RETRACTED: Remdesivir Efficacy in COVID-19 Treatment: A Randomized Controlled Trial
et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-0606, NCT04345419, Sep 2021
This paper was retracted.
Gérard, Zhou, Wu, Kamo, Choi, Kim show increased risk of acute kidney injury, Leo, Briciu, Muntean, Petrov show increased risk of liver injury, and Negru, Cheng, Mohammed show increased risk of cardiac disorders with remdesivir.
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Kamo et al., Association of Antiviral Drugs for the Treatment of COVID-19 With Acute Renal Failure, In Vivo, doi:10.21873/invivo.13637.
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Choi et al., Comparative effectiveness of combination therapy with nirmatrelvir–ritonavir and remdesivir versus monotherapy with remdesivir or nirmatrelvir–ritonavir in patients hospitalised with COVID-19: a target trial emulation study, The Lancet Infectious Diseases, doi:10.1016/S1473-3099(24)00353-0.
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Kim et al., Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study, Pharmacoepidemiology and Drug Safety, doi:10.1002/pds.70043.
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Leo et al., Hepatocellular liver injury in hospitalized patients affected by COVID-19: Presence of different risk factors at different time points, Digestive and Liver Disease, doi:10.1016/j.dld.2021.12.014.
8.
Briciu et al., Evolving Clinical Manifestations and Outcomes in COVID-19 Patients: A Comparative Analysis of SARS-CoV-2 Variant Waves in a Romanian Hospital Setting, Pathogens, doi:10.3390/pathogens12121453.
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Muntean et al., Effects of COVID-19 on the Liver and Mortality in Patients with SARS-CoV-2 Pneumonia Caused by Delta and Non-Delta Variants: An Analysis in a Single Centre, Pharmaceuticals, doi:10.3390/ph17010003.
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Abd-Elsalam et al., 10 Sep 2021, Egypt, peer-reviewed, 15 authors, trial NCT04345419 (history).
Contact: sherif.abdelbaky@med.tanta.edu.eg.
Remdesivir Efficacy in COVID-19 Treatment: A Randomized Controlled Trial
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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"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> < 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 < 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>",
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Late treatment
is less effective
is less effective
