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    The EU Clinical Trials Register currently displays   42174   clinical trials with a EudraCT protocol, of which   6938   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-003746-33
    Sponsor's Protocol Code Number:REVC006
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-003746-33
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled trial of the safety, tolerability, and efficacy of RV521 in the treatment of adult subjects who have undergone hematopoietic cell transplantation (HCT) with a documented upper respiratory tract infection (URTI) with respiratory syncytial virus (RSV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of RV521 for the treatment of adults who have received a blood cell transplant and that have a respiratory infection caused by the virus RSV
    A.4.1Sponsor's protocol code numberREVC006
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorReViral Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportReViral
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReViral Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressStevenage Bioscience Catalyst, Gunnels Wood Road
    B.5.3.2Town/ cityStevenage
    B.5.3.3Post codeSG1 2FX
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailhwelch@reviral.co.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code RV521
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSisunatovir
    D.3.9.2Current sponsor codeRV521 Hydrochloride, RV521.HCl
    D.3.9.3Other descriptive nameRV521
    D.3.9.4EV Substance CodeSUB184917
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic RSV infection (upper airway involvement only) in subjects who have undergone HCT transplantation within 1 year of Randomization and who are moderately to severely immunocompromised.
    E.1.1.1Medical condition in easily understood language
    respiratory infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035732
    E.1.2Term Pneumonia respiratory syncytial viral
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10024970
    E.1.2Term Respiratory tract infections
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10024968
    E.1.2Term Lower respiratory tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10065188
    E.1.2Term Lower respiratory tract infection viral
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate clinical improvement relative to placebo, defined as the proportion of subjects who do not experience lower respiratory tract complications (LRTC) during the study period
    And
    To compare the anti-viral activity of RV521 to that of placebo, measured by time weighted average change in viral load (DAVG) measured by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) from nasal swab samples.
    E.2.2Secondary objectives of the trial
    To evaluate clinical improvement relative to placebo as defined by duration of RSV-related symptoms over 28 days
    To evaluate the anti-viral effect of RV521 defined as the timeweighted average change in viral load (DAVG) measured by a cell-based infectivity assay (CBIA) from nasal swab samples
    To evaluate the proportion of days with lowest daily pulse oximetry oxygen saturation (SpO2) ≥ 90% on room air
    To evaluate the requirements for respiratory supportive measures (oxygen and/or mechanical ventilation) and hospitalization/intensive care unit (ICU) utilization
    To compare the rates of mortality between subjects receiving RV521 to those receiving placebo
    To evaluate the safety and tolerability of RV521 in subjects with RSV URTI
    To evaluate of the pharmacokinetics/pharmacodynamic (PK/PD) relationship of RV521 treatment in adults with RSV URTI.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Has undergone autologous or allogeneic HCT using any conditioning regimen within 1
    year of randomization. Subjects who have undergone HCT more than 1 year before
    Randomization are eligible if all other inclusion/exclusion criteria are satisfied and
    under at least one of the following conditions:
    a Diagnosed with Chronic Graft-vs-Host Disease (GVHD), or
    b Has used systemic corticosteroids in the 30 days prior to RSV infection
    2 Has moderate to severe immunocompromise, defined as a score ≥ 5 on the ISI-RSV
    and/or an ALC of ≤ 500 cells/ mm3
    3 Documentation of positive RSV infection in the upper airway
    E.4Principal exclusion criteria
    1 Use of non-marketed investigational agents within 30 days, OR use of an
    investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of
    screening, whichever is longer, OR use of any investigational RSV vaccines after HCT.
    2 Receiving a prescription, OTC, or herbal medication that is a potent inducer or inhibitor
    of CYP3A4, within 2 weeks of Randomization.
    3 Receiving a prescription, OTC, or herbal medication that is a substrate of CYP3A4 with
    a narrow therapeutic index where monitoring blood levels is not possible.
    4 Known chronic infection with hepatitis B, C, or HIV.
    5 Is in the pre-engraftment period during RSV infection.
    6 Admitted to the hospital primarily for lower respiratory tract disease of any cause as
    determined by the Investigator.
