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    Clinical Trial Results:
    A multi-centre, adaptive, randomized, double-blind, placebo-controlled comparative clinical study of the safety and efficacy of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg (NPO Petrovax Pharm LLC, Russia) in patients with coronavirus disease (COVID-19).

    Summary
    EudraCT number
    		 2020-001782-37
    Trial protocol
    		 SK  
    Global end of trial date
    05 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2021
    First version publication date
    04 Sep 2021
    Other versions
    Summary report(s)
    		 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    PО-COV-III-20
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04381377
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ID RCB: 2020-001782-37/1
    Sponsors
    Sponsor organisation name
    NPO Petrovax Pharm, LLC
    Sponsor organisation address
    1 Sosnovaya St., Pokrov village, Podolsk, Moscow region, Russian Federation, 142143
    Public contact
    PVX Clinical Trials Information, NPO Petrovax Pharm, LLC, +7 495730-75-45*125, dodonovns@petrovax.ru
    Scientific contact
    PVX Clinical Trials Information, NPO Petrovax Pharm, LLC, +7 495730-75-45*125, dodonovns@petrovax.ru
    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 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess safety and efficacy of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg (NPO Petrovax Pharm LLC, Russia) in comparison with placebo in hospitalized patients with coronavirus disease (COVID-19).
    Protection of trial subjects
    Insurance against damage to health as a result of the clinical trial has been concluded
    Background therapy
    		 Background therapy is based on the available international and national guidelines that are in force during the study period. The following medications (in any dosage form except for the drug products that are used to treat COVID-19 according to the local and/or international guidelines that are in force during the study) are prohibited: • Antiviral medications • Immunomodulators (except for the IP) • Immunostimulants • Immunosuppressants • Interferon and interferon inductors
    Evidence for comparator
    		 The use of placebo in the comparison group is primarily associated with masking and blinding, which increases the reliability of the data. Considering that the standard treatment of coronavirus disease (COVID-19, SARS-CoV-2) has not been developed at the time of the study conduction, the group of comparison in the study PO-COV-III-20 uses placebo. All the enrolled patients have received full treatment in accordance with the available international and national guidelines that are in force during the study period.
    Actual start date of recruitment
    28 Apr 2020
    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
    Slovakia: 9
    Country: Number of subjects enrolled
    Russian Federation: 385
    Worldwide total number of subjects
    394
    EEA total number of subjects
    9
    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)
    299
    From 65 to 84 years
    95
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on 28 Apr 2020 (the first patient screened) in Russia. End of recruitment date: 05 Feb 2021 - the last patient in the study was screened in Slovakia. The last patient's last visit was done 05 Mar 2021.

    Pre-assignment
    Screening details
    		 The patient screening had to be done one day before or at the same date as the randomization. From the 399 patients screened: 5 patients failed the screening, 394 were randomized.

    Pre-assignment period milestones
    Number of subjects started
    		 399 [1]
    Number of subjects completed
    		 394

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, serious fatal: 2
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Physician decision: 2
    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: 5 subjects were not randomized due to the following reasons: Adverse event, serious fatal - 2 subjects Consent is withdrawn by subject -1 subject Physician decision - 2 subjects,
    Period 1
    Period 1 title
    Whole study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Masked IP use. Access to randomization codes was provided to unblinded Sponsor/CRO team members only.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Polyoxidonium®
    Arm description
    		 Dose 12 mg IV on Days 1, 2, 3, then IM on Days 5, 7, 9, 11, 13, 15, 17
    Arm type
    		 Experimental

    Investigational medicinal product name
    Polyoxidonium®
    Investigational medicinal product code
    Other name
    Azoximer bromide
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    12 mg IV on the Days 1, 2, 3 12 mg IM on the Days 5, 7, 9, 11, 13, 15, 17

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching 12 mg of Polyoxidonium IV on Days 1, 2, 3, then IM on Days 5, 7, 9, 11, 13, 15, 17
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    Placebor mathcing 12 mg of Polyoxidonium IV on the Days 1, 2, 3 Placebor mathcing 12 mg of Polyoxidonium IM on the Days 5, 7, 9, 11, 13, 15, 17

