Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience

Kalligeros, Markos; Tashima, Karen T.; Mylona, Evangelia K.; Rybak, Natasha; Flanigan, Timothy P.; Farmakiotis, Dimitrios; Beckwith, Curt G.; Sanchez, Martha; Neill, Marguerite A.; Johnson, Jennie; Garland, Joseph; Aung, Su; Byrd, Katrina; O’Brien, Thomas F.; Pandita, Aakriti; Aridi, Jad; Gil, Raul Macias; Larkin, Jerome; Shehadeh, Fadi; Mylonakis, Eleftherios

doi:10.1093/ofid/ofaa319

Cited by 22 publications

(36 citation statements)

References 16 publications

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“…In line with the results seen so far, there are also those observed in another retrospective study where a group of 99 patients treated with remdesivir was compared with 125 patients who had received supportive care [ 53 ]. Despite not reaching statistical significance, patients treated with remdesivir presented numerically lower all-cause in-hospital mortality (HR = 0.44; 95% CI = 0.16–1.23; p > 0.05).…”

Section: Resultssupporting

confidence: 82%

Antiviral Therapeutic Approaches for SARS-CoV-2 Infection: A Systematic Review

2021

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Background: Due to the lack of an etiologic treatment for SARS-CoV-2 and the difficulties involved in developing new drugs, some drugs already approved for other diseases or with efficacy against SARS and MERS, have been used in patients with COVID-19. This systematic review aims to summarize evidence on the efficacy and safety of five antivirals applied to patients with COVID-19, that have proven to be effective either in vitro studies or in studies on SARS-CoV and MERS.; Methods: An intensive search of different databases (Pub Med, WoS, MEDLINE and Cochrane COVID-19 Study Register) has been carried out until the end of April 2021. This systematic review has been conducted according to the PRISMA statement. From each of the included studies, the characteristics of the intervention and comparison groups, demographic data and results were extracted independently; Results: Remdesivir is well tolerated and helps to accelerate clinical improvement but is ineffective in reducing mortality. Favipiravir is safe and shows promising results regarding symptom resolution but does not improve viral clearance. The use of lopinavir/ritonavir has been associated with an increased risk of gastrointestinal adverse events and it has not proven to be effective. No significant differences were observed between patients treated with ribavirin or umifenovir and their respective control groups; Conclusions: Remdesivir and favipiravir are well tolerated and effective in accelerating clinical improvement. This systematic review does not support the use of lopinavir/ritonavir, ribavirin and umifenovir in hospitalized patients with COVID-19.

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Section: Resultssupporting

confidence: 82%

Antiviral Therapeutic Approaches for SARS-CoV-2 Infection: A Systematic Review

2021

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“…Similarly, remdesivir was associated with a 24% lower risk of AST elevation (RR 0.76; 95% CI 0.60–0.96; p = 0.02) with significant heterogeneity ( I 2 = 71%) compared with placebo. Removing the observational study by Kalligeros et al [ 33 ] improved the heterogeneity ( I 2 = 46%) with a lower risk of AST elevation in the remdesivir group (RR 0.58; 95% CI 0.43–0.79, p < 0.001). There was also a lower risk of ALT elevation (RR 0.80; 95% CI 0.69–0.94; p = 0.006) and renal function (RR 0.66; 95% CI 0.55–0.80; p < 0.001) in the remdesivir group compared to standard treatment or placebo (Fig.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of remdesivir in hospitalised COVID-19 patients: a systematic review and meta-analysis

2021

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Purpose This review was aimed to synthesise the best available evidence on the effectiveness and safety of remdesivir in the treatment of moderate to severe COVID-19. Method Randomised controlled trials (RCTs) and observational studies reporting the effectiveness and safety of remdesivir were searched via databases and other sources from December 2019 to December 2020. Two independent reviewers performed literature screening, data extraction and assessment of risk bias. Seven studies involving 3686 patients were included. Results Treatment with remdesivir was associated with an increase in clinical recovery rate by 21% (RR 1.21; 95% CI 1.08–1.35) on day 7 and 29% (RR 1.29; 95% CI 1.22–1.37) on day 14. The likelihoods of requiring high-flow supplemental oxygen and invasive mechanical ventilation in the remdesivir group were lower than in the placebo group by 27% (RR 0.73; 95% CI 0.54–0.99) and 47% (RR 0.53; 95% CI 0.39–0.72), respectively. Remdesivir-treated patients showed a 39% (RR 0.61; 95% CI 0.46–0.79) reduction in the risk of mortality on day 14 compared to the control group; however, there was no significant difference on day 28. Serious adverse effects (SAEs) were significantly less common in patients treated with remdesivir, with an absolute risk difference of 6% (RD −0.06; 95% CI −0.09 to −0.03). Conclusion Despite conditional recommendation against its use, remdesivir could still be effective in early clinical improvement; reduction of early mortality and avoiding high-flow supplemental oxygen and invasive mechanical ventilation among hospitalised COVID-19 patients. Remdesivir was also well tolerated without significant SAEs compared to placebo, yet available evidence from clinical studies support the need to conduct close monitoring. Supplementary Information The online version contains supplementary material available at 10.1007/s15010-021-01671-0.

