Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Failure
- ARDS, Human
- COVID-19
- Cytokine Storm
- SARS (Severe Acute Respiratory Syndrome)
- SARS COV2
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled, open label, multi-centre clinical trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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 mortality in severe cases of COVID-19. reduces morbidity associated with COVID-19. reduce the load on ICU resourc...
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 mortality in severe cases of COVID-19. reduces morbidity associated with COVID-19. reduce the load on ICU resources in COVID-19. mitigate the inflammatory reaction in COVID-19. Other secondary objectives (in selection): To evaluate if HBO is safe for SARS-CoV-2 positive patients and staff. Study design: Randomized, controlled, phase II, open label, multicentre Study population: Adult patients with SARS-CoV-2 infection, with at least two risk factor for increased mortality, likely to develop ARDS criteria and need intubation within 7 days of admission to hospital. Number of subjects: 200 (20+180) Investigational product: Hyperbaric oxygen (HBO) compared with best practice treatment HBO: HBO 1.6-2.4 ATA for 30-60 min, maximum 5 treatments first 7 days Control: Best practice treatment for COVID-19
Tracking Information
- NCT #
- NCT04327505
- Collaborators
- Karolinska Trial Alliance
- University of California, San Diego
- Blekinge County Council Hospital
- JK Biostatistics AB
- The Swedish Research Council
- University of Regensburg
- Investigators
- Principal Investigator: Anders Kjellberg, MD Karolinska Institutet Study Chair: Peter Lindholm, MD, PhD Karolinska Institutet Study Chair: Kenny Rodriguez-Wallberg, MD, PhD Karolinska Institutet
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