Heterogeneity of treatment effect of higher dose dexamethasone by geographic region (Europe vs. India) in patients with COVID-19 and severe hypoxemia – a post hoc evaluation of the COVID STEROID 2 trial.

Heterogeneity of treatment effect of higher dose dexamethasone by geographic region (Europe vs. India) in patients with COVID-19 and severe hypoxemia – a post hoc evaluation of the COVID STEROID 2 trial.

Publication date: Jan 01, 2024

In the COVID-STEROID 2 trial there was suggestion of heterogeneity of treatment effects (HTE) between patients enrolled from Europe vs. India on the primary outcome. Whether there was HTE for the remaining patient-centred outcomes is unclear. In this post hoc analysis of the COVID-STEROID 2 trial, which compared 12 mg vs. 6 mg dexamethasone in adults with COVID-19 and severe hypoxemia, we evaluated HTE by geographical region (Europe vs. India) for secondary outcomes with analyses adjusted for stratification variables. Results are presented as risk differences (RDs) or mean differences (MDs) with 99% confidence intervals (CIs) and P-values from interaction tests. There were differences in mortality at day 28 (RD for Europe -8. 3% (99% CI: -17. 7 to 1. 0) vs. India 0. 1% (99% CI: -10. 0 to 10. 0)), mortality at day 90 (RD for Europe -7. 4% (99% CI: -17. 1 to 2. 0) vs. India -1. 4% (99% CI: -12. 8 to 9. 8)), mortality at day 180 (RD for Europe -6. 7% (99% CI: -16. 4 to 2. 9) vs. India -1. 0% (99% CI: -12. 3 to 10. 3)), and number of days alive without life support at day 90 (MD for Europe 6. 1 days (99% CI: -1. 3 to 13. 4) vs. India 1. 7 days (99% CI: -8. 4 to 11. 8)). For serious adverse reactions, the direction was reversed (RD for Europe -1. 0% (99% CI: -7. 1 to 5. 2) vs. India -5. 3% (99% CI: -16. 2 to 5. 0). Our analysis suggests higher dose dexamethasone may have less beneficial effects for patients in India as compared with those in Europe; however, the evidence is weak, and this could represent a chance finding. None for this analysis. The COVID STEROID 2 trial was funded by The Novo Nordisk Foundation and supported by Rigshospitalet’s Research Council.

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Concepts Keywords
12mg COVID-19
Adults Developing countries
Europe Randomised controlled trials
Hypoxemia Steroids
Nordisk

Semantics

Type Source Name
disease VO dose
drug DRUGBANK Dexamethasone
disease MESH COVID-19
disease IDO geographical region
drug DRUGBANK Coenzyme M
disease VO population
disease MESH comorbidity
disease MESH infections
drug DRUGBANK Oxygen
disease IDO infection
disease MESH fungal infection
disease MESH septic shock
disease MESH invasive fungal infection
disease MESH bleeding
disease MESH anaphylactic reaction
disease MESH death
disease IDO country
disease IDO site
disease MESH morbidities
disease MESH heart failure
disease MESH Diabetes mellitus
disease MESH Emergency
disease VO vaccination
disease MESH bacterial meningitis
drug DRUGBANK Proline
disease IDO immunodeficiency
disease IDO pathogen
disease MESH sepsis
disease IDO symptom
disease MESH asthma
pathway KEGG Asthma
drug DRUGBANK Etoperidone
disease MESH critically ill
disease VO device
disease MESH urinary tract infections
disease MESH Health care associated infection
drug DRUGBANK Fenamole
disease VO protocol
disease MESH Mucormycosis
drug DRUGBANK Trestolone

Original Article

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