COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001349-37/SE

Karolinska Institutet - Anders Kjellberg

anders.kjellberg@ki.se

2020-04-24

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

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 pregnabest practicency 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 9) Prisoner (Exclusion criteria according to IRB at UCSD)

2

Karolinska Institutet

18

90

Germany;Netherlands;Spain;United States;Sweden

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

50

The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnea or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failiure with maximum standard of care availible outside ICU

TODO

Phase 2

[{"arm_notes": "cryogenic", "treatment_id": 943, "treatment_name": "Oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "compressed", "treatment_id": 943, "treatment_name": "Oxygen", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}]