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Treatment of COVID-19 in Hospitalized Patients with Remdesivir, Convalescent Plasma or Both in a Resource Limited Setting: A Prospective Study
14 Pages Posted: 3 Mar 2021
More...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 <5% of the patients.
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 Population
Declaration 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.
Suggested Citation: Suggested Citation