Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients

Long COVID Clinical Trial

— QoL COVID HBOT  

Official title:

Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159309
• Other study ID #: MEC-2023-0433
• Status: Recruiting
• Start date: February 6, 2023
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Hyperbaar Geneeskundig Centrum Rijswijk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

Other:
• Hyperbaric oxygen therapy
HBOT per local protocol, i.e. 40 sessions 2.4 ATA, at the discretion of the hyperbaric physician

Locations

Country	Name	City	State
Netherlands	DVK Amersfoort	Amersfoort	Utrecht
Netherlands	DVK Geldrop	Geldrop	Noord-Brabant
Netherlands	DVK Hogeveen	Hoogeveen	Drenthe
Netherlands	HGC Rijswijk	Rijswijk	South-Holland
Netherlands	DVK Rotterdam	Rotterdam	South-Holland
Netherlands	DVK Waalwijk	Waalwijk	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Rutger Lalieu	DaVinci Kliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Long Covid symptoms	What symptoms do Long COVID patients who were referred for HBOT suffer from?	3 and 12 months
Secondary	Cognitive complaints	Is there any improvement of symptoms in Long COVID patients with cognitive symptoms during HBOT and after HBOT?	3 and 12 months
Secondary	Work	Do changes in absence at work occur after treatment with HBOT in Long COVID patients with cognitive symptoms?	3 and 12 months
Secondary	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
Secondary	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