Convalescent plasma as a potential management option in COVID-19: A critical review of randomized controlled registered trials

Abstract

Currently, there is no approved antiviral agent to treat COVID-19. The management is based on reducing the virus spread in communities, providing supportive treatment to patients, and recently receiving immunization. In this critical review, we focus on randomized and controlled clinical trials. ClinicalTrials.gov, Chinese Clinical Trial Registry (ChiCTR), Japan Primary Registries Network (JPRN), the Australian New Zealand Clinical Trials Registry (ANZCTR), and six other Clinical Trials Registers were searched. Only randomized controlled trials covering treatment or prevention with convalescent plasma in COVID-19 patients were included. Data were extracted into summary tables. The matrix developed was used to identify common themes and compare primary and secondary outcomes of each trial against other parameters/ characteristics of the trial. Microsoft Excel was used to create grids of numbers, texts and analysis using various formulae. A total of 3109 trial registry entries were identified, and 44 fulfilled the inclusion and exclusion criteria of the study. The majority of trials (n= 42, 95%) explored the therapeutic potential; only two examined prevention use. The trial's outcome measures varied and were 59 primary (median:1, IQR, 0) and 267 secondary measure outcomes (median: 6, IQR, 8). While 17 studies were recruiting for Phase 1 or 2, the remaining 16 studies were in Phase 2, and 3 and 11 studies had no phases. The total number of participants in these studies was 9432, including control groups (median: 120, IQR, 211). This review provides an overall analysis of clinical trials currently available from seventeen countries and highlights critical issues that we can learn from these trials based on available information.