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    Clinical Trial Results:
    Efficacy of E-52862 in the early treatment of confirmed mild symptomatic COVID-19 patients

    Summary
    EudraCT number
    		 2020-003603-33
    Trial protocol
    		 ES  
    Global end of trial date
    20 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2023
    First version publication date
    08 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SIGMA4COVID
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Consorci Mar Parc de Salut de Barcelona
    Sponsor organisation address
    Passeig Marítim de la Barceloneta, 25-29, Barcelona, Spain, 08003
    Public contact
    Jordi Monfort Faure, Hospital del Mar, 34 93248 33 32, JMonfort@parcdesalutmar.cat
    Scientific contact
    Jordi Monfort Faure, Hospital del Mar, 34 93248 33 32, JMonfort@parcdesalutmar.cat
    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
    20 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the evolution of viral load in mild symptomatic patients with confirmed COVID-19.
    Protection of trial subjects
    The trial was conducted in compliance with the approved protocol, the Declaration of Helsinki (amended Fortaleza, Brazil, October 2013),the principles of Good Clinical Practice (GCP) published by ICH (E6 R2).This study was conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), which develop the European Directive on clinical trials (Regulation EU No 536/2014). Participants were provided trial treatment for a 14-day period , and remained on the trial for a total of 21 days. Averse Events were collected throughout the trial and treated accordingly. As participation was voluntary, participants were free to discontinue at any given time without giving reason and without it affecting their normal standard of care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2020
    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: 118
    Worldwide total number of subjects
    118
    EEA total number of subjects
    118
    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)
    109
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients over 18 years who were visited at one of the participating health care centres, with confirmed COVID-19. Once they expressed their consent and the COVID-19 infection was confirmed by a positive RT-qPCR test, they were randomized to one of the two groups.

    Pre-assignment
    Screening details
    		 The participant signed the informed consent document prior to any procedures being done specifically for the study. The first study procedure was the obtention of a nasopharyngeal sample for the RT-qPCR test. Also clinical laboratory parameters, vital signs and ECG were obtained.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The Hospital del Mar’s Pharmacy Department prepared the study medication, according to the randomisation schedule (1:1), and were the only one who knew the actual content of each medication box. The Hospital del Mar’s Pharmacy Department provided study capsules (blinded E-52862 or Placebo, according to the assigned patient ID code).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E-52862
    Arm description
    		 Daily dose of 400 mg of E-52862
    Arm type
    		 Experimental

    Investigational medicinal product name
    E-52862
    Investigational medicinal product code
    MR309
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Patients in the treatment group received a daily dose of 400 mg of E-52862 during 14 days.

    Arm title
    		 Placebo
    Arm description
    		 Placebo (corn starch)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (corn starch)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Daily dose of 400mg of Placebo (corn starch) for 14 days

    Number of subjects in period 1
    		E-52862 Placebo
    Started
    59
    59
    Completed
    59
    59

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E-52862
    Reporting group description
    		 Daily dose of 400 mg of E-52862

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (corn starch)

    Reporting group values
    		 E-52862 Placebo Total
    Number of subjects
    		 59 59 118
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 53 56 109
        From 65-84 years
    		 6 3 9
    Gender categorical
    Units: Subjects
        Female
    		 33 34 67
        Male
    		 26 25 51
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set (FAS): all the patients, with positive baseline viral load, who undergo randomization and receive at least one dose of the assigned treatment, but regardless that they received or not the complete treatment.

    Subject analysis set title
    Virology per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Virology PPAS: will exclude from the corresponding analyses those data points in which protocol deviations may affect the viral load assessment (i.e., assesments made out of the predermined time window)

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Saety Analysis Set (SAS),: all the patients who undergo randomization and receive at least one dose of study medication

    Subject analysis sets values
    		 Full analysis set Virology per protocol analysis set Safety analysis set
    Number of subjects
    118
    108
    118
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    109
    99
    109
        From 65-84 years
    9
    9
    9
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    67
    60
    67
        Male
    51
    48
    51

    End points

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    End points reporting groups
    Reporting group title
    E-52862
    Reporting group description
    		 Daily dose of 400 mg of E-52862

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (corn starch)

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set (FAS): all the patients, with positive baseline viral load, who undergo randomization and receive at least one dose of the assigned treatment, but regardless that they received or not the complete treatment.

