Summary of COVID-19 budesonide studies

146 patient budesonide early treatment RCT: 82% fewer combined hospitalization/ER visits (p=0.02) and 67% improved recovery (p=0.003).
RCT with 73 budesonide patients and 73 control patients, showing significantly lower combined risk of an ER visit or hospitalization, and lower risk of no recovery at day 14.
Feb 2021, Lancet Respiratory Medicine, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00160-0/fulltext, https://c19p.org/ramakrishnan

2. Dhanger et al., To estimate the efficacy of inhaled corticosteroid in-patient of moderate COVID-19 pneumonia - randomized controlled study

80 patient budesonide late treatment RCT: 43% lower mortality (p=0.52), 78% lower ICU admission (p<0.0001), and 70% improved recovery (p<0.0001).
RCT inhaled budesonide with 80 moderate COVID-19 pneumonia patients. The budesonide group had significantly faster time to clinical improvement, fewer ICU admissions, shorter oxygen therapy duration, and lower mortality. Inhaled budesonide 400mcg twice daily for 14 days.
Sep 2023, Int. J. Academic Medicine and Pharmacy, https://academicmed.org/Uploads/Volume5Issue5/101.%20[1518.%20JAMP_Bhavani%20Vaidiyanathan]%20517-521.pdf, https://c19p.org/dhanger

3. Yu et al., 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

1,856 patient budesonide late treatment RCT: 39% lower mortality (p=0.45), 6% lower ventilation (p=1), 52% lower ICU admission (p=0.07), and 25% lower combined mortality/hospitalization (p=0.96).
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.
Apr 2021, The Lancet, https://www.sciencedirect.com/science/article/pii/S014067362101744X, https://c19p.org/yu3

4. Bhandari et al., Effectiveness of Inhaled Steroids in Post COVID Cough

120 patient budesonide late treatment study: 33% lower need for oxygen therapy (p=0.009), 26% shorter hospitalization (p=0.02), and 37% faster recovery (p=0.001).
Retrospective 120 hospitalized COVID-19 patients with persistent cough in India, showing faster resolution of cough, shorter duration of oxygen support, and shorter hospitalization with inhaled budesonide treatment compared to standard of care alone.
Mar 2022, Int. J. Scientific Development and Research, https://mail.ijsdr.org/viewpaperforall.php?paper=IJSDR2203020, https://c19p.org/bhandari2

5. Monserrat Villatoro et al., A Case-Control of Patients with COVID-19 to Explore the Association of Previous Hospitalisation Use of Medication on the Mortality of COVID-19 Disease: A Propensity Score Matching Analysis

budesonide prophylaxis PSM study: 49% lower mortality (p=0.01).
PSM retrospective 3,712 hospitalized patients in Spain, showing lower mortality with existing use of azithromycin, bemiparine, budesonide-formoterol fumarate, cefuroxime, colchicine, enoxaparin, ipratropium bromide, loratadine, mepyramine theophylline acetate, oral rehydration salts, and salbutamol sulphate, and higher mortality with acetylsalicylic acid, digoxin, folic acid, mirtazapine, linagliptin, enalapril, atorvastatin, and allopurinol.
Jan 2022, Pharmaceuticals, https://www.mdpi.com/1424-8247/15/1/78, https://c19p.org/monserratvillatoro

6. Ramlall et al., Melatonin is significantly associated with survival of intubated COVID-19 patients

948 patient budesonide ICU study: 71% lower mortality (p=0.01).
Retrospective 948 intubated patients, 33 treated with budesonide, showing lower mortality with treatment.
Oct 2020, medRxiv, https://www.medrxiv.org/content/10.1101/2020.10.15.20213546v1, https://c19p.org/ramlallu

7. Samajdar et al., Effectiveness of budesonide formoterol fixed-dose combination MDI in reducing cough symptoms in COVID-19 patients: A real-world evidence study

102 patient budesonide late treatment study: 69% lower hospitalization (p=0.07) and 29% improved recovery (p=0.008).
Prospective study of 102 patients in India, showing improved recovery of cough with budesonide+formoterol. Authors note better results with earlier treatment. Budesonide 800mcg + formoterol 12mcg bid for 7 days.
Mar 2023, Lung India, https://journals.lww.com/10.4103/lungindia.lungindia_268_22, https://c19p.org/samajdar2

8. Loucera et al., Real-world evidence with a retrospective cohort of 15,968 COVID-19 hospitalized patients suggests 21 new effective treatments

