NCT04842448CompletedPhase 2
Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome
Hyperbaric Oxygen for Treatment of Long COVID Syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 9 Apr 2021
- Start date
- 15 Sept 2021
- Primary completion date
- 27 Sept 2023
- Lead sponsor
- Karolinska University Hospital
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT04842448
- EudraCT number
- 2021-000764-30
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 15 Sept 2021 to the primary completion date, 27 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosed with hypertension prior to COVID-19
- Participation or recent participation in a clinical trial with an investigational product
Other illness
- ASA 3 or more from other cause than Long COVID
- Diabetes
Age
- Known pregnancy or positive pregnancy test in women of childbearing age
Other
- Score above 70 in RAND-36 Role Limitation Physical Health (RP) or Physical Functioning (PF)
- Contraindication for hyperbaric oxygen treatment according to local guidelines
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.