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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001928-34
    Sponsor's Protocol Code Number:HALT_Covid-19
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-24
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-001928-34
    A.3Full title of the trial
    Inhalation of Ciclesonide for patients with Covid-19: A randomised open treatment study (HALT Covid-19).
    HALT Covid-19-studien: Inhalation av Ciklesonid mot SARS-coronavirus-2 orsakad lunginflammation: En randomiserad oblindad behandlingsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with inhalation of Ciclesonide for patients with coronavirus disease: A randomised open study.
    Behandling med inhalation av Ciklesonid till patienter med coronavirussjukdom: En randomiserad oblindad behandlingsstudie.
    A.4.1Sponsor's protocol code numberHALT_Covid-19
    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 SponsorCapio S:t Görans Sjukhus
    B.1.3.4CountrySweden
    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 supportAxel och Margaret Ax:son Johnsons stiftelse för allmännyttiga ändamål
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCapio S:t Görans Sjukhus
    B.5.2Functional name of contact pointGunilla Wahlström
    B.5.3 Address:
    B.5.3.1Street AddressSankt Göransplan 1
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code112 19
    B.5.3.4CountrySweden
    B.5.6E-mailgunilla.wahlstrom@capiostgoran.se
    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 Alvesco
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLESONIDE
    D.3.9.1CAS number 141845-82-1
    D.3.9.4EV Substance CodeSUB06236MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 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 Alvesco
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLESONIDE
    D.3.9.1CAS number 141845-82-1
    D.3.9.4EV Substance CodeSUB06236MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Covid-19 pneumonia
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Can inhalation treatment with ciclesonide decrease the number of days with oxygen therapy for hospitalized patients with Covid-19?
    Minskar inhalationsbehandling med ciklesonid antalet dygn med syrgasbehandling för sjukhusvårdade patienter med covid-19?
    E.2.2Secondary objectives of the trial
    - Can inhalation treatment with ciclesonide decrease the risk for intubation and/or death within 30 days?
    - Can inhalation treatment with ciclesonide decrease respiratory symptoms after 1 month and 5-7 months?
    - Minskar inhalationsbehandling med ciklesonid risken för intubation och/eller död inom 30 dygn?
    - Minskar inhalationsbehandling med ciklesonid respiratoriska besvär efter 1 månad respektive 5-7 månader?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients 18 years or older, who have signed informed consent for participation in the study
    2. Hospitalized patients who have received oxygen therapy for maximum 48 hours
    3. Verified Covid-19: Positive test for Sars-Cov-2-RNA or a positive Sars-Cov2 antigen test from upper respiratory tract
    4. Receives oxygen therapy
    5. Negative pregnancy test (female subjects of childbearing potential)
    6. Female subjects of childbearing potential must use contraceptive method categorized as "highly effective" according to CTFG during study treatment and 7 days after finished treatment.
    1. Patienter 18 år eller äldre, som har givit sitt skriftliga samtycke till att delta i studien.
    2. Vårdas inneliggande på sjukhus och har haft behandling med syrgas i maximalt 48 timmar
    3. Verifierad Covid-19: Positivt prov för Sars-Cov2-RNA eller ett positivt Sars-Cov2 antigentest från övre luftvägar, det vill säga nasofarynx eller sputa.
    4. Erhåller syrgasbehandling.
    5. Negativt graviditetsprov (kvinnliga forskningspersoner i fertil ålder)
    6. Villig att utöva antikonception kategoriserat som ”mycket effektiva” enligt Clinical Trial Facilitation Group under pågående studiebehandling + 7 dygn. (kvinnliga forskningspersoner i fertil ålder)
    E.4Principal exclusion criteria
    1. Pregnancy, breast feeding or plans for pregnancy.
    2. Known intolerance or hypersensitivity to ciclesonide or any of the other components of the study drug
    3. Concomitant treatment with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir
    4. Therapy with >8 L oxygen/min or therapy with >50 % oxygen through high flow nasal cannula
    5. Ongoing palliative treatment or life expectancy less than 72 hours
    6. Expected admission to ICU within 48 hours
    7. Active or inactive tuberculosis
    8. Severe liver disease (Child-Pugh C)
    9. Pulmonary arterial hypertension (PAH) or fibrosis
    10. Mental incapacity, unwillingness or language difficulties
    11. Participation in another clinical trial within 30 days before inclusion in the present study. Earlier participation in the present study.
