise) f. Hospitalized, not requiring supplemental oxygen – no longer requires ongoing medical Care g. Not hospitalized
    End point type
    Secondary
    End point timeframe
    On Day 0, Day 5 and Day 21 – 28.
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: number
        Number of analysed subjects
    3
    3
    3
    Attachments
    		 14.4.1. Shift table of patients´ clinical status
    16.2.9.4. Listing of patient’s clinical status
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [2] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Secondary: Secondary Objective - Influence of subjects' clinical condition (symptom score)

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    End point title
    		 Secondary Objective - Influence of subjects' clinical condition (symptom score)
    End point description
    During the study, symptoms were recorded by staff daily during hospitalization, and upon discharge from the hospital, subjects were asked to report daily temperature (morning and evening) and symptoms (once daily, in the evening) in the diary provided and they are listed below: Days of study: 1-28 Date DD/MM/YYYY Temperature morning evening Presence of cough per day, per night heavy/attacks Presence of fatigue Changes in taste perception Changes in smell perception Gastrointestinal symptoms Other symptoms
    End point type
    Secondary
    End point timeframe
    Daily during hospitalization: between baseline (D1) and D14 (or day of discharge). Upon discharge from the hospital: daily temperature (morning and evening) and symptoms (once daily, in the evening).
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: point
        Number of analysed subjects
    3
    3
    3
    Attachments
    		 14.4.2. Summary of symptom score
    16.2.9.3. Listing of individual symptom score
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [3] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Secondary: Secondary Objective - Monitoring the frequency of subjects whose condition worsens into a critical state necessitating a ventilator

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    End point title
    		 Secondary Objective - Monitoring the frequency of subjects whose condition worsens into a critical state necessitating a ventilator
    End point description
    Clinical examinations including vital signs – blood pressure, heart and respiratory rate, temperature, O2 saturation, oxygen flow if oxygen administered and its changes were monitored daily during hospitalization.
    End point type
    Secondary
    End point timeframe
    Daily during hospitalisation: D1 - day of discharge.
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: number of subjects
        Number of analysed subjects
    3
    3
    3
    Attachments
    		 14.3.14. Summary statistics and changes from BL
    14.4.4.-6. O2 saturation, Oxygen flow, Ventilator
    16.2.9.1.-2. Clinical assessments - Listings
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [4] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Secondary: Secondary Objective - Time to normalization of chosen blood parameters

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    End point title
    		 Secondary Objective - Time to normalization of chosen blood parameters
    End point description
    Hematology: hemoglobin [g/L], hematocrit [L/L], RBC count [10!12/L], WBCl count [109/L], PL count [109/L], Bas[%], Eos[%], Neu[%], Mon[%], Lym[%], MCV [fL], MCH [pg], mean corpuscular hemoglobin conc. [g/L], red cell distribution width [%], D-dimers [µg/L], PT [s], aPTT [s], INR. Biochemistry : ALT [µkat/L], AST [µkat/L], ALP [µkat/L], lactate dehydrogenase [µkat/L], Mg[mmol/L], total bilirubin [µmol/L], direct bilirubin [µmol/L], blood area N [mmol/L], creatinine [µmol/L], P [mmol/L], Cl[mmol/L], Ca [mmol/L], K [mmol/L], Na[mmol/L], Glc[mmol/L], CRP [mg/L], ferritin [µg/L], IL-6 [ng/L]. Immunology parameters: CD3+ [% and absolute value in 109/L], CD4+ [% and absolute value in 109/L], CD8+ [% and absolute value in 109/L]. Urinalysis parameters: color, pH, specific gravity [kg/m3], RBC count [106/L], WBC count [106/L], epithelial cells [106/L], positive/negative testing for: glucose, protein, ketones, blood, casts, bacteria, crystals.
    End point type
    Secondary
    End point timeframe
    Hematology, immunological and biochemistry examinations were performed within 60 minutes before the first administration of bazedoxifene, then on days 2, 3, 5, 7, 10, 14 and/or EoT, and if was possible after discharge from the hospital on D21 to D28 (EoS)
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: number
        Number of analysed subjects
    3
    3
    3
    Attachments
    		 14.4.7. Summary statistics of time to 1st normal
    16.2.8.5.-6. Listing of abnormal and normalization
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [5] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Secondary: Secondary Objective - Length of hospital stay

