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

Phase 3

Not yet recruiting

• Conditions: Post-COVID Syndrome; Post COVID-19 Condition, Unspecified; Post COVID-19 Condition; Post-COVID Condition; Long COVID; Long Covid19; Post-COVID-19 Syndrome
• Interventions: Drug: Hyperbaric oxygen

• Registration Number: NCT06267300
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-20
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Start: 2024-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen therapy	Hyperbaric oxygen	40 sessions of HBOT at 2.4 ATM

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).	Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)
Cost-effectiveness	Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).

Trial Locations

Locations (3)

HGC Rijswijk; 🇳🇱 Rijswijk, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Da Vinci Clinic; 🇳🇱 Waalwijk, Netherlands