Hyperbaric Oxygen for Treatment of Long COVID Syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial

HOT-LoCO

Long COVID Syndrome (Long COVID), Post Acute COVID-19 Syndrome (PACS) or Post COVID-19 Syndrome (PCS) is defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis'. 1 in 10 infected individuals may suffer persistent symptoms, and we are facing an emerging problem that will severely affect individuals, health care systems and society for years to come. We explore hyperbaric oxygen administered in a randomized placebo-controlled clinical trial as a potential treatment for patients suffering from Long COVID. The overall hypothesis to be evaluated is that hyperbaric oxygen (HBO2) alleviates symptoms associated with Long COVID.

2021-09-15

2023-09-27

2024-07-30

Active (not recruiting)

Early phase I

80

Inclusion Criteria: 1. Aged 18-60 years 2. Healthy or mild systemic disease (ASA 1-2) prior to COVID-19 3. Symptoms consistent with Long COVID for at least 12 weeks 4. Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9) 5. Working or studying prior to COVID-19 6. Documented informed consent according to GCP and national regulations Exclusion Criteria: 1. Known pregnancy or positive pregnancy test in women of childbearing age 2. ASA 3 or more from other cause than Long COVID 3. Score above 70 in RAND-36 Role Limitation Physical Health (RP) or Physical Functioning (PF) 4. Diabetes 5. Diagnosed with hypertension prior to COVID-19 6. Contraindication for hyperbaric oxygen treatment according to local guidelines 7. Participation or recent participation in a clinical trial with an investigational product 8. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

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2024-03-19