Remdesivir linked with clinical improvement and safety — Johns Hopkins hospital study

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Hospitalised COVID-19 patients treated with remdesivir at Baltimore-based Johns Hopkins Medicine demonstrated faster clinical improvement than patients who did not receive the drug, according to a study.

Researchers analysed data on 2,438 patients with COVID-19 who were hospitalised across the system's five hospitals between 4 March and 29 August, 2020. Of these patients, 184 received remdesivir and corticosteroids, and 158 received remdesivir alone. About 80% of patients who received remdesivir were not white.

The median time to clinical improvement for remdesivir recipients was five days, compared to seven days for matched control patients.

Patients treated with remdesivir had a 7.7% 28-day mortality rate. The control group had a 14% mortality rate, though this difference was not statistically significant when researchers performed a time-to-death analysis. Adding corticosteroids to a patient's treatment regimen was not linked to reduced mortality.

"These results provide further evidence that remdesivir may be effective in reducing the duration of COVID-19 illness, that a (five)-day treatment course may be sufficient, and that patients with milder disease likely benefit most," study authors said. "The inclusion of a larger proportion of patients from underrepresented minority groups provides much-needed evidence suggesting the effectiveness of remdesivir administration in these groups."

 

Study details
Comparison of Time to Clinical Improvement With vs Without Remdesivir Treatment in Hospitalized Patients With COVID-19

Brian T Garibaldi; Kunbo Wang; Matthew L Robinson; Scott L Zeger; Karen Bandeen-Roche; Mei-Cheng Wang; G Caleb Alexander; Amita Gupta; Robert Bollinger; Yanxun Xu

Published in JAMA Network Open on 24 March 2021

Abstract
Importance
Clinical effectiveness data on remdesivir are urgently needed, especially among diverse populations and in combination with other therapies.
Objective
To 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 Participants
This 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.
Exposures
Remdesivir treatment with or without corticosteroid administration.
Main Outcomes and Measures
The 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.
Results
Of 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 Relevance
In 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.

 

Beckers Hospital material

JAMA Network Open study (Open access)

 

See also MedicalBrief archives:

Baricitinib plus remdesivir in reducing recovery time in COVID-19 patients — ACTT-2 trial

WHO doubles down on antibodies and steroids; shuns remdesivir

FDA approves remdesivir as COVID-19 treatment despite negative WHO study

SA’s private hospitals order cut-price remdesivir generic but state holds back

Remdesivir for COVID-19 improves time to recovery – peer-reviewed Adaptive COVID-19 Treatment Trial


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