A Randomized, Controlled, Open Label, Multicentre Clinical Trial to explore Safety and Efficacy of Hyperbaric Oxygen for preventingICU admission, Morbidity and Mortality in Adult Patients With COVID-19

Phase 2

Conditions: SARS-CoV-2

Registration Number: DRKS00021626

Lead Sponsor: Karolinska Institutet, Departement Physiology und Pharmacology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>1. rapid progression over hours<br>2. lack of improvement in oxygen with high flow >40L/min or non-invasive ventilation with a proportion of inhaled oxygen (FiO2) > 0.6<br>3. developing hypercapnea or increased work of breathing that does not respond to increased oxygen despite maximum standard therapy available outside the ICU<br>4. haemodynamic instability or multi-organ failure with maximum standard care available outside the IC

Secondary Outcome Measures

Name	Time	Method
I. 1. percentage of subjects with 30-day deaths, all deaths caused, percentage of subjects, from day 1 to day 30<br>II. 2. time-to-intubation, i.e. cumulative days without invasive mechanical ventilation, from day 1 to day 30<br>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<br>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