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    Summary
    EudraCT Number:2020-001375-32
    Sponsor's Protocol Code Number:PreToVid
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-001375-32
    A.3Full title of the trial
    Pre-emptive tocilizumab in hypoxic COVID-19 patients, a prospective randomized trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early intervention with Tocilizumab in patients with COVID-19 and hypoxia
    Vroege interventie met Tocilizumab in patiënten met COVID-19 en zuurstoftekort
    A.3.2Name or abbreviated title of the trial where available
    PreToVid
    A.4.1Sponsor's protocol code numberPreToVid
    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 SponsorUMCG
    B.1.3.4CountryNetherlands
    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 supportUMCG
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMCG
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.6E-maila.rutgers@umcg.nl
    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 Roactemra
    D.2.1.1.2Name of the Marketing Authorisation holdernetherlands
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameroactemra
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeL04AC07
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8 to 16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Hypoxia
    E.1.1.1Medical condition in easily understood language
    low oxygen
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess in a randomized comparison the effect of pre-emptive Tocilizumab in patients with hypoxia due to COVID-19 on 30-day mortality (from randomization)
    E.2.2Secondary objectives of the trial
    To asses in a randomized comparison:
    - days in hospital (calculated from randomization)
    - the percentage of patients who need ICU care.
    - the percentage of patients who develop respiratory failure and need mechanical ventilation
    - the days on a ventilator.
    - normalization of HRCT after resolution of disease
    - seroconversion 14 days after randomization
    - To identify potential biomarkers predictive of response (blood: cytokines (including Il-6 and IL-18), lymphopenia, CRP, ferritin, LDH, sCD25; nasal epithelial brushes: epithelial transcriptome immune response by bulk and single-cell RNA seq; faeces: microbiome, viral load), gender, age, co-morbidity and plasma levels tocilizumab by exploratory analysis.
    - To assess safety and feasibility of pre-emptive use of tocilizumab (AE grade 4, increase in dyspnea according to CRS scale)
    - OS after 3 months (after randomization)
    - quality of life and pulmonary function after 3 months (after randomization)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ♦ Patients 18 years and older
    ♦ Patients with a diagnosis of COVID-19 based on a compatible clinical presentation AND a positive SARS-CoV-2 PCR on a respiratory sample such as a nasopharyngeal swab, sputum, or BAL fluid
    ♦ Clinical features compatible with hyperinflammation:
    - Hypoxia, without other explanation for hypoxia than COVID-19 OR
    - ferritin >2000 μg/L or doubling of serum ferritin in 20-48 hours
    Hypoxia is defined according to ASTCT CRS Consensus grading: grade II. [Lee DW, et al. BBMT 2019;25(4):625-638] Inclusion of patients already requiring oxygen administration prior to COVID-19 should be discussed with the study team.
    ♦ Not be pregnant
    ♦ Written informed consent.
    ♦ Patient is capable of giving informed consent.
    ♦ No known allergy to tocilizumab.
    E.4Principal exclusion criteria
    pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    ♦ 30-day mortality (from randomization)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after randomization
    E.5.2Secondary end point(s)
    • To asses in a randomized comparison days in hospital (calculated from randomisation).
    • To asses in a randomized comparison the percentage of patients who need ICU care.
    • To asses in a randomized comparison the percentage of patients who develop respiratory failure and need mechanical ventilation.
    • To asses in a randomized comparison the days on a ventilator.
    • To asses in a randomized comparison normalisation of HRCT after resolution of disease.
    • To asses in a randomized comparison seroconversion 14 days after randomisation
    • To identify potential biomarkers predictive of response (blood: cytokines (including Il-6 and IL-18), lymphopenia, CRP, ferritin, LDH, sCD25; nasal epithelial brushes: epithelial transcriptome immune response by bulk and single-cell RNA seq; faeces: microbiome, viral load), gender, age, co-morbidity and plasma levels tocilizumab by exploratory analysis.
    • To assess safety and feasibility of pre-emptive use of tocilizumab (AE grade ≥4).
    • To assess in a randomized comparison OS after 3 months (after randomization).
    • To asses in a randomized comparison quality of life and pulmonary function after 3 months (after randomization)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to three months after randomization
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 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 concerned15
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 254
    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 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 state354
    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)
    none
    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 Decision2020-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
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