A PILOT STUDY PROPOSITION FOR THE SAFETY AND EFFICACY OF HYPERBARIC OXYGEN FOR THE PREVENTION AND TREATMENT OF CHRONIC POST-COVID SYMPTOMS. “POST-COVID SYNDROME”

A PILOT STUDY PROPOSITION FOR THE SAFETY AND EFFICACY OF HYPERBARIC OXYGEN FOR THE PREVENTION AND TREATMENT OF CHRONIC POST-COVID SYMPTOMS. “POST-COVID SYNDROME”

March 09, 2022

Clinical Research, Midlands Diving Chamber, Hospital of St Cross, Rugby, Warwickshire.

info@midlandsdivingchamber.co.uk

Introduction: SARS-CoV-2 affects the innate immune response and activates an inflammatory cascade. Hyperbaric oxygen (HBOT) has proven anti-inflammatory effects. This has been seen in the acute hospitalised phase of infection and evidence has also shown that discharged patients still show Chest X-ray changes of pulmonary fibrosis. Post-SARS studies have shown up to 43% prevalence of impaired lung gas diffusion up to 2 years from discharge.

Previous post SARS studies have shown a high incidence of Post Viral Syndrome, even up to 4 years post-infection and notably high in health workers.

A prevalent symptom of SARS-CoV-2 infection is “silent hypoxia”. When severe, this will lead to the patient’s hospitalization or death. If moderate, the home-isolator can have oxygen saturations below 90% for several days.

There is no evidence as to the long term effects of this, but using a model of the chronic hypoxia of carbon monoxide poisoning – similar symptoms in the Delayed Neuropsychological Syndrome of COP are seen in Post-Covid Syndrome.

Hyperbaric oxygen has been shown to be effective across all 3 aetiologies that can cause chronic symptoms after SARS-CoV-2. Our hypothesis is that early use of HBOT after discharge – in patients, who needed supplemental oxygen whilst hospitalized, will prevent long term symptoms. Our secondary hypothesis is that HBOT will alleviate symptoms in those already with long-term symptoms.

Materials and Methods: This is a pre-trial proposition and if successful will go to a full “randomised, controlled trial for the safety and efficacy of hyperbaric oxygen for the prevention and treatment of chronic post-covid symptoms- “Post-Covid Syndrome”. This will take place at Midlands Diving Chamber, Rugby, Warwickshire.

Study Design: An observational study where positive results will lead to a full RCT

Study Population: 10 patients already with long term symptoms. 10 patients recently discharged who had received supplemental oxygen either CPAP or ventilation

Intervention: HBOT at 2.4 atm for 90 minutes with air breaks. One session daily. 10 in total across 2 weeks.

Control: Current best practise for discharged SARS-CoV-2 patients and those still with chronic symptoms.

Indices: FEV1, FVC , Sa02, TCOM – at MDC //  IL6, CRP, DLCO, Lung CT – local provider

Study endpoint: Participants will have 10 HBOT sessions. After this their indices will be compared to those at the beginning. If they have improved and they are symptom free then they will leave the trial with a 30 day follow up. If indices have improved but there are still Post-covid symptoms another 10 sessions of HBOT will be given with follow up after. A maximum of 40 sessions will be allowed.

Results: All results will be peer reviewed and published in a relevant journal. We await a Clinical Trial number

Funding: The Diving Chamber Treatment Trust. Charity Number: 1139049

Summary and Conclusions: A positive result from this observational study will lead to full RCT. The implications of this would new best practice in discharged SARS-CoV-2 patients who needed supplemental oxygen whilst in hospital, as well as a new treatment modality for Post-Covid Syndrome.