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

NCT06267300 | Not Yet Recruiting Phase 3

• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

clinical relevance; quality of life; absence from work; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

• 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).

• Cost-effectiveness

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

Study Arms (2)

Hyperbaric Oxygen therapy

EXPERIMENTAL

40 sessions of HBOT at 2.4 ATM

Drug: Hyperbaric oxygen

Standard care

NO INTERVENTION

Interventions

Hyperbaric oxygen DRUG

Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)

Also known as: HBO, HBOT, Hyperbaric oxygen therapy

Hyperbaric Oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Unfit for hyperbaric treatment
• Previous diagnosis of ME/CFS
• Unable to provide informed consent

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Da Vinci Clinic: collaborator
• HGC Rijswijk: collaborator

Study Sites (7)

Da Vinci Clinic

Amersfoort, Netherlands

Location

Da Vinci Clinic

Geldrop, Netherlands

Location

Da Vinci Clinic

Hoogeveen, Netherlands

Location

HGC Rijswijk

Rijswijk, Netherlands

Location

Da Vinci Clinic

Rotterdam, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Da Vinci Clinic

Waalwijk, Netherlands

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized controlled trial comparing HBOT to standard care alone, with a cross-over from standard care to HBOT in case primary outcome is positive after 6 months follow-up.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 20, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (7)