    Number of subjects in period 1
    		Polyoxidonium® Placebo
    Started
    195
    199
    Completed
    185
    186
    Not completed
    10
    13
         Adverse event, serious fatal
    5
    10
         Physician decision
    1
    1
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Polyoxidonium®
    Reporting group description
    		 Dose 12 mg IV on Days 1, 2, 3, then IM on Days 5, 7, 9, 11, 13, 15, 17

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching 12 mg of Polyoxidonium IV on Days 1, 2, 3, then IM on Days 5, 7, 9, 11, 13, 15, 17

    Reporting group values
    		 Polyoxidonium® Placebo Total
    Number of subjects
    		 195 199 394
    Age categorical
    Male and female hospitalized patients of 18-95 y.o. with COVID-19.
    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)
    		 155 144 299
        From 65-84 years
    		 40 55 95
        85 years and over
    		 0 0 0
        Adults 65-85 years
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.3 ( 13.3 ) 56.0 ( 12.6 ) -
    Gender categorical
    Both male and female patients are allowed for enrolment
    Units: Subjects
        Female
    		 99 97 196
        Male
    		 96 102 198
    Severity of disease
    Severe disease: requiring mechanical ventilation or oxygen, a SpO2 ≤ 94% or tachypnoea (respiratory rate ≥ 24 breaths/min) Mild-moderate disease: SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen.
    Units: Subjects
        Severe disease
    		 105 102 207
        Mild-moderate disease
    		 90 97 187
    Subject analysis sets

    Subject analysis set title
    All enrolled patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients that were enrolled in the study and randomized, according to the treatment assignments.

    Subject analysis sets values
    		 All enrolled patients
    Number of subjects
    394
    Age categorical
    Male and female hospitalized patients of 18-95 y.o. with COVID-19.
    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)
    299
        From 65-84 years
    95
        85 years and over
        Adults 65-85 years
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.1 ( 13.0 )
    Gender categorical
    Both male and female patients are allowed for enrolment
    Units: Subjects
        Female
    196
        Male
    198
    Severity of disease
    Severe disease: requiring mechanical ventilation or oxygen, a SpO2 ≤ 94% or tachypnoea (respiratory rate ≥ 24 breaths/min) Mild-moderate disease: SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen.
    Units: Subjects
        Severe disease
    207
        Mild-moderate disease
    187

    End points

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    End points reporting groups
    Reporting group title
    Polyoxidonium®
    Reporting group description
    		 Dose 12 mg IV on Days 1, 2, 3, then IM on Days 5, 7, 9, 11, 13, 15, 17

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching 12 mg of Polyoxidonium IV on Days 1, 2, 3, then IM on Days 5, 7, 9, 11, 13, 15, 17

    Subject analysis set title
    All enrolled patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients that were enrolled in the study and randomized, according to the treatment assignments.

    Primary: Clinical status at Day 15

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    End point title
    		 Clinical status at Day 15
    End point description
    The ordinal scale is used to estimate a proportional odds model, which is fitted with clinical status at day 15 as the outcome, treatment group as the main explanatory variable, and with randomization stratification variables as the other explanatory variables. The primary hypothesis test is based on a test of whether the common odds ratio for treatment is equal to one. It was evaluated the model fit using a goodness-of-fit likelihood ratio test. A stratified hypothesis test to account for baseline severity of disease is used. The distribution of clinical status at day 15 is summarized by treatment arm as percentages.
    End point type
    Primary
    End point timeframe
    Day 15
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    190
    196
    Units: 7 point ordinal scale
        1. Not hospitalized, no limitations on activities
    44
    47
        2. Not hospitalized, limitation on activities
    23
    15
        3. Hospitalized, not requiring supplemental oxygen
    109
    119
        4. Hospitalized, requiring supplemental oxygen
    8
    4
        5. Hospitalized, on non-invasive ventilation or hi
    1
    1
        6. Hospitalized, on invasive mechanical ventilatio
    1
    0
        7. Death
    4
    10
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    Statistical analysis of the data collected during the study is performed with the use of programming language R for statistical computing (version 3.6.0 or higher), statistical software SAS (version 9.4 or higher) or other special software that ensures adequate quality of the results.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Proportional odds module
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.7

    Secondary: The 7-point ordinal scale: time to improvement by one category from admission on the ordinal scale.

