Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study)
Background/Aims Corticosteroids (CSs) are frequently used in coronavirus disease 2019 (COVID-19); however, their utility remains controversial in mild to moderate cases. The timing of CSs initiation during the disease course remains unaddressed. The study aims to evaluate the impact of early CSs in...
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| Format: | Article |
| Language: | English |
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The Korean Association of Internal Medicine
2023-03-01
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| Series: | The Korean Journal of Internal Medicine |
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| Online Access: | http://www.kjim.org/upload/kjim-2022-232.pdf |
| _version_ | 1811160686682701824 |
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| author | Emad R. Issak Mariam M. Amin |
| author_facet | Emad R. Issak Mariam M. Amin |
| author_sort | Emad R. Issak |
| collection | DOAJ |
| description | Background/Aims Corticosteroids (CSs) are frequently used in coronavirus disease 2019 (COVID-19); however, their utility remains controversial in mild to moderate cases. The timing of CSs initiation during the disease course remains unaddressed. The study aims to evaluate the impact of early CSs in non-severe COVID-19. Methods A randomized controlled, open-label study was conducted on 754 COVID-19 patients randomized into a study group (n = 377) in which patients received CSs with COVID-19 protocol and a control group (n = 377) in which patients received COVID-19 protocol only. Results Both groups were comparable regarding baseline characteristics, presenting symptoms, and inflammatory markers. The composite endpoint (need for O2, need for hospitalization or 28-day mortality) was significantly (p = 0.004) lower in the CS group 42 (11.14%) versus the control group 70 (18.67%) with odds ratio 0.55 (95% confidence interval [CI], 0.36 to 0.83), absolute risk reduction 7.53% (95% CI, 2.46% to 12.59%) and number needed to treat of 13.29 (95% CI, 7.94 to 40.61). Regarding severity at day 10, only (11.1%) of the study group patients were severe versus (18.7%) of the control group patients (p < 0.001). The median time-to-return to daily activity in the CS group was 8.0 days, while in the control group, it was 22.0 days (p < 0.001). Conclusions In non-severe COVID-19, CS may decrease hospitalization, severity, and mortality. |
| first_indexed | 2024-04-10T06:02:41Z |
| format | Article |
| id | doaj.art-609e37b1954c4c42855324810a241b4a |
| institution | Directory Open Access Journal |
| issn | 1226-3303 2005-6648 |
| language | English |
| last_indexed | 2024-04-10T06:02:41Z |
| publishDate | 2023-03-01 |
| publisher | The Korean Association of Internal Medicine |
| record_format | Article |
| series | The Korean Journal of Internal Medicine |
| spelling | doaj.art-609e37b1954c4c42855324810a241b4a2023-03-03T07:00:11ZengThe Korean Association of Internal MedicineThe Korean Journal of Internal Medicine1226-33032005-66482023-03-0138220721710.3904/kjim.2022.232170765Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study)Emad R. Issak0Mariam M. Amin1 Department of Internal Medicine, Allergy and Clinical Immunology, Faculty of Medicine, Ain Shams University, Cairo, Egypt Department of Internal Medicine, Allergy and Clinical Immunology, Faculty of Medicine, Ain Shams University, Cairo, EgyptBackground/Aims Corticosteroids (CSs) are frequently used in coronavirus disease 2019 (COVID-19); however, their utility remains controversial in mild to moderate cases. The timing of CSs initiation during the disease course remains unaddressed. The study aims to evaluate the impact of early CSs in non-severe COVID-19. Methods A randomized controlled, open-label study was conducted on 754 COVID-19 patients randomized into a study group (n = 377) in which patients received CSs with COVID-19 protocol and a control group (n = 377) in which patients received COVID-19 protocol only. Results Both groups were comparable regarding baseline characteristics, presenting symptoms, and inflammatory markers. The composite endpoint (need for O2, need for hospitalization or 28-day mortality) was significantly (p = 0.004) lower in the CS group 42 (11.14%) versus the control group 70 (18.67%) with odds ratio 0.55 (95% confidence interval [CI], 0.36 to 0.83), absolute risk reduction 7.53% (95% CI, 2.46% to 12.59%) and number needed to treat of 13.29 (95% CI, 7.94 to 40.61). Regarding severity at day 10, only (11.1%) of the study group patients were severe versus (18.7%) of the control group patients (p < 0.001). The median time-to-return to daily activity in the CS group was 8.0 days, while in the control group, it was 22.0 days (p < 0.001). Conclusions In non-severe COVID-19, CS may decrease hospitalization, severity, and mortality.http://www.kjim.org/upload/kjim-2022-232.pdfcovid-19glucocorticoidshospitalizationseverity of illness indexmortality |
| spellingShingle | Emad R. Issak Mariam M. Amin Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study) The Korean Journal of Internal Medicine covid-19 glucocorticoids hospitalization severity of illness index mortality |
| title | Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study) |
| title_full | Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study) |
| title_fullStr | Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study) |
| title_full_unstemmed | Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study) |
| title_short | Timing of corticosteroids in non-severe non-hospitalized COVID-19 patients: open-label, two-center, randomized controlled study (TICS-COV19 study) |
| title_sort | timing of corticosteroids in non severe non hospitalized covid 19 patients open label two center randomized controlled study tics cov19 study |
| topic | covid-19 glucocorticoids hospitalization severity of illness index mortality |
| url | http://www.kjim.org/upload/kjim-2022-232.pdf |
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