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. 2021 Jul 5;11(7):e046738. doi: 10.1136/bmjopen-2020-046738

Table 3.

COVID-19-HBO: trial endpoints

Primary endpoint The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria:
(1) Rapid progression over hours
(2) Lack of improvement on high flow oxygen >40 L/min or non-invasive ventilation with fraction of inspired oxygen (FiO2) >0.6
(3) Evolving hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU
(4) Haemodynamic instability or multiorgan failure with maximum standard of care available outside ICU
Secondary endpoints (in selection)
Main secondary efficacy endpoints (1) Proportion of subjects with 30-day mortality, all-cause mortality, from day 1 to day 30.
(2) Time-to-intubation, that is, cumulative days free of invasive mechanical ventilation, from day 1 to day 30
(3) Time-to-ICU, that is, cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30
(4) Mean change in inflammatory response from day 1 to day 30

  1. White cell count+differentiation

  2. Procalcitonin

  3. C-reactive protein

  4. Cytokines (IL-6) (if available at local laboratory)

  5. Ferritin

  6. D-dimer

  7. LDH

(5) Overall survival
Safety endpoints (1) The number of subjects, proportion of subjects and number of events of AE
(2) The number of subjects, proportion of subjects and number of events of SAE
(3) The number of subjects, proportion of subjects and number of events of SADR
(4) Mean change in PaO2/FiO2 before and after HBO compared with mean variance in PaO2/FiO2 in the control group during day 1 to day 7
(5) Mean change in NEWS before and after HBO compared with mean change in daily NEWS in the control group during day 1 day 7
(6) Number of negative events in staff associated with treatment of subject (eg, contact with aerosol from subject), number of events from day 1 to day 30 or last day in hospital if subject is discharged earlier, or at withdrawal

ABG, arterial blood gas; AE, adverse event; COPD, chronic obstructive pulmonary disease; HBO, hyperbaric oxygen; ICU, intensive care unit; LDH, lactate dehydrogenase; PFI, Ratio of arterial oxygen partial pressure to fraction of inspired oxygen; SADR, suspected adverse drug reaction; SAE, serious adverse events.