3- Wednesday Research News – 4th August

1 – BNT162b2 Vaccination efficacy is marginally affected by the SARS-CoV-2 B.1.351 variant in fully vaccinated individuals

• Israeli has vaccinated over 80% of its adult population, with two doses of the Pfizer BNT162b2 vaccine.
• This intervention has been highly successful in curtailing the coronavirus 2 outbreak.
• One major concern is the ability of the virus to mutate which potentially can cause SARS-CoV-2 to partially escape from the immune system.
• Here they evaluate the efficacy of the Pfizer vaccine against the B.1.351 variant.
• Despite the concerns caused by the B.1.351 variant, the BNT162b2 vaccine seems to provide substantial immunity against both that variant and the B.1.1.7. Our results suggest that from 14 days following the second vaccine dose the efficacy of BNT162b2 vaccine is at most marginally affected by the B.1.351 variant.

Source: MedRxiv

2- SGLT2-Inhibition reverts urinary peptide changes associated with severe COVID-19: an in-silico proof-of-principle of proteomics-based drug repurposing

• Severe COVID-19 is reflected by significant changes in multiple urine peptides. Based on this observation, a clinical test based on urinary peptides predicting COVID-19 severity, CoV50, was developed and registered as IVD in Germany.
• They have hypothesized that molecular changes displayed by CoV50, to a large degree likely reflective of endothelial damage, can be significantly reversed by specific drugs.
• In a study population without COVID-19, empagliflozin demonstrated a partial, yet significant reversion of the CoV50 signature, indicating a potential benefit in the context of severe COVID-19.

Source: MedRxiv

3- Prevention and Control of Acute Respiratory Viral Infections in Adult Population: A Systematic Review and Meta-Analysis on Ginseng-Based Clinical Trials.

• Acute respiratory infections are continuously emerging.
• This paper aims to evaluate the therapeutic effectiveness of ginseng for the prevention and control of acute respiratory illness including SARS-COV-2 in the adult population.
• Ginseng was found to be effective in the reduction of risk by 38 % and 3-days shorter duration of acute respiratory illness (ARI) in all trials than placebo.
• As the world continues to race to find a cure, it is important to consider the use of ginseng which has been proven over the years to be effective in the treatment of acute respiratory illnesses.
• Further studies should however be conducted to determine the right dosage to improve efficacy and prevent adverse events.

Source: MedRxiv

4- A telehealth-based randomized controlled trial: A model for outpatient trials of off-label medications during the COVID-19 pandemic

• SARS-CoV-2 is a novel coronavirus disease (COVID-19) that presents with fever, cough, and shortness of breath, and has a mortality rate of 2-4%.
• Outcomes are worse among the elderly and those with cardiovascular, respiratory, cancer and other co-morbidities.
• Several treatments are also emerging as promising therapeutic candidates, hydroxychloroquine and azithromycin – both available as generic pills and widely used for other indications – are potential options for treatment.
• A small randomized controlled trial (RCT) of hospitalized patients suggests chloroquine may be superior to placebo in promoting viral elimination and shortening disease course.
• Hydroxychloroquine is preferred to chloroquine in the U.S.
• A small non-randomized trial found azithromycin had a clinical benefit.
• When azithromycin and hydroxychloroquine are given together, they can cause cardiac side-effects that limit use in the outpatient setting.
• These drugs, however, have independent potential benefits against COVID-19 that require more rigorous study before either is considered standard of care.

Source: Sage Journals

5- Alternative models and randomization techniques for Bayesian response-adaptive randomization with binary outcomes

• Bayesian response-adaptive designs, which data adaptively alter the allocation ratio in favor of the better performing treatment, are often criticized for engendering a non-trivial probability of a subject imbalance in favor of the inferior treatment, inflating type I error rate, and increasing sample size requirements.
• The implementation of these designs using the Thompson sampling methods has generally assumed a simple beta-binomial probability model in the literature; however, the effect of these choices on the resulting design operating characteristics relative to other reasonable alternatives has not been fully examined.
• Motivated by the Advanced R2 Eperfusion STrategies for Refractory Cardiac Arrest trial, we posit that a logistic probability model coupled with an urn or permuted block randomization method will alleviate some of the practical limitations engendered by the conventional implementation of a two-arm Bayesian response-adaptive design with binary outcomes.
• In this article, we discuss up to what extent this solution works and when it does not.

Source: Sage Journals

6- Strategies for facilitating the delivery of cluster randomized trials in hospitals: A study informed by the CFIR-ERIC matching tool

• Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging.
• Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial.
• This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals.
• This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.

Source: Sage Journals

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