Psychological capital and organizational citizenship behavior among nurses during the COVID-19 epidemic: mediation of organizational commitment.

BACKGROUND: Nurses' organizational citizenship behavior, a spontaneous "altruistic work behavior", may be affected by psychological capital and organizational commitment, but its mechanism is not clear. The aim of this study was to investigate the characteristics and distribution of psychological capital, organizational commitment and organizational citizenship behavior among nurses during the COVID-19 epidemic, and explore the mediating role of organizational commitment in psychological capital and organizational citizenship behavior. METHODS: A cross-sectional survey was conducted among 746 nurses from 6 designated hospitals for COVID-19 treatment in China. Descriptive statistics, Pearson correlation analysis, and structural equation model were used in this study. RESULTS: Nurses' psychological capital, organizational commitment and organizational citizenship behavior scores were 103.12 ± 15.57, 46.53 ± 7.14 and 101.47 ± 12.14, respectively. Additionally, organizational commitment partially mediates between psychological capital and organizational citizenship behavior. CONCLUSIONS: During the COVID-19 pandemic, nurses' psychological capital, organizational commitment, and organizational citizenship behavior were found to be at an upper-middle level, influenced by various social-demographic factors. Furthermore, the results illustrated that psychological capital can affect organizational citizenship behavior through the mediating role of organizational commitment. Therefore, the findings emphasize the importance of nursing administration to monitor and prioritize the mental health and organizational behavior of nurses during the ongoing COVID-19 crisis. It is crucial to focus on developing and nurturing nurses' psychological capital, strengthening their organizational commitment, and ultimately promoting their organizational citizenship behavior.

The Effects of Extrinsic and Intrinsic Factors on Neurogenesis.

In the mammalian brain, neurogenesis is maintained throughout adulthood primarily in two typical niches, the subgranular zone (SGZ) of the dentate gyrus and the subventricular zone (SVZ) of the lateral ventricles and in other nonclassic neurogenic areas (e.g., the amygdala and striatum). During prenatal and early postnatal development, neural stem cells (NSCs) differentiate into neurons and migrate to appropriate areas such as the olfactory bulb where they integrate into existing neural networks; these phenomena constitute the multistep process of neurogenesis. Alterations in any of these processes impair neurogenesis and may even lead to brain dysfunction, including cognitive impairment and neurodegeneration. Here, we first summarize the main properties of mammalian neurogenic niches to describe the cellular and molecular mechanisms of neurogenesis. Accumulating evidence indicates that neurogenesis plays an integral role in neuronal plasticity in the brain and cognition in the postnatal period. Given that neurogenesis can be highly modulated by a number of extrinsic and intrinsic factors, we discuss the impact of extrinsic (e.g., alcohol) and intrinsic (e.g., hormones) modulators on neurogenesis. Additionally, we provide an overview of the contribution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to persistent neurological sequelae such as neurodegeneration, neurogenic defects and accelerated neuronal cell death. Together, our review provides a link between extrinsic/intrinsic factors and neurogenesis and explains the possible mechanisms of abnormal neurogenesis underlying neurological disorders.

The Association of Symptom Severity and Functional Status Among Patients Who Received Palliative Consults (Sch476)

1. Describe the association of functional status and symptom severity for 10 common symptoms among patients who receive palliative care consultation. 2. Consider the interaction of functional status and different symptoms when managing symptoms of patients who receive palliative care consultations. The interaction of functional status and individual symptoms has never been comprehensively investigated in palliative care (PC) populations. Therefore, we studied the relationship between the Karnofsky Performance Status (KPS) and the prevalence and severity of 10 common symptoms among hospitalized patients at the time of PC consult. Weretrospectively analyzed data from a registry of PC consults across five hospitals within the Mount Sinai Health System between January 1, 2020, and December 31, 2021. Demographics and ICD-10 codes were extracted from electronic medical and billing records. During consult, PC clinicians assessed functional status using the KPS at the time of consult (0%-100%) and symptom burden using the 10-item Edmonton Symptom Assessment Scale (ESAS), which rates each symptom as none, mild, moderate, or severe. The association of KPS and ESAS symptom severity was assessed using ordinal logistic regression models, adjusting for age, gender, Elixhauser comorbidity index, and the underlying serious illness (cancer, sepsis, dementia, COVID-19). The study population included 6,065 patients (mean age 70±16 years, 50.9% male). The most frequent underlying serious illnesses were sepsis (36.6%), cancer (32.9%), and dementia (22.8%). In regression analysis, KPS was significantly associated with symptom severity for all ESAS symptoms (p<0.001). However, symptoms separated into two different groups. Drowsiness (β=-0.85), inactivity (β=-0.71), dyspnea (β=-0.21), anorexia (β=-0.19), and agitation (β=-0.06) were negatively associated with KPS (ie, lower functional status was associated with more severe symptoms), whereas nausea (β=0.2), anxiety (β=0.15), physical discomfort (β=0.13), depression (β=0.13), and constipation (β=0.06) were positively associated with KPS (ie, lower functional status was associated with milder symptoms). These associations remained statistically significant after adjusting for baseline characteristics. While some symptoms were more severe, other symptoms were less severe among patients with poor functional status. This observation can inform symptom management and warrants further investigation. [ FROM AUTHOR] Copyright of Journal of Pain & Symptom Management is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Functional Status Changes in Patients Receiving Palliative Care Consult During COVID-19 Pandemic.

