Status:
TERMINATED
Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska Trial Alliance
University of California, San Diego
Conditions:
SARS (Severe Acute Respiratory Syndrome)
Cytokine Storm
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief 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 the...
Detailed Description
Main objective: To evaluate if HBO reduce the number of ICU admissions compared to Best practice for COVID-19 Secondary objectives: Main secondary objectives: To evaluate if HBO: * reduces mortali...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged 18-90 years
- PaO2/FiO2 (PFI) below 200 mmHg (26.7 kPa)
- Suspected or verified SARS-CoV-2 infection
- 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
- Documented informed consent according to ICH-GCP and national regulations
- Exclusion Criteria:
- ARDS/pneumonia caused by other viral infections (positive for other virus)
- ARDS/pneumonia caused by other non-viral infections or trauma
- Known pregnancy or positive pregnancy test in women of childbearing age
- Patients with previous lung fibrosis more than 10%
- CT- or Spirometry-verified severe COPD with Emphysema
- Contraindication for HBO according to local guidelines
- 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)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Prisoner (Exclusion criteria according to IRB at UCSD)
Exclusion
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04327505
Start Date
June 3 2020
End Date
December 1 2022
Last Update
January 9 2023
Active Locations (3)
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1
Krankenhaus St. Joesf
Regensburg, Germany, 93053
2
Blekingesjukhuset
Karlskrona, Blekinge County, Sweden
3
Karolinska University Hospital
Stockholm, Sweden, 171 76