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    End point title
    		 The 7-point ordinal scale: time to improvement by one category from admission on the ordinal scale.
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    185
    186
    Units: day
        arithmetic mean (standard deviation)
    15.6 ( 9.6 )
    16.3 ( 10.3 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    371
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9935
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Clinical status of the patient (according to 7-point ordinal scale) on day 3

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    End point title
    		 Clinical status of the patient (according to 7-point ordinal scale) on day 3
    End point description
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    194
    198
    Units: score
        arithmetic mean (standard deviation)
    3.85 ( 0.95 )
    3.88 ( 0.98 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clinical status of the patient (according to 7-point ordinal scale) on day 5

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    End point title
    		 Clinical status of the patient (according to 7-point ordinal scale) on day 5
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    193
    198
    Units: score
        arithmetic mean (standard deviation)
    3.70 ( 0.96 )
    3.76 ( 0.94 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clinical status of the patient (according to 7-point ordinal scale) on day 8

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    End point title
    		 Clinical status of the patient (according to 7-point ordinal scale) on day 8
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    190
    197
    Units: score
        arithmetic mean (standard deviation)
    3.42 ( 0.97 )
    3.46 ( 1.16 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clinical status of the patient (according to 7-point ordinal scale) on day 11

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    End point title
    		 Clinical status of the patient (according to 7-point ordinal scale) on day 11
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 11
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    190
    197
    Units: score
        arithmetic mean (standard deviation)
    3.05 ( 1.03 )
    3.09 ( 1.28 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Clinical status of the patient (according to 7-point ordinal scale) on day 29

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    End point title
    		 Clinical status of the patient (according to 7-point ordinal scale) on day 29
    End point description
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    192
    195
    Units: score
        arithmetic mean (standard deviation)
    1.34 ( 1.08 )
    1.43 ( 1.37 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The 7-point ordinal scale: change of the clinical status of the patient on day 3

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    End point title
    		 The 7-point ordinal scale: change of the clinical status of the patient on day 3
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    194
    198
    Units: score change
        arithmetic mean (standard deviation)
    -0.03 ( 0.42 )
    -0.01 ( 0.50 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The 7-point ordinal scale: change of the clinical status of the patient on day 5

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    End point title
    		 The 7-point ordinal scale: change of the clinical status of the patient on day 5
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 5
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    193
    198
    Units: score change
        arithmetic mean (standard deviation)
    -0.18 ( 0.59 )
    -0.13 ( 0.61 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The 7-point ordinal scale: change of the clinical status of the patient on day 8

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    End point title
    		 The 7-point ordinal scale: change of the clinical status of the patient on day 8
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    190
    197
    Units: score change
        arithmetic mean (standard deviation)
    -0.48 ( 0.85 )
    -0.44 ( 0.96 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The 7-point ordinal scale: change of the clinical status of the patient on day 11

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    End point title
    		 The 7-point ordinal scale: change of the clinical status of the patient on day 11
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 11
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    190
    197
    Units: score change
        arithmetic mean (standard deviation)
    -0.85 ( 1.01 )
    -0.81 ( 1.13 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Placebo v Polyoxidonium®
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The 7-point ordinal scale: change of the clinical status of the patient on day 29

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    End point title
    		 The 7-point ordinal scale: change of the clinical status of the patient on day 29
    End point description
    The values of the changes in the clinical status score compared to baseline
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    192
    195
    Units: score change
        arithmetic mean (standard deviation)
    -2.55 ( 1.14 )
    -2.46 ( 1.32 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first

