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
Organizational Data
- DRKS-ID:
- DRKS00021626
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2020-05-11
- Last update in DRKS:
- 2020-05-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
COVID-19-HBO
URL of the study
No Entry
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.
Brief summary in scientific language
Safety and effectiveness of hyperbaric oxygen therapy for ARDS in patients with COVID-19.
Health condition or problem studied
- Free text:
- SARS-CoV-2
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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
- Arm 2:
- Best possible therapy for COVID-19 pneumonitis
Endpoints
- 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
- 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
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Sweden
- United States
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Dept. Physiology and Pharmacology Stockholm
- University medical center St. Josefshospital Regensburg
- University medical center Department of Emergency Medicine San Diego
- Medical center Bergmannsheil Buer Gelsenkirchen
Recruitment period and number of participants
- Planned study start date:
- 2020-05-25
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 90 Years
- 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
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
Addresses
Primary Sponsor
- Address:
- Karolinska Institutet, Departement Physiology und PharmacologyDr. Peter LindholmC3 FyFa17177 StockholmSweden
- Telephone:
- +46730621184
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Dept. Physiology and PharmacologyHyperbaric MedicineDr. Anders KjiellbergC3 FyFa17177 StockholmSweden
- Telephone:
- +468760657355
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Bergmannsheil Buer GmbHGeorg RinnebergSchernerweg 445894 GelsenkirchenGermany
- Telephone:
- +4920959027446
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil-buer.de
Principal Investigator
- Address:
- Dept. Physiology and PharmacologyHyperbaric MedicineDr. Anders KjiellbergC3 FyFa17177 StockholmSweden
- Telephone:
- +468760657355
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Bergmannsheil Buer GmbHSchernerweg 445894 GelsenkirchenGermany
- Telephone:
- +492095902281
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bergmannsheil-buer.de
Ethics Committee
Address Ethics Committee
- Address:
- Swedish Medical Products AgencyP.O. Box 26751 03 UppsalaSweden
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.lakemedelsverket.se
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-04-03
- Ethics committee number:
- 5.1-2020-36673
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-04-29
Further identification numbers
- Other primary registry ID:
- NCT04327505 - clinicaltrials.gov
- EudraCT Number:
- 2020-001349-37
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- COVID-19-HBO Studie
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry