Dataset Information

Clinical improvement, outcomes, antiviral activity, and costs associated with early treatment with remdesivir for patients with COVID-19.

ABSTRACT:

Background

Evidence remains inconclusive on any significant benefits of remdesivir in mild-to-moderate COVID-19 patients. This study explored the disease progression, various clinical outcomes, changes in viral load, and costs associated with early remdesivir treatment among COVID-19 patients.

Methods

A territory-wide retrospective cohort of 10,419 patients with COVID-19 hospitalized from 21st January 2020 to 31st January 2021 in Hong Kong were identified. Early remdesivir users were matched with controls using propensity-score matching in a ratio of up to 1:4. Study outcomes were time to clinical improvement on the WHO clinical progression scale of at least 1 score; hospital discharge; recovery; viral clearance; low viral load; positive IgG antibody; in-hospital death; and composite outcomes of in-hospital death, requiring invasive ventilation or intensive care.

Results

After multiple imputation and propensity-score matching, the median follow-up was 14 days for both remdesivir (n=352) and control (n=1,347) groups. Time to clinical improvement was significantly shorter in the remdesivir group than that of control (hazard ratio (HR)=1.14, 95%CI 1.01-1.29, p=0.038), as well as for achieving low viral load (HR=1.51, 95%CI 1.24-1.83, p<0.001) and positive IgG antibody (HR=1.50, 95%CI 1.31-1.70, p<0.001). Early remdesivir treatment was associated with a lower risk of in-hospital death (HR=0.58, 95%CI 0.34-0.99, p=0.045), in addition to a significantly shorter length of hospital stay (difference -2.56 days, 95%CI -4.86 to -0.26, p=0.029), without increasing the risks of composite outcomes for clinical deterioration.

Conclusions

Early remdesivir treatment could be extended to hospitalized patients presenting with moderate COVID-19 and not requiring oxygen therapy on admission.

SUBMITTER: Wong CKH

PROVIDER: S-EPMC8406861 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceClinical effectiveness data on remdesivir are urgently needed, especially among diverse populations and in combination with other therapies.ObjectiveTo examine whether remdesivir administered with or without corticosteroids for treatment of coronavirus disease 2019 (COVID-19) is associated with more rapid clinical improvement in a racially/ethnically diverse population.Design, setting, and participantsThis retrospective comparative effectiveness research study was conducted from March 4 to August 29, 2020, in a 5-hospital health system in the Baltimore, Maryland, and Washington, DC, area. Of 2483 individuals with confirmed severe acute respiratory syndrome coronavirus 2 infection assessed by polymerase chain reaction, those who received remdesivir were matched to infected individuals who did not receive remdesivir using time-invariant covariates (age, sex, race/ethnicity, Charlson Comorbidity Index, body mass index, and do-not-resuscitate or do-not-intubate orders) and time-dependent covariates (ratio of peripheral blood oxygen saturation to fraction of inspired oxygen, blood pressure, pulse, temperature, respiratory rate, C-reactive protein level, complete white blood cell count, lymphocyte count, albumin level, alanine aminotransferase level, glomerular filtration rate, dimerized plasmin fragment D [D-dimer] level, and oxygen device). An individual in the remdesivir group with k days of treatment was matched to a control patient who stayed in the hospital at least k days (5 days maximum) beyond the matching day.ExposuresRemdesivir treatment with or without corticosteroid administration.Main outcomes and measuresThe primary outcome was rate of clinical improvement (hospital discharge or decrease of 2 points on the World Health Organization severity score), and the secondary outcome, mortality at 28 days. An additional outcome was clinical improvement and time to death associated with combined remdesivir and corticosteroid treatment.ResultsOf 2483 consecutive admissions, 342 individuals received remdesivir, 184 of whom also received corticosteroids and 158 of whom received remdesivir alone. For these 342 patients, the median age was 60 years (interquartile range, 46-69 years), 189 (55.3%) were men, and 276 (80.7%) self-identified as non-White race/ethnicity. Remdesivir recipients had a shorter time to clinical improvement than matched controls without remdesivir treatment (median, 5.0 days [interquartile range, 4.0-8.0 days] vs 7.0 days [interquartile range, 4.0-10.0 days]; adjusted hazard ratio, 1.47 [95% CI, 1.22-1.79]). Remdesivir recipients had a 28-day mortality rate of 7.7% (22 deaths) compared with 14.0% (40 deaths) among matched controls, but this difference was not statistically significant in the time-to-death analysis (adjusted hazard ratio, 0.70; 95% CI, 0.38-1.28). The addition of corticosteroids to remdesivir was not associated with a reduced hazard of death at 28 days (adjusted hazard ratio, 1.94; 95% CI, 0.67-5.57).Conclusions and relevanceIn this comparative effectiveness research study of adults hospitalized with COVID-19, receipt of remdesivir was associated with faster clinical improvement in a cohort of predominantly non-White patients. Remdesivir plus corticosteroid administration did not reduce the time to death compared with remdesivir administered alone.

Project description:BACKGROUND:Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious. METHODS:We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. RESULTS:A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%). CONCLUSIONS:Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).