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“… 4 In subsequent studies supporting the beneficial effect of remdesivir, the drug was administered early, ranging from a median six to eight days from symptom onset. 5 6 However, the Solidarity Trial, designed early in the COVID-19 pandemic by the World Health Organization, reported negative results of remdesivir treatment (rate ratio, 0.95; 95% confidence interval [CI], 0.81–1.11; P = 0.50). 7 Although randomization time from symptom onset was not considered in this trial due to practical issues, the outcomes of this large trial (including about 2,700 patients per arm) cannot be disregarded.…”

Section: Discussionmentioning

confidence: 99%

“… 4 Based on the findings of the ACTT-1 trial, remdesivir has been widely used for the treatment of COVID-19 but controversies regarding its clinical effectiveness remain. 5 6 7 8 9 Previous studies have focused on clinical outcomes of remdesivir treatment, with heterogeneous results depending on study design, administration timing, and severity of host. 3 4 5 6 7 For more rational use of remdesivir for COVID-19, further detailed investigations regarding clinical and virologic response are required.…”

Section: Introductionmentioning

confidence: 99%

Clinical and Virologic Effectiveness of Remdesivir Treatment for Severe Coronavirus Disease 2019 (COVID-19) in Korea: a Nationwide Multicenter Retrospective Cohort Study

Joo

Kim

et al. 2021

J Korean Med Sci

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Background Remdesivir is widely used for the treatment of coronavirus disease 2019 (COVID-19), but controversies regarding its efficacy still remain. Methods A retrospective cohort study was conducted to evaluate the effect of remdesivir on clinical and virologic outcomes of severe COVID-19 patients from June to July 2020. Primary clinical endpoints included clinical recovery, additional mechanical ventilator (MV) support, and duration of oxygen or MV support. Viral load reduction by hospital day (HD) 15 was evaluated by calculating changes in cycle threshold (Ct) values. Results A total of 86 severe COVID-19 patients were evaluated including 48 remdesivir-treated patients. Baseline characteristics were not significantly different between the two groups. Remdesivir was administered an average of 7.42 days from symptom onset. The proportions of clinical recovery of the remdesivir and supportive care group at HD 14 (56.3% and 39.5%) and HD 28 (87.5% and 78.9%) were not statistically different. The proportion of patients requiring MV support by HD 28 was significantly lower in the remdesivir group than in the supportive care group (22.9% vs. 44.7%, P = 0.032), and MV duration was significantly shorter in the remdesivir group (average, 1.97 vs. 5.37 days; P = 0.017). Analysis of upper respiratory tract specimens demonstrated that increases of Ct value from HD 1–5 to 11–15 were significantly greater in the remdesivir group than the supportive care group (average, 10.19 vs. 5.36; P = 0.007), and the slope of the Ct value increase was also significantly steeper in the remdesivir group (average, 5.10 vs. 2.68; P = 0.007). Conclusion The remdesivir group showed clinical and virologic benefit in terms of MV requirement and viral load reduction, supporting remdesivir treatment for severe COVID-19.

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Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience

Cited by 22 publications

References 16 publications

Antiviral Therapeutic Approaches for SARS-CoV-2 Infection: A Systematic Review

Antiviral Therapeutic Approaches for SARS-CoV-2 Infection: A Systematic Review

Efficacy and safety of remdesivir in hospitalised COVID-19 patients: a systematic review and meta-analysis

Clinical and Virologic Effectiveness of Remdesivir Treatment for Severe Coronavirus Disease 2019 (COVID-19) in Korea: a Nationwide Multicenter Retrospective Cohort Study

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