Trial | NCT04327505  Report issue

Title

Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    34
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 there is no effective cure.

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.
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
Study Started
Jun 03
2020
Primary Completion
Jun 30
2022
Study Completion
Dec 01
2022
Last Update
Jan 09
2023

Drug Hyperbaric oxygen

1.6- 2.4 ATA, 30-60 min (excluding compression/recompression)

  • Other names: HBO

Hyperbaric oxygen Experimental

Hyperbaric oxygen 1,6-2.4 Bar for 30-60 minutes (compression/decompression time, according to local routines) in addition to best practice

Control No Intervention

Best practice

Criteria 

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)
No Results Posted