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    The EU Clinical Trials Register currently displays   43614   clinical trials with a EudraCT protocol, of which   7207   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2021-001126-21
    Sponsor's Protocol Code Number:100423
    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:2021-04-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2021-001126-21
    A.3Full title of the trial
    Hyperbaric Oxygenation for patients with post-COVID-19 sequelae. Pilot study.
    Hyperbare Sauerstofftherapie bei Patienten mit post-COVID-19 Symptomen. Pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of 100% oxygen inhaled under hyperbaric conditions in patients with symptoms after COVID-19 infection.
    Einfluss von 100% Sauerstoff, eingeatmet unter hyperbaren Bedingungen, bei Patienten mit Symptomen nach COVID-19 Infektionen.
    A.4.1Sponsor's protocol code number100423
    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 SponsorDivision of Thoracic and Hyperbaric Surgery, Medical University Graz
    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 supportMedical University of Graz
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 29
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    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. name Oxygen
    D. of the Marketing Authorisation holderAir-Liquide Austria GmbH
    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.3.1Product nameSauerstoff medizinisch – Air Liquide
    D.3.2Product code V03AN01
    D.3.4Pharmaceutical form Inhalation vapour
    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 INNOXYGEN
    D.3.9.1CAS number 7782-44-7
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number99.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Multiorgan symptoms after COVID-19 infection (Long COVID)
    Multiorgan-Symptome nach COVID-19 Infektion (Long COVID)
    E.1.1.1Medical condition in easily understood language
    Symptoms as breathing difficulties, fatigue and neuropathies in patients weeks to months after having contracted a COVID-19 infection.
    Symptome wie Atembeschwerden, Mattigkeit und Neuropathien bei Patienten Wochen bis Monate nach durchgemachter COVID-19 Infektion.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    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
    The aim of the current study is to investigate the feasibility, safety and success of hyperbaric oxygen therapy in patients suffering from multiorgan symptoms after having contracted a COVID-19 infection (i.e. "Long COVID").
    Das Ziel dieser Studie ist es, die Machbarkeit, Sicherheit und Effektivität von hyperbarer Sauerstofftherapie bei Patienten mit Multiorgan-Symptomen nach durchgemachter COVID-19 Infektion zu untersuchen (d.h. "Long COVID").
    E.2.2Secondary objectives of the trial
    Not applicable.
    Nicht zutreffend.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-90 years
    - Persistent, predominantly pulmonary symptoms with no or little tendency for remission, necessitating in-patient treatment at rehabilitation unit.
    - No active COVID-19 disease (as documented by three subsequent negative PCR-tests at three days intervals).
    - Subject willing and able to read, understand and sign an informed consent and to do self-reporting according to questionnaire.
    - Alter 18-90 Jahre
    - Persistierende, hauptsächlich pulmonale Symptome mit keiner oder nur minimaler Tendenz zur Remission, eine stationäre Behandlung in einer Rehabilitationseinheit benötigend.
    - Keine aktive COVID-19 Infektion (dokumentiert mittels dreier aufeinanderfolgender negativer PCR-Tests in einem dreitägigen Intervall)
    - TeilnehmerInnen können die Einwilligungserklärung lesen, verstehen und unterschreiben, und sind dazu fähig, selbstständig Fragebögen auszufüllen.
    E.4Principal exclusion criteria
    - Active malignancy
    - HBO-treatment for any reason prior to study enrolment
    - Chest pathology incompatible with pressure changes (including untreated pneumothorax, bullous emphysema, moderate to severe asthma)
    - Ear or sinus pathology incompatible with pressure changes
    - Pregnancy or lactation
    - Patients unable to give informed consent
    - Aktive maligne Erkrankung
    - Frühere HBO-Behandlung jeglicher Ursache
    - Pathologien des Thorax, welche inkompatibel mit Druckänderungen sind (u.a. nicht behandelter Pneumothorax, bullöses Emphysem, moderates/schweres Asthma)
    - Ohren/Sinus-Pathologien die mit Druckänderungen inkompatibel sind
    - Schwangerschaft oder Stillzeit
    - Patienten, die selbst keine Einwilligung abgeben können
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility, safety and success of hyperbaric oxygen therapy in Long COVID patients as assessed via:
    - Chest x-ray
    - Neurological status
    - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies)
    - SF-36 questionnaire
    - Pulse-oxymetry
    - Blood pressure
    - Heart rate
    - Blood gases
    - Need for oxygen-supplementation
    Machbarkeit, Sicherheit und Effektivität hyperbarer Sauerstofftherapie bei Long COVID Patienten, analysiert anhand von:
    - Thoraxröntgen
    - Neurologischer Status
    - Laborparameter (inklusive Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 Antikörper)
    - SF-36 Fragebogen
    - Puls-Oxymetrie
    - Blutdruck
    - Herzschlag
    - Blutgase
    - Notwendigkeit der Sauerstoff-Supplementierung
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Before and at the end of treatment:
    - Chest x-ray
    - Neurological status
    - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies)
    - SF-36 questionnaire
    2. Before, after the 1st, after the 6th, and after the last treatment
    - Pulse Oxymetry
    3. Regularly during HBO-treatment
    - Blood pressure
    - Heart rate
    - Blood gases
    - Need for oxygen-supplementation
    1. Vor erster und nach Ende der letzten HBO-Behandlung:
    - Thoraxröntgen
    - Neurologischer Status
    - Laborparameter (inklusive Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 Antikörper)
    - SF-36 Fragebogen
    2. Vor der ersten, nach der 6. und nach Ende der letzten HBO-Einheit
    - Puls-Oxymetrie
    3. Regelmäßig während der HBO-Behandlungen
    - Blutdruck
    - Herzschlag
    - Blutgase
    - Notwendigkeit der Sauerstoff-Supplementierung
    E.5.2Secondary end point(s)
    Not applicable.
    Nicht zutreffend.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Nicht zutreffend.
    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. 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 No
    E.8.1.2Open No
    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 Yes
    E. trial design description
    Pilot study
    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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-04-08. Yes
    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 state50
    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)
    Treatment and care after participants have ended participation in the trial is not different from usual treatment of Long COVID patients.
    Die Behandlung und Betreuung von TeilnehmerInnen nach Ende der Teilnahme an der Studie unterscheidet sich nicht von der üblichen Behandlung von Patienten mit Long COVID.
    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 Decision2021-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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