Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial

4/12 Late treatment study

Yu et al., The Lancet, doi:10.1016/S0140-6736(21)01744-X (preprint 4/12/21) (Peer Reviewed)
Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial

Source PDF Share Tweet

Interim results from the PRINCIPLE trial, 1,073 treated with budesonide starting a median of 6 days after symptom onset, showing lower hospitalization/death, and faster recovery with treatment. ISRCTN86534580.

Yu et al., 4/12/2021, Randomized Controlled Trial, United Kingdom, Europe, peer-reviewed, 24 authors.

risk of death, 39.1% lower, RR 0.61, p = 0.45, treatment 6 of 787 (0.8%), control 10 of 799 (1.3%).

risk of mechanical ventilation, 6.0% lower, RR 0.94, p = 1.00, treatment 13 of 776 (1.7%), control 14 of 784 (1.8%).

risk of ICU admission, 52.0% lower, RR 0.48, p = 0.07, treatment 10 of 771 (1.3%), control 21 of 779 (2.7%).

risk of combined hospitalization/death, 25.0% lower, RR 0.75, p = 0.96, treatment 72 of 787 (9.1%), control 116 of 1069 (10.9%), adjusted per study, day 28.

recovery time, 17.4% lower, relative time 0.83, p = 0.001, treatment 787, control 1069, adjusted per study.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. For an individual study the most serious outcome may have a smaller number of events and lower statistical signficance, however this provides the strongest evidence for the most serious outcomes when combining the results of many trials.

All 4 studies All Outcomes

Please send us corrections, updates, or comments. Vaccines and treatments are both extremely valuable and complementary. All practical, effective, and safe means should be used. Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases the risk of COVID-19 becoming endemic; and increases mortality, morbidity, and collateral damage. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. Treatment protocols for physicians are available from the FLCCC.

Submit