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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

NCT04343183

COVID-19

WITHDRAWN NA

Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress

NCT04800120

Covid19

COMPLETED NA

Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

NCT01099995

Carbon Monoxide Poisoning

TERMINATED PHASE3

One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning

NCT00465855

Carbon Monoxide Poisoning

COMPLETED PHASE4

Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning

NCT01100515

Carbon Monoxide Poisoning

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hyperbaric Oxygen therapy

40 sessions of HBOT at 2.4 ATM

Group Type EXPERIMENTAL

Hyperbaric oxygen

Intervention Type DRUG

Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperbaric oxygen

Hyperbaric oxygen therapy (2.4 ATA, 40 sessions)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HBO HBOT Hyperbaric oxygen therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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