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    Clinical Trial Results:
    Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

    Summary
    EudraCT number
    		 2020-005305-54
    Trial protocol
    		 DE  
    Global end of trial date
    18 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Oct 2022
    First version publication date
    01 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CPI-006-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04734873
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Corvus Pharmaceuticals, Inc.
    Sponsor organisation address
    863 Mitten Road, Burlingame, CA, United States, 94010
    Public contact
    Clinical Trial Information, Corvus Pharmaceuticals, Inc, clinicaltrials@corvuspharma.com
    Scientific contact
    Clinical Trial Information, Corvus Pharmaceuticals, Inc, clinicaltrials@corvuspharma.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
    18 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the proportion of participants alive and respiratory failure free during the 28 days after dosing with CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection
    Protection of trial subjects
    The study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP), all applicable regulatory requirements, and the general ethical principles outlined in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2021
    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
    Spain: 1
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    42
    EEA total number of subjects
    1
    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)
    38
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 46 participants were screened and 42 were randomized. Of the 42 participants randomized, only 40 received the treatment assigned at randomization (2 were randomized but withdrew consent prior to receiving study treatment).

    Pre-assignment
    Screening details
    		 46 participants were screened and 42 were randomized. Of the 42 participants randomized, only 40 received the treatment assigned at randomization (2 were randomized but withdrew consent prior to receiving study treatment).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment A: CPI-006 2 mg/kg + SOC
    Arm description
    		 IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CPI-006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care

    Arm title
    		 Treatment B: CPI-006 1 mg/kg + SOC
    Arm description
    		 IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CPI-006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care

    Arm title
    		 Treatment C : Placebo + SOC
    Arm description
    		 IV placebo on Day 1 plus standard of care.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV placebo on Day 1 plus standard of care

    Number of subjects in period 1
    		Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C : Placebo + SOC
    Started
    16
    14
    12
    Completed
    14
    11
    9
    Not completed
    2
    3
    3
         Lost to follow-up
    1
    3
    2
         Randomised but not dosed
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment A: CPI-006 2 mg/kg + SOC
    Reporting group description
    		 IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care.

    Reporting group title
    Treatment B: CPI-006 1 mg/kg + SOC
    Reporting group description
    		 IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care.

    Reporting group title
    Treatment C : Placebo + SOC
    Reporting group description
    		 IV placebo on Day 1 plus standard of care.

    Reporting group values
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C : Placebo + SOC Total
    Number of subjects
    		 16 14 12 42
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 13 13 12 38
        From 65-84 years
    		 3 1 0 4
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 56.5 (28 to 69) 53.0 (25 to 67) 55.0 (21 to 63) -
    Gender categorical
    Units: Subjects
        Female
    		 6 3 9 18
        Male
    		 10 11 3 24
    Ethinicity
    Units: Subjects
        Hispanic or Latino
    		 6 3 3 12
        Not Hispanic or Latino
    		 8 11 8 27
        Unknown or Not Reported
    		 2 0 1 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 2 2 2 6
        White
    		 13 11 9 33
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 0 0 1
    Region of Enrollment
    Units: Subjects
        United States
    		 16 13 12 41
        Spain
    		 0 1 0 1
    8-point Ordinal Scale
    Scale Categories: 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities and/or requiring home oxygen; 3= Hospitalized, not requiring supplemental oxygen- no longer requiring ongoing medical care; 4= Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (Covid-19 related or otherwise); 5= Hospitalized, requiring supplemental oxygen; 6= Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7= Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8= Death
    Units: Subjects
        Four
    		 0 3 2 5
        Five
    		 7 10 7 24
        Six
    		 9 1 3 13

    End points

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    End points reporting groups
    Reporting group title
    Treatment A: CPI-006 2 mg/kg + SOC
    Reporting group description
    		 IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care.

    Reporting group title
    Treatment B: CPI-006 1 mg/kg + SOC
    Reporting group description
    		 IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care.

