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

February 26, 2024 updated by: Merel Hellemons, Erasmus Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amersfoort, Netherlands
        • Da Vinci Clinic
      • Geldrop, Netherlands
        • Da Vinci Clinic
      • Hoogeveen, Netherlands
        • Da Vinci Clinic
      • Rijswijk, Netherlands
        • HGC Rijswijk
        • Contact:
          • Rutger Lalieu, Dr.
      • Rotterdam, Netherlands
        • Erasmus MC
        • Contact:
          • Merel Hellemons, Dr.
      • Rotterdam, Netherlands
        • Da Vinci Clinic
        • Contact:
          • Nina Lansdorp, Dr.
      • Waalwijk, Netherlands
        • Da Vinci Clinic
        • Contact:
          • Nina Lansdorp, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
Experimental: Hyperbaric Oxygen therapy
40 sessions of HBOT at 2.4 ATM
Drug: Hyperbaric oxygen
Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)
Other Names:
  • HBOT
  • HBO
  • Hyperbaric oxygen therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns
Time Frame: Worn continuously until week 34
Worn continuously until week 34
Biochemical parameters
Time Frame: Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
Week 0, 8 and 34 (i.e. at start of HBOT, directly after HBO and 3-months after treatment)
Absence from work
Time Frame: 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).
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
Time Frame: Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).
Week 0/4/20/34 (i.e. at start of HBOT, directly after treatment and 3 and 6 months after treatment).
Euroqol-5D (EQ-5D)
Time Frame: 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)
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Da Vinci Clinic
HGC Rijswijk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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