Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients (QoL COVID HBOT)

Post-Covid syndrome, also known as long Covid, is a clinical condition in which patients experience long term symptoms after Covid-19 infection. Treatment options for post-Covid are not effective. Therefore, there is an urgent need for a novel therapy. The first study results of HBOT in post-Covid patients are promising. Previous research from Israel has shown improvements in quality of life after HBOT. However, long term results are unknown. Therefore, this study aims to evaluate quality of life at one year after hyperbaric oxygen therapy in post-Covid patients with cognitive symptoms. It is hypothesized that quality of life at one year after HBOT is improved. Furthermore, this study aims to evaluate return to work after HBOT. To our knowledge this was not done before. An observational prospective cohort study will be conducted to answer the research questions. All post-Covid patients who are treated with hyperbaric oxygen therapy in participating centers, will be eligible for inclusion. Questionnaires and medical doctor consultations will be used in order to collect all data.

There are no risks for participants, since only 7 questionnaires are not part of standard clinical care. The burden is approximately 40 minutes extra in total for participants, compared to standard clinical care.

Study Overview

• Status: Active, not recruiting
• Conditions: Long COVID; Long Covid19; Long COVID-19 Syndrome; Long Covid 19
• Intervention / Treatment: Other: Hyperbaric oxygen therapy

Detailed Description

The study design is a prospective observational cohort study. Questionnaires and medical doctor consultations will be used in order to collect all data. All patients treated with HBOT have medical doctor consultations at baseline and every 10th session of HBOT (standard clinical care).

At baseline, the following characteristics will be collected: gender, age, BMI, medical history, Covid infection information, vaccination status, work status before Covid infection, previous Covid treatments, hospital and/or intensive care unit admission during Covid infection and smoking status. Furthermore, all patients treated are asked to fill out the SF-36 and EQ-5D questionnaires, a proprietary post-Covid symptoms questionnaire, and a questionnaire regaring work status. These questionnaires are repeated after 20, 40 (50) sessions of HBOT and after 3 and 12 months after the last treatment session.

During the following medical doctor consultations, side effects, changes in medication and interruptions of HBOT will be recorded as well to monitor compliance.

An interim analysis will be performed after 6 months to continue or stop treatments, based on the clinical results (as measured with the Physical Component Score of the SF-36 questionnaire). The minimal clinically important difference (MCID) to warrant early termination of therapy is if <5% of patients improves 3 points. The upper limit (and reason to continue) is if >50% achieve an MCID of 7 points.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Netherlands
  • Drenthe
    • Hoogeveen, Drenthe, Netherlands, 7909 AK
      • DVK Hogeveen
  • Noord-Brabant
    • Geldrop, Noord-Brabant, Netherlands, 5664 HB
      • DVK Geldrop
    • Waalwijk, Noord-Brabant, Netherlands, 5141 BM
      • DVK Waalwijk
  • South-Holland
    • Rijswijk, South-Holland, Netherlands, 2288EG
      • HGC Rijswijk
    • Rotterdam, South-Holland, Netherlands, 3081 AA
      • DVK Rotterdam
  • Utrecht
    • Amersfoort, Utrecht, Netherlands, 3813 TZ
      • DVK Amersfoort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population will consist of post-Covid patients from the Netherlands, who are treated with hyperbaric oxygen therapy at several different treatment centers. All patients are adults and will receive standard clinical hyperbaric oxygen therapy at these clinics.

Description

Inclusion Criteria:

• Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
• Patients are suffering from cognitive symptoms for >3 months after Covid infection

Exclusion Criteria:

• Patients who are not able to fill in questionnaires and informed consent.
• Patients who can't read or do not understand the Dutch language

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Long Covid patients; All post-COVID patients that are referred for hyperbaric oxygen (and that are eligible for treatment)	Other: Hyperbaric oxygen therapy; HBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life 3 and 12 months	Is the expected improvement in quality of life in Long COVID patients after treatment with HBOT maintained at 12-months follow-up	3 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Covid symptoms	What symptoms do Long COVID patients who were referred for HBOT suffer from?	3 and 12 months
Cognitive complaints	Is there any improvement of symptoms in Long COVID patients with cognitive symptoms during HBOT and after HBOT?	3 and 12 months
Work	Do changes in absence at work occur after treatment with HBOT in Long COVID patients with cognitive symptoms?	3 and 12 months
Risk factors quality of life	What are risk factors for low health related quality of life in Long COVID patients with cognitive symptoms who are treated with HBOT?	3 and 12 months
Profile of non-responders versus responders	What are the differences in baseline characteristics of patients that are non-responders and responders after HBOT?	3 and 12 months

Collaborators and Investigators

• Sponsor: Rutger Lalieu
• Collaborators: DaVinci Kliniek

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 31, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: covid; registry; post-covid; long-covid
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: MEC-2023-0433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is retrieved from patient files (after informed consent). Even though the data is pseudonymised, there is too much risk of confidentialty breach.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No