CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Hyperbaric oxygen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04842448
NCT04842448Phase 2Completed

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

Karolinska University Hospital·interventional·Posted Apr 13, 2021·Updated Aug 22, 2024

In Brief

A Phase 2 clinical trial evaluating Hyperbaric oxygen and Sham treatment for COVID-19 and 5 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed 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 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.

Study Details

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedApr 13, 2021
Enrollment StartSep 15, 2021
Primary CompletionSep 27, 2023
Study CompletionJun 17, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.2 years ago

Interventions

Hyperbaric oxygendrug

Hyperbaric oxygen 240 kPa for 90 minutes (with 10 min compression time, 2 air bakes and 10 minutes decompression time).

Sham treatmentprocedure

Sham treatment 134-120 kPa Air (with 5 min compression time, and 5 min decompression to 120 kPa, two air brakes will be reported to the subjects)