Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial

NCT06267300 — Phase 3, Unknown, 120 participants, Erasmus Medical Center

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Registry	NCT06267300
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	Erasmus Medical Center (Other); collaborators: Da Vinci Clinic, HGC Rijswijk
Conditions	Post-COVID-19 Syndrome, Post-COVID Syndrome, Post COVID-19 Condition, Post-COVID Condition, Post COVID-19 Condition, Unspecified, Long COVID, Long Covid19
Interventions	Hyperbaric oxygen (Drug)
Dates	start 2024-10-01 (estimated), primary completion 2025-10-01 (estimated), completion 2026-04-01 (estimated), first posted 2024-02-20, last updated 2024-02-28
Locations	7 sites in Netherlands

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Hyperbaric Oxygen therapy	Experimental	Drug: Hyperbaric oxygen	40 sessions of HBOT at 2.4 ATM
Standard care	No intervention

Hyperbaric oxygen (Drug), also known as HBO, HBOT, Hyperbaric oxygen therapy: Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)

+Outcome measures

Primary outcomes

Physical and mental component scores of the 36-item Short Form Survey (SF-36) [Week 20 (i.e. 3-months after end of HBOT)]: Range 0-100, with higher scores indicating higher quality of life

Secondary outcomes

Euroqol-5D (EQ-5D) [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).]: Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)
Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns [Worn continuously until week 34]
Biochemical parameters [Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)]
Absence from work [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 [Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* Unfit for hyperbaric treatment
* Previous diagnosis of ME/CFS
* Unable to provide informed consent

+Locations (7)

Facility	City	Country
Da Vinci Clinic	Amersfoort	Netherlands
Da Vinci Clinic	Geldrop	Netherlands
Da Vinci Clinic	Hoogeveen	Netherlands
HGC Rijswijk	Rijswijk	Netherlands
Da Vinci Clinic	Rotterdam	Netherlands
Erasmus MC	Rotterdam	Netherlands
Da Vinci Clinic	Waalwijk	Netherlands