    Reporting group title
    Treatment C : Placebo + SOC
    Reporting group description
    		 IV placebo on Day 1 plus standard of care.

    Primary: Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC

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    End point title
    		 Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC [1]
    End point description
    Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen -no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen -requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
    End point type
    Primary
    End point timeframe
    During the 28 days after dosing.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Primary endpoint consists of proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm and such percentages cannot be populated in EudraCT.
    End point values
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C : Placebo + SOC
    Number of subjects analysed
    15
    14
    11
    Units: Participants
    14
    12
    9
    No statistical analyses for this end point

    Secondary: Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC

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    End point title
    		 Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
    End point description
    Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activitiesand/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen -no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen -requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized,requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
    End point type
    Secondary
    End point timeframe
    During the 28 days after dosing.
    End point values
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C : Placebo + SOC
    Number of subjects analysed
    14
    14
    10
    Units: Days
        median (confidence interval 95%)
    6.0 (4.0 to 9.0)
    4.5 (3.0 to 8.0)
    7.0 (2.0 to 12.0)
    No statistical analyses for this end point

    Secondary: Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC

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    End point title
    		 Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
    End point description
    Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen -no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen -requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death. Clinical improvement is defined as ≥ 2 points improvement in the 8-point ordinal scale.
    End point type
    Secondary
    End point timeframe
    During the 28 days after dosing.
    End point values
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C : Placebo + SOC
    Number of subjects analysed
    14
    14
    11
    Units: Days
        median (confidence interval 95%)
    6.0 (4.0 to 9.0)
    4.5 (3.0 to 8.0)
    7.0 (2.0 to 12.0)
    No statistical analyses for this end point

    Secondary: Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC

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    End point title
    		 Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
    End point description
    Proportion of participants who died in each active arm compared to placebo arm.
    End point type
    Secondary
    End point timeframe
    During the 28 days after dosing.
    End point values
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C : Placebo + SOC
    Number of subjects analysed
    15
    14
    11
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From initiation of study treatment through study Day 28 (4 weeks)
    Adverse event reporting additional description
    The Safety Population includes all participants who received any amount of study treatment (CPI-006, placebo, or SOC).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Treatment A: CPI-006 2 mg/kg + SOC
    Reporting group description
    		 IV CPI-006 2 mg/kg up to a maximum dose of 200 mg on Day 1 plus standard of care.

    Reporting group title
    Treatment B: CPI-006 1 mg/kg + SOC
    Reporting group description
    		 IV CPI-006 1 mg/kg up to a maximum dose of 100 mg on Day 1 plus standard of care.

    Reporting group title
    Treatment C: Placebo + SOC
    Reporting group description
    		 IV placebo on Day 1 plus standard of care.

    Serious adverse events
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C: Placebo + SOC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    2 / 11 (18.18%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment A: CPI-006 2 mg/kg + SOC Treatment B: CPI-006 1 mg/kg + SOC Treatment C: Placebo + SOC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    2 / 14 (14.29%)
    2 / 11 (18.18%)
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Dyskinesia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Myopia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia escherichia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Skin candida
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2021
    Protocol version 002 (Amendment 1) main updates: - An additional study drug treatment arm for 1 mg/kg CPI-006 plus standard of care (SOC) was added to create a 3-arm study, increasing the total sample size to 1000 participants, and changing the randomization schedule - Primary Endpoint: proportion of patients alive and free of respiratory deterioration has been added and replaces prior primary endpoint of time to recovery during the 28 days after dosing (Section 3). The primary endpoint was updated to account for mortality in the efficacy evaluation of the study treatment.
    23 Mar 2021
    Protocol version 003 (Amendment 2) main changes: - Update of Supportive Secondary Endpoints and Key Secondary Endpoints - Clarification and update of inclusion criteria for increased flexibility of disease onset and duration

    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.
    The study was terminated due to enrollment difficulties and, as a result, some of the originally planned efficacy analyses could not be performed.
    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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