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    End point title
    		 The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    190
    189
    Units: day
        arithmetic mean (standard deviation)
    8.9 ( 7.8 )
    8.6 ( 5.8 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    The values of NEWS scores change in the Placebo and Polyoxidonium treatment arms were compared. Mann-Whitney U-test with Benjamini-Yekutieli correction was used for analysis.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4603
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Change in NEWS from baseline to day 3

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    End point title
    		 Change in NEWS from baseline to day 3
    End point description
    End point type
    Secondary
    End point timeframe
    Day 3
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    191
    196
    Units: value
        arithmetic mean (standard deviation)
    -0.90 ( 1.83 )
    -0.67 ( 2.05 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    387
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in NEWS from baseline to day 5

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    End point title
    		 Change in NEWS from baseline to day 5
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    189
    195
    Units: value
        arithmetic mean (standard deviation)
    -1.59 ( 2.09 )
    -1.36 ( 2.48 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in NEWS from baseline to day 8

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    End point title
    		 Change in NEWS from baseline to day 8
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    181
    182
    Units: value
        arithmetic mean (standard deviation)
    -2.43 ( 2.74 )
    -2.21 ( 3.02 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in NEWS from baseline to day 11

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    End point title
    		 Change in NEWS from baseline to day 11
    End point description
    End point type
    Secondary
    End point timeframe
    Day 11
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    183
    181
    Units: value
        arithmetic mean (standard deviation)
    -3.08 ( 3.07 )
    -2.86 ( 3.01 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    364
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in NEWS from baseline to day 15

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    End point title
    		 Change in NEWS from baseline to day 15
    End point description
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    179
    177
    Units: value
        arithmetic mean (standard deviation)
    -3.63 ( 3.24 )
    -3.66 ( 3.23 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change in NEWS from baseline to day 29

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    End point title
    		 Change in NEWS from baseline to day 29
    End point description
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    149
    143
    Units: value
        arithmetic mean (standard deviation)
    -4.05 ( 3.41 )
    -3.99 ( 3.40 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    292
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Oxygenation free days in the first 28 days (to day 29)

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    End point title
    		 Oxygenation free days in the first 28 days (to day 29)
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    195
    199
    Units: day
        arithmetic mean (standard deviation)
    24.17 ( 6.01 )
    24.24 ( 5.19 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7614
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Incidence and duration of new oxygen use during the study

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    End point title
    		 Incidence and duration of new oxygen use during the study
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    195
    199
    Units: patients
        Patients with new oxygen incidence
    16
    19
        Patients without new oxygen incidence
    179
    180
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7242
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Duration of new oxygen use

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    End point title
    		 Duration of new oxygen use
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    19
    23
    Units: day
        arithmetic mean (standard deviation)
    2.47 ( 2.37 )
    3.22 ( 2.24 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2473
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mechanical ventilator-free days in the first 28 days (to day 29)

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    End point title
    		 Mechanical ventilator-free days in the first 28 days (to day 29)
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    195
    199
    Units: day
        arithmetic mean (standard deviation)
    28.93 ( 0.57 )
    28.79 ( 1.16 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1664
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Incidence of new mechanical ventilation use

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    End point title
    		 Incidence of new mechanical ventilation use
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    195
    199
    Units: patients
        Patients with new mechanical ventilation use
    1
    5
        Patients without new mechanical ventilation use
    194
    194
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2153
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Duration of new mechanical ventilation use

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    End point title
    		 Duration of new mechanical ventilation use
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    1
    5
    Units: day
        arithmetic mean (standard deviation)
    5.00 ( 0 )
    3.60 ( 2.70 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5582
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Duration of hospitalization

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    End point title
    		 Duration of hospitalization
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    195
    199
    Units: day
        arithmetic mean (standard deviation)
    17.98 ( 6.49 )
    17.57 ( 5.78 )
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9653
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: 28-day mortality

