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

Erasmus Medical Center3 sites in 1 country120 target enrollmentOctober 1, 2024

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

InterventionsHyperbaric oxygen

DrugsHyperbaric oxygen

Overview

Phase: Phase 3
Intervention: Hyperbaric oxygen
Conditions: Post-COVID-19 Syndrome
Sponsor: Erasmus Medical Center
Enrollment: 120
Locations: 3
Primary Endpoint: Physical and mental component scores of the 36-item Short Form Survey (SF-36)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2024

End Date

April 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Erasmus Medical Center

Responsible Party

Principal Investigator

Merel Hellemons

Dr.

Erasmus Medical Center

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

Arms & Interventions

Hyperbaric Oxygen therapy

40 sessions of HBOT at 2.4 ATM

Intervention: Hyperbaric oxygen

Outcomes

Primary Outcomes

Physical and mental component scores of the 36-item Short Form Survey (SF-36)

Time Frame: Week 20 (i.e. 3-months after end of HBOT)

Range 0-100, with higher scores indicating higher quality of life

Secondary Outcomes

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).)
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).)
Cost-effectiveness(Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).)