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

Sponsor
Lebanese University (Other)
Overall Status
Completed
CT.gov ID
NCT05844410
Collaborator
(none)
422
1
4.5
93.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
422 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Predictors of All-cause Mortality in Hospitalized COVID-19 Patients Taking Corticosteroids: a Multicenter Retrospective Cross-sectional Study
Actual Study Start Date :
Oct 20, 2021
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Mar 7, 2022

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lebanese University Faculty of pharmacy Beirut Lebanon 0000

Sponsors and Collaborators

  • Lebanese University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Georges Hatem, Principal investigator, Lebanese University
ClinicalTrials.gov Identifier:
NCT05844410
Other Study ID Numbers:
  • CRU329
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023