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Remdesivir Efficacy in COVID-19 Treatment: A Randomized Controlled Trial

Abd-Elsalam et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-0606, NCT04345419
Sep 2021  
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This paper was retracted.
Gérard, Zhou, Wu, Kamo, Choi, Kim show significantly increased risk of acute kidney injury with remdesivir.
Abd-Elsalam et al., 10 Sep 2021, Egypt, peer-reviewed, 15 authors, trial NCT04345419 (history). Contact: sherif.abdelbaky@med.tanta.edu.eg.
This PaperRemdesivirAll
Remdesivir Efficacy in COVID-19 Treatment: A Randomized Controlled Trial
Sherief Abd-Elsalam, Ossama Ashraf Ahmed, Noha O Mansour, Doaa H Abdelaziz, Marwa Salama, Mohamed Hassan Ahmed Fouad, Shaimaa Soliman, Ahmed Mohamed Naguib, Mohamed Sayed Hantera, Ibrahim S Ibrahim, Mohamed Torky, Hany M Dabbous, Mohamed Samir Abd El Ghafar, Enas A Abdul-Baki, Mohammed Elhendawy
The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-0606
To date, no antiviral therapy has shown proven clinical effectiveness in treating patients with COVID-19. We assessed the efficacy of remdesivir in hospitalized Egyptian patients with COVID-19. Patients were randomly assigned at a 1:1 ratio to receive either remdesivir (200 mg on the first day followed by 100 mg daily for the next 9 days intravenously infused over 30-60 minutes) in addition to standard care or standard care alone. The primary outcomes were the length of hospital stay and mortality rate. The need for mechanical ventilation was assessed as a secondary outcome. Two hundred patients (100 in each group) completed the study and were included in the final analysis. The remdesivir group showed a significantly lower median duration of hospital stay (10 days) than the control group (16 days; P , 0.001). Eleven of the patients in the remdesivir group needed mechanical ventilation compared with eight patients in the control group (P 5 0.469). The mortality rate was comparable between the two groups (P 5 0.602). Mortality was significantly associated with older age, elevated C-reactive protein levels, elevated D-dimer, and the need for mechanical ventilation (P 5 0.039, 0.003, 0.001, and , 0.001 respectively). Remdesivir had a positive influence on length of hospital stay, but it had no mortality benefit in Egyptian patients with COVID-19. Its use, in addition to standard care including dexamethasone, should be considered, particularly in low-and middle-income countries when other effective options are scarce.
R E T R A C T E D
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DOI record: { "DOI": "10.4269/ajtmh.21-0606", "ISSN": [ "0002-9637", "1476-1645" ], "URL": "http://dx.doi.org/10.4269/ajtmh.21-0606", "abstract": "<jats:p>To date, no antiviral therapy has shown proven clinical effectiveness in treating patients with COVID-19. We assessed the efficacy of remdesivir in hospitalized Egyptian patients with COVID-19. Patients were randomly assigned at a 1:1 ratio to receive either remdesivir (200 mg on the first day followed by 100 mg daily for the next 9 days intravenously infused over 30–60 minutes) in addition to standard care or standard care alone. The primary outcomes were the length of hospital stay and mortality rate. The need for mechanical ventilation was assessed as a secondary outcome. Two hundred patients (100 in each group) completed the study and were included in the final analysis. The remdesivir group showed a significantly lower median duration of hospital stay (10 days) than the control group (16 days; <jats:italic>P</jats:italic> &lt; 0.001). Eleven of the patients in the remdesivir group needed mechanical ventilation compared with eight patients in the control group (<jats:italic>P</jats:italic> = 0.469). The mortality rate was comparable between the two groups (<jats:italic>P</jats:italic> = 0.602). Mortality was significantly associated with older age, elevated C-reactive protein levels, elevated D-dimer, and the need for mechanical ventilation (<jats:italic>P</jats:italic> = 0.039, 0.003, 0.001, and &lt; 0.001 respectively). Remdesivir had a positive influence on length of hospital stay, but it had no mortality benefit in Egyptian patients with COVID-19. Its use, in addition to standard care including dexamethasone, should be considered, particularly in low- and middle-income countries when other effective options are scarce.</jats:p>", "author": [ { "affiliation": [ { "name": "1Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt;" } ], "family": "Abd-Elsalam", "given": "Sherief", "sequence": "first" }, { "affiliation": [ { "name": "2Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt;" } ], "family": "Ahmed", "given": "Ossama Ashraf", "sequence": "additional" }, { "affiliation": [ { "name": "3Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt;" } ], "family": "Mansour", "given": "Noha O.", "sequence": "additional" }, { "affiliation": [ { "name": "4Department of Clinical Pharmacy, The National Hepatology and Tropical Medicine Research Institute, Egypt;" }, { "name": "5Pharmacy Practice 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Late treatment
is less effective
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