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    Summary
    EudraCT Number:2021-000764-30
    Sponsor's Protocol Code Number:HOT-LOCO
    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:2021-05-28
    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 number2021-000764-30
    A.3Full title of the trial
    Hyperbaric Oxygen for Treatment of Long COVID syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can hyperbaric oxygen be used to cure for Long COVID? A clinical trial.
    Kan hyperbar oxygenbehandling bota Lång COVID?
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome
    A.4.1Sponsor's protocol code numberHOT-LOCO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04842448
    A.5.4Other Identifiers
    Name:Karolinska University hospitalNumber:K2021-1592
    Name:Karolinska InstitutetNumber:4-621/2021
    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 SponsorKarolinska University Hospital
    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 supportKarolinska University Hospital
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportKarolinska Institutet
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportHjärt-Lungfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointHyperbaric unit F3:76
    B.5.3 Address:
    B.5.3.1Street AddressGävlegatan 52
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code171 76
    B.5.3.4CountrySweden
    B.5.4Telephone number+468123 946 80
    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 Conoxia, medicinal gas, cryogenic 100%
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Gas 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.3.1Product nameOxygen 100%
    D.3.4Pharmaceutical form Medicinal gas, cryogenic
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 Yes
    D.3.11.13.1Other medicinal product typeMedicinal gas
    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 placeboMedicinal gas, compressed
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Long COVID, post-acute COVID-19 Syndrome, post COVID-19 Syndrome (ICD-10 U09.0)
    E.1.1.1Medical condition in easily understood language
    Long COVID
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10057244
    E.1.2Term Post viral fatigue syndrome
    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 10063080
    E.1.2Term Postural orthostatic tachycardia syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if HBOT improves HRQoL (role limitations due to physical health and physical functioning) for patients with Long COVID compared to placebo (sham treatment).
    E.2.2Secondary objectives of the trial
    Main secondary objectives:
    To evaluate if HBOT improves endothelial dysfunction in Long COVID.
    To evaluate if HBOT improves objective physical performance in Long COVID.
    To evaluate if HBOT improves HRQoL short term.
    To evaluate if HBOT can normalise physical function in Long COVID

    Other secondary objectives:
    To evaluate if HBOT improves autonomic dysfunction.
    To evaluate if HBOT improves restorative sleep.
    To evalute if HBOT has a long term effect on subjective symptoms, HRQoL and objective physical performance in Long COVID
    To evaluate the potential health-economic benefits of the treatment.
    To explore changes in general and organ-specific questionaires, physical tests and radiology used in clinical follow-up before and after treatment
    To explore biomarkers in plasma, erythrocytes and PBMCs for HBO2 effect on inflammation, endothelial function and chronic hypoxia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Aged 18–60 years
    2) Healthy or mild systemic disease prior to COVID-19
    3) Symptoms consistent with Long COVID for at least 12 weeks
    4) Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
    5) Working or studying prior to COVID-19
    6) Documented informed consent according to ICH-GCP and national regulations
    E.4Principal exclusion criteria
    1) Known pregnancy or positive pregnancy test in women of childbearing age
    2) ASA 3 or more from other cause than Long COVID
    3) Score above 70 in RAND-36 domain Role Limitation Physical Health (RP) or Physical Functioning (PF)
    4) Diabetes
    5) Diagnosed with Hypertension prior to COVID-19
    6) Contraindication for HBO2 treatment according to local guidelines
    7) Participation or recent participation in a clinical trial with an investigational product
    8) Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of trialstudy participation
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF).
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 weeks after randomization
    E.5.2Secondary end point(s)
    Main Secondary Efficacy Endpoints
    I. Mean change from baseline to 13 weeks in Reactive Hyperemia Index (RHI).
    II. Mean change from baseline to 13 weeks in the 6-min walk test.
    III. Mean change from baseline to 13 weeks in the 30/60 sec chair stand.
    IV. Mean change from baseline to 13 weeks in EQ-5D.
    V. Proportion of subjects with a normalisation of levels in RAND-36 domains RP and PF respectively, at 13 weeks.

    Other Efficacy Endpoints
    I. Mean change in other RAND-36 domains at 13, 26 and 52 weeks compared to baseline.
    II. Mean change in EQ-5D at 6, 26 and 52 weeks compared to baseline.
    III. Mean change in physical activity using an activity meter at 6, 13 and 26 weeks compared to baseline
    IV. Mean change in HRV using an activity meter at 6, 13 and 26 weeks compared to baseline
    V. Mean change in sleeping pattern using an activity meter at 6, 13 and 26 weeks compared to baseline.

    Explorative/Descriptive Endpoints
    I. Mean change from baseline in hypoxia pathways in PBMCs evaluated by RNA sequencing, at 6, 13 and 26 weeks.
    II. Mean change from baseline in inflammatory PBMCs evaluated by RNA sequencing, at 6, 13 and 26 weeks
    III. Mean change from baseline of reactive oxygen species in red blood cells measured by EPR, at, 6 and 13 weeks.
    IV. Mean change from baseline of microRNA in plasma, at 6 and 13 weeks.
    V. Mean change from baseline in study specific clinical biochemistry at 6 and 13 weeks.
    a. D-Dimer
    b. Ferritin
    c. LDH
    d. Troponin T
    VI. Mean change from baseline in objective organ specific findings on imaging at 13 and 26 weeks (from medical records).
    VII. Mean change from baseline in objective organ specific and general physical tests (6-min walk test, 30/60-sec chair stand, HUT, Jamar, MIP/MEP and Spirometry at 13 and 26 weeks (from medical records).
    VIII. Mean change from baseline in subjective rating of physical and cognitive symptoms evaluated by self-reported questionnaires (CAT, Frändin-Grimby, FSS, GAD-7, MFS, mMRC, MOCA, PCL-5, PHQ-9, WAI) at 13 and 26 weeks (from medical records).
    IX. Long term post-trial follow-up of HRQoL using EQ-5D as variable up to 4 years post trial.

    Safety and Compliance Endpoints
    I. Number of subjects, proportion of subjects and number of AEs at 13 weeks.
    II. Number of subjects, proportion of subjects that have completed planned treatments after 6 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main Secondary efficacy endpoints 13 weeks after randomization. Other timepoints as specified in respective endpoint.
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 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 years2
    E.8.9.1In the Member State concerned months3
    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: 80
    F.1.3Elderly (>=65 years) No
    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 2021-05-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state80
    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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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