Hanshiyi Formula treatment in patients with COVID-19: study protocol and statistical analysis plan (SAP) of an open-label randomized controlled clinical trial (preprint)

Background As COVID-19 continues to spread rapidly in 2019, the risks to human health cannot be underestimated. There is still lack of antiviral drugs for COVID-19, and the development of effective treatments is urgent. Traditional Chinese Medicine (TCM) has been widely used in the treatment of epidemic infectious diseases, The purpose of this randomized controlled clinical trial will to evaluate the clinical efficacy and safety of Hanshiyi Formula (HSYF) in patients with COVID-19.Methods We will conduct this randomized, controlled, open, non-inferiority test clinical study in 240 COVID-19 subjects. Eligible patients will be divided into a control group ( LH granule ) or a treatment group ( HSYF ) in a 1:1 ratio. The intervention duration will be 14 days, and the medication could be stopped in advance if the discharge standard was reached. Clinical efficacy measures will be analyzed at baseline and on day 1–14 of enrollment, The occurrence of adverse events will be monitored throughout the trial. The statistical analysis plan included the treatment of missing data, the analysis of outcome measures, and the method of safety endpoints.Discussion To investigate the efficacy and safety of HSYF in the treatment of COVID-19, provide more sufficient high-quality evidence-based medical basis for TCM intervention in the diagnosis and treatment of COVID-19. To avoid selective reporting bias and data-driven analysis, the statistical analysis plan will standardize the statistical analysis of clinical trials.Trial registration: Chinese Clinical Trial Registry, ChiCTR2200058384. Version V1.2, created on April 11, 2022.https://www.chictr.org.cn/com/25/hvshowproject.aspx?id=159938.

COVID-19 Vaccine Perceptions in the Initial Phases of US Vaccine Roll-out: An Observational Study on Reddit (preprint)

Background: Open online forums like Reddit provide an opportunity to quantitatively examine COVID-19 vaccine perceptions early in the vaccine timeline. We examine COVID-19 misinformation on Reddit following vaccine scientific announcements, in the initial phases of the vaccine timeline. Methods: We collected all posts on Reddit from January 1 2020 - December 14 2020 (n=266,840) that contained both COVID-19 and vaccine-related keywords. We used topic modeling to understand changes in word prevalence within topics after the release of vaccine trial data. Social network analysis was also conducted to determine the relationship between Reddit communities (subreddits) that shared COVID-19 vaccine posts, and the movement of posts between subreddits. Results: There was an association between a Pfizer press release reporting 90\% efficacy and increased discussion on vaccine misinformation. We observed an association between Johnson and Johnson temporarily halting its vaccine trials and reduced misinformation. We found that information skeptical of vaccination was first posted in a subreddit (r/Coronavirus) which favored accurate information and then reposted in subreddits associated with antivaccine beliefs and conspiracy theories (e.g. conspiracy, NoNewNormal). Conclusions: Our findings can inform the development of interventions where individuals determine the accuracy of vaccine information, and communications campaigns to improve COVID-19 vaccine perceptions, early in the vaccine timeline. Such efforts can increase individual- and population-level awareness of accurate and scientifically sound information regarding vaccines and thereby improve attitudes about vaccines, especially in the early phases of vaccine roll-out. Further research is needed to understand how social media can contribute to COVID-19 vaccination services.