CONTEXT: Hospitalized patients with functional impairment have higher symptom burden and mortality. Little is known about how increased patient volume and acuity during the coronavirus disease 2019 (COVID-19) pandemic affected access to palliative care among patients with functional impairment. OBJECTIVES: To examine changes in functional status and hospital outcomes among patients receiving inpatient palliative care consultation before, during and after the COVID-19 pandemic. METHODS: We conducted a retrospective, multisite cohort study of all adult patients (≥ 18 years) admitted to four hospitals in New York City, USA, who received inpatient palliative care consultation between March 1, 2019 and February 28, 2022 with documented functional status at the time of consultation measured by Karnofsky Performance Status scale. RESULTS: Among 13,180 eligible patients identified, patients' functional status at the time of consultation decreased as palliative care consult volume increased with the onset of the pandemic. Compared to pre-pandemic, there was a statistically significant trend of lower functional status (P < 0.001) and higher in-hospital mortality (P < 0.001) among patients with noncancer and non-COVID-19 diagnoses two years after the pandemic. In contrast, patients with cancer had a statistically significant trend of higher functional status (P < 0.001) and no significant changes in in-hospital mortality over time. CONCLUSION: As the healthcare system was stressed with high demand and limited resources, palliative care consultation prioritized highest acuity patients by shifting towards those with lower functional status and higher in-hospital mortality. This shift disproportionately affected noncancer patients. Innovative approaches to ensure upstream palliative care consultation during increased resource constraints are needed.

Changes in health communication in the age of COVID-19: A study on the dissemination of preprints to the public.

Introduction: Preprints have become an important tool for meeting the challenges of health communication in the context of COVID-19. They allow scientists to disseminate their results more quickly due to the absence of a peer review process. Preprints have been well-received by scientists, however, there have been concerns about the exposure of wider public audiences to preprints due in part to this lack of peer review. Methods: The aim of this study is to examine the dissemination of preprints on medRxiv and bioRxiv during the COVID-19 pandemic using content analysis and statistical analysis. Results: Our findings show that preprints have played an unprecedented role in disseminating COVID-19-related science results to the public. Discussion: While the overall media coverage of preprints is unsatisfactory, digital native news media performed better than legacy media in reporting preprints, which means that we could make the most of digital native media to improve health communication. This study contributes to understanding how science communication has evolved in response to the COVID-19 pandemic and provides some practical recommendations.

Suggestions of management on emergency responses to epidemic outbreaks in outpatient or emergency departments of tertiary teaching hospitals.

Image, graphical abstract.

Experience in the development of nurses' personal resilience: A meta-synthesis.

AIM: Nurses play roles in hospitals, families, society and other aspects and often face stress sources, such as heavy workload, doctor-patient conflict and medical accidents. Resilience can help the nurses to avoid or reduce various adverse consequences caused by stress sources; however, this phenomenon remains ill-defined and under-researched. The aim of this review was to summarize the experiences of development of nurses' resilience and explore the reasons for the formation of resilience by examining the findings of the existing qualitative studies. DESIGN: The review is a systematic review and meta-synthesis of qualitative studies. DATA SOURCES: PubMed, Cochrane Library, CINAHL, Web of Science, Embase, and Ovid and Chinese databases include the following: Chinese National Knowledge Infrastructure (CNKI), Wanfang Database (CECDB), VIP Database and China Biomedical Database (CBM). REVIEW METHODS: Relevant publications were identified by systematic searches across 11 databases in June 2021. All qualitative and mixed-method studies in English and Chinese that explored the experiences of development of nurses' resilience were included. The qualitative meta-synthesis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. Two independent reviewers selected the studies and assessed the quality of each study. Meta-synthesis was performed to integrate the results. RESULTS: A total of nine studies revealed 10 sub-themes and three descriptive themes: being psychologically strong, physical positive coping and adoption of external support. CONCLUSION: Several factors contributed to the development of nurses' resilience, and various supporting strategies in the nursing management and education are helpful to their adaption ability. However, it is necessary to focus on the cultivation of nurses' resilience to improve the quality of clinical nursing. Leaders or organizations are required to establish and sustain multifaceted strategies to improve nurse' resilience through scientific resilience training programmes and improved organizational support.

The prevalence of social frailty among older adults: A systematic review and meta-analysis.

Social frailty is a geriatric public health problem that deeply affects healthy aging. Currently, evidence on the prevalence and factors associated with social frailty in older adults remains unclear. Our study aims to estimate the prevalence and related factors of social frailty in older adults. This study retrieved nine electronic databases searched through July 5th, 2022. The prevalence of social frailty was pooled using Stata software. It was found that older adults suffered from a "moderate" level of social frailty. We found a higher prevalence of social frailty in the United Kingdom, Greece, Croatia, The Netherlands, and Spain, in people over 75 years, in hospitals, and during the Coronavirus Disease 2019 (COVID-19). We believed that countries, age, research sites, and the pandemic of COVID-19 were influencing factors of social frailty among older adults. These findings may provide a theoretical basis for the development of ameliorating social frailty among older adults.

Post-traumatic growth experience of first-line emergency nurses infected with COVID-19 during the epidemic period-A qualitative study in Shanghai, China.

Background: In March 2022, Shanghai, China, was hit by a severe wave of SARS-CoV-2 transmission caused by the Omicron variant strain. The medical staff was greatly infected during this period, which posed a traumatic event for them. Meanwhile, they also experience post-traumatic growth under introspection and positive change. However, the psychological coping and growth after infection with COVID-19 among medical staff have rarely been investigated. Objectives: To explore the process and influencing factors of post-traumatic growth among emergency nurses infected with coronavirus disease (COVID-19) so as to provide a new perspective and theoretical basis for psychological rehabilitation or intervention for medical staff who experienced traumatic events. Methods: The study used a qualitative design based on the phenomenological approach. A purposive sampling method was used to explore the subjective feelings and post-traumatic growth among 13 first-line emergency nurