Efficacy and Safety of Remdesivir in Indian Patients With Moderate to Severe Covid-19: Results From the Open Label Period of a Phase Ii, Randomized Controlled Trial

Abstract

BACKGROUND: Remdesivir has proved its antiviral efcacy on COVID-19 virus in-vitro, but its role in infected patients is still obscure. OBJECTIVE:To evaluate the efcacy and safety of Remdesivir in COVID-19 patients with signicant pulmonary involvement. STUDYDESIGN AND METHOD:We conducted a single center, two-arm, prospective, open-label, phase II study from June 2020 to December 2020 on COVID-19 patients (≥18 years), admitted at Jagjivan Ram Railway Hospital, Mumbai. The primary outcome was to evaluate the all-cause mortality up to 28 days in COVID-19 patients; secondary outcome was to assess the length of hospital stay (LOHS) and duration of respiratory supports, using PASS v11.0 software (19). RESULTS:Overallmortality status at 28 dayswas notsignicant(62 (31.2%)in the remdesivir group vs 65 (32.5%)in the control group), and themean LOHS was less in remdesivir arm which was statistically signicant in the female subgroup although the remdesivir group had delay in hospital admission from the onset of the symptoms and statistically higher index IL6 values. Duration of invasive mechanical ventilation showed signicant statistical difference among the study groups(4.7±1.18 daysin control vs 2.8±1.88 daysin remdesivir), and across both the genders. Hypertension and diabetesmellitusfoundtobe themost commoncomorbiditiesinCOVID-19.Nosafetyconcernswere reportedinRemdesivirgroup. CONCLUSION: Remdesivir was well tolerated without any adverse events, but did not show any signicant effect on COVID-19 survival rate, however it decreases the length of hospital stay and duration of invasive ventilator support. More studies are needed to understand the effects of Remdesivir in larger populations.