Influence of 100% oxygen inhaled under hyperbaric conditions in patients with cardiac symptoms after COVID-19 infection.

Hyperbaric oxygenation for patients with orthostatic dysregulation (postural orthostatic tachycardia) in Long- COVID. Prospectively randomized cross- over study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-004166-37-AT

Enrollment

Registered

2023-02-06

Start date

2023-05-02

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiorgan symptoms after COVID-19 infection (Long COVID)

Interventions

Trade Name: Oxygen Product Name: Sauerstoff medicAL Product Code: V03AN01 Pharmaceutical Form: Inhalation vapour INN or Proposed INN: Oxygen CAS Number: 7782-44-7 Other descriptive name: OXYGEN Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 -90 years 2. Evident COVID-19 infection based on clinical diagnosis and at least one positive PCR test or Antibody test 3. Patients beyond 12 weeks after initial COVID-19 diagnosis, having failed to reassume their former life because of at least two lingering symptoms such as fatigue, dizziness, muscle weakness, insomnia, joint pain, myalgia, or headache lasting at least for 12 weeks (corresponding to grade 2- 4 of the current post-COVID-19 functional status scale) 4. Patients wit orthostatic dysregulation (postural orthostatic tachycardia) in Long- COVID 5. No active COVID-19 disease (as documented by negative PCR-test prior to enrolment). 6. Subject willing and able to read, understand and sign an informed consent and to do self-reporting according to questionnaire. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Active malignancy 2. HBOT for any reason prior to study enrolment 3. Chest pathology incompatible with pressure changes (including untreated pneumothorax, bullous emphysema, moderate to severe asthma) 4. Ear or sinus pathology incompatible with pressure changes 5. Pregnancy or breast feeding 6. Patients unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the current study is to investigate the feasibility, safety and success of hyperbaric oxygen therapy in patients suffering from multiorgan symptoms considering orthostatic dysregulation (postural orthostatic tachycardia) after having contracted a COVID-19 infection (i.e."Long COVID").;Secondary Objective: not applicable.;Primary end point(s): Hyperbaric oxygen treatment (HBO) leads to a significant improvement of the peak oxygen consumption of more than at least 15%, improvement of the blood gas values, the vital signs, the personal oxygen demand, the personal well being and the orthostatic dysregulation in patients with Long-COVID symptoms.;Timepoint(s) of evaluation of this end point: 1. At the start and after 4 weeks: - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 2. During HBO (cross over time point) - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 3. Regularly during HBO - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation 4. 3 months - Questionnaires mentioned above	—

Measure

Time frame

Main Objective: The aim of the current study is to investigate the feasibility, safety and success of hyperbaric oxygen therapy in patients suffering from multiorgan symptoms considering orthostatic dysregulation (postural orthostatic tachycardia) after having contracted a COVID-19 infection (i.e."Long COVID").;Secondary Objective: not applicable.;Primary end point(s): Hyperbaric oxygen treatment (HBO) leads to a significant improvement of the peak oxygen consumption of more than at least 15%, improvement of the blood gas values, the vital signs, the personal oxygen demand, the personal well being and the orthostatic dysregulation in patients with Long-COVID symptoms.;Timepoint(s) of evaluation of this end point: 1. At the start and after 4 weeks: - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 2. During HBO (cross over time point) - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 3. Regularly during HBO - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation 4. 3 months - Questionnaires mentioned above

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Secondary

Measure	Time frame
Secondary end point(s): Effect of HBO treatment on laboratory parameters related to inflammation and epithelial damage, tissue oxygen levels, lung function parameters, Borg dyspnea score (46), fatigue assessment scale, post-COVID-19 functional status scale (PCFS) and parameters from the SF-36 questionnaire.;Timepoint(s) of evaluation of this end point: 1. At the start and after 4 weeks: - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 2. During HBO (cross over time point) - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 3. Regularly during HBO - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation 4. 3 months - Questionnaires mentioned above	—

Measure

Time frame

Secondary end point(s): Effect of HBO treatment on laboratory parameters related to inflammation and epithelial damage, tissue oxygen levels, lung function parameters, Borg dyspnea score (46), fatigue assessment scale, post-COVID-19 functional status scale (PCFS) and parameters from the SF-36 questionnaire.;Timepoint(s) of evaluation of this end point: 1. At the start and after 4 weeks: - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 2. During HBO (cross over time point) - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire, Borg dyspnea score, fatigue assessment scale and Post-COVID-19 Functional Status scale (PCFS) - Schellong test - Bodyplethysmography - Spiroergometry 3. Regularly during HBO - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation 4. 3 months - Questionnaires mentioned above

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Countries

Austria

Contacts

Public ContactClinical Trials Information

Medical University of Graz

freyja.smolle@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026