Clinical use of remdesivir in COVID-19 treatment: a retrospective cohort study.
Ontology highlight
ABSTRACT: Objectives
This study investigated remdesivir's clinical use to provide direct evidence of effectiveness for a low-middle income Asian setting.Design
A one-to-one propensity score matching retrospective cohort study.Setting
A tertiary hospital with COVID-19 treatment facilities in Vietnam.Participants
A total of 310 patients in standard of care (SoC) group were matched with 310 patients in SoC+remdesivir (SoC+R) group.Primary and secondary outcome measures
The primary outcome was time to critical progression, defined as all-cause mortality or critical illness. The secondary outcomes were length of oxygen therapy/ventilation and need for invasive mechanical ventilation. Outcome reports were presented as HR, OR or effect difference with 95% CI.Results
Patients receiving remdesivir had a lower risk for mortality or critical illness (HR=0.68, 95% CI 0.47 to 0.96, p=0.030). Remdesivir was not associated with a shorter length of oxygen therapy/ventilation (effect difference -0.17 days, 95% CI -1.29 to 0.96, p=0.774). The need for invasive mechanical ventilation was lower in SoC+R group (OR=0.57, 95% CI 0.38 to 0.86, p=0.007).Conclusions
This study's results showing remdesivir's benefits in non-critical patients with COVID-19 may be extrapolated to other similar low-middle income countries, allowing more regimens for limited resource areas and reducing poor outcomes and equity gap worldwide.
SUBMITTER: Pham HT
PROVIDER: S-EPMC10276957 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
Publications
Clinical use of remdesivir in COVID-19 treatment: a retrospective cohort study.
Pham Hong Tham HT Mai-Phan Tuong-Anh TA Vu Anh Kiet AK Truong Thi Ha TH Tran Minh-Hoang MH
BMJ open 20230609 6
<h4>Objectives</h4>This study investigated remdesivir's clinical use to provide direct evidence of effectiveness for a low-middle income Asian setting.<h4>Design</h4>A one-to-one propensity score matching retrospective cohort study.<h4>Setting</h4>A tertiary hospital with COVID-19 treatment facilities in Vietnam.<h4>Participants</h4>A total of 310 patients in standard of care (SoC) group were matched with 310 patients in SoC+remdesivir (SoC+R) group.<h4>Primary and secondary outcome measures</h4 ...[more]
Similar Datasets
Project description:BackgroundRemdesivir is widely used for the treatment of coronavirus disease 2019 (COVID-19), but controversies regarding its efficacy still remain.MethodsA 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.ResultsA 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).ConclusionThe remdesivir group showed clinical and virologic benefit in terms of MV requirement and viral load reduction, supporting remdesivir treatment for severe COVID-19.
| S-EPMC7985289 | biostudies-literature
Project description:Remdesivir is presently been considered as 'molecule of hope' to curb the menace of COVID19. Non-availability of any USFDA approved drug has led to several attempt of drug-repurposing and development of new therapeutic molecules. However, Remdesivir has been found to be effective against a broad range of virus including SARS, MERS and COVID 19 through in-vitro studies. Several clinical research attempt are presently being conducted showing promising result yet not conclusive. This review summarized all such clinical trials to critically appraise the usage of Remdesivir against COVID 19 along with the publications related to the results of the clinical studies. The present regulatory aspect i. e. Emergency Use Authorization (EYA) and information of molecule and plausible mechanism is also dealt.
| S-EPMC8043717 | biostudies-literature
Project description:Background and objectivesRemdesivir is an antiviral drug used to treat coronavirus disease 2019 (COVID-19) with a relatively obscure cardiac effect profile. Previous studies have reported bradycardia associated with remdesivir, but few have examined its clinical characteristics. The objective of this study was to investigate remdesivir associated bradycardia and its associated clinical characteristics and outcomes.MethodsThis is a single-institution retrospective study that investigated bradycardia in 600 patients who received remdesivir for treatment of COVID-19. A total of 375 patients were included in the study after screening for other known causes of bradycardia (atrioventricular [AV] nodal blockers). All patients were analyzed for episodes of bradycardia from when remdesivir was initiated up to 5 days after completion, a time frame based on the drug's putative elimination half-life. Univariate and multivariate statistical tests were conducted to analyze the data.ResultsThe mean age of the sample was 56.63 ± 13.23 years. Of patients who met inclusion criteria, 49% were found to have bradycardia within 5 days of remdesivir administration. Compared to the cohort without a documented bradycardic episode, patients with bradycardia were significantly more likely to experience inpatient mortality (22% vs 12%, p = 0.01). The patients with bradycardia were found to have marginally higher serum D-dimer levels (5.2 vs 3.4 µg/mL, p = 0.05) and were more likely to undergo endotracheal intubation (28% vs 14%, p = 0.008). Male sex, hyperlipidemia, and bradycardia within 5 days of completing remdesivir were significant predictors of inpatient mortality. No significant differences in length of stay were found.ConclusionsBradycardia that occurs during or shortly after remdesivir treatment in COVID-19 patients may be associated with an increased rate of in-hospital mortality. However, COVID-19 and its cardiac complications cannot be excluded as potential contributors of bradycardia in the present study. Future studies are needed to further delineate the cardiac characteristics of COVID-19 and remdesivir.