    7 Any condition requiring mechanical ventilation or vasopressor support at the time of
    randomization.
    8 Clinically significant bacteremia or fungemia within 5 days prior to Screening that has
    not been adequately treated.
    9 Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to
    Screening that has not been adequately treated.
    10 Excessive nausea/vomiting at Screening or an inability to swallow capsules.
    11 Elevation of hepatic enzymes or renal compromise.
    E.5 End points
    E.5.1Primary end point(s)
    1 Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC)
    during the study [ Time Frame: Pre-dose baseline (Day 1) through Visit 8 (Day 28) ]
    Progression to LRTC during the study defined as one of the following:
    Primary LRTI caused by RSV
    Secondary bacterial LRTI
    LRTI caused by another pathogen
    LRTC of unknown etiology
    2 Change in RSV nasal viral load (via RT-qPCR) [ Time Frame: Pre-dose baseline (Day 1)
    through study completion; up to Visit 8 (Day 28) ]
    RSV change measured by the time-weighted average (DAVG) viral load using RT
    qPCR
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 Pre-dose baseline (Day 1) through Visit 8 (Day 28)
    2 Pre-dose baseline (Day 1)
    through study completion; up to Visit 8 (Day 28)
    E.5.2Secondary end point(s)
    1 Percent of participants who experience AEs, TEAEs, SAEs and withdrawals due to TEAEs.
    2 Evaluate safety and tolerability of RV521 by assessing changes from baseline in systolic and diastolic BP (vital sign parameters).
    3 Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters).
    4 Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters).
    5 Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters).
    6 Evaluate safety and tolerability of RV521 by assessing changes from baseline weight/BMI Weight and height will be collected and combined to report BMI
    7 Evaluate the proportion of subjects with changes and shifts in hematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from
    baseline.
    8 Evaluate the proportion of subjects with changes in ECG measurements and changes in clinical impression from baseline
    9 Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by RT-qPCR.
    10 Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by CBIA.
    11 Mean change in RSV viral load assessed via CBIA
    12 Mean change from baseline in viral RNA shedding
    13 Proportion of subjects who no longer shed RSV assessed by both RT-qPCR and CBIA
    14 Time to improvement in RSV-related symptoms
    15 Time to total resolution of all RSV-related symptoms
    16 Proportion of days with lowest daily SpO2 ≥ 90% on room air SpO2 measured at every visit. For subjects on oxygen or who are mechanically ventilated may have this waived.
    17 Number of days where supplementary oxygen was required
    Use of daily supplementary oxygen will be collected throughout the study.
    18 Proportion of subjects who require hospitalization during the study
    19 Mean number of days of hospitalization during the study [ Time
    20 Proportion of subjects requiring ICU
    21 Mean number of days in ICU
    22 Proportion of subjects requiring mechanical ventilation
    23 Number of subjects who experience death (all-cause mortality)
    24 Number of subjects who experience death attributable to LRTC
    E.5.2.1Timepoint(s) of evaluation of this end point
    End points 1, 23-24 : First
    dose of study drug through Visit 8 (Day 28)
    End points 2-6, 17-22 : Baseline (Day 1)
    through Visit 8 (Day 28)
    End point 7: Collected at Visit 2/Day 1 (pre-dose), Visit 4/Day 3, Visit 6/Day 14 and Visit 8/Day 28
    End points 8: Measurements will be taken at Day
    1/Visit 2 (pre-dose and at 5-hours post-dose), on Day 3/Visit 4 (at 5 hours post-dose), and at Visit 6 (Day 14)
    End points 9-10: Pre-dose baseline (Day 1) and every visit
    through Visit 8 (Day 28)
    End points 11-13: Pre-dose baseline
    (Day 1) through study completion; up to Visit 8 (Day 28)
    End points 14-15: Daily from baseline (Day
    1) through Visit 8 (Day 28)
    End points 23-24: First dose
    of study drug through Visit 8 (Day 28)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    France
    Israel
    Italy
    Korea, Democratic People's Republic of
    Malaysia
    Spain
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS (31 May 2023)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The treatment of the subject after the participation in the study is N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-07
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