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COVID-19
+5

Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome

Sponsored by Karolinska University Hospital

About this trial

Last updated 8 months ago

Study ID

HOT-LoCO

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 60 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status