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All Studies   Meta Analysis    Recent:   

Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial

Yu et al., The Lancet, doi:10.1016/S0140-6736(21)01744-X (date from preprint), PRINCIPLE, ISRCTN86534580
Apr 2021  
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Mortality 39% Improvement Relative Risk Ventilation 6% ICU admission 52% Death/hospitalization 25% Recovery time 17% Budesonide  PRINCIPLE  LATE TREATMENT  RCT Is late treatment with budesonide beneficial for COVID-19? RCT 1,856 patients in the United Kingdom (November 2020 - March 2021) Faster recovery with budesonide (p=0.0012) c19early.org Yu et al., The Lancet, April 2021 Favorsbudesonide Favorscontrol 0 0.5 1 1.5 2+
Budesonide for COVID-19
19th treatment shown to reduce risk in April 2021
 
*, now with p = 0.0000011 from 15 studies, recognized in 8 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
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.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects (early treatment may be more beneficial).
risk of death, 39.1% lower, RR 0.61, p = 0.45, treatment 6 of 787 (0.8%), control 10 of 799 (1.3%), NNT 204.
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%), NNT 905.
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%), NNT 71.
risk of death/hospitalization, 25.0% lower, RR 0.75, p = 0.96, treatment 72 of 787 (9.1%), control 116 of 1,069 (10.9%), NNT 59, adjusted per study, day 28.
recovery time, 17.4% lower, relative time 0.83, p = 0.001, treatment 787, control 1,069, adjusted per study, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Yu et al., 12 Apr 2021, Randomized Controlled Trial, United Kingdom, peer-reviewed, 26 authors, study period 27 November, 2020 - 31 March, 2021, average treatment delay 6.0 days, trial ISRCTN86534580 (PRINCIPLE).
This PaperBudesonideAll
Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial
Ly-Mee Yu, PhD, M I Mona Bafadhel, Jienchi Dorward, Gail Hayward, Benjamin R Saville, Oghenekome Gbinigie, Oliver Van Hecke, Emma Ogburn, Philip H Evans, Nicholas P B Thomas, Mahendra G Patel, Duncan Richards, Nicholas Berry, Michelle A Detry, Christina Saunders, PhD Mark Fitzgerald, Victoria Harris, Milensu Shanyinde, Simon De Lusignan, Monique I Andersson, Peter J Barnes, Richard E K Russell, Dan V Nicolau, Sanjay Ramakrishnan, F D Richard Hobbs, Prof Christopher C Butler, Ly-Mee Yu, PhD, M I Mona Bafadhel, Jienchi Dorward, Gail Hayward, Benjamin R Saville, Oghenekome Gbinigie, Oliver Van Hecke, Emma Ogburn, Philip H Evans, Nicholas Pb Thomas, Mahendra G Patel, Duncan Richards, Nicholas Berry, Michelle A Detry, Christina T Saunders, PhD Mark Fitzgerald, Victoria Harris, Milensu Shanyinde, Simon De Lusignan, Monique I Andersson, Peter J Barnes, Richard Ek Russell, Dan V Nicolau, Sanjay Ramakrishnan, Fd Richard Hobbs, Prof Christopher C Butler
The Lancet, doi:10.1016/s0140-6736(21)01744-x
Background A previous efficacy trial found benefit from inhaled budesonide for COVID-19 in patients not admitted to hospital, but effectiveness in high-risk individuals is unknown. We aimed to establish whether inhaled budesonide reduces time to recovery and COVID-19-related hospital admissions or deaths among people at high risk of complications in the community. Methods PRINCIPLE is a multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial done remotely from a central trial site and at primary care centres in the UK. Eligible participants were aged 65 years or older or 50 years or older with comorbidities, and unwell for up to 14 days with suspected COVID-19 but not admitted to hospital. Participants were randomly assigned to usual care, usual care plus inhaled budesonide (800 µg twice daily for 14 days), or usual care plus other interventions, and followed up for 28 days. Participants were aware of group assignment. The coprimary endpoints are time to first self-reported recovery and hospital admission or death related to COVID-19, within 28 days, analysed using Bayesian models. The primary analysis population included all eligible SARS-CoV-2-positive participants randomly assigned to budesonide, usual care, and other interventions, from the start of the platform trial until the budesonide group was closed. This trial is registered at the ISRCTN registry (ISRCTN86534580) and is ongoing. Findings The trial began enrolment on April 2, 2020, with randomisation to budesonide from Nov 27, 2020, until March 31, 2021, when the prespecified time to recovery superiority criterion was met. 4700 participants were randomly assigned to budesonide (n=1073), usual care alone (n=1988), or other treatments (n=1639). The primary analysis model includes 2530 SARS-CoV-2-positive participants, with 787 in the budesonide group, 1069 in the usual care group, and 974 receiving other treatments. There was a benefit in time to first self-reported recovery of an estimated 2•94 days (95% Bayesian credible interval [BCI] 1•19 to 5•12) in the budesonide group versus the usual care group (11•8 days [95% BCI 10•0 to 14•1] vs 14•7 days [12•3 to 18•0]; hazard ratio 1•21 [95% BCI 1•08 to 1•36]), with a probability of superiority greater than 0•999, meeting the prespecified superiority threshold of 0•99. For the hospital admission or death outcome, the estimated rate was 6•8% (95% BCI 4•1 to 10•2) in the budesonide group versus 8•8% (5•5 to 12•7) in the usual care group (estimated absolute difference 2•0% [95% BCI -0•2 to 4•5]; odds ratio 0•75 [95% BCI 0•55 to 1•03]), with a probability of superiority 0•963, below the prespecified superiority threshold of 0•975. Two participants in the budesonide group and four in the usual care group had serious adverse events (hospital admissions unrelated to COVID-19). Interpretation Inhaled budesonide improves time to recovery, with a chance of also reducing hospital admissions or deaths (although our results..
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Late treatment
is less effective
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