Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome

Phase 2

Completed

• Conditions: COVID-19; Post COVID-19 Condition; Post COVID-19 Condition, Unspecified; Post COVID Condition; Post-COVID Syndrome; Post-Acute COVID-19 Syndrome

• Registration Number: NCT04842448
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RAND 36 change

Secondary Outcome Measures

Name	Time	Method
Endothelial dysfunction;6-min walk test;30/60 min chair stand;EQ-5D;RAND 36 normalization