Treatment of COVID-19 in Hospitalized Patients with Remdesivir, Convalescent Plasma or Both in a Resource Limited Setting: A Prospective Study

Abstract

Background: In the absence of legal provision for emergency use authorization, Nepal government approved convalescent plasma therapy (CPT) and remdesivir for investigational use to treat COVID-19.Methods: This prospective, multicentered, observational study describes the safety and outcomes of hospitalized CPT and remdesivir treated COVID-19 patients. The study enrolled 1315 patients from 31 hospitals across Nepal. Patients over 18 years age received remdesivir, CPT, or both. Clinical findings, lab results, adverse events, and outcomes were recorded.Findings: Patients were classified as having moderate (24.2%), severe (64%) or life-threatening (11.7%) COVID-19. Of 1083 patients with reported outcomes, 78.4% were discharged (74% in good condition, 4.4% with disability) and 21.6% died. Discharge rates were 84% for remdesivir only recipients (N=910), 39% for CPT only recipients (N=59), and 54.4% for CPT+REM (N=114) recipients. The vast majority of CPT and CPT+REM recipients had severe to life-threatening infections (CPT 98.3%; CPT+REM 92.1%) and were admitted to the ICU (CPT 91.8%; CPT+REM 94.6%) compared to REM alone recipients (73.3% and 57.5%, respectively). In a logistic model comparing death vs discharge and adjusted for age, gender, steroid use, and severity, the predicted margin for discharge was higher for remdesivir alone recipients (0.82; 95%CI 0.79-0.84) compared to CPT (0.58; 95%CI 0.47-0.70) or CPT+REM (0.67; 95%CI 0.60-0.74) recipients. Adverse events of Remdesivir and CPT were reported in Interpretation: CPT recipients had more severe COVID-19 infection and a higher mortality. Outcomes for remdesivir recipients were comparable to other studies.Trial Registration: ClinicalTrials.gov (NCT04570982)Funding Statement: Government of Nepal, Ministry of Health and PopulationDeclaration of Interests: None of the authors have a conflict of interest with the study.Ethics Approval Statement: This study was approved by the Ethics Review Board of NHRC.