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    Summary
    EudraCT Number:2021-006485-20
    Sponsor's Protocol Code Number:CHANCE
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-12-22
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-006485-20
    A.3Full title of the trial
    COVID-19: Reducing Symptoms and Hospitalization rates by use of Azelastine Nasal spray in patients suffering from COVID-19 in Early stages
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19: Reducing Hospitalization rates by use of Azelastine Nasal spray in patients suffering from COVID-19 in Early stages
    A.4.1Sponsor's protocol code numberCHANCE
    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 SponsorURSAPHARM Arzneimittel GmbH
    B.1.3.4CountryGermany
    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 supportURSAPHARM Arzneimittel GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinCompetence Cologne GmbH
    B.5.2Functional name of contact pointContract Research Organization
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Heuss-Ring 14
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50668
    B.5.3.4CountryGermany
    B.5.4Telephone number+4922171613320
    B.5.5Fax number+4922171613329
    B.5.6E-mailinfo@clincompetence.de
    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 Pollival 1 mg/ml Nasenspray, Lösung
    D.2.1.1.2Name of the Marketing Authorisation holderURSAPHARM Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzelastine hydrochloride
    D.3.9.3Other descriptive nameAZELASTINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboNasal spray, solution
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)
    E.1.1.1Medical condition in easily understood language
    Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 the treatment with azelastine nasal spray in COVID-positive patients is to evaluate the treatment effect of azelastine (0.1%) on the proportion of sustained-recovery from COVID-19 related symptoms.
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives:
    1. To evaluate the efficacy of azelastine (0.1%) treatment preventing hospitalization or death in COVID-19 infected patients.
    2. To evaluate the treatment effect of azelastine (0.1%) on the development of COVID-19 Symptoms
    3. To assess the treatment effect on virus load of SARS-CoV-2
    4. To evaluate the treatment effect on patient Status

    Secondary Safety objective:
    1. To evaluate safety of Azelastine in subjects in COVID-19 infected patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria in order to participate in this study:

    - Legally competent patients who are personally capable of giving informed consent and to sign and date the Consent Form prior to any trial related activity,
    - Patients that exhibit COVID-19-related symptoms, of which a) at least two are scored at baseline with “2” or “3” OR b) at least six are scored at baseline at “1” or higher, but which have not yet lasted longer than 2 days.
    - Patients aged from 18 to 80 years, whether vaccinated to SARS-CoV-2 or not. Unvaccinated patients can be included only if they do not fulfil the following risk factors for a severe course of SARS-CoV-2 infection: Diabetes, obesity (BMI > 25), chronic lung disease (including asthma), chronic kidney disorder, current smoking, immunosuppressive disease or immunosuppressive therapy, heart disease, hypertension, sickle cell disease, neurodevelopmental disorders, active cancer, medical technological dependence, or age 60 years or older, regardless of comorbidities. The patient’s family physician will take the decision on the inclusion of unvaccinated patients, considering the patient’s anamnesis and concomitant medication.
    - Having the diagnosis of SARS-CoV-2 infection documented by a positive Rapid Antigen Test or positive PCR testing. Positive Rapid Antigen Test results must be confirmed through another Rapid Antigen test performed in presence of the investigator during the inclusion visit. The patients, will be included in the study based on eligibility criteria and after signing the informed consent. The patient will undergo all study related procedures on the same day (baseline RT-PCR test using nasal swabs, physical examination, vital signs, concomitant medications etc) including study drug administration. The decision of continuing the patient further in the study will be decided on the results of RT-PCR (patients exhibiting baseline Ct-values ≤ 25 will be continued, patients exhibiting baseline Ct-values > 25 will be discontinued from the study). In case of baseline Ct-values > 25, the drug will be immediately withdrawn, and patients will be discontinued from the study.
    E.4Principal exclusion criteria
    Patients must not meet any of the following non-inclusion criteria in order to participate in this study:

    - Patients requiring hospitalization at the time of enrolment,
    - Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
    - Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
    - Inability to understand instructions/study documents,
    - Inability to administer the nasal spray
    - Specific vulnerable patients: subjects who are detained or committed to institutions by law court or by legal authorities, such as psychiatric wards, prisons or other state institutions
    - Any additional anti-histamine therapy from Day 1 of the trial to Day 16 (locally or systemically applied), any antihistamine therapy 7 days prior to enrolment
    - Any concurrent nasalia including nasal lavage fluids
    - Any concurrent anti-COVID therapy (including off-label use) such as (inhalative) corticosteroids or anti-viral and immune-modulatory active substances, for example Sotrovimab, Molnupiravir, Paxlovid (Nirmatrelvir and Ritonavir).
    - Unvaccinated patients who are eligible for therapy with already approved COVID-19 medicinal products
    - Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method until D60. Females in post-menopausal state may be included.
    - Having any contraindication for the use of azelastine nasal spray (incl. hypersensitivity to the active substance or other ingredients).
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    -Time to sustained clinical recovery, defined as (a) all symptoms from the FDA COVID-19 symptom list scored with „2“ or „3“ at baseline are subsequently scored with „0“ or „1“, AND (b) all symptoms from the FDA COVID-19 symptom list scored with „0“ or „1“ at baseline are subsequently scored as „0“, with no subsequent worsening up to Day 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the primary endpoint will be performed in the period from baseline up to Day 29.
    E.5.2Secondary end point(s)
    Secondary Endpoints
    1. Rate of COVID-19 related hospitalizations or all-cause mortality up to V6 (composite endpoint).
    2. Rate of COVID-19 related hospitalizations or all-cause mortality up to V7 (composite endpoint).
    3. Time to sustained clinical recovery, defined as (a) all symptoms from the FDA COVID-19 symptom list scored with „2“ or „3“ at baseline are subsequently scored with „0“ or „1“, AND (b) all symptoms from the FDA COVID-19 symptom list scored with „0“ or „1“ at baseline are subsequently scored as „0“, with no subsequent worsening up to Day 15
    4. Change in symptom severity in the total symptom score from baseline up to V6
    5. Change in symptom severity in the total symptom score between baseline, V4, V5 and V6
    6. Change in symptom severity for individual symptoms up to V6
    7. Change in symptom severity for individual symptoms between baseline, V4, V5 and V6
    8. Persistence of COVID-19 related symptoms at V7
    9. Change in Ct-value (measured with semi-quantitative methods) between baseline and V4.
    10. Change of blood oxygen saturation from baseline up to V6 and on V7
    11. Change in WHO status from baseline up to V6 and on V7
    12. Frequency, severity and relationship of AEs to treatment up to V7.
    13. Patients’ subjective assessment of tolerability and efficacy of azelastine treatment at V4
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Period from baseline up to V6
    2. Period from baseline up to V7
    3. Period from baseline up to Day 15
    4. Change from baseline up to V6
    5. Change between baseline, V4, V5 and V6
    6. Change from baseline up to V6
    7. Change between baseline, V4, V5 and V6
    8. at V7
    9. Change between baseline and V4
    10. Change from baseline up to V6 and on V7
    11. Change from baseline up to V6 and on V7
    12. up to V7
    13. at V4
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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.8.5The 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 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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    SARS-CoV-2 positive patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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)
    Patients suffering from persistent symptoms after the 11-day treatment as part of the study, or patients getting much worse condition during the study willbe treated according to the current medical guidelines.
    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 Decision2023-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-11-06
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    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
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