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Article: Evaluating treatment efficacy in hospitalized COVID-19 patients, with applications to Adaptive COVID-19 Treatment Trials
Title | Evaluating treatment efficacy in hospitalized COVID-19 patients, with applications to Adaptive COVID-19 Treatment Trials |
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Authors | |
Keywords | Clinical status hazard ratio mortality odds ratio time to recovery totality of evidence |
Issue Date | 15-Apr-2024 |
Publisher | SAGE Publications |
Citation | Clinical Trials, 2024, v. 21, n. 4 How to Cite? |
Abstract | BackgroundThe current endpoints for therapeutic trials of hospitalized COVID-19 patients capture only part of the clinical course of a patient and have limited statistical power and robustness. MethodsWe specify proportional odds models for repeated measures of clinical status, with a common odds ratio of lower severity over time. We also specify the proportional hazards model for time to each level of improvement or deterioration of clinical status, with a common hazard ratio for overall treatment benefit. We apply these methods to Adaptive COVID-19 Treatment Trials. ResultsFor remdesivir versus placebo, the common odds ratio was 1.48 (95% confidence interval (CI) = 1.23–1.79; p < 0.001), and the common hazard ratio was 1.27 (95% CI = 1.09–1.47; p = 0.002). For baricitinib plus remdesivir versus remdesivir alone, the common odds ratio was 1.32 (95% CI = 1.10–1.57; p = 0.002), and the common hazard ratio was 1.30 (95% CI = 1.13–1.49; p < 0.001). For interferon beta-1a plus remdesivir versus remdesivir alone, the common odds ratio was 0.95 (95% CI = 0.79–1.14; p = 0.56), and the common hazard ratio was 0.98 (95% CI = 0.85–1.12; p = 0.74). ConclusionsThe proposed methods comprehensively characterize the treatment effects on the entire clinical course of a hospitalized COVID-19 patient. |
Persistent Identifier | http://hdl.handle.net/10722/347611 |
ISSN | 2023 Impact Factor: 2.2 2023 SCImago Journal Rankings: 1.148 |
DC Field | Value | Language |
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dc.contributor.author | Lin, Dan-Yu | - |
dc.contributor.author | Wang, Jianqiao | - |
dc.contributor.author | Gu, Yu | - |
dc.contributor.author | Zeng, Donglin | - |
dc.date.accessioned | 2024-09-25T06:05:40Z | - |
dc.date.available | 2024-09-25T06:05:40Z | - |
dc.date.issued | 2024-04-15 | - |
dc.identifier.citation | Clinical Trials, 2024, v. 21, n. 4 | - |
dc.identifier.issn | 1740-7745 | - |
dc.identifier.uri | http://hdl.handle.net/10722/347611 | - |
dc.description.abstract | <h3>Background</h3><p>The current endpoints for therapeutic trials of hospitalized COVID-19 patients capture only part of the clinical course of a patient and have limited statistical power and robustness.</p><h3>Methods</h3><p>We specify proportional odds models for repeated measures of clinical status, with a common odds ratio of lower severity over time. We also specify the proportional hazards model for time to each level of improvement or deterioration of clinical status, with a common hazard ratio for overall treatment benefit. We apply these methods to Adaptive COVID-19 Treatment Trials.</p><h3>Results</h3><p>For remdesivir versus placebo, the common odds ratio was 1.48 (95% confidence interval (CI) = 1.23–1.79; p < 0.001), and the common hazard ratio was 1.27 (95% CI = 1.09–1.47; p = 0.002). For baricitinib plus remdesivir versus remdesivir alone, the common odds ratio was 1.32 (95% CI = 1.10–1.57; p = 0.002), and the common hazard ratio was 1.30 (95% CI = 1.13–1.49; p < 0.001). For interferon beta-1a plus remdesivir versus remdesivir alone, the common odds ratio was 0.95 (95% CI = 0.79–1.14; p = 0.56), and the common hazard ratio was 0.98 (95% CI = 0.85–1.12; p = 0.74).</p><h3>Conclusions</h3><p>The proposed methods comprehensively characterize the treatment effects on the entire clinical course of a hospitalized COVID-19 patient.</p> | - |
dc.language | eng | - |
dc.publisher | SAGE Publications | - |
dc.relation.ispartof | Clinical Trials | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Clinical status | - |
dc.subject | hazard ratio | - |
dc.subject | mortality | - |
dc.subject | odds ratio | - |
dc.subject | time to recovery | - |
dc.subject | totality of evidence | - |
dc.title | Evaluating treatment efficacy in hospitalized COVID-19 patients, with applications to Adaptive COVID-19 Treatment Trials | - |
dc.type | Article | - |
dc.identifier.doi | 10.1177/17407745241238443 | - |
dc.identifier.scopus | eid_2-s2.0-85190424179 | - |
dc.identifier.volume | 21 | - |
dc.identifier.issue | 4 | - |
dc.identifier.eissn | 1740-7753 | - |
dc.identifier.issnl | 1740-7745 | - |