Is inhaled budesonide (an asthma drug) really “90% effective” against covid? Not so fast.
First of all, two British budesonide trials, not one, have been published in recent days: the smaller Oxford trial published in the Lancet (about 70 patients receiving budesonide) and the larger PRINCIPLE trial published as a preprint (about 750 patients receiving budesonide).
In both trials, budesonide achieved no significant improvement in any “hard endpoint”: in the PRINCIPLE trial, there was no significant difference in hospitalizations, deaths, hospital assessment without admission, oxygen administration, and ICU admission. In the Oxford trial, there was no significant difference in the proportion of people and days with an oxygen saturation below 94%, PCR cycle threshold reduction, and FluPRO-measured symptom resolution.
Instead, both trials used “soft endpoints” to claim an effect of budesonide: in the PRINCIPLE trial, the time to “self-reported recovery” was 3 days faster (11 days vs. 14 days); in the Oxford trial, the number of hospitalizations OR “urgent care visits” was about 90% lower (1 vs. 10 persons), BUT only one person actually WAS hospitalized and required oxygen.
These “soft results” without “hard results” are best explained by a combination of the placebo effect (there was no placebo in the control group) and some superficial “feel good” symptom suppression by budesonide (a corticosteroid).
In the Oxford trial, people who received no treatment (and no placebo) were a bit more likely to contact a doctor, but weren’t actually worse off in terms of oxygen saturation. In the PRINCIPLE trial, people receiving budesonide “self-reported” symptom resolution a little bit earlier, but they weren’t actually better off in terms of hospitalization or ICU admission.
Both trials started in early 2020 and, therefore, massively overestimated the severity of covid in the general population (they assumed a 20% hospitalization rate). In the Oxford trial, the median age of “patients” (participants) was just 45 years, and their initial PCR ct value was already a very high 32. In the Principle trial, most “patients” (participants) at least were older than 65 years.
Conclusion: The Oxford and PRINCIPLE trials showed no real benefit of budesonide in terms of hard endpoints.