| S-EPMC9385079 | biostudies-literature
Project description:BackgroundRelatively little is known about the use patterns of potential pharmacologic treatments of COVID-19 in the United States.ObjectiveTo use the National COVID Cohort Collaborative (N3C), a large, multicenter, longitudinal cohort, to characterize the use of hydroxychloroquine, remdesivir, and dexamethasone, overall as well as across individuals, health systems, and time.DesignRetrospective cohort study.Setting43 health systems in the United States.Participants137 870 adults hospitalized with COVID-19 between 1 February 2020 and 28 February 2021.MeasurementsInpatient use of hydroxychloroquine, remdesivir, or dexamethasone.ResultsAmong 137 870 persons hospitalized with confirmed or suspected COVID-19, 8754 (6.3%) received hydroxychloroquine, 29 272 (21.2%) remdesivir, and 53 909 (39.1%) dexamethasone during the study period. Since the release of results from the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial in mid-June, approximately 78% to 84% of people who have had invasive mechanical ventilation have received dexamethasone or other glucocorticoids. The use of hydroxychloroquine increased during March 2020, peaking at 42%, and started declining by April 2020. By contrast, remdesivir and dexamethasone use gradually increased over the study period. Dexamethasone and remdesivir use varied substantially across health centers (intraclass correlation coefficient, 14.2% for dexamethasone and 84.6% for remdesivir).LimitationBecause most N3C data contributors are academic medical centers, findings may not reflect the experience of community hospitals.ConclusionDexamethasone, an evidence-based treatment of COVID-19, may be underused among persons who are mechanically ventilated. The use of remdesivir and dexamethasone varied across health systems, suggesting variation in patient case mix, drug access, treatment protocols, and quality of care.Primary funding sourceNational Center for Advancing Translational Sciences; National Heart, Lung, and Blood Institute; and National Institute on Aging.
| S-EPMC8372837 | biostudies-literature
Project description:BackgroundNon-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to reduce pain, fever, and inflammation but have been associated with complications in community-acquired pneumonia. Observations shortly after the start of the COVID-19 pandemic in 2020 suggested that ibuprofen was associated with an increased risk of adverse events in COVID-19 patients, but subsequent observational studies failed to demonstrate increased risk and in one case showed reduced risk associated with NSAID use.MethodsA 38-center retrospective cohort study was performed that leveraged the harmonized, high-granularity electronic health record data of the National COVID Cohort Collaborative. A propensity-matched cohort of 19,746 COVID-19 inpatients was constructed by matching cases (treated with NSAIDs at the time of admission) and 19,746 controls (not treated) from 857,061 patients with COVID-19 available for analysis. The primary outcome of interest was COVID-19 severity in hospitalized patients, which was classified as: moderate, severe, or mortality/hospice. Secondary outcomes were acute kidney injury (AKI), extracorporeal membrane oxygenation (ECMO), invasive ventilation, and all-cause mortality at any time following COVID-19 diagnosis.ResultsLogistic regression showed that NSAID use was not associated with increased COVID-19 severity (OR: 0.57 95% CI: 0.53-0.61). Analysis of secondary outcomes using logistic regression showed that NSAID use was not associated with increased risk of all-cause mortality (OR 0.51 95% CI: 0.47-0.56), invasive ventilation (OR: 0.59 95% CI: 0.55-0.64), AKI (OR: 0.67 95% CI: 0.63-0.72), or ECMO (OR: 0.51 95% CI: 0.36-0.7). In contrast, the odds ratios indicate reduced risk of these outcomes, but our quantitative bias analysis showed E-values of between 1.9 and 3.3 for these associations, indicating that comparatively weak or moderate confounder associations could explain away the observed associations.ConclusionsStudy interpretation is limited by the observational design. Recording of NSAID use may have been incomplete. Our study demonstrates that NSAID use is not associated with increased COVID-19 severity, all-cause mortality, invasive ventilation, AKI, or ECMO in COVID-19 inpatients. A conservative interpretation in light of the quantitative bias analysis is that there is no evidence that NSAID use is associated with risk of increased severity or the other measured outcomes. Our results confirm and extend analogous findings in previous observational studies using a large cohort of patients drawn from 38 centers in a nationally representative multicenter database.
