ABSTRACT
Background. Remdesivir (RDV) reduced time to recovery and mortality in some subgroups of hospitalized patients in the NIAID ACTT-1 RCT compared to placebo. Comparative effectiveness data in clinical practice are limited. Methods. Using the Premier Healthcare Database, we compared survival for adult non-mechanically ventilated hospitalized COVID-19 patients between Aug-Nov 2020 and treated with RDV within 2 days of hospitalization vs. those who did not receive RDV. Preferential within-hospital propensity score matching with replacement was used. Patients were matched on baseline O2 and 2-month admission period and were excluded if discharged within 3 days of RDV initiation (to exclude anticipated discharges/transfers within 72 hrs consistent with ACTT-1 study). Time to 14- and 28-day mortality was examined separately for patients on high-flow/non-invasive ventilation (NIV), low-flow, and no supplemental O2 using Cox Proportional Hazards models. Results. RDV patients (n=27,559) were matched to unique non-RDV patients (n=15,617) (Fig 1). The two groups were balanced;median age 66 yrs and 73% white (RDV);68 yrs and 74% white (non-RDV), and 55% male. At baseline, 21% required high-flow O2, 50% low-flow O2, and 29% no O2, overall. Mortality in RDV patients was 9.6% and 13.8% on days 14 and 28, respectively. For non-RDV patients, mortality was 14.0% and 17.3% on days 14 and 28, respectively. Kaplan-Meier curves for time to mortality are shown in Fig 2. After adjusting for baseline and clinical covariates, RDV patients on no O2 and low-flow O2 had a significantly lower risk of death within 14 days (no O2, HR: 0.69, 95% CI: 0.57-0.83;low-flow, HR: 0.67, 95% CI: 0.59-0.77) and 28 days (no O2, HR: 0.80, 95% CI: 0.68-0.94;low-flow, HR: 0.76, 95% CI: 0.68-0.86). Additionally, RDV patients on high-flow O2/NIV had a significantly lower risk of death within 14 days (HR: 0.81, 95% CI: 0.70-0.93);but not at 28 days (Fig 3). Conclusion. In this large study of patients in clinical care hospitalized with COVID-19, we observed a significant reduction of mortality in RDV vs. non-RDV treated patients in those on no O2 or low-flow O2. Mortality reduction was also seen in patients on high-flow O2 at day 14, but not day 28. These data support the use of RDV early in the course of COVID-19 in hospitalized patients.
ABSTRACT
Background. Evidence on outcomes after COVID-19 hospitalization is limited. This study aimed to characterize 30-day readmission beyond the initial COVID-19 hospitalization. Methods. This descriptive retrospective cohort study included adult patients admitted between 07/01/2020 and 01/31/2021 with a discharge diagnosis of COVID-19 (ICD-10-CM: U07.1), using a large hospital inpatient chargemaster with a linked open claims dataset. The first COVID-19 hospitalization was considered index hospitalization;baseline was defined as first 2 days of index hospitalization;readmission was assessed within 30 days of discharge from index hospitalization. We describe the demographics, treatments and outcomes of the index hospitalization and readmission. Results. For index hospitalization, we identified 111,624 COVID-19 patients from 327 hospitals across US. Mean age was 63 and 54% were male. Over the study period, use of remdesivir (RDV) increased from 11% to 50% while use of steroids (66% -73%) and anticoagulants (32% - 35%) remained relatively stable (Figure 1). Overall, 21% required ICU or CCU admission, 13% died, and median length of stay (LOS) was 7 days (range 4 -11 days). Among 61,182 (55%) with ≥ 30-day follow-up post discharge, all-cause 30-day readmission was 16% and remained stable (15% - 17%) over the study period;median days to readmission was 6 days (range 1-30). All-cause readmission (13 % vs 17%) was lower in patients treated with RDV during index hospitalization over time (Figure 2), particularly in those requiring high flow oxygen (17% vs 18%), low flow oxygen (13% vs 16%) or no oxygen (12% vs 17%), but not in ECMO or invasive ventilation (33% vs 29%). Compared to non-readmitted, readmitted patients were older (60 vs 65), had more comorbidities such as COPD (24% vs 37%) (see Table 1) and LOS (6 vs 7 days) in index hospitalization. Overall, the most frequent diagnoses of readmission were COVID-19 (63%), other viral pneumonia (36%), and acute respiratory failure with hypoxia (34%). Conclusion. In a large, geographically diverse cohort of hospitalized COVID-19 patients, 16% required readmission, especially in those with greater age and comorbidities. Over the study period, all-cause readmission remained stable and was lower in RDV treated patients.
