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Journal of Clinical and
Translational Research Remdesivir outcomes in hospitalized COVID-19
Writing – review & editing: Basem M. Alraddadi, Wafaa 6. FDA. Coronavirus (COVID-19) Update: FDA
Adel Toonsi, Mohammad Al Hroub Issues Emergency Use Authorization for Potential
COVID-19 Treatment. U.S. Food Drug Administration;
Ethics approval and consent to participate 2020. Available form: https://www.fda.gov/news-events/
press-announcements/coronavirus-covid-19-update-fda/
This study was reviewed and approved by the Research issues/emergency/use/authorization/potential/covid/19/
Ethics Committee at King Faisal Specialist Hospital and treatment#:~:text=today%2c/the/u.s/food/and/children/
Research Center, Jeddah, Saudi Arabia (Approval ID: hospitalized/with/severe/disease [Last accessed on
IRB 2023 – 33). Given the retrospective nature of the study 2024 Mar 17].
and use of hospital medical records, the requirement for 7. FDA. Approves First Treatment for COVID-19. FDA.
written informed consent was waived by the REC. All Available from; https://www.fda.gov/news/events/press/
patient data were handled confidentially in compliance announcements/fda/approves/first/treatment/covid-19
with institutional and national ethical standards. [Last accessed on 2024 Mar 17].
Consent for publication 8. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for
the treatment of Covid-19 - final report. N Engl J Med.
As this study involved retrospective analysis of de-identified 2020;383:1813-1826.
patient data without any identifiable images, individual doi: 10.1056/NEJMOA2007764
informed consent for publication was not required and
waived by Research Ethics Committee at King Faisal 9. Kaka AS, MacDonald R, Linskens EJ, et al. Major
Specialist Hospital and Research Center, Jeddah, Saudi update 2: Remdesivir for adults with COVID-19: A living
Arabia. systematic review and meta-analysis for the American
college of physicians practice points. Ann Intern Med.
Availability of data 2022;175:701-709.
doi: 10.7326/M21-4784
Clinical researchers may request to gain access to the
patient-level data and related study documents. Data used 10. WHO Solidarity Trial Consortium. Remdesivir and three
in this work are available from the corresponding author other drugs for hospitalised patients with COVID-19: Final
on reasonable request. Before sharing, patient-level data results of the WHO Solidarity randomised trial and updated
will be anonymized, and study documents will be redacted meta-analyses. Lancet. 2022;399:1941-1953.
to protect the privacy of trial participants. doi: 10.1016/S0140-6736(22)00519-0
References 11. Mozaffari E, Chandak A, Zhang Z, et al. Remdesivir
treatment in hospitalized patients with coronavirus disease
1. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 2019 (COVID-19): A comparative analysis of in-hospital all-
hospitalized patients with 2019 novel coronavirus-infected cause mortality in a large multicenter observational cohort.
pneumonia in Wuhan, China. JAMA. 2020;323:1061-1069. Clin Infect Dis. 2022;75:e450-e458.
doi: 10.1001/jama.2020.1585 doi: 10.1093/CID/CIAB875
2. World Health Organization: WHO Coronavirus (COVID-19) 12. Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir
Dashboard. Available from: https://data.who.int/ vs standard care on clinical status at 11 days in patients with
dashboards/covid19/cases [Last accessed on 2024 Mar 17]. moderate COVID-19: A randomized clinical trial. JAMA.
2020;324:1048-1057.
3. Zhou F, Yu T, Du R, et al. Clinical course and risk factors
for mortality of adult inpatients with COVID-19 in doi: 10.1001/JAMA.2020.16349
Wuhan, China: A retrospective cohort study. Lancet. 13. Ali K, Azher T, Baqi M, et al. Remdesivir for the treatment
2020;395:1054-1062.
of patients in hospital with COVID-19 in Canada: A
doi: 10.1016/S0140-6736(20)30566-3 randomized controlled trial. CMAJ. 2022;194:E242-E251.
4. Harapan H, Itoh N, Yufika A, et al. Coronavirus disease doi: 10.1503/CMAJ.211698
2019 (COVID-19): A literature review. J Infect Public Health. 14. Gottlieb RL, Vaca CE, Paredes R, et al. Early remdesivir
2020;13:667-673. to prevent progression to severe Covid-19 in outpatients.
doi: 10.1016/J.JIPH.2020.03.019 N Engl J Med. 2022;386:305-315.
5. Sheahan TP, Sims AC, Graham RL, et al. Broad-spectrum doi: 10.1056/NEJMOA2116846
antiviral GS-5734 inhibits both epidemic and zoonotic 15. Boglione L, Dodaro V, Meli G, et al. Remdesivir treatment
coronaviruses. Sci Transl Med. 2017;9(396):eaal3653.
in hospitalized patients affected by COVID‐19 pneumonia:
doi: 10.1126/scitranslmed.aal3653 A case‐control study. J Med Virol. 2022;94:3653-3660.
Volume 11 Issue 3 (2025) 86 doi: 10.36922/jctr.24.00027

