(P-018) Clinical Characteristics and Biomarkers of sars-cov-2 Infection in Patients Treated with Remdesivir in Hospital - A Population Based Cohort Study

Background: Remdesivir, a SARS-CoV-2 nucleotide analog RNA polymeras, is the first antiviral drug approved by the FDA for treating coronavirus disease 2019 (COVID-19) in hospitalized patients. Literature on clinical characteristics and biomarkers of COVID 19 in patients treated with Remdesivir in real-world settings is scarce.

Objectives: To describe baseline demographic characteristics, comorbidities and medications, estimate the incidence of clinical manifestation/outcome of SARS-CoV-2 infection, and understand the change from baseline of clinical biomarkers among COVID-19 inpatients taking Remdesivir.

Methods: This is a retrospective descriptive cohort study using US OPTUM EHR COVID-19 data. Adult patients with SARS-CoV-2 infection who initiated remdesivir in hospital and not on clinical trials during 2/1/2020-9/17/2020 were included. Baseline for patient characteristics was defined as 6 months prior to the index date (i.e. Remdesivir start date). Changes from baseline of clinical biomarkers (CRP, LDH, and Ferritin), were measured by differences of lab values on the discharge date or 30 days after the index date (if missing the discharge date) and on/closest date prior to index date. Descriptive statistics for characterization and incidence proportion calculation of clinical outcomes since SARS-CoV-2 Infection were performed.

Results: Among the total of 2795 remdesivir users identified, mean age was 60 years, 56% were males, and 52% were white vs 16% black. Prevalent baseline comorbidities/medications included serious infections with hospitalization (54%), hypertension (52%), obesity (40%), hyperlipidemia (36%), diabetes (35%), chronic kidney disease (30%), and corticosteroid (43%). Pre-remdesivir inpatient treatments included azithromycin (53%), methylprednisolone (18%), hydroxychloroquine (5%), and tocilizumab (4%). Incidences of clinical outcomes were ICU admission (38%), mechanical ventilation/ECMO (25%), acute respiratory distress syndrome (78%), multi-organ dysfunction (78%), sepsis/septic shock (32%), and death (16%). Common biomarker reductions from baseline included CRP (82%), LDH (65%), and Ferritin (60%).

Conclusions: Using one of the largest Remedesivir samples from US EHR data, these results provide insight on patients treated with Remdesivir in the real-world setting, which may inform biomarker identification and development of antiviral drugs to treat COVID-19. Future research to understand the difference between COVID-19 hospitalized patients with or without Remdisivir treatment and biomarker identification using real world data are warranted.