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    End point title
    		 28-day mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Whole study
    End point values
    		 Polyoxidonium® Placebo
    Number of subjects analysed
    195
    199
    Units: patients
        Alive
    189
    189
        Dead
    6
    10
    Statistical analysis title
    		 SAR v. 1.1 of 03 Jun 2021
    Statistical analysis description
    No statistically significant difference between Placebo and Polyoxidonium® groups was found.
    Comparison groups
    Polyoxidonium® v Placebo
    Number of subjects included in analysis
    394
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 % (95% CI)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the ICF signing till the follow-up/Early Termination visit (in the period of Screening only the SAEs and AEs related to the study procedures are registered)
    Adverse event reporting additional description
    The safety is evaluated (from signing the ICF to the follow-up/Early Termination visit) based on the following: − Cumulative rate of SAEs during the study. − Cumulative rate of ARs registered during the study and related to the IP administration. − Discontinuation of treatment (for any reason). − Results of haematolo
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Polyoxidonium
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Polyoxidonium Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 194 (4.12%)
    12 / 198 (6.06%)
         number of deaths (all causes)
    6
    10
         number of deaths resulting from adverse events
    6
    10
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon neoplasm
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 198 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    3 / 194 (1.55%)
    3 / 198 (1.52%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Angina unstable
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
    Additional description: On 17-Aug-2020 the subject developed SAE – cerebrovascular accident. The SAE was classified as severe (grade 3) and medically important SAE. Drug treatment was assigned. Overall outcome of SAE was classified as “recovered/resolved”.
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 194 (1.03%)
    4 / 198 (2.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Immune system disorders
    Cytokine storm
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 198 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 194 (0.52%)
    3 / 198 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pulmonary embolism
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    0 / 194 (0.00%)
    1 / 198 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial sepsis
         subjects affected / exposed
    1 / 194 (0.52%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Polyoxidonium Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 194 (34.02%)
    71 / 198 (35.86%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    18 / 194 (9.28%)
    20 / 198 (10.10%)
         occurrences all number
    18
    20
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 194 (2.58%)
    9 / 198 (4.55%)
         occurrences all number
    5
    9
    Oxygen saturation decreased
         subjects affected / exposed
    5 / 194 (2.58%)
    3 / 198 (1.52%)
         occurrences all number
    8
    3
    Blood creatine increased
         subjects affected / exposed
    0 / 194 (0.00%)
    4 / 198 (2.02%)
         occurrences all number
    0
    4
    C-reactive protein increased
         subjects affected / exposed
    3 / 194 (1.55%)
    2 / 198 (1.01%)
         occurrences all number
    3
    2
    Blood glucose increased
         subjects affected / exposed
    2 / 194 (1.03%)
    2 / 198 (1.01%)
         occurrences all number
    2
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 194 (1.03%)
    1 / 198 (0.51%)
         occurrences all number
    2
    1
    Hypotension
         subjects affected / exposed
    1 / 194 (0.52%)
    2 / 198 (1.01%)
         occurrences all number
    1
    2
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    3 / 194 (1.55%)
    3 / 198 (1.52%)
         occurrences all number
    3
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 194 (2.58%)
    2 / 198 (1.01%)
         occurrences all number
    5
    2
    Dizziness
         subjects affected / exposed
    0 / 194 (0.00%)
    2 / 198 (1.01%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    6 / 194 (3.09%)
    3 / 198 (1.52%)
         occurrences all number
    6
    3
    Anaemia
         subjects affected / exposed
    1 / 194 (0.52%)
    3 / 198 (1.52%)
         occurrences all number
    1
    3
    Thrombocytopenia
         subjects affected / exposed
    2 / 194 (1.03%)
    2 / 198 (1.01%)
         occurrences all number
    2
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 194 (2.06%)
    3 / 198 (1.52%)
         occurrences all number
    4
    4
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 194 (1.03%)
    4 / 198 (2.02%)
         occurrences all number
    2
    4
    Asthenia
