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    Summary
    EudraCT Number:2020-001777-71
    Sponsor's Protocol Code Number:RAVEN
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-30
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2020-001777-71
    A.3Full title of the trial
    Ruxolitinib therapy to Avoid Ventilation and improve outcome for deteriorating COVID-19 patiENts - RAVEN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ruxolitinib therapy to Avoid Ventilation and improve outcome for deteriorating COVID-19 patients
    A.3.2Name or abbreviated title of the trial where available
    RAVEN
    A.4.1Sponsor's protocol code numberRAVEN
    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 SponsorGuy’s and St Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMasterstroke Polycythaemia Fund a charitable fund within the Guy’s and St Thomas’ Charity
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNovartis Pharmaceuticals UK Ltd (free of charge drug supply)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportLifeArc, a UK-based medical research charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy’s and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointDonal McLornan
    B.5.3 Address:
    B.5.3.1Street AddressHaematology, 4th Floor Southwark Wing, Guy’s Tower, Great Maze Pond
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440207188 1431
    B.5.6E-mailDonal.mclornan@gstt.nhs.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 Yes
    D.2.1.1.1Trade name Jakavi tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.1Product nameJakavi Tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe COVID-19 infection with risk of need for mechanical ventilation.
    E.1.1.1Medical condition in easily understood language
    COVID-19 is a viral infection that has a risk of harm to patients due to pneumonia and organ damage.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084382
    E.1.2Term Coronavirus disease 2019
    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
    Primary objective of this trial is to investigate the efficacy of the JAK1/2 inhibitor ruxolitinib in preventing deterioration to the point of requiring mechanical ventilation in COVID19 patients admitted to hospital.
    E.2.2Secondary objectives of the trial
    To evaluate time to progression free survival and clinical/ laboratory responses to the intervention.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients admitted to Guy’s and St. Thomas’ NHS Foundation Trust with swab proven COVID-19
    2. Deemed eligible at the time of admission for escalation to mechanical ventilation if required.
    3. Worsening clinical and laboratory features suggestive of COVID-19 disease progression:
    ‘Yellow or Amber Category’ as judged on the current GSTT action card 21: Adult Escalation Plan for Patients with Confirmed or Suspected Covid-19 despite optimisation (example in Figure 2)
    –and
    have respiratory rate >/= 20 at any time in 24 hours prior to recruitment.
    - and
    At least two of either:
    CRP: >100
    or
    Serum ferritin levels >1000ng/mL
    or
    D-dimer raised >1 μg/mL
    4. Greater than 18 years of age and ability to grant full consent for repurposed use of ruxolitinib
    5. No excluded concomitant medication
    6. Written informed consent to participate in the study
    E.4Principal exclusion criteria
    1. Those patients below age 18 years of age
    2. Not proven to have COVID-19 disease
    3. Inability to grant informed consent
    4. Not meeting the inclusion criteria for both clinical and biochemical features as above.
    5. Pregnant or lactating and breast-feeding women
    6. Unwilling to use contraception as detailed in section 5.3
    7. Neutrophil counts <1.0X109/L or platelets <100x109/L
    8. Inadequate liver function as defined by ALT/AST >5 x ULN
    9. Inadequate renal function as defined by GFR < 30 mls/min
    10. Patients already taking JAK inhibitor therapy
    11. Patients currently enrolled in another study of an investigational medicinal product. Of note, treatment with the antiviral agent remdesivir is permitted.
    12. Any known contraindication or hypersensitivity to JAK inhibitor therapy (or any of the IMP excipients) such as untreated active hepatitis B or HIV
    E.5 End points
    E.5.1Primary end point(s)
    Number requiring mechanical ventilation or death in patients with COVID-19 disease [Time Frame: 28 days]
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    1. To evaluate time to progression free survival and clinical/ laboratory responses to the intervention
    2.Clinical responses to Ruxolitinib Therapy [Time Frame: 28 days]
    Number of patients requiring admission to critical care unit
    Number of patients requiring non-invasive mechanical ventilation
    Time to independence from mechanical ventilation
    Time to independence from non-invasive mechanical ventilation
    Length of stay in critical care if admitted
    Time to independence from oxygen therapy and maintaining saturations >94% on room air.
    Number of patients requiring vasopressors
    Number of patients requiring renal replacement therapy
    Proportion of patients with radiological response at 7 days compared to baseline (Chest radiograph or CT scan) if available (recognising fit patients will be discharged) [Time frame 7 days]
    Biochemical/ laboratory response to Ruxolitinib Therapy [Time Frame 2 weeks] if available (recognising fit patients will be discharged)
    Partial response is at least a 25% improvement in two or more markers of CRP/Ferritin/D-dimers
    Time to Discharge
    Readmission rate
    3. Assessment of Treatment related Adverse Events of Grade 3 and above as per Common Terminology Criteria for Adverse Events (CTCAE) that are not listed in the SmPC [Time frame 28 days]
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days with the exception of Proportion of patients with radiological response at 7 days compared to baseline and Biochemical/ laboratory response to Ruxolitinib Therapy (2 weeks)
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    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 state59
    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 trial treatment is COVID-19 specific. Subjects will finish participation in the trial when they finish their treatment and then any further treatment will be as per standard of care for COVID-19 patients.
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-04
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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