| S-EPMC9107579 | biostudies-literature
Project description:BackgroundNon-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to reduce pain, fever, and inflammation but have been associated with complications in community-acquired pneumonia. Observations shortly after the start of the COVID-19 pandemic in 2020 suggested that ibuprofen was associated with an increased risk of adverse events in COVID-19 patients, but subsequent observational studies failed to demonstrate increased risk and in one case showed reduced risk associated with NSAID use.MethodsA 38-center retrospective cohort study was performed that leveraged the harmonized, high-granularity electronic health record data of the National COVID Cohort Collaborative. A propensity-matched cohort of COVID-19 inpatients was constructed by matching cases (treated with NSAIDs) and controls (not treated) from 857,061 patients with COVID-19. The primary outcome of interest was COVID-19 severity in hospitalized patients, which was classified as: moderate, severe, or mortality/hospice. Secondary outcomes were acute kidney injury (AKI), extracorporeal membrane oxygenation (ECMO), invasive ventilation, and all-cause mortality at any time following COVID-19 diagnosis.ResultsLogistic regression showed that NSAID use was not associated with increased COVID-19 severity (OR: 0.57 95% CI: 0.53-0.61). Analysis of secondary outcomes using logistic regression showed that NSAID use was not associated with increased risk of all-cause mortality (OR 0.51 95% CI: 0.47-0.56), invasive ventilation (OR: 0.59 95% CI: 0.55-0.64), AKI (OR: 0.67 95% CI: 0.63-0.72), or ECMO (OR: 0.51 95% CI: 0.36-0.7). In contrast, the odds ratios indicate reduced risk of these outcomes, but our quantitative bias analysis showed E-values of between 1.9 and 3.3 for these associations, indicating that comparatively weak or moderate confounder associations could explain away the observed associations.ConclusionsStudy interpretation is limited by the observational design. Recording of NSAID use may have been incomplete. Our study demonstrates that NSAID use is not associated with increased COVID-19 severity, all-cause mortality, invasive ventilation, AKI, or ECMO in COVID-19 inpatients. A conservative interpretation in light of the quantitative bias analysis is that there is no evidence that NSAID use is associated with risk of increased severity or the other measured outcomes. Our findings are the largest EHR-based analysis of the effect of NSAIDs on outcome in COVID-19 patients to date. Our results confirm and extend analogous findings in previous observational studies using a large cohort of patients drawn from 38 centers in a nationally representative multicenter database.
| S-EPMC8077581 | biostudies-literature
Project description:Background and objectivesRemdesivir, an antiviral drug routinely used in the treatment of COVID-19 has not yet received FDA approval for use in patients with advanced kidney disease defined as GFR < 30 mL/min/1.73 m2. There is concern that an excipient in Veklury (Gilead's proprietary name for remdesivir) called sulfobutylether-beta-cyclodextrin (SBECD), which is renally cleared, may accumulate and reach toxic levels in patients with advanced kidney disease. The aim of this study was to summarize characteristics and incidence of adverse events of chronic kidney disease (CKD) patients who received remdesivir during hospitalization.Design, setting, participants, and measurements.We retrospectively studied patients admitted to one of several hospitals of the Mayo Clinic Foundation with the diagnosis of COVID-19 pneumonia and CKD. Laboratory values were also measured when remdesivir was first administered and stopped. All analyses were performed in the overall patient group and three separate subgroups of patients with a GFR ≥ 15, a GFR < 15 and dialysis, and a GFR < 15 and no dialysis.ResultsA total of 444 CKD patients who were admitted to the hospital with COVID-19 pneumonia between May 2020 and September 2021 were included. Information was collected on patient characteristics, hospitalization, and adverse events. In the overall cohort, median age was 72 years (Range: 21-100 years), 55.2 % of patients were male, and most (86.5 %) were Caucasian. CKD stage was 3 for 114 patients (25.7 %), 4 for 229 patients (51.6 %), and 5 for 101 patients (22.7 %). A total of 146 patients (32.9 %) were admitted to the ICU, 103 (23.2 %) died in the hospital, and 120 (27.0 %) were on dialysis. The proportion of patients with an adverse event did not differ dramatically between the GFR ≥ 15 (20.9 %), GFR < 15 and dialysis (30.2 %), and GFR < 15 and no dialysis (32.3 %) groups (P = 0.12).ConclusionOur results suggest that the use of remdesivir in patients with very severe CKD is safe, even in those who are not on renal replacement therapy.