    Subject analysis set title
    Virology per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Virology PPAS: will exclude from the corresponding analyses those data points in which protocol deviations may affect the viral load assessment (i.e., assesments made out of the predermined time window)

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Saety Analysis Set (SAS),: all the patients who undergo randomization and receive at least one dose of study medication

    Primary: Viral load

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    End point title
    		 Viral load
    End point description
    Change in SARS-COV-2 viral load (log10 copies per milliliter) from baseline to day 7 (±1)
    End point type
    Primary
    End point timeframe
    Measured at baseline and Day 7 (±1).
    End point values
    		 E-52862 Placebo
    Number of subjects analysed
    59
    59
    Units: log 10
        arithmetic mean (standard deviation)
    -3.21 ± 1.54
    -3.28 ± 1.55
    Statistical analysis title
    		 E-52862 vs Placebo
    Statistical analysis description
    Full analysis set
    Comparison groups
    E-52862 v Placebo
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Viral load

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    End point title
    		 Viral load
    End point description
    Change in SARS-COV-2 viral load (log10 copies per milliliter) from baseline to day 4 (±1)
    End point type
    Secondary
    End point timeframe
    Measured at baseline and Day 4 (±1)
    End point values
    		 E-52862 Placebo
    Number of subjects analysed
    59
    59
    Units: log10
        arithmetic mean (standard deviation)
    -1.80 ± 1.36
    -2.04 ± 1.49
    No statistical analyses for this end point

    Secondary: Viral load

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    End point title
    		 Viral load
    End point description
    Change in SARS-COV-2 viral load (log10 copies per milliliter) from baseline to day 14 (±1)
    End point type
    Secondary
    End point timeframe
    Measured at baseline and Day 14 (±1)
    End point values
    		 E-52862 Placebo
    Number of subjects analysed
    59
    59
    Units: log10
        arithmetic mean (standard deviation)
    -4.06 ± 1.60
    -4.09 ± 1.72
    No statistical analyses for this end point

    Secondary: Viral load

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    End point title
    		 Viral load
    End point description
    End point type
    Secondary
    End point timeframe
    Viral load to Day 7 (+-1) Per Protocol Analysis Set (PPAS).
    End point values
    		 E-52862 Placebo
    Number of subjects analysed
    57
    51
    Units: log10
        arithmetic mean (standard deviation)
    -3.21 ± 1.57
    -3.31 ± 1.54
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to Day 21
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    E-52862
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo E-52862
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 59 (1.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    International normalised ratio increased
    Additional description: Patient had a medically important increased anticoagulation titer (INR >8) on study day 11. Relevant medical history includes atrial fibrillation (since December 2019).
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (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: 5%
    Non-serious adverse events
    		 Placebo E-52862
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 59 (28.81%)
    35 / 59 (59.32%)
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal dryness
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 59 (3.39%)
         occurrences all number
    2
    2
    Insomnia
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Nervousness
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 59 (3.39%)
         occurrences all number
    2
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 59 (3.39%)
    19 / 59 (32.20%)
         occurrences all number
    2
    19
    Vertigo
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Foreign body in eye
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Photophobia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Abdominal distention
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Dry mouth
         subjects affected / exposed
    3 / 59 (5.08%)
    2 / 59 (3.39%)
         occurrences all number
    3
    2
    Dyspepsia
         subjects affected / exposed
    0 / 59 (0.00%)
    11 / 59 (18.64%)
         occurrences all number
    0
    11
    Gastrooesophageal reflux
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Glossitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 59 (1.69%)
    5 / 59 (8.47%)
         occurrences all number
    1
    5
    Vomiting
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Papule
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Rash
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Skin exfoliation
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Limb discomfort
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 59 (3.39%)
    5 / 59 (8.47%)
         occurrences all number
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Dec 2021
    -Update of participating centers (Barcelona and Galicia) -A PCR for SARS-COV-2 with a positive result in the previous 48 hours carried out as part of the care routine would be accepted as inclusion criteria, so that the baseline quantitative PCR collected at the screening visit (study-specific) could be analyzed a posteriori along with the rest of subsequent samples from each patient. -Telephone follow-up visits are eliminated (since the clinical information for these patients is already collected in the rest of the scheduled visits and access to the clinical history) -The registry of the vaccination status of patients has been added

    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
    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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