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

Erasmus University logo

Erasmus University

Status and phase

Begins enrollment in 4 months
Phase 3

Conditions

Long Covid19
Post COVID-19 Condition
Post-COVID Syndrome
Long COVID
Post-COVID Condition
Post COVID-19 Condition, Unspecified
Post-COVID-19 Syndrome

Treatments

Drug: Hyperbaric oxygen

Study type

Interventional

Funder types

Other

Identifier

NCT06267300

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

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy 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

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Hyperbaric Oxygen therapy
Experimental group
Description:
40 sessions of HBOT at 2.4 ATM
Treatment:
Drug: Hyperbaric oxygen
Standard care
No Intervention group

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems