Death and invasive mechanical ventilation risk in hospitalized COVID-19 patients treated with anti-SARS-CoV-2 monoclonal antibodies and/or antiviral agents: A systematic review and network meta-analysis protocol.

ABSTRACT

BACKGROUND: The ongoing COVID-19 pandemic has claimed >4 million lives globally, and these deaths often occurred in hospitalized patients with comorbidities. Therefore, the proposed review aims to distinguish the inpatient mortality and invasive mechanical ventilation risk in COVID-19 patients treated with the anti-SARS-CoV-2 monoclonal antibodies and/or the antiviral agents. METHODS: A search in PubMed, Embase, and Scopus will ensue for the publications on randomized controlled trials testing the above, irrespective of the publication date or geographic boundary. Risk of bias assessment of the studies included in the review will occur using the Cochrane risk of bias tool for randomized trials (RoB 2). Frequentist method network meta-analyses (NMA) will compare each outcome's risk across both types of anti-SARS-CoV-2 agents in one model and each in separate models. Additional NMA models will compare these in COVID-19 patients who were severely or critically ill, immunocompromised, admitted to the intensive care unit, diagnosed by nucleic acid amplification test, not treated with steroids, <18 years old, and at risk of infection due to variants of concern. The plan of excluding non-hospitalized patients from the proposed review is to minimize intransitivity risk. The acceptance of the network consistency assumption will transpire if the local and overall inconsistency assessment indicates no inconsistency. For each NMA model, the effect sizes (risk ratio) and their 95% confidence intervals will get reported in league tables. The best intervention prediction and quality of evidence grading will happen using the surface under the cumulative ranking curve values and the Grading of Recommendations Assessment, Development and Evaluation-based Confidence in Network Meta-Analysis approach, respectively. Sensitivity analysis will repeat the preliminary NMA while excluding the trials at high risk of bias. The Stata statistical software (v16) will be used for analysis. The statistical significance will get determined at p<0.05 and 95% confidence interval. TRIAL REGISTRATION PROSPERO Registration No https//www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021277663.