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    Summary
    EudraCT Number:2020-001198-55
    Sponsor's Protocol Code Number:KronLungesyg_COVID_19_protokol_2
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-21
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-001198-55
    A.3Full title of the trial
    Proactive Prophylaxis with Azithromycin and Hydroxychloroquine Patients Hospitalized with COVID
    Pro-aktiv Beskyttelse af Indlagte Patienter med COVID
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early Treatment to Patients with Coronavirus (COVID)
    A.3.2Name or abbreviated title of the trial where available
    ProPAC-COVID
    ProBe-COVID
    A.4.1Sponsor's protocol code numberKronLungesyg_COVID_19_protokol_2
    A.5.4Other Identifiers
    Name:Videnskabsetisk KomiteNumber:H-20023010
    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 SponsorChronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
    B.1.3.4CountryDenmark
    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 supportCOP:TRIN
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCOP:TRIN
    B.5.2Functional name of contact pointwww.coptrin.dk
    B.5.3 Address:
    B.5.3.1Street AddressKildegårdsvej 28
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number4528938168
    B.5.6E-mailjens.ulrik.jensen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameAzithromycin
    D.3.2Product code Azithromycin
    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 INNAzithromycin
    D.3.9.1CAS number 121470-24-4
    D.3.9.3Other descriptive nameAZITHROMYCIN MONOHYDRATE
    D.3.9.4EV Substance CodeSUB87696
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250 to 500
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderPL 04425/0621
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePlaquenil
    D.3.2Product code Hydroxyghloroquine
    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 INNHydroxychloroquine
    D.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 2
    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
    This trial will investigate infection with coronavirus (COVID-19) in
    patients who are admitted to hospital
    E.1.1.1Medical condition in easily understood language
    This trial will investigate infection with coronavirus in patients who are admitted to hospital
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10070255
    E.1.2Term Coronavirus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients who are admitted urgently to hospital with coronavirus infection (COVID-19) and symptoms, treatment with virus-modifying agent Hydroxyhloroquine as well as virus-immunomodulatory and antibacterial drug Azithromycin can lead to a shorter hospitalization.
    Hos patienter der indlægges akut og som har en positiv test for 2019-nCoV og symptomer svarende til COVID-19 sygdom, kan behandling med virus-modificerende stof hydroxychloroquin samt virus-immunmodulerende og antibakterielle stof azithromycin føre til kortere indlæggelse.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to clarify whether the patients riscs of non-invasive ventilation, intensive care unit admittance and death can be reduced by hydroxychloroquine and azithromycine treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients admitted to a danish emergency department or department of respiratory medicine or internal medicine
    - Age >18 år
    - Hospitalized <48 hours
    - Positive COVID-19 test/diagnosis during hospitalization
    - fertile women must present a negative pregnancy test
    - signed informed consent
    • Patient indlagt på en dansk akutmodtagelse, lungemedicinsk afdeling eller medicinsk afdeling
    • Indlagt <48 timer
    • Alder >18 år
    • Positiv COVID-19 test / diagnose under pågældende indlæggelse (bekræftet).
    • Fertile kvinder skal have negativ graviditetstest
    • Informeret samtykke underskrevet
    E.4Principal exclusion criteria
    - If the patient uses >5 LO2/min on time of recruitment
    - Known intolerance/allergy to azithromcyin or hydroxychloroquine
    - Liver diseases other than amoebiasis
    - Severe gastrointestinal, neurological and hematological disorders
    -eGFR <45 ml/min/1.73m2
    - Severe cardiac conduction disorders or (risk of) prolonged QT interval
    - Myasthenia gravis
    - Neurogenic hearing loss
    - Psoriasis
    - Retinopathy
    - Maculopathy
    - Visual fiels changes
    - Breastfeeding
    - Hypersensitivity to quinine or 4-aminoquinoderivates
    -Uses Digoxin
    - Shortage of glucose-6-phosphatedehydrogenase
    - Porphyria
    - Hypoglycemia
    - Severe mental illness which significantly complicates cooperation
    - Severe linguistic problems that significantly complicates cooperation
    - Concomitant administration of sickle alkaloids
    • På rekrutteringstidspunktet bruger patienten >5 LO2/min (svarende til 40% FiO2, hvis dette måles)
    o NB: 5 LO2/min tillades, det er først >5 LO2/min at det er eksklusionsgrund.
