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

Long COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06267300
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Disease
• Long COVID
• Post-COVID-19 Syndrome
• Syndrome

Intervention

Drug:
• Hyperbaric oxygen
Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)

Locations

Country	Name	City	State
Netherlands	Da Vinci Clinic	Amersfoort
Netherlands	Da Vinci Clinic	Geldrop
Netherlands	Da Vinci Clinic	Hoogeveen
Netherlands	HGC Rijswijk	Rijswijk
Netherlands	Da Vinci Clinic	Rotterdam
Netherlands	Erasmus MC	Rotterdam
Netherlands	Da Vinci Clinic	Waalwijk

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Da Vinci Clinic, HGC Rijswijk

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical and mental component scores of the 36-item Short Form Survey (SF-36)	Range 0-100, with higher scores indicating higher quality of life	Week 20 (i.e. 3-months after end of HBOT)
Secondary	Euroqol-5D (EQ-5D)	Descriptive for 5 dimensions + visual analogue score (VAS, range 0-100 with higher scores indicating higher quality of life)	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).
Secondary	Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns		Worn continuously until week 34
Secondary	Biochemical parameters		Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
Secondary	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).
Secondary	Cost-effectiveness		Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).