Abstract
Introduction: Vaccination is a public health strategy that aims to reduce the burden of viral illness, especially important for populations known or likely to be at increased risk for inequitable outcomes due to the disease itself or disparities in care accessed and received. The role of weight status in COVID-19 susceptibility and disease burden remains unclear. Despite this, higher weight is frequently described as a definitive risk factor for both susceptibility and disease severity. Therefore, COVID-19 vaccine trials should recruit a study group representative of the full weight spectrum, and undertake appropriate subgroup analysis by weight status to evaluate response and titrate dose regimes where indicated to ensure equitable outcomes for higher weight people.
Methods and analysis: We aim to review inclusion and exclusion criteria of clinical trial protocols registered with ClinicalTrials.gov, ISRCTN Register, the WHO official vaccine trial register, and ‘The COVID-19 Vaccine Tracker’. To determine the number of trials including higher weight (body mass index >30 kg/m 2 ) individuals and the number of trials conducting efficacy subgroup analyses by weight status. Screening, data extraction and quality appraisal of trial protocols will be completed independently by a minimum of two reviewers. Clinical trials will be assessed for risk of bias using the Risk of Bias-2 tool. We will conduct a descriptive analysis of extracted data. The following subsets are proposed: participation of higher weight people in COVID-19 vaccine trials by trial phase, country and vaccine platform.
Ethics and dissemination: Ethical approval was not required for this review. The results of this rapid review will be presented at appropriate conferences and published in a suitable peer reviewed journal.
Prospero registration number: CRD42020226573.
Keywords: COVID-19; clinical trials; protocols & guidelines.
【저자키워드】 COVID-19, clinical trials, protocols &, guidelines, 【초록키워드】 public health, Efficacy, clinical trial, protocol, Trial, susceptibility, disease severity, Ethics, clinical trials, outcome, risk factor, Population, Screening, body mass index, Participation, clinical, Descriptive analysis, vaccine platform, disease, Care, COVID-19 susceptibility, Analysis, dose, protocols, exclusion criteria, registration number, body mass, Subgroup analyses, trial protocol, PROSPERO, study group, increased risk, ISRCTN, individual, COVID-19 vaccine trials, data extraction, Registered, subgroup analysis, Ethical approval, inclusion and exclusion criteria, minimum, vaccine trial, Inclusion, country, described, evaluate, indicated, the disease, required, determine, reduce, the WHO, subset, COVID-19 vaccine trial, recruit, risk of bia, 【제목키워드】 clinical trial, exclusion criteria, vaccine trial, Inclusion,