Protocol of a randomised controlled trial to assess medical staff's inhalation exposure to infectious particles exhaled by patients during oesophagogastroduodenoscopy and the efficacy of surgical masks in this context.

BACKGROUND: Aerosol-generating procedures such as oesophagogastroduodenoscopy (OGD) result in infectious particles being exhaled by patients. This substantially increases the medical staff's risk of occupational exposure to pathogenic particles via airway inhalation and facial mucosal deposition. Infectious particles are regarded as a key route of transmission of SARS-CoV-2 and, thus, represents a major risk factor for medical staff during the ongoing COVID-19 pandemic. There is a need for quantitative evidence on medical staff's risk of multiroute exposure to infectious particles exhaled by patients during OGD to enable the development of practical, feasible and economical methods of risk-reduction for use in OGD and related procedures. This randomised controlled trial (RCT)-Personal protective EquiPment intervention TrIal for oesophagogastroDuodEnoscopy (PEPTIDE)-aims to establish a state-of-the-art protocol for quantifying the multiroute exposure of medical staff to infectious particles exhaled by patients during real OGD procedures. METHOD AND ANALYSIS: PEPTIDE will be a prospective, two-arm, RCT using quantitative methods and will be conducted at a tertiary hospital in China. It will enrol 130 participants (65 per group) aged over 18. The intervention will be an anthropomorphic model with realistic respiratory-related morphology and respiratory function that simulates a medical staff member. This model will be used either without or with a surgical mask, depending on the group allocation of a participant, and will be placed beside the participants as they undergo an OGD procedure. The primary outcome will be the anthropomorphic model's airway dosage of the participants' exhaled infectious particles with or without a surgical mask, and the secondary outcome will be the anthropomorphic model's non-surgical mask-covered facial mucosa dosage of the participants' exhaled infectious particles. Analyses will be performed in accordance with the type of data collected (categorical or quantitative data) using SPSS (V.26.0) and RStudio (V.1.3.959). ETHICS AND DISSEMINATION: Ethical approval for this RCT was obtained from the Ethics Committee of Peking Union Medical College Hospital (ZS-3377). All of the potential participants who agree to participate will provide their written informed consent before they are enrolled. The results will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05321056.

Spray freeze dried niclosamide nanocrystals embedded dry powder for high dose pulmonary delivery.

Based on the drug repositioning strategy, niclosamide (NCL) has shown potential applications for treating COVID-19. However, the development of new formulations for effective NCL delivery is still challenging. Herein, NCL-embedded dry powder for inhalation (NeDPI) was fabricated by a novel spray freeze drying technology. The addition of Tween-80 together with 1,2-Distearoyl-sn-glycero-3-phosphocholine showed the synergistic effects on improving both the dispersibility of primary NCL nanocrystals suspended in the feed liquid and the spherical structure integrity of the spray freeze dried (SFD) microparticle. The SFD microparticle size, morphology, crystal properties, flowability and aerosol performance were systematically investigated by regulating the feed liquid composition and freezing temperature. The addition of leucine as the aerosol enhancer promoted the microparticle sphericity with greatly improved flowability. The optimal sample (SF- 80D-N20L2D2T1) showed the highest fine particle fraction of ∼47.83%, equivalently over 3.8 mg NCL that could reach the deep lung when inhaling 10 mg dry powders.

Gastrointestinal endoscopy infection control strategy during COVID-19 pandemic: Experience from a tertiary medical center in China.

OBJECTIVES: Coronavirus disease 2019 (COVID-19) has spread globally and become a pandemic. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not only infects the gastrointestinal (GI) tract and causes GI symptoms, but also increases nosocomial transmission risk during endoscopic procedures for aerosol generation. We hereby share our infection control strategies aiming to minimize COVID-19 transmission in the endoscopy center. METHODS: We established our infection control strategies based on the guidance of Chinese Society of Digestive Endoscopy and inputs from hospital infection control experts: admission control through the procedure and patient triage, environmental control to reduce possible virus exposure, proper usage of personal protective equipment (PPE), and scope disinfection and room decontamination. All endoscopic procedures accomplished during COVID-19 outbreak and progress of stepwise resumption of elective endoscopy procedures were retrospectively reviewed. RESULTS: Only urgent or semi-urgent procedures were performed during COVID-19 outbreak. After no local new-onset COVID-19 case in Beijing for four weeks, we reopened the endoscopy center for elective procedures and monitored the outbreak continuously while maintaining a sustainable endoscopy service. CONCLUSIONS: It is imperative that all endoscopy centers should establish standard infection control strategies in order to fight COVID-19 pandemic based on national guidance and academic society guidelines and tailor them to individual resources. These measures and setup can also be reserved for future pandemics.

Rational Use of Tocilizumab in the Treatment of Novel Coronavirus Pneumonia.

Since December 2019, a novel coronavirus pneumonia (COVID-19) has broken out in Wuhan, China and spread rapidly. Recent studies have found that ⁓ 15.7% of patients develop severe pneumonia, and cytokine storm is an important factor leading to rapid disease progression. Currently, there are no specific drugs for COVID-19 and the cytokine storm it causes. IL-6 is one of the key cytokines involved in infection-induced cytokine storm. Tocilizumab, which is the IL-6 receptor antagonist, has been approved by the US FDA for the treatment of cytokine release syndrome (CRS), is expected to treat cytokine storm caused by COVID-19 and is now in clinical trials. In this paper, we will elaborate the role of cytokine storm in COVID-19, the mechanism of tocilizumab on cytokine storm and the key points of pharmaceutical care based on the actual clinical application for COVID-19 in our hospital, the latest research reports, clinical trial progress of tocilizumab, drug instruction from the US FDA, and "Diagnosis and Treatment Plan of Novel Coronavirus Pneumonia (seventh trial edition)" in China, so as to provide reference for the treatment of COVID-19.

Novel coronavirus (SARS-CoV-2) infection in a renal transplant recipient: Case report.

An ongoing outbreak of pneumonia associated with the severe acute respiratory coronavirus 2 (SARS-CoV-2) started in Wuhan, China, with cases now confirmed in multiple countries. The clinical course of patients remains to be fully characterized, clinical presentation ranges from asymptomatic infection to acute respiratory distress syndrome and acute renal failure, and no pharmacological therapies of proven efficacy yet exist. We report a case of SARS-CoV-2 infection in a renal transplant recipient with excellent outcome. This case states the importance of close monitoring of the concentration of cyclosporine in patients treated with lopinavir/ritonavir; the routine treatment of corticosteroid can be continued. This is a rare report of SARS-CoV-2 infection in a renal transplant recipient. Further data are needed to achieve better understanding of the impact of immunosuppressive therapy on the clinical presentation, severity, and outcome of SARS-CoV-2 infections in solid organ transplant recipients.