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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet; Karolinska University Hospital
• Collaborators: Blekinge County Council Hospital; JK Biostatistics AB; Karolinska Institutet; Karolinska Trial Alliance; The Swedish Research Council; University of California, San Diego; University of Regensburg

Criteria

Inclusion criteria:

1. Aged 18-90 years

2. PaO2/FiO2 (PFI) below 200 mmHg (26.7 kPa)

3. Suspected or verified SARS-CoV-2 infection

4. At least two risk factors for increased morbidity/mortality

• Age above 50 years

• Hypertension

• Cardiovascular disease

• Diabetes or pre-diabetes

• Active or cured cancer

• Asthma/COPD

• Smoking

• D-Dimer > 1.0 mg/L

• Auto-immune disease

5. Documented informed consent according to ICH-GCP and national regulations

Exclusion Criteria:

1. ARDS/pneumonia caused by other viral infections (positive for other virus)

2. ARDS/pneumonia caused by other non-viral infections or trauma

3. Known pregnancy or positive pregnancy test in women of childbearing age

4. Patients with previous lung fibrosis more than 10%

5. CT- or Spirometry-verified severe COPD with Emphysema

6. Contraindication for HBO according to local guidelines

7. Not likely to need ICU admission < 7 days of screening (Subjective criteria that may exclude any patients that fulfil the other inclusion criteria but where the treating physician suspect a spontaneous recovery)

8. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

9. Prisoner (Exclusion criteria according to IRB at UCSD)