Post-COVID-19 SyndromePhase 3NCT06267300
Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
A Phase 3 study testing Hyperbaric oxygen in people with Post-COVID-19 Syndrome and Post-COVID Syndrome, run by Erasmus Medical Center at 7 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Post-COVID Syndrome, Post COVID-19 Condition
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesNetherlands
- Study dates
- 1 Oct 2024to 1 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognitive and/or physical symptoms ≥ 12 months after acute COVID-19 infection
- Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by questionnaires and/or NASA LEAN test
- Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical functioning' score of ≤ 50 at baseline).
- Current treatment regimen is stable for at least 1 months before inclusion
Who cannot join
- Unfit for hyperbaric treatment
- Previous diagnosis of ME/CFS
- Unable to provide informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Da Vinci Clinic
Amersfoort
Da Vinci Clinic
Geldrop
Da Vinci Clinic
Hoogeveen
HGC Rijswijk
Rijswijk
Rutger Lalieu, Dr.
Da Vinci Clinic
Rotterdam
Nina Lansdorp, Dr.
Erasmus MC
Rotterdam
Merel Hellemons, Dr.
Da Vinci Clinic
Waalwijk
Nina Lansdorp, Dr.
About this study
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:
Read more
- 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.
- Conditions
- Post-COVID-19 Syndrome, Post-COVID Syndrome, Post COVID-19 Condition, Post-COVID Condition, Post COVID-19 Condition, Unspecified, Long COVID
- Being tested
- Hyperbaric oxygen
- Keywords
- clinical relevance, quality of life, absence from work, cost-effectiveness
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
Also called HBO, HBOT, Hyperbaric oxygen therapy
Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen therapy | Experimental | 40 sessions of HBOT at 2.4 ATM Receives: Drug: Hyperbaric oxygen |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical and mental component scores of the 36-item Short Form Survey (SF-36)
Range 0-100, with higher scores indicating higher quality of life
Measured: Week 20 (i.e. 3-months after end of HBOT)
Secondary outcomes (5)
Euroqol-5D (EQ-5D)
Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)
Measured: Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).
Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns
Measured: Worn continuously until week 34
Biochemical parameters
Measured: Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
Absence from work
Measured: Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).
Cost-effectiveness
Measured: Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Da Vinci Clinic, HGC Rijswijk
- Responsible party
- Principal investigator, Merel Hellemons, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267300
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06267300
- Conditions
- Post-COVID-19 Syndrome, Post-COVID Syndrome, Post COVID-19 Condition, Post-COVID Condition, Post COVID-19 Condition, Unspecified, Long COVID
- Keywords
- clinical relevance, quality of life, absence from work, cost-effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Da Vinci Clinic, HGC Rijswijk
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen therapy | Experimental | Drug: Hyperbaric oxygen40 sessions of HBOT at 2.4 ATM |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cognitive and/or physical symptoms ≥ 12 months after acute COVID-19 infection
- Symptoms include post-exertional malaise (PEM) and/or dysautonomia as assessed by questionnaires and/or NASA LEAN test
- Symptoms affect day-to-day life (based on SF-36 'role limitations due to physical functioning' score of ≤ 50 at baseline).
- Current treatment regimen is stable for at least 1 months before inclusion
Key exclusion criteria (3 listed)
- Unfit for hyperbaric treatment
- Previous diagnosis of ME/CFS
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygenAlso: HBO, HBOT, Hyperbaric oxygen therapyHyperbaric oxygen therapy (2.4 ATA, 40 sessions) | Drug | Hyperbaric Oxygen therapy |
Primary outcome
Physical and mental component scores of the 36-item Short Form Survey (SF-36)
Time frame: Week 20 (i.e. 3-months after end of HBOT)
Range 0-100, with higher scores indicating higher quality of life
5 secondary outcomes
Euroqol-5D (EQ-5D)
Time frame: Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).
Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns
Time frame: Worn continuously until week 34
Biochemical parameters
Time frame: Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
Absence from work
Time frame: Week 0/4/8/20/34 (i.e. at start of HBOT, halfway during treatment, directly after treatment and 3 and 6 months after treatment).
Cost-effectiveness
Time frame: Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperbaric oxygen in people with Post-COVID-19 Syndrome and Post-COVID Syndrome, run by Erasmus Medical Center at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical and mental component scores of the 36-item Short Form Survey (SF-36) (time frame: Week 20 (i.e. 3-months after end of HBOT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.