ABSTRACT
Background. There are few real-world data on the use of remdesivir (RDV) looking at timing of initiation in relation to symptom onset and severity of presenting disease. Methods. We conducted multi-country retrospective study of clinical practice and use of RDV in COVID-19 patients. De-identified medical records data were entered into an e-CRF. Primary endpoints were all-cause mortality at day 28 and hospitalization duration. We assessed time from symptom onset to RDV start and re-admission. We included adults with PCR-confirmed symptomatic COVID-19 who were hospitalized after Aug 31, 2020 and received at least 1 dose of RDV. Descriptive analyses were conducted. Kaplan-Meier methods were used to calculate the mortality rate, LogRank test to compare groups defined by severity of disease. Competing risk regression with discharge and death as competing events was used to estimate duration of hospitalization, and Gray's test to compare the groups. Results. 448 patients in 5 countries (12 sites) were included. Demographics are summarized (table) by 3 disease severity groups at baseline: no supplemental oxygen (NSO), low flow oxygen ≤6 L/min (LFO), and high-flow oxygen > 6L/min (HFO). No demographic differences were found between groups except for the higher percentage of cancer/chemotherapy patients in NSO group. Corticosteroids use was HFO 73.6%, LFO 62.7%, NSO 58.0%. Mortality rate was significantly lower in NSO, and LFO groups compared with HFO (6.2%, 10.2%, 23.6%, respectively;Fig1). Median duration of hospitalization was 9 (95%CI 8-10), 9 (8-9), 13 (10-15) days, respectively (Fig2). Median time from first symptom to RDV start was 7 days in all 3 groups. Patients started RDV on day 1 of hospitalization in HFO and LFO and day 2 on NSO groups. And received a 5 day course (median). Readmission within 28-days of discharge was < 5% and similar across all 3 groups. Conclusion. In this real-world cohort of COVID-19 positive hospitalized patients, RDV use was consistent across countries. RDV was started within a median of 7 days from symptom within 2 days of admission and given for a median of 5 days. Higher mortality rate and duration of hospitalization was seen in the HFO group and similar rates seen in the LFO and NSO groups. Readmission was consistently low across all 3 groups.
ABSTRACT
Objectives: This study aimed to characterize the 30-day readmission in hospitalized COVID-19 patients. Methods: We conducted an observational cohort study including adult hospitalized COVID-19 patients admitted between 07/01/2020 and 01/31/2021 using a large inpatient chargemaster (billing) linked with open administrative healthcare claims database. The first COVID-19 hospitalization in the study period was considered as the index hospitalization. Readmission was assessed within 30 days of discharge. Results: We identified 111,624 COVID-19 patients admitted to 327 hospitals with 13% (N=14,763) mortality rate during index hospitalization. Among 61,182 patients discharged alive with ≥30-day follow-up, the overall all-cause readmission rate was 16% (N=9,748) and remained stable between 15% and 17% over the study period. 32% (N=19,770) of the discharged patients were treated with remdesivir (RDV) during their index hospitalization, and readmission was lower in RDV-treated patients (13%, N=2,627) compared to those not treated with RDV during their index hospitalization (17%, N=7,121). Among patients who received RDV in their initial hospitalization, those who started therapy upon admission (Day 1 or 2) had lower readmission rates (12%), compared to those who received RDV later in the hospitalization course, 15% (Day 3-5) and 27% (Day >5). The most frequent diagnoses upon readmission were COVID-19 (63%), other viral pneumonia (36%), and acute respiratory failure with hypoxia (34%). Compared to non-readmitted, readmitted patients were older (60 vs 65), had more comorbidities such as COPD (24% vs 37%) and congestive heart failure (28% vs 44%), and longer median LOS (6 vs 7 days) during index hospitalization. Conclusions: This study of a large and geographically diverse population revealed substantial burden on patients beyond the initial COVID-19 hospitalization, as 16% of the patients were re-admitted within 30-days. Over the study period, lower readmission was observed in patients who were treated with RDV during their index hospitalization.
ABSTRACT
Objectives: In this comparative effectiveness study, we compare the survival outcomes for hospitalized COVID-19 patients treated with remdesivir (RDV) upon admission vs. those not treated with RDV. Methods: We used the Premier Healthcare Database to examine patients hospitalized between Aug-Nov 2020 and treated with RDV within 2 days of hospitalization vs. those who did not receive RDV during their hospitalization. Preferential within-hospital propensity score matching with replacement was used. Patients were matched on baseline oxygen requirement and 2-month admission period and were excluded if discharged within 3 days of RDV initiation (to exclude anticipated discharges/transfers within 72 hrs consistent with ACTT-1 study). Cox Proportional Hazards models were used to examine 14- and 28-day mortality overall and for patients on no supplemental oxygen (NSO), low-flow oxygen (LFO), high-flow oxygen/non-invasive ventilation (HFO/NIV) and invasive mechanical ventilation/ECMO (IMV/ECMO) separately. Results: RDV patients (n=28,855) were matched to unique non-RDV patients (n=16,687). The two groups were balanced. At baseline, 28% required NSO, 48% LFO, 20% HFO/NIV and 4% IMV/ECMO. Mortality in RDV patients was 10.6% and 15.4% on days 14 and 28, respectively. For non-RDV patients, mortality was 15.4% and 19.1% on days 14 and 28, respectively. After adjusting for baseline and clinical covariates, RDV patients had significantly lower risk of mortality at 14-days (HR[95% CI]: 0.76[0.70−0.83]) and 28-days (0.89[0.82−0.96]). This mortality benefit was also seen for NSO, LFO and IMV/ECMO patients at 14-days (NSO: 0.69[0.57−0.83], LFO: 0.68[0.80−0.77], IMV/ECMO: 0.70[0.58−0.84]) and 28-days (NSO: 0.80[0.68−0.94], LFO: 0.77[0.68−0.86], IMV/ECMO: 0.81[0.69−0.94]). Additionally, HFO/NIV RDV patients had a significantly lower risk of mortality at 14-days (0.81[0.70−0.93]);but not at 28-days. Conclusions: In this observational study, treatment with RDV was associated with statistically significant reduction in mortality among hospitalized COVID-19 patients. These results complement the findings from the ACTT-1 and contribute to the growing body of evidence on the survival benefits of RDV.
