Chapter 7 152 Compassionate Use of Remdesivir for Patients with Severe Covid-19 Setup The expanded access program provided access to remdesivir to patients hospitalized with COVID-19 in the United States, Europe, Canada, and Japan. The report is based on prospectively collected data from patients that received remdesivir between January 2020 and May 2020. Regulatory and institutional review board or independent ethics committee approval was obtained before each patient was treated with remdesivir and the program was funded by the sponsor, Gilead Sciences. The research was initiated, coordinated, and conducted by Gilead Sciences, and the report was written by a medical writer employed by the company. Patients The expanded access program was open to patients hospitalized with Covid-19, who had a confirmed SARS-CoV-2 infection and who were receiving oxygen support or had an oxygen saturation of 94% or less while they were breathing ambient air. Of 61 patients that received ≥ 1 dose of remdesivir, 53 patients were included in the analysis. Patients had a median age of 64 years (range, 23-82). Nineteen patients received non-invasive oxygen support (36%) and 34 patients received invasive ventilation at baseline (64%) of which 30 received mechanical ventilation (92%) and four extracorporeal membrane oxygenation (8%). Intervention Patients received remdesivir, a broad-spectrum antiviral. Forty of the 53 patients received a full 10-day course of remdesivir, consisting of 200 mg administered intravenously on day one, followed by 100 mg daily for the remaining nine days of treatment. Ten patients received five to nine days of treatment and three patients got fewer than five days of treatment. Outcome Data on oxygen-support requirements, hospital discharge, and adverse events were collected. In addition, the authors assessed the clinical improvement based on a 6-point ordinal scale. During a median follow-up of 18 days, 36 of the 53 patients showed improvement (68%) in oxygen-support requirements, including 17 of the 30 patients (57%) who received mechanical ventilation and were now extubated. By the date of the most recent follow-up, 25 of 53 patients (47%) had been discharged and seven patients died (13%). By 28 days of follow-up, the cumulative incidence of clinical improvement, as defined by either a decrease of 2 points or more on the sixpoint ordinal scale or live discharge, was 84% (95% CI, 70 - 99).
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