Thanks to Scott for summarizing this trial today! COLDSTER
In patients who had COVID 3-8 weeks ago, who have dyspnea or hypoxia and >20% abnormalities on CT, do high vs low dose steroids help and is one dose better than the other?
290 patients -> 160 excluded (82 too mild lung abnormalities)
130 randomized 1:1 -> high dose (40 x1 w then 30mg x1w then 20mgx2w then 10mg x2w) vs low dose (10mg x6w) treatment
Baseline tests, 2, 4 weeks in telephone checkin for adherence, adverse effects, final 6 week checkin – lost 4 in one arm and 5 in another arm
57yo, only 32% female, 73% had at least one comorbidity, all had required hospitalization for acute COVID, 98% having WHO severe disease, 43% received mech vent, 91% had organizing pneumonia patterns on CT
Scored images by lobe and averaged and primary outcome was >90% radiological improvement and they also had numerous subgroups.
There were low rates of ‘complete radiological response’ in both groups 25%-19%. Both groups had improvements in FVC, 6MWT, symptom scores, and overall CT scores.
Both groups had adverse effects including hyperglycemia (though only 30%), hypertension (23-21%), cushinoid habitus (20%). No deaths in either groups, 3 infections in high dose and 1 in low dose group, all treated.
It seems that in these post-acute COVID patients, low steroid dose with 10mg prednisolone performs similarly to high dose steroids to improve symptoms and imaging.
Limitations include the small size and lack of blinding. There haven’t yet been a placebo trial either, so that could be a next step. Also, was this done too soon, as patients may still have been recovering from the original infection? Multi-center would be nice as well, and blinding where able (for example, reviewers of the CT).
Thanks, Dr. Laurenzo!
