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    Summary
    EudraCT Number:2020-001327-13
    Sponsor's Protocol Code Number:OnCoVID19Trial
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-30
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-001327-13
    A.3Full title of the trial
    A SINGLE-BLINDED RANDOMIZED, PLACEBO-CONTROLLED PHASE II TRIAL OF PROPHYLACTIC TREATMENT WITH ORAL AZITHROMYCIN VERSUS PLACEBO IN CANCER PATIENTS UNDERGOING ANTINEOPLASTIC TREATMENT DURING THE COVID-19 PANDEMIC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A SINGLE-BLINDED RANDOMIZED, PLACEBO-CONTROLLED PHASE II TRIAL OF PROPHYLACTIC TREATMENT WITH ORAL AZITHROMYCIN VERSUS PLACEBO IN CANCER PATIENTS UNDERGOING ANTINEOPLASTIC TREATMENT DURING THE COVID-19 PANDEMIC
    A.4.1Sponsor's protocol code numberOnCoVID19Trial
    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 SponsorMed. Univ. Wien
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMed. Univ. Wien
    B.5.2Functional name of contact pointMatthias Preusser
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040044450
    B.5.5Fax number+4314040044451
    B.5.6E-mailmattias.preusser@meduniwien.ac.at
    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 Zithromax
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Corporation Austria Ges.m.b.H., Wien
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.4Pharmaceutical form Film-coated tablet
    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 INNAZITHROMYCIN DIHYDRATE
    D.3.9.1CAS number 83905-01-5
    D.3.9.2Current sponsor codeOnCoVID19
    D.3.9.4EV Substance CodeSUB16399MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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, hard
    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
    Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Cumulative number of SARS-COV-2 infections as verified by PCR from routine nasal swabs performed every 28 days (symptomatic or asymptomatic) at week 12 after
    initiation of therapy
    E.2.2Secondary objectives of the trial
    - To evaluate the capacity of azithromycin to prevent severe COVID-19 infections, defined as a combined endpoint of hospitalization and death in cancer patients undergoing active treatment with chemotherapy
    - Severity of COVID-19 cases (see grading as defined by the WHO)
    - All-cause mortality
    - Safety and tolerability of IMP (clinical and laboratory, CTCAE criteria)
    - Occurrence of viral or bacterial infections other than COVID-19
    - Development of azithromycin-resistant bacterial strains as assessed by nasal swabs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed cancer diagnosis
    - Active disease in need of antineoplastic therapy
    o treatment may include classical cytostatic agents, molecular targeted therapy, monoclonal antibodies bevacizumab, cetuximab, rituximab and
    obinutuzumab (either alone or in combination with chemotherapy) and checkpoint inhibitors
    o treatment may be ongoing or newly started
    o oral, intravenous or subcutaneous application route is allowed
    o adjuvant, neoadjuvant or palliative chemotherapy is allowed
    o the planned treatment duration must be at least 3 months, i.e. 12 weeks
    - Age ≥ 18 years
    - Life expectancy of at least 3 months
    - Adequate renal, cardiac and liver function to tolerate the treatment
    - Normal QTc (≤ 450 ms) on ECG
    - ECOG performance status of < 3
    - Negative PCR for SARS-COV-2 not older than 28 days
    - Capable of understanding the study and giving informed consent
    E.4Principal exclusion criteria
    - Active COVID-19 as defined by clinical WHO criteria and a positive PCR for SARS-COV2
    - Use of any investigational agent within 28 days prior to study start
    - Ongoing radiotherapy
    - A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
    - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction
    abnormalities, and long QT syndrome (QTc interval >450ms).
    - Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator
    assessment)
    - Inadequate kidney function: serum-creatinine >2.0 times upper normal limit
    - Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due cancer involvement of liver or a known history of Gilbert's disease); ALT >2.5 times upper normal limit (unless due to disease involvement of liver); alkaline phosphatase >2.5 times upper normal
    limit (unless due to disease involvement of the liver or bone marrow)
    - Patients with active opportunistic infections
    - Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days of administration of IMP. Approved methods of
    birth control must be used
    - Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is
    defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
    - Inability to swallow tablets/study medication
    E.5 End points
    E.5.1Primary end point(s)
    Number of SARS-COV-2 infections (symptomatic or asymptomatic): detected by routine SARS-COV-2 tests in all patients treated at the Division of Oncology, Medical University of Vienna. During the SARSCOV-2 pandemic, the routine approach to patients undergoing
    chemotherapy at our institution is PCR from nasal swabs taken every 28 days. The cumulative number of infections detected (symptomatic or asymptomatic) at week 8 after initiation of therapy in both treatment arms serves as the primary endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 12 weeks
    E.5.2Secondary end point(s)
    Number of patients experiencing severe COVID-19 infection defined as a combined endpoint of hospitalization or death at week 12 after initiation of therapy. COVID-19 cases are defined as outlined by the WHO, including a PCR for COVID-19 from any specimen (respiratory, blood,
    urine, stool, other bodily fluids).
    Severity of COVID-19 cases: The severity of cases will be classified as
    suggested in the Blue Print for COVID-19 therapeutic trials by the WHO (range 0-8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    after EOS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LPLV
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state200
    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 Decision2020-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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