    • Kendt intolerance/allergi overfor azithromycin eller hydroxychloroquin eller Overfølsomhed over for quinin
    • Neurogen hørenedsættelse
    • Psoriasis
    • Retinopati
    • Makulopati
    • Synsfeltsforandringer
    • Amning
    • Andre svære leversygdomme end amøbiasis (INR>1.5 spontant)
    • Svære gastro-intestinale, neurologiske og hæmatologiske lidelser (investigator-vurderet)
    • eGFR<45 ml/min/1.73 m2
    Pro-aktiv Beskyttelse af Indlagte patienter med COVID
    ProBe-COVID-trial
    8
    • Klinisk betydende kardielle overledningsforstyrrelser/arrytmier eller forlænget QTc interval (QTc(f) på>500 ms.
    • Myasthenia gravis
    • Bruger Digoxin
    • Glucose-6-phosphatedehydrogenasemangel
    • Porfyri
    • Hypoglykæmi (Blod-glukose på et hvilket som helst tidspunkt siden indlæggelse på <3.0 mmol/L)
    • Svær psykisk sygdom som betydeligt vanskeliggør kooperation
    • Svære sproglige problemer som betydeligt
    E.5 End points
    E.5.1Primary end point(s)
    Days alive and discharged from hospital within 14 days
    • Dage i live og udskrevet fra hospital indenfor 14 dage (opsummerer både om patienten er i live og er udskrevet fra hospital)
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 days
    E.5.2Secondary end point(s)
    Secondary endpoint nr 1: Patient will be categorized within 1 of the following 8 categories on day 15:
    1. Dead
    2. Admitted, uses mecanical ventilate or ExtraCorporalMembranOxygering (ECMO)
    3. Admitted, uses Non-invasive ventilation or "high-flow oxygen device"
    4. Admitted, gets oxygen but doesn't live up to (2) or (3)
    5. Admitted, no need for oxygen treatment but gets other treatment (COVID related or other)
    6. Admitted for observation
    7. Discharged, but with limitations of activity level
    8. Discharged, no limitations of activity level

    - Admitted to intensive care unit
    then Length of Stay, ICU
    - has used Non-invasive ventilation (NIV) during hospitalization
    - death on day 30
    - Length of index-hospitalization (days)
    - days alive and discharged from hospital within 30 days
    - death on day 90
    - death within 12 months
    - number of readmissions (all causes) within 30 days
    - number of days of non-invasive ventilation (NIV)
    - Delta PaO2 day 1 to day 4
    - Delta PaCO2 day 1 to day 4
    - pH day 4 (72 hours)
    - Time without oxygen supplement (or regular LTOT oxygen supplement)
    Sekundært endpoint nr 1:
    Ordinalt outcome. Patienten kategoriseres I en af følgende 8 kategorier på dag 15:
    1. Død
    2. Indlagt og på mekanisk ventilation eller ExtraCorporalMembranOxygenering (ECMO)
    3. Indlagt og på Non-invasiv ventilation eller ”high-flow oxygen device”
    4. Indlagt og får ilttilskud som ikke lever op til ilttilskud i (2) eller (3) – f.eks. ilt på ”næsebrille”
    5. Indlagt og får ikke ilttilskud, men har brug for behandling (COVID-19-relateret eller anden)
    6. Indlagt og får ikke ilttilskud, og har ikke brug for behandling (observeres blot)
    7. Udskrevet med begrænsning i aktiviteter, kan være fri af ilttliskud eller bruge LTOT (”hjemmeilt”)
    8. Udskrevet, ingen begrænsninger i aktiviteter

    • Indlagt på intensivafdeling i de to grupper (0 vs. 1) under index indlæggelsen
    o For patienter indlagt på intensiv afdeling: antal dage på intensiv (Length of stay, ICU)
    • Har brugt Non-invasiv ventilation, NIV (0 vs. 1) under index indlæggelsen
    • Død på dag 30
    • Dage indlagt på hospital under index-indlæggelsen
    • Dage i live og udskrevet fra hospital indenfor 30 dage (opsummerer både om patienten er i live og er udskrevet fra hospital)
    • Død på dag 90 (rapporteres senere)
    • Død indenfor 12 måneder (rapporteres senere)
    • Antal genindlæggelser af alle årsager indenfor 30 dage
    • Antal dage med non-invasiv-ventilation (NIV) eller respiratorbehandling under index indlæggelsen
    • Delta PaO2 dag 1 (baseline) til dag 4 (72 timer). Der registreres samtidigt ilttilskud og ilt-system
    • Delta PaCO2 dag 1 (baseline) til dag 4 (72 timer)
    • pH dag 4 (72 timer)
    • Tid til intet ilttilskud (eller til vanlig LTOT ilttilskud)
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 days and 1 year
    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) 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 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 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 concerned9
    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
    The trial ends after the last follow up, which will be 12 months after the last patient is included.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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 state226
    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)
    Not different from the expected standard treatment
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Chronic Obstructive Pulmonary Trial Network (COP:TRIN)
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-29
    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 StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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