    1. Graviditet, amning eller planerad graviditet.
    2. Överkänslighet mot ciklesonid eller mot något hjälpämne.
    3. Samtidig medicinering med kortison, ketokonazol, itrakonazol, ritonavir eller nelfinavir.
    4. Behandling med >8 l syrgas /min eller tillförsel av >50 % syrgas med nasal högflödesgrimma
    5. Pågående palliativt inriktad vård eller förväntad överlevnad mindre än 72 timmar.
    6. Förväntad inskrivning på intensivvårdsavdelning inom 48 timmar.
    7. Aktiv eller inaktiv lungtuberkulos.
    8. Grav leversvikt (Child-Pugh C)
    9. Diagnosticerad med pulmonell arteriell hypertension (PAH) eller fibros.
    10. Mental oförmåga, ovilja eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien.
    11. Deltar eller nyligen deltagit eller i en klinisk läkemedelsprövning den senaste 30 dagarna. Tidigare deltagande i denna studie.
    E.5 End points
    E.5.1Primary end point(s)
    Number of days with oxygen therapy (30 days follow up after study inclusion). Terminated oxygen therapy is defined as discharge from hospital, without subsequent rehospitalization with oxygen therapy within 2 days, or at least 2 days without oxygen therapy for hospitalized patients.
    Antal dygn med syrgasbehandling (30 dagars uppföljning efter studieinklusion). Avslutad syrgasbehandling definieras som utskrivning till hemmet utan en återinskrivning med syrgasbehandling inom 2 dygn eller minst 2 dygn utan syrgasbehandling vid inneliggande vård. Det primära utfallsmåttet representerar ”klinisk förbättring” enligt en nominell skala som använts i tidigare studier på behandling av Covid-19 och som rekommenderas av WHO.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after inclusion
    30 dagar efter inklusion
    E.5.2Secondary end point(s)
    1. Rate of, and time to need for invasive mechanical ventilation and/or death
    2. Rate of, and time to death
    3. Rate of, and time to invasive mechanical ventilation
    4. Need for intensive care (yes/no and time from inclusion to ICU admission)
    5. Rate of, and time to discharge from hospital
    6. Number of subjects with residual respiratory symptoms measured with the Modified Medical Research Council Dyspnea scale
    1. Tid till, respektive andel patienter med behov av respiratorvård och/eller dör inom 30 dygn från studieinklusion
    2. Tid till, respektive andel patienter som dör inom 30 dygn från studieinklusion
    3. Tid till, respektive andel patienter som erhåller respiratorvård inom 30 dygn från studieinklusion
    4. Behov av intensivvård (ja/nej samt tid till IVA-vård från inklusion)
    5. Andel som skrivs ut från sjukhus till hemmet eller boende samt tid till utskrivning
    6. Andel patienter med kvarvarande respiratoriska besvär mätt med Modified Medical Research Council Dyspnea scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 30 days after inclusion
    2. 30 days after inclusion
    3. 30 days after inclusion
    4. 30 days after inclusion
    5. 30 days after inclusion
    6. 1 month and 5-7 months after inclusion
    1. 30 dagar efter inklusion
    2. 30 dagar efter inklusion
    3. 30 dagar efter inklusion
    4. 30 dagar efter inklusion
    5. 30 dagar efter inklusion
    6. 1 månad och 5-7 månader efter inklusion
    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 Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standardbehandling
    Standard treatment
    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 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
    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 months9
    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: 178
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 268
    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 state446
    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 Decision2020-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    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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