Long COVID, Long Covid19, Post COVID-19 Condition, Post COVID-19 Condition, Unspecified, Post-COVID-19 Syndrome, Post-COVID Condition, Post-COVID Syndrome
Conditions
Keywords
clinical relevance, quality of life, absence from work, cost-effectiveness
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.
Interventions
DRUGHyperbaric oxygen
Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)
Sponsors
Da Vinci Clinic
HGC Rijswijk
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed