Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal