Clinical trial NCT06267300: Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
Official title: Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Post-COVID-19 Syndrome
Post-COVID Syndrome
Post COVID-19 Condition
Post-COVID Condition
Post COVID-19 Condition, Unspecified
Long COVID
Long Covid19
Keywords: clinical relevance
quality of life
absence from work
cost-effectiveness
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Da Vinci Clinic
name: HGC Rijswijk
First posted: 2024-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Physical and mental component scores of the 36-item Short Form Survey (SF-36)
timeFrame: Week 20 (i.e. 3-months after end of HBOT)
Secondary outcomes:
measure: Euroqol-5D (EQ-5D)
timeFrame: 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).
measure: Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns
timeFrame: Worn continuously until week 34
measure: Biochemical parameters
timeFrame: Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
measure: Absence from work
timeFrame: 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).
measure: Cost-effectiveness
timeFrame: Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Da Vinci Clinic
city: Geldrop
country: Netherlands
facility: Da Vinci Clinic
city: Hoogeveen
country: Netherlands
facility: Da Vinci Clinic
city: Rijswijk
country: Netherlands
facility: HGC Rijswijk
city: Rotterdam
country: Netherlands
facility: Da Vinci Clinic
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Waalwijk
country: Netherlands
facility: Da Vinci Clinic
Study officials:
References: