Trial document




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  DRKS00021626

Trial Description

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Title

A Randomized, 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

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Trial Acronym

COVID-19-HBO

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URL of the Trial

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Brief Summary in Lay Language

In a randomized multicenter clinical trial, we are investigating a treatment method that could prevent admission to the intensive care unit and reduce mortality.

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Brief Summary in Scientific Language

Safety and effectiveness of hyperbaric oxygen therapy for ARDS in patients with COVID-19.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021626
  •   2020/05/11
  •   2020/03/31
  •   yes
  •   Approved
  •   5.1-2020-36673, Swedish Medical Products Agency
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Secondary IDs

  •   2020-001349-37 
  •   NCT04327505  (clinicaltrials.gov)
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Health Condition or Problem studied

  •   SARS-CoV-2
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Interventions/Observational Groups

  •   Intervention:
    Hyperbaric oxygen therapy (HBO) in addition to the best possible therapy COVID-19 pneumonitis
    Product, dosage: HBO, HBO 1.6-2.4 ATA for 30-60 min, maximum 5 treatments in the first 7 days
  •   Best possible therapy for COVID-19 pneumonitis
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   No
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Primary Outcome

The proportion of subjects admitted to the intensive care unit from day 1 to day 30, based on at least one of the following criteria
1. rapid progression over hours
2. lack of improvement in oxygen with high flow >40L/min or non-invasive ventilation with a proportion of inhaled oxygen (FiO2) > 0.6
3. developing hypercapnea or increased work of breathing that does not respond to increased oxygen despite maximum standard therapy available outside the ICU
4. haemodynamic instability or multi-organ failure with maximum standard care available outside the ICU

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Secondary Outcome

I. 1. percentage of subjects with 30-day deaths, all deaths caused, percentage of subjects, from day 1 to day 30
II. 2. time-to-intubation, i.e. cumulative days without invasive mechanical ventilation, from day 1 to day 30
III. 3. time to ICU, i.e. cumulative ICU-free days, derived as the number of days from day 1 to ICU, counting all ICU-free subjects on day 30
IV. 4. mean change in the inflammatory response from day 1 to day 30 or last day in hospital if the patient is discharged earlier, or if the subject withdraws his or her consent to the study

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Countries of Recruitment

  •   Germany
  •   Sweden
  •   United States
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/05/25
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional 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
• Auto-immune disease
5) Documented informed consent according to ICH-GCP and national regulations

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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 fullfill 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

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Addresses

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    • Karolinska Institutet, Departement Physiology und Pharmacology
    • Mr.  Dr.  Peter  Lindholm 
    • C3 FyFa
    • 17177  Stockholm
    • Sweden
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    • St. Josefshospital
    • Mr.  PD Dr.  Michael  Pawlik 
    • Landshuter Strasse 65
    • 93053  Regensburg
    • Germany
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    • Dept. Physiology and PharmacologyHyperbaric Medicine
    • Mr.  Dr.  Anders  Kjiellberg 
    • C3 FyFa
    • 17177  Stockholm
    • Sweden
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    • Bergmannsheil Buer GmbH
    • Mr.  Georg  Rinneberg 
    • Schernerweg 4
    • 45894  Gelsenkirchen
    • Germany
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Sources of Monetary or Material Support

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    • Bergmannsheil Buer GmbH
    • Mr.  Dr. med.  Michael  Kraus 
    • Schernerweg 4
    • 45894  Gelsenkirchen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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