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Completed

NCT Number: NCT05844410

Evaluation of Corticosteroids Use and Clinical Outcomes in Hospitalized COVID-19 Patients: A Retrospective Study

Despite the recommendations to avoid using corticosteroids systematically for hospitalized coronavirus disease of 2019 (COVID-19) patients, healthcare professionals used personalized treatments, including corticosteroids, as adjuncts to treat their patients due to their limited access to treatment options. This study aims to evaluate the use of corticosteroids among hospitalized COVID-19 patients with all-cause mortality as the primary outcome and to assess the predictors of all-cause mortality associated with the characteristics of the patients and the corticosteroid regimens adopted.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lebanese University Faculty of pharmacy

Beirut, 0000, Lebanon

About this study

A multicenter retrospective study was performed over three months targeting 422 COVID-19 patients from six hospitals in Lebanon. Data were collected from patients' medical charts retrospectively and covered a period of one year (September 2020 to August 2021). The study sample included 422 patients, predominantly males, with 59% of cases classified as severe or critical cases. Dexamethasone and methylprednisolone were the most used corticosteroids. Around 22% of the patients died during hospitalization. After adjusting for covariates, performing a polymerase chain reaction test before admission increased the mortality rate by 424% compared to doing it at hospital admission (adjusted Hazard Ratio (aHR) 4.24, 95% Confidence Interval (CI) 1.35-13.3), with 18.11 times higher mortality rate among critical cases (aHR 18.11, 95% CI 9.63-31.05). Exposure to side effects from corticosteroids increased the mortality rate by 514% compared to others (aHR 5.14, 95% CI 1.28-8.58). In particular, the mortality rate among patients having hyperglycemia dropped by 73% compared to others (aHR 0.27, 95% CI 0.06-0.98). Corticosteroids are frequently used in treating hospitalized COVID-19 patients. The all-cause mortality rate was higher among older and critical cases and lower among smokers and those treated for more than 7 days. Research exploring the safety and efficacy of corticosteroids is required to allow better in-hospital management of COVID-19 cases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients admitted to the hospital after a confirmed COVID-19 infection, irrespective of the stage and severity of the disease, were included in the study.

Exclusion criteria

  • Only those receiving corticosteroids as a treatment were in the study sample, with no preferences based on race or ethnicity.

Treatment and study plan

Corticosteroid

Drug

Adults patients admitted to the hospital after a confirmed COVID-19 infection, irrespective of the stage and severity of the disease, were included in the study. Only those receiving corticosteroids as a treatment were in the study sample, with no preferences based on race or ethnicity

Primary outcomes

  1. All-cause mortality

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Lebanese University

Other

Registry information

Official study title

Predictors of All-cause Mortality in Hospitalized COVID-19 Patients Taking Corticosteroids: a Multicenter Retrospective Cross-sectional Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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