Remdesivir in Severe COVID-19 and Non-Invasive Ventilation: A Real-Life Experience

Abstract

Background: Antiviral treatment is a hot topic regarding therapy for COVID-19. Several antiviral drugs have been tested in the months since the pandemic began. Yet only Remdesivir obtained approval after first trials. The best time to administer Remdesivir is still a matter for discussion and this could also depend upon the severity of lung damage and the staging of the infection. Methods: We performed a real-life study of patients hospitalized forCOVID-19 and receiving non-invasive ventilation (NIV). In this single-center study, a 5 day course of Remdesivir was administered as compassionate use. Further therapeutic supports included antibiotics, low molecular weight heparin and steroids. Data collection included clinical signs and symptoms, gas exchange, laboratory markers of inflammation, and radiological findings. Major outcomes were de-escalation of oxygen-support requirements, clinical improvement defined by weaning from ventilation to oxygen therapy or discharge, and mortality. Adverse drug reactions were also recorded. All data were collected during hospitalization and during a 20-day follow up after treatment. Results: 51 patients were enrolled. A global clinical improvement was recorded in 22 patients (43%) at 12 days, and 36 (71%) at 20 days; in particular, at 12 days, 27 patients (53%) also had a de-escalation of oxygen-support class from a therapeutic point of view. Remdesivir use was associated with a lower hazard ratio for clinical improvement in the elderly (older than 70 years) and in subjects with more extensive lung involvement (total severity score at HRCT of more than 14). The 20-day mortality was 13%. Conclusions: Results demonstrated that Remdesivir is associated with an improvement in clinical, laboratory and radiological parameters in patients with severe COVID-19 and showed an overall mortality of 13%. We conclude that, in this cohort, Remdesivir was a beneficial add-on therapy for severe COVID-19, especially in adults with moderate lung involvement at HRCT.

Efficacy and Safety of Remdesivir over Two Waves of the SARS-CoV-2 Pandemic

“…Recent real-life studies support the use of Remdesivir as related to a reduction in mortality rate compared to placebo [23,25,26] and associated with a good safety profile [23,26]. This is the first report, in Italy, of Remdesivir use in patients hospitalized in the course of the year 2021.…”

“…After a median (IQR) 15 (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23) days, clinical recovery was observed in 197 pts (89%), 159 of whom also reported virological recovery after a median (IQR) 20 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28) days.…”

“…Up until nowadays, limited data exist regarding the use of Remdesivir in real life [ 22 , 23 , 24 , 25 , 26 ]. Could Remdesivir represent a therapeutic option in the current epidemiological scenario, considering the scarcity of valid therapeutic alternatives available and the frequent, rapid evolution of SARS-CoV-2 pneumonia also in patients with mild COVID-19 and recent symptom onset?…”

“…Differences reported in median (IQR) duration of hospital stay (16 (11-25) vs. 15 (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22) days, p = 0.412) and median (IQR) time to first negative SARS-CoV-2 PCR on nasal-pharyngeal swab (21 (13-35) vs. 19 (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24) days, p = 0.062) was also non-significant between the two Groups.…”

Host Response to SARS-CoV2 and Emerging Variants in Pre-Existing Liver and Gastrointestinal Diseases

“…The double-blind, randomized, placebo-controlled trial of intravenous remdesivir in severe COVID-19 patients (n=1,062, remdesivir, n=541 and placebo, n= 521) found remdesivir superior to placebo in shortening the time to recovery ( Beigel et al., 2020 ). In a real-life study of severe COVID-19 patients (n=52) receiving non-invasive ventilation, global clinical improvement was observed in 43% of patients at 12 days, 71% at 20 days, and 53% patients had de-escalation of oxygen support post-treatment with remdesivir ( Simioli et al., 2021 ). In a controlled open-label trial of dexamethasone (n= 2,104 patients vs usual care n= 4,321), reduction of mortality by 3.5% was observed in patients on oxygen and reduction of mortality by 11.7% in those requiring mechanical ventilation ( Horby et al., 2020 ).…”