Investigational medications in 9,638 hospitalized patients with severe COVID-19: lessons from the “fail-and-learn” strategy during the first two waves of the pandemic in 2020
Delgado et al.,
Investigational medications in 9,638 hospitalized patients with severe COVID-19: lessons from the..,
Research Square, doi:10.21203/rs.3.rs-2596201/v1 (Preprint)
PSM retrospective 9,638 patients in the USA, showing significantly lower mortality with HCQ in early 2020 (1,157 HCQ patients), and no significant difference in late 2020 (82 HCQ patients). The few patients treated in the later period may be in more serious condition due to the effort required to overcome the politicization and censorship in the study country. Authors refer to their result as "no relevant benefit in mortality between the two surges".
risk of death, 26.0% lower, OR 0.74, p = 0.002, treatment 1,239, control 8,399, both periods combined, RR approximated with OR.
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risk of death, 28.0% lower, OR 0.72, p = 0.001, treatment 1,157, control 2,064, early 2020, propensity score matching, RR approximated with OR.
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risk of death, 10.0% higher, OR 1.10, p = 0.82, treatment 82, control 6,335, late 2020, propensity score matching, RR approximated with OR.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Delgado et al., 20 Feb 2023, retrospective, USA, preprint, 7 authors, study period 1 March, 2020 - 31 December, 2020.
Contact:
stahelp23@ecu.edu.
Abstract: Investigational medications in 9,638 hospitalized patients with severe
COVID-19: lessons from the “fail-and-learn” strategy during the first two
waves of the pandemic in 2020
Adam C. Delgado
Sky Ridge Medical Center
Brendon Cornett
HCA Healthcare Continental Division
Ye Ji Choi
HCA Healthcare Continental Division
Christina Colosimo
Sky Ridge Medical Center
Vincent P. Stahel
University of Colorado
Oliwier Dziadkowiec
HCA Healthcare Continental Division
Philip F. Stahel ( stahelp23@ecu.edu )
East Carolina University
Research Article
Keywords: COVID-19, corticosteroids, remdesivir, azithromycin, hydroxychloroquine, tocilizumab, mechanical ventilation, mortality
Posted Date: February 20th, 2023
DOI: https://doi.org/10.21203/rs.3.rs-2596201/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License
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Abstract
Background:
The early surge of the novel coronavirus disease 2019 (COVID-19) pandemic introduced a significant clinical challenge due to the high case-fatality
rate in absence of evidence-based treatment recommendations. The empirical modalities were relegated to historical expertise from the traditional
management of acute respiratory distress syndrome (ARDS) in conjunction with off-label pharmaceutical agents endorsed under the “emergency use
authorization” paradigm by regulatory agencies. This study was designed to evaluate the insights from the “fail-and-learn” strategy in 2020 before the
availability of COVID-19 vaccines and access to reliable insights from high-quality randomized controlled trials.
Methods:
A retrospective, multicenter, propensity-matched, case-control study was performed on a data registry comprising 186 hospitals from a national health
care system in the United States, designed to investigate the efficacy of empirical treatment modalities during the early surge of the COVID-19
pandemic in 2020. Reflective of the time-windows of the initial two surges of the pandemic in 2020, patients were stratified into “early” (March 1–June
30) versus “late” (July 1–December 31) study cohorts. Logistic regression was applied to determine the efficacy of prevalent medications (remdesivir,
azithromycin, hydroxychloroquine, corticosteroids, tocilizumab) and supplemental oxygen delivery modalities (invasive vs. non-invasive ventilation) on
patient outcomes. The primary outcome measure was in-hospital mortality. Group comparisons were adjusted for covariates related to age, gender,
ethnicity, body weight, comorbidities, and treatment modalities pertinent to organ failure replacement.
Results:
From a total of 87,788 patients in the multicenter data registry screened in this study, 9,638 patients were included who received 19,763 COVID-19
medications during the first two waves of the 2020 pandemic.The results showed inconclusive variable results pertinent to the impact of empirical
medications on patient outcomes. In contrast, the necessity for oxygen supply showed significantly increased odds of mortality beyond the effect of
the investigational medications. Of all the covariates associated with increased mortality, invasive mechanical ventilation had the highest odds ratios
of 8.34 in the first surge and 9.46 in in the second surge of the pandemic (P<0.01).
Conclusion:
This retrospective multicenter observational cohort study on 9,638 hospitalized patients with severe COVID-19 during revealed that the necessity for
invasive ventilation had the highest odds of..
Late treatment
is less effective
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