Kan vi bota långvariga besvär efter COVID-19 med hyperbar oxygen (HBO): En randomiserad placebokontrollerad läkemedelsprövning.

Bakgrund:

We are currently running a multicenter randomized clinical trial (RCT) according to ICH-GCP treating acute COVID-19 with hyperbaric oxygen (HBO). Its one of few trials with a proposed curative treatment of severe COVID-19, and it follows the pattern of previously published case-series that showed faster recovery in the treated group. HBO is also used by Karolinska to treat other chronic inflammatory conditions e.g. radiation cystitis.

Case reports and published data from lung perfusion scans with Magnetic Resonance Imaging (MRI) or Dual Energy Computed Tomography (DECT) (own preliminary data) indicate lung perfusion anomalies even in areas not looking pathological on regular chest x-ray or non-enhanced computer tomography. This would suggest microvascular pathology in the lungs and/or small airways disease.

We hypothesize that Long COVID (LCOV) is caused by with a dysregulated adaption to hypoxia with chronic inflammatory component that can be treated by the anti-inflammatory effects of hyperbaric oxygen. Målsättning: To evaluate the efficacy of HBO in alleviating symptoms associated with LCOV. Arbetsplan:

Study design: Prospective randomized, placebo-controlled, double blind, phase II, estimated enrolment: 80 Study population: Adult patients, 18-60-years old with LCOV for at least 12 weeks duration. Intervention: Hyperbaric oxygen (HBO). HBO: 2.4 ATA for 90 min, maximum 10 treatments within 30 days from inclusion.

Control: Placebo treatment with “sham” breathing air at moderately higher pressure (1.34 ATA) to simulate pressure chamber treatment. Primary endpoint: Health related quality of life using RAND 36-item health survey. Secondary efficacy endpoints (in selection): Subjective rating of physical and cognitive symptoms after HBO

treatment using self-reported questionnaires at baseline, 1 month and 3 months. Mean change in objective organ specific and general physical tests at baseline, 1 month and 3 months. Mean change in objective organ specific finding on MRI and DECT at baseline, and 3 months. Post study economical cost/benefit evaluation after 1-year.

Betydelse:

LCOV seems to affect approximately 10% of people infected with SARS-CoV-2. With over 100 million confirmed COVID-19 cases globally (600 000 in Sweden), the healthcare systems and their infrastructure are at risk of collapse if we cannot find an effective way of treating these patients. To date few treatment options are available.