protocolSection identificationModule nctId: NCT06267300, briefTitle: Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Da Vinci Clinic, collaborators name: HGC Rijswijk, descriptionModule briefSummary: The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.The main questions it aims to answer are:* What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?* What are the changes in absence from work after treatment with HBOT?* What is the cost-effectiveness of treatment with HBOT?* What are possible mechanisms of action of HBOT?Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months., conditionsModule conditions: Post-COVID-19 Syndrome, conditions: Post-COVID Syndrome, conditions: Post COVID-19 Condition, conditions: Post-COVID Condition, conditions: Post COVID-19 Condition, Unspecified, conditions: Long COVID, conditions: Long Covid19, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized controlled trial comparing HBOT to standard care alone, with a cross-over from standard care to HBOT in case primary outcome is positive after 6 months follow-up., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Hyperbaric oxygen, outcomesModule primaryOutcomes measure: Physical and mental component scores of the 36-item Short Form Survey (SF-36), secondaryOutcomes measure: Euroqol-5D (EQ-5D), secondaryOutcomes measure: Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns, secondaryOutcomes measure: Biochemical parameters, secondaryOutcomes measure: Absence from work, secondaryOutcomes measure: Cost-effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Da Vinci Clinic, city: Amersfoort, country: Netherlands, geoPoint lat: 52.155, lon: 5.3875, locations facility: Da Vinci Clinic, city: Geldrop, country: Netherlands, geoPoint lat: 51.42167, lon: 5.55972, locations facility: Da Vinci Clinic, city: Hoogeveen, country: Netherlands, geoPoint lat: 52.7225, lon: 6.47639, locations facility: HGC Rijswijk, city: Rijswijk, country: Netherlands, contacts name: Rutger Lalieu, Dr., role: CONTACT, geoPoint lat: 52.03634, lon: 4.32501, locations facility: Da Vinci Clinic, city: Rotterdam, country: Netherlands, contacts name: Nina Lansdorp, Dr., role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Erasmus MC, city: Rotterdam, country: Netherlands, contacts name: Merel Hellemons, Dr., role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Da Vinci Clinic, city: Waalwijk, country: Netherlands, contacts name: Nina Lansdorp, Dr., role: CONTACT, geoPoint lat: 51.6825, lon: 5.07083, hasResults: False