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 increase (i.e. viral clearance), 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 percentage of hospitalizations OR “urgent care visits” was significantly lower (2 vs. 11 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 suppression of covid symptoms by budesonide (a corticosteroid, which may reduce chest pain and facilitate breathing).
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, strongly 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, at least, most “patients” (participants) were older than 60 years.
Conclusion: The Oxford and PRINCIPLE trials showed no real benefit of budesonide in terms of hard endpoints. Their press releases were embellished and exaggerated. Moreover, both trials had financial ties to AstraZeneca, the manufacturer of budesonide.
Why did most researchers, doctors, and the media fall for it? Because ‘Oxford’, ‘Lancet’, and ‘PRINCIPLE’. The same people already fell for the fraudulent remdesivir, anti-HCQ and WHO mask studies published in the Lancet and the New England Journal of Medicine.
Nevertheless, in the PRINCIPLE trial, participants receiving budesonide had a somewhat lower combined risk of hospitalization and death (8.5% vs. 10.3%), of oxygen administration (5.8% vs. 8.4%), and of ICU admission (1.2% vs. 2.2%). These differences were not statistically significant (too few events), but they might indicate a positive effect of budesonide in some patients.
Note: Patients are asked to consult a doctor.
Table: Outcomes of the PRINCIPLE trial