Safety and Efficacy of Hyperbaric Oxygen Therapy for Long COVID Syndrome

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.

Conditions

• COVID-19
• Post COVID-19 Condition
• Post COVID-19 Condition, Unspecified
• Post COVID Condition
• Post-COVID Syndrome
• Post-Acute COVID-19 Syndrome

Interventions

DRUG

Hyperbaric oxygen

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

PROCEDURE

Sham treatment

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)

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Karolinska Trial Alliance

  collaborator INDUSTRY

• EDC Scandinavia AB

  collaborator UNKNOWN

• Swedish Heart Lung Foundation

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• The Swedish Research Council

  collaborator OTHER_GOV

• Karolinska University Hospital

  lead OTHER

Principal Investigators

• Anders Kjellberg, MD, PhD · Karolinska University Hospital (and Karolinska Insitutet)

• Judith Bruchfeld, MD, PhD · Karolinska University Hospital (and Karolinska Insitutet)

• Malin Nygren-Bonnier, PhD · Karolinska University Hospital (and Karolinska Insitutet)

• Michael Runold, MD, PhD · Karolinska University Hospital (and Karolinska Insitutet)

• Marcus Ståhlberg, MD, PhD · Karolinska University Hospital (and Karolinska Insitutet)

• Peter Lindholm, MD, PhD · Karolinska Insitutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2023-09-27

Completion

2024-06-17

Countries

• Sweden

Study Locations