| S-EPMC9557110 | biostudies-literature
Project description:Data on the efficacy of remdesivir in Coronavirus Disease 2019 (COVID-19) are limited in pregnant patients since they have been excluded from clinical trials. We aimed to investigate some clinical outcomes following remdesivir administration in pregnancy. This was a retrospective cohort study conducted on pregnant women with moderate to severe COVID-19. The enrolled patients were divided into two groups with and without remdesivir treatment. The primary outcomes of this study were the length of hospital and intensive care unit stay; respiratory parameters of hospital day 7 including respiratory rate, oxygen saturation, and mode of oxygen support; discharge until days 7 and 14, and need for home oxygen therapy. Secondary outcomes included some maternal and neonatal consequences. Eighty-one pregnant women (57 in the remdesivir group and 24 in the non-remdesivir group) were included. The two study groups were comparable according to the baseline demographic and clinical characteristics. Of the respiratory outcomes, remdesivir was significantly associated with a reduced length of hospital stay (p = 0.021) and also with a lower level of oxygen requirement in patients on low-flow oxygen [odds ratio (OR) 3.669]. Among the maternal consequences, no patients in the remdesivir group developed preeclampsia but three patients (12.5%) experienced this complication in the non-remdesivir group (p = 0.024). Furthermore, in patients with moderate COVID-19, the percentage of emergency termination was significantly lower in remdesivir group (OR 2.46). Our results demonstrated some probable benefits of remdesivir in respiratory and also maternal outcomes. Further investigations with a larger sample size should confirm these results.
| S-EPMC10241383 | biostudies-literature
Project description:Objectives: The dysregulated immune response occurring upon COVID-19 infection can lead to tissue damage and organ failure. Different therapeutic strategies are needed to cope with the current and future outspread of COVID-19, including antiviral and anti-inflammatory agents. We describe the outcome of hospitalized patients treated with canakinumab and remdesivir plus the standard of care therapy. Methods: This observational study describes the outcome of the combination of canakinumab (450 mg for patients ≥40 and <60 kg, 600 mg for those ≥60 and <80 kg, or 750 mg for patients ≥80 kg) and 200 mg remdesivir intravenous infusion, plus standard of care (SOC), in 17 moderate-to-severe COVID-19 patients hospitalized in the "Annunziata" Hospital, Cosenza, Italy, between August and November 2021. Hematological markers, biochemical, and hemogasanalysis values at baseline versus day 7 of combination treatment were compared by paired t test after checking for normal distribution and correcting for multiple comparison. Results: The median age of patients was 64 years (range: 39-85), and the median hospitalization time (calculated on the 16 patients that were not transferred to intensive care unit) was of 12.5 days (range: 7-35 days); 15/17 patients (88%) did not experience complications. After 7 days of combination therapy, all the inflammatory parameters were significantly reduced with the exception of procalcitonin; moreover, hematological prognostic markers such neutrophil-to-lymphocyte ratio, CRP-to-lymphocyte ratio, and derived neutrophil-to-lymphocyte ratio reduced. Overall, 16/17 patients (94%) recovered after 14 days. Conclusions: Canakinumab and remdesivir treatment, in addition to SOC, in the early stage of moderate-to-severe COVID-19 showed promising outcomes in terms of safety and effectiveness potentially leading to a reduction in inflammatory and hematological prognostic markers after 7 days of treatment.
| S-EPMC10402280 | biostudies-literature
Project description:BackgroundThe COVID-19 pandemic remains an immediate and present concern, yet as of now there is still no approved therapeutic available for the treatment of COVID-19.This study aimed to investigate and report evidence concerning demographic characteristics and currently-used medications that contribute to the ultimate outcomes of COVID-19 ICU patients.MethodsA retrospective cohort study was conducted among all COVID-19 patients in the Intensive Care Unit (ICU) of Asir Central Hospital in Saudi Arabia between the 1st and 30th of June 2020. Data extracted from patients' medical records included their demographics, home medications, medications used to treat COVID-19, treatment durations, ICU stay, hospital stay, and ultimate outcome (recovery or death).Descriptive statistics and regression modelling were used to analyze and compare the results. The study was approved by the Institutional Ethics Committees at both Asir Central Hospital and King Khalid University.ResultsA total of 118 patients with median age of 57 years having definite clinical and disease outcomes were included in the study. Male patients accounted for 87% of the study population, and more than 65% experienced at least one comorbidity. The mean hospital and ICU stay was 11.4 and 9.8 days, respectively. The most common drugs used were tocilizumab (31.4%), triple combination therapy (45.8%), favipiravir (56.8%), dexamethasone (86.7%), and enoxaparin (83%). Treatment with enoxaparin significantly reduced the length of ICU stay (p = 0.04) and was found to be associated with mortality reduction in patients aged 50-75 (p = 0.03), whereas the triple regimen therapy and tocilizumab significantly increased the length of ICU stay in all patients (p = 0.01, p = 0.02 respectively).ConclusionCOVID-19 tends to affect males more significantly than females. The use of enoxaparin is an important part of COVID-19 treatment, especially for those above 50 years of age, while the use of triple combination therapy and tocilizumab in COVID-19 protocols should be reevaluated and restricted to patients who have high likelihood of benefit.
| S-EPMC8401211 | biostudies-literature