Status:
COMPLETED
Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Karolinska Institutet
Karolinska Trial Alliance
Conditions:
COVID-19
Post COVID-19 Condition
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 CO...
Detailed Description
Phase II Clinical Trial Prospective randomized, placebo-controlled, double blind, phase II, clinical trial, estimated enrolment: 80 subjects Parallel groups Intervention: HBO2: 240 kPa for 90 min, ma...
Eligibility Criteria
Inclusion
- Aged 18-60 years
- Healthy or mild systemic disease (ASA 1-2) prior to COVID-19
- Symptoms consistent with Long COVID for at least 12 weeks
- Diagnosed with Long COVID, PACS, PCS (ICD-10 U09.9)
- Working or studying prior to COVID-19
- Documented informed consent according to GCP and national regulations
Exclusion
- Known pregnancy or positive pregnancy test in women of childbearing age
- ASA 3 or more from other cause than Long COVID
- Score above 70 in RAND-36 Role Limitation Physical Health (RP) or Physical Functioning (PF)
- Diabetes
- Diagnosed with hypertension prior to COVID-19
- Contraindication for hyperbaric oxygen treatment according to local guidelines
- Participation or recent participation in a clinical trial with an investigational product
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04842448
Start Date
September 15 2021
End Date
June 17 2024
Last Update
August 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karolinska University Hospital
Stockholm, Sweden, 171 76