ABSTRACT
Objectives: Remdesivir is an FDA approved treatment for hospitalized patients with COVID-19 infection and, in randomized controlled trials, RDV shortened time to recovery and improved clinical outcomes. Data are scarce on RDV utilization in real-world settings or how use has changed over the course of the pandemic. Using chargemaster inpatient data from the Premier Healthcare Database, we describe the patient population and use of RDV following Emergency Use Authorization. Methods: In this retrospective cohort study, adult patients admitted May 1st - Nov 30th 2020 with a primary or secondary discharge diagnosis of COVID-19 (ICD-10-CM: U07.1) were identified and their first COVID-related hospital admission was considered. Descriptive statistics were reported for demographic characteristics of RDV and non-RDV treated patients. RDV utilization over time and by region was examined. Results: Of the 190,529 patients hospitalized for COVID-19 in 823 hospitals, 55,030 (29%) were treated with RDV in 589 hospitals. RDV utilization over time increased from 5% of patients in May to 47% in Nov 2020. In Nov, RDV utilization was 57% in the West, followed by 49% in the South, 48% in the Midwest and 27% in the Northeast. Over time, RDV was initiated earlier in the course of hospitalization. Initiation within the first 2 days of hospitalization increased from 40% to 85% from May to Nov 2020. The average age was 63.6 years (SD=15.3) and 63.5 years (SD=17.3) for RDV-treated and non-RDV treated patients, respectively. More than half of the patients were male (RDV: 56%;Non-RDV: 52%) and about a quarter had commercial insurance (RDV: 28%;Non-RDV: 22%). Racial distribution (white, black, and other) was similar between RDV and non-RDV patients. Conclusions: Overall use of RDV and initiation within the first two days of hospitalization have substantially increased over the course of the pandemic in the United States.
ABSTRACT
Background: Clinical practice patterns for hospitalized COVID-19 patients have rapidly evolved, including specific treatment utilization. In turn, outcomes including time to improvement and mortality have also changed, but some reports have shown disproportionate mortality in Blacks. Data on the use of COVID-19 treatments over time and temporal association with hospital mortality and length of stay (LOS), along with assessments by race, are lacking. Methods: This was a retrospective cohort study of adult patients with a discharge diagnosis of COVID-19 (ICD-10-CM: U07.1) admitted between May-Nov 2020 using the chargemaster inpatient data from the Premier Healthcare Database. Demographic characteristics of the cohort were summarized. Utilization of remdesivir (RDV), dexamethasone, anticoagulants, tocilizumab, sarilumab and baricitinib were examined. Median hospital and intensive care unit (ICU) LOS were assessed over time. In-hospital mortality was identified through discharge status. Unadjusted mortality rates over time are reported. Results: Between May-Nov 2020, 190,529 patients were hospitalized for COVID-19 in 823 US hospitals. Patients had a mean age of 64 years, 64% were White, 19% Black, 53% male and 65% had Medicare/ Medicaid as primary payor. Black patients were younger than White (mean 60 vs. 66 years). Significant comorbidities (>20%) were similar between overall cohort and Black patients and included chronic pulmonary disease, hypertension and obesity. From May to Nov, overall RDV utilization increased from 5% to 47%, dexamethasone utilization increased from 7% to 77% and anticoagulant treatment utilization decreased from 32% to 24% (Figure). Few patients received tocilizumab (5%), sarilumab (0.02%) and baricitinib (0.003%). Among Black patients, RDV use increased from 5% to 39% and dexamethasone use increased from 6% to 74%. The median LOS of the overall cohort and Black cohort decreased from 6 days in May to 5 days in Nov, and overall ICU LOS for patients decreased from 5 to 4 days during this time;5 to 3 in Black patients. Overall in-hospital mortality rate decreased by 35%, and by 38% in Black patients. Conclusion:In US hospitalized patients, use of both dexamethasone and RDV has increased approximately 10-fold from May to Nov. Over this same time, a 35% reduction in mortality, a 17% reduction in LOS and 20% reduction in ICU stay were observed. Besides age, no notable differences were apparent by race. Understanding the drivers of improvement in outcomes requires further analyses.