Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19
NCT ID: NCT04327505
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
34 participants
INTERVENTIONAL
2020-06-03
2022-12-01
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hyperbaric oxygen
Hyperbaric oxygen 1,6-2.4 Bar for 30-60 minutes (compression/decompression time, according to local routines) in addition to best practice
Hyperbaric oxygen
1.6- 2.4 ATA, 30-60 min (excluding compression/recompression)
Control
Best practice
No interventions assigned to this group
Interventions
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Hyperbaric oxygen
1.6- 2.4 ATA, 30-60 min (excluding compression/recompression)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
8. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Exclusion Criteria
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
18 Years
90 Years
ALL
No
Sponsors
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Karolinska Trial Alliance
INDUSTRY
University of California, San Diego
OTHER
Blekinge County Council Hospital
OTHER
JK Biostatistics AB
UNKNOWN
The Swedish Research Council
OTHER_GOV
University of Regensburg
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Anders Kjellberg, MD
ICU Consultant/PhD student
Principal Investigators
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Anders Kjellberg, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Peter Lindholm, MD, PhD
Role: STUDY_CHAIR
Karolinska Institutet
Kenny Rodriguez-Wallberg, MD, PhD
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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Krankenhaus St. Joesf
Regensburg, , Germany
Blekingesjukhuset
Karlskrona, Blekinge County, Sweden
Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Oscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16.
Thibodeaux K, Speyrer M, Raza A, Yaakov R, Serena TE. Hyperbaric oxygen therapy in preventing mechanical ventilation in COVID-19 patients: a retrospective case series. J Wound Care. 2020 May 1;29(Sup5a):S4-S8. doi: 10.12968/jowc.2020.29.Sup5a.S4.
Gorenstein SA, Castellano ML, Slone ES, Gillette B, Liu H, Alsamarraie C, Jacobson AM, Wall SP, Adhikari S, Swartz JL, McMullen JJS, Osorio M, Koziatek CA, Lee DC. Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls. Undersea Hyperb Med. 2020 Third Quarter;47(3):405-413. doi: 10.22462/01.03.2020.1.
Kjellberg A, De Maio A, Lindholm P. Can hyperbaric oxygen safely serve as an anti-inflammatory treatment for COVID-19? Med Hypotheses. 2020 Nov;144:110224. doi: 10.1016/j.mehy.2020.110224. Epub 2020 Aug 30.
Kjellberg A, Douglas J, Hassler A, Al-Ezerjawi S, Bostrom E, Abdel-Halim L, Liwenborg L, Hetting E, Jonasdottir Njastad AD, Kowalski J, Catrina SB, Rodriguez-Wallberg KA, Lindholm P. COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO). J Clin Med. 2023 Jul 24;12(14):4850. doi: 10.3390/jcm12144850.
Kjellberg A, Douglas J, Pawlik MT, Kraus M, Oscarsson N, Zheng X, Bergman P, Franberg O, Kowalski JH, Nyren SP, Silvanius M, Skold M, Catrina SB, Rodriguez-Wallberg KA, Lindholm P. Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19. BMJ Open. 2021 Jul 5;11(7):e046738. doi: 10.1136/bmjopen-2020-046738.
Related Links
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Hyperbaric medicine research group, Karolinska Institutet
COVID-19 EUBS-ECHM position statement on HBOT
KI News-description of trial in layman language
Other Identifiers
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2020-001349-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
K-1199/2020
Identifier Type: REGISTRY
Identifier Source: secondary_id
COVID-19-HBO
Identifier Type: -
Identifier Source: org_study_id
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