         subjects affected / exposed
    0 / 194 (0.00%)
    2 / 198 (1.01%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 194 (3.61%)
    4 / 198 (2.02%)
         occurrences all number
    10
    4
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    2 / 194 (1.03%)
    5 / 198 (2.53%)
         occurrences all number
    2
    6
    Cough
         subjects affected / exposed
    0 / 194 (0.00%)
    2 / 198 (1.01%)
         occurrences all number
    0
    2
    Hypoxia
         subjects affected / exposed
    0 / 194 (0.00%)
    2 / 198 (1.01%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    3 / 194 (1.55%)
    0 / 198 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 194 (1.03%)
    1 / 198 (0.51%)
         occurrences all number
    2
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 194 (1.55%)
    0 / 198 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 194 (0.52%)
    6 / 198 (3.03%)
         occurrences all number
    1
    6
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 194 (1.03%)
    1 / 198 (0.51%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2020
    1. Posology and Mode of Administration is updated 2. The telephone contact visits are added to the Visit Schedule. 2. Additional contact visits are added. 3. C-reactive protein (CRP) is added to the Biochemistry panel. 4. Data Safety Monitoring Board and Interim Analysis are described in details. 5. DSMB functions are described in detail. 6. Storage and Unblinding section is updated 7. Exclusion Criteria # 17 changed to:"17. Participation in any clinical study within 30 days before enrolment in this study." 8. SUSARs section is updated 9. Info about Data Safety Monitoring Board and Interim Analysis is added 10. The PPS population is added to Populations for Analyses section
    30 Jun 2020
    1.List of coutries-participants is updated 2. Timepoints for test SARS-COV-2 are clarified 3. Timepoints for safety tests and HIV, syphilis, Hepatitis B tests are clarified 4. Telephone contact visits procedures are clarified 5. IP preparation procedures are described in detail 6. Section Randomization is updated
    10 Sep 2020
    1. Study title is changed. 2. Dosage and Dosage Schedule are clearly reflected in the Protocol 3. The following inclusion criterion has been added: “Hospitalized at the time of recruitment”. 4. The following inclusion criterion: “The patient (or his/her legal representative, if the patient is not able to sign the form) can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol” was added. 5. Updated the list of adequate methods of contraception for inclusion in the study. 6. The criterion: Need for the prohibited medications Has been updated to: Need for prohibited medications that are not part of the locally/internationally approved treatment of COVID-19. 7. The excl. criterion about concomitant medication has been updated to: Concomitant use of medications cytostatic drugs (including but not limited to alkylating agents, platinum analogues, dna intercalating agents, anticancer antibiotics, mitosisinhibitors, taxanes, topoisomerase inhibitors, antimetabolites) to treat a concomitant disease. 8. The following excl. criteria have been added: - Administration of convalescent plasma or IVIg for coronavirus disease COVID-19 therapy ever. - Administration of any live vaccine within 4 weeks before screening or intending to receive a live vaccine during the study. - Administration or intending to receive an EBP device to remove pro-inflammatory cytokines from the blood, such as a cytokine filtering or absorption device (for example, CytoSorb®). 9. Withdrawal criteria were removed: - SAEs or AEs that do not classify as serious, but that could jeopardize health or well-being of the patient with further development, as judged by the investigator. - Allergic reaction to the study products that leads to the discontinuation of treatment. - Termination of the study. - Death of the patient.
    26 Oct 2020
    It was added to the protocol that patients in an unconscious state can be enrolled in the study, including those in the drug-induced hibernation. In order to be included in the study prior to any study procedures, the patient should, if possible, sign a Patient Information Sheet with an Informed Consent Form. In the absence of the possibility of making a decision by the patient due to his/her critical condition, the decision to include the patient in this study is made by a Concilium consisting of 3 doctors. As soon as the patient is able to read and understand the information in the Patient Information Sheet with the Informed Consent Form for health reasons, he/she will be asked, if he/she voluntarily wishes to continue participating in the study, to sign and date the Patient Information Sheet and the Informed Consent Form. The procedure for holding the Concilium of doctors is described in detail in Section 11.3.

    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.
    No limitations
    For support, Contact us.
    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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