Clinical trial NCT06159309: Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients
Official title: Quality of Life After Hyperbaric Oxygen Therapy in Post-COVID Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Long COVID
Long COVID-19 Syndrome
Long Covid19
Long Covid 19
Keywords: registry
covid
long-covid
post-covid
Lead sponsor: Hyperbaar Geneeskundig Centrum Rijswijk
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Long COVID patients who are reffered for treatment with hyperbaric oxygen therapy
* Patients are suffering from cognitive symptoms for \&gt;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

Primary outcomes:
measure: Quality of life 3 and 12 months
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Long Covid symptoms
timeFrame: 3 and 12 months
measure: Cognitive complaints
timeFrame: 3 and 12 months
measure: Work
timeFrame: 3 and 12 months
measure: Risk factors quality of life
timeFrame: 3 and 12 months
measure: Profile of non-responders versus responders
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Hoogeveen
country: Netherlands
facility: DVK Hogeveen
state: Drenthe
city: Geldrop
country: Netherlands
facility: DVK Geldrop
state: Noord-Brabant
city: Waalwijk
country: Netherlands
facility: DVK Waalwijk
state: Noord-Brabant
city: Rijswijk
country: Netherlands
facility: HGC Rijswijk
state: South-Holland
city: Rotterdam
country: Netherlands
facility: DVK Rotterdam
state: South-Holland
city: Amersfoort
country: Netherlands
facility: DVK Amersfoort
state: Utrecht
Study officials:
References: