Clinical trial evaluating the safety and efficacy of hyperbaric oxygen therapy for persistent fatigue symptoms after COVID-19 infection.
- Conditions
- Codes for special purposes
- Registration Number
- KCT0008274
- Lead Sponsor
- Myongji Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 50
1) Subjects who have passed more than 12 weeks from the date of diagnosis of COVID-19 infection by RT-PCR or expert rapid antigen test
2) Subjects whose fatigue symptoms newly occurred within 6 months after COVID-19 was confirmed and continues to this day, and who scored 4 or more on the Chalder Fatigue scale (CFS)
3) Adults aged 20 to 69 years old
4) ECOG (Eastern Cooperative Oncology Group) PS of 0 or 1
5) Subjects (or legal representatives) agree to participate before clinical trial begins and provide informed written consent
6) Those who can read Korean
1) Brain disease: Subjects with brain disease including dementia, stroke, epilepsy, and head trauma with loss of consciousness
2) Cardiac disease: Subjects with ischemic heart disease, heart failure, uncontrolled symptomatic arrhythmias, or those who have suggestive findings with the relevant disease based on electrocardiogram (ECG) and chest x-ray examination performed before clinical trials
3) Lung disease: Subjects with a history of chronic obstructive pulmonary disease (COPD), emphysema, asthma, pneumothorax, or chest surgery, and those with findings suggesting the corresponding disease on chest x-ray or before clinical trials.
4) Upper respiratory infection: Subjects with symptoms suggesting upper respiratory infection, such as fever of 38 degrees or higher, cough, sore throat, nasal congestion, runny nose, etc. at the time of participating in hyperbaric oxygen therapy.
5) Otology disease: Subjects who may have problems with ear pressure control, such as otitis media, severe rhinitis, and a history of barotrauma
6) Cancer (malignant tumor): Subjects with a history of malignant disease that is currently ongoing or has required active treatment within the past year. Participation in the study is possible if the subject has been in a stable condition without disease recurrence for more 1 year after complete cure.
Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal carcinoma in situ and cervical carcinoma in situ) who have received potentially curative treatment are not excluded if treatment is completed within 6 months.
7) Subjects who are confirmed to be alcohol or drug dependent within 4 weeks before participation in the study
8) Subjects who have been diagnosed with schizophrenia or has a mental illness that cannot be controlled at the opinion of investigator
9) Subjects who cannot receive hyperbaric oxygen therapy due to claustrophobia
10) Subjects with a diagnosis of immunodeficiency or receiving long-term systemic steroid treatment (dose exceeding the equivalent of 10 mg of prednisone per day) or subjects who have received any form of other immunosuppressive treatment within 7 days prior to clinical trial treatment
Note: If it is undergoing a reduction in steroid for discontinuation during the screening period, they are not excluded from the study.
11) Women who are currently pregnant
12) The subject is currently participating in a trial for clinical investigational medical devices, or clinical investigational drugs or medical devices within 4 weeks prior to participating in this study
13) Subjects who have received hyperbaric oxygen therapy after diagnosed COVID-19
infection
14) Subject has had major surgery within 2 weeks before participating in the clinical trial or did not recover from any effects of major surgery
15) Subject is unlikely to comply with the study procedures and limitations and requirements of the study in the opinion of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CFS (Chalder Fatigue scale) score
- Secondary Outcome Measures
Name Time Method eurocognitive Function Test score(Verbal Learning Test , Trail Making Test, Stroop test, Digit span test, MOCA-K (Montreal Cognitive Assessment);Psychiatric Symptom Questionnaire(HADS(Hospital Depression and Anxiety Scale) score, IES-K (Impact of Event Scale) score, PSQI (Pittsburgh Sleep Quality Index) score);Immune markers(ESR, CRP, Cytokine (IL-2,6,8,10));symptoms of COVID-19;Adverse events