Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19

Summary

COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure.

We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality.

The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.

Conditions

• SARS (Severe Acute Respiratory Syndrome)
• Cytokine Storm
• ARDS, Human
• COVID-19
• Sars-CoV2
• Acute Respiratory Failure

Interventions

DRUG

Hyperbaric oxygen

1.6- 2.4 ATA, 30-60 min (excluding compression/recompression)

Sponsors & Collaborators

• Karolinska Trial Alliance

  collaborator INDUSTRY

• University of California, San Diego

  collaborator OTHER

• Blekinge County Council Hospital

  collaborator OTHER

• JK Biostatistics AB

  collaborator UNKNOWN

• The Swedish Research Council

  collaborator OTHER_GOV

• University of Regensburg

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Anders Kjellberg, MD · Karolinska Institutet

• Peter Lindholm, MD, PhD · Karolinska Institutet

• Kenny Rodriguez-Wallberg, MD, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-03

Primary Completion

2022-06-30

Completion

2022-12-01

Countries

• Germany
• Sweden

Study Locations