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    End point title
    		 Secondary Objective - Length of hospital stay
    End point description
    The length of hospital stay was monitored during the whole study continuously.
    End point type
    Secondary
    End point timeframe
    Continuously during the study.
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: number
        Number of analysed subjects
    3
    3
    3
    Attachments
    		 14.4.8.-9. Lenght of hospital stay
    16.2.9.5. Length of hospital stay - per patient
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [6] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Secondary: Secondary Objective - Rate of virus elimination from upper respiratory tract secretions

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    End point title
    		 Secondary Objective - Rate of virus elimination from upper respiratory tract secretions
    End point description
    PCR smear done before the first IMP administration (Screening) and further samples on the day 8 (or on the day of hospital discharge, whichever came first) and further once a week till EoS, if was possible.
    End point type
    Secondary
    End point timeframe
    Before the first IMP administration (Screening), on D8 (or the day of hospital discharche), further once a week till EoS (if possible)
    End point values
    		 Arm of treatment period Arm of follow-up period Safety analysis set
    Number of subjects analysed
    3
    3
    3
    Units: number
        Number of analysed subjects
    3
    3
    3
    Attachments
    		 16.2.8.7. Listing of NP smear (PCR) results per pt
    Statistical analysis title
    		 Changes of the individual parameters
    Statistical analysis description
    Categorical data were summarized using the number and percentage of subjects in each category. Continuous data were summarized using the mean, 95% confidence interval for mean (CI), standard deviation (SD), median, minimum and maximum values.
    Comparison groups
    Arm of treatment period v Safety analysis set
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    Parameter type
    		 Multiple parameters
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Notes
    [7] - Since this was a pilot administration to a small number of subjects in order to verify primarily the safety of the product Conbriza® (bazedoxifene) in COVID-19 patients treated with standard therapy (SoC), the output of a full statistically significant result could not have been expected, but rather a trend of changes of the individual parameters.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the day of signed ICF until the EoS Visit.
    Adverse event reporting additional description
    Safety of bazedoxifene in patients with COVID-19 disease was assessed by incidence and spectrum of reported AEs, and laboratory and clinical findings. All AEs were recorded on the AE eCRF at all scheduled and unscheduled visits, as well as those reported during a telephone contact throughout the study (from day of signed ICF until EoS Visit).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    AEs Reporting Group
    Reporting group description
    		 AEs Reporting Group consists of all enrolled subjects.

    Serious adverse events
    		 AEs Reporting Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 AEs Reporting Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    Blood and lymphatic system disorders
    D-dimer elevation
    Additional description: AE of mild intensity (Grade 1) in 1 subject was reported before the 1st IMP administration: D-dimer elevation - 3160 µg/L. In the course of the study, D-dimer levels have significantly decreased. AE was not considered as related to study treatment.
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2021
    Substantial Amendment n°1 to the protocol, final version dated 21 July 2021 was issued. The aim of this protocol amendment was an important update of the inclusion criterium of study participants. The change concerned the extension of the COVID-19 diagnosis interval from 7 to 14 days before enrolment. The rationale for this amendment was to increase the availability of the treatment to the patients in response to the changes in epidemiologic situation as COVID-19 was diagnosed earlier.

    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/24077366
    http://www.ncbi.nlm.nih.gov/pubmed/31978945
    http://www.ncbi.nlm.nih.gov/pubmed/32007143
    http://www.ncbi.nlm.nih.gov/pubmed/31986264
    http://www.ncbi.nlm.nih.gov/pubmed/32031570
    http://www.ncbi.nlm.nih.gov/pubmed/15271897
    http://www.ncbi.nlm.nih.gov/pubmed/32171076
    http://www.ncbi.nlm.nih.gov/pubmed/32167524
    http://www.ncbi.nlm.nih.gov/pubmed/30995492
    http://www.ncbi.nlm.nih.gov/pubmed/31958792
    http://www.ncbi.nlm.nih.gov/pubmed/25898198
    http://www.ncbi.nlm.nih.gov/pubmed/32273618
    http://www.ncbi.nlm.nih.gov/pubmed/32303591
    http://www.ncbi.nlm.nih.gov/pubmed/18665787
    http://www.ncbi.nlm.nih.gov/pubmed/23871271
    http://www.ncbi.nlm.nih.gov/pubmed/32871847
    http://www.ncbi.nlm.nih.gov/pubmed/33527314
    http://www.ncbi.nlm.nih.gov/pubmed/30648776
    http://www.ncbi.nlm.nih.gov/pubmed/26424839
    http://www.ncbi.nlm.nih.gov/pubmed/30885958
    http://www.ncbi.nlm.nih.gov/pubmed/32678530
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