15,968 patient budesonide prophylaxis study: 22% lower mortality (p=0.004).
Retrospective 15,968 COVID-19 hospitalized patients in Spain, showing lower mortality with existing use of several medications including metformin, HCQ, azithromycin, aspirin, vitamin D, vitamin C, and budesonide. Since only hospitalized patients are included, results do not reflect different probabilities of hospitalization across treatments.
Aug 2022, Virology J., https://virologyj.biomedcentral.com/articles/10.1186/s12985-023-02195-9, https://c19p.org/loucera3u

9. Al Sulaiman et al., The Role of Inhaled Corticosteroids (ICS) in Critically Ill Patients With COVID-19: A Multicenter, Cohort Study

130 patient budesonide ICU PSM study: 32% lower mortality (p=0.13).
Combined retrospective (Mar-Jun 2020) and prospective (until Mar 2021) study of 954 COVID+ ICU patients in Saudi Arabia, 68 treated with ICS (80% budesonide or budesonide/formoterol, 20% fluticasone/salmeterol), showing lower mortality with treatment, statistically significant for 30-day but not in-hospital mortality.
Nov 2021, J. Intensive Care Medicine, https://journals.sagepub.com/doi/full/10.1177/08850666211053548, https://c19p.org/alsulaiman3

10. Bai et al., COPD patients with high blood eosinophil counts exhibit a lower rate of omicron infection and milder post‐infection symptoms

315 patient budesonide prophylaxis study: 31% lower hospitalization (p=0.18) and 24% fewer cases (p=0.0001).
Retrospective 315 COPD patients in China showing significantly lower COVID-19 cases with budesonide/formoterol or budesonide/glycopyrronium/formoterol use. Note that Table 4 includes only infected patients, we show the COVID-19 hospitalization risk among all patients with known medication status. Minimal details are provided for the groups on these medications.
May 2024, The Clinical Respiratory J., https://onlinelibrary.wiley.com/doi/10.1111/crj.13790, https://c19p.org/bai

11. Lee et al., Association Between Inhaled Corticosteroid Use and the Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Nationwide Population-based Study in South Korea

7,019 patient budesonide prophylaxis study: 33% fewer cases (p=0.1).
Retrospective 44,968 patients in South Korea, 7,019 on inhaled corticosteroids, showing no statistically significant differences in COVID-19 cases.
Sep 2021, Research Square, https://www.researchsquare.com/article/rs-72221/v1, https://c19p.org/lee2

12. Yang et al., The relationship between oxygen therapy, drug therapy, and COVID-19 mortality

185 patient budesonide late treatment study: 11% higher mortality (p=0.85).
Retrospective 185 hospitalized COVID-19 patients in China, showing no significant difference in mortality with budesonide use in unadjusted results.
Aug 2022, Open Medicine, https://www.degruyter.com/document/doi/10.1515/med-2022-0569/html, https://c19p.org/yang3

13. Agustí et al., Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial

89 patient budesonide late treatment RCT: 23% higher mortality (p=1) and 39% lower progression (p=0.69).
Small early-terminated RCT with 40 inhaled budesonide and 49 control patients, showing no significant differences. 400µg/12h via Pulmicort Turbuhaler.
Feb 2022, European Respiratory J., https://erj.ersjournals.com/content/early/2022/01/13/13993003.03036-2021, https://c19p.org/agusti2

14. Alsultan et al., Efficacy of Colchicine and Budesonide in Improvement Outcomes of Patients with Coronavirus Infection 2019 in Damascus, Syria: A Randomized Control Trial

35 patient budesonide late treatment RCT: 7% higher mortality (p=1) and 20% shorter hospitalization.
Small RCT 49 severe condition hospitalized patients in Syria, showing lower mortality with colchicine and shorter hospitalization time with both colchicine and budesonide (all of these are not statistically significant).
Dec 2021, Interdisciplinary Perspectives on Infectious Diseases, https://www.hindawi.com/journals/ipid/2021/2129006/, https://c19p.org/alsultan

15. Reis et al., Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19

1,476 patient budesonide early treatment RCT: 12% lower hospitalization (p=1) and 50% lower progression (p=0.04).
Low-risk (1% hospitalization) outpatient RCT with 738 fluvoxamine + budesonide patients and 738 placebo patients, showing significantly lower hospitalization/ER visits with treatment.
Apr 2023, Annals of Internal Medicine, https://www.acpjournals.org/doi/epdf/10.7326/M22-3305, https://c19p.org/reis10u

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