Australia will be initiating a randomized trial of BCG vaccination of health care professionals https://www.clinicaltrialsarena.com/news/australia-bcg-vaccine-trial-covid-19/
They are deciding how to classify Covid-19 by severity of disease. Does this group have definitions for mild, moderate & severe Covid-19 that I could share with the trialists?
Well, here is an ordered list in this study
Percentage of subjects reporting each severity rating on an 8-point ordinal scale [ Time Frame: Day 15 ]
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
2 Likes
This might be great resource we can try, too. @Vojtech_Huser
By using Korean claim data, I don’t think we can distinguish 3 and 4, though ( 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen).
1 Like
Thank you @Vojtech_Huser. Looking at some of the Covid-19 study codes, I suggested severe= hospitalized with diagnosis of ARDS or ARF, use of mechanical ventilation, tracheostomy, ECMO; moderate = hospitalized without requiring intensive services, and mild= not hospitalized. But nice to have this finer gradation. Thanks for the reference
1 Like
I agree with @SCYou! maybe we could try this in the COVID-tested (alpha protocol) study @agolozar? perhaps it is too late now to implement in the protocol…
1 Like
This is a great resource. We had a similar discussion during the study-a-thon to add these categories in the tested-protocol but did not move forward with it because we did not have a clear way to define severity without looking into future. We can add this to the protocol and look at these categories at Index pending availability of data? @SCYou, any thoughts?
1 Like
Thanks for the clarification! Yes, this severity score is based on outcomes and not clinical presentation so I would see it fitting for the second part of the study: outcomes of covid-positive patients. In regards to this, I always find it very appropriate (and elegant) to use predefined scores that have already been used even if not perfectly fitting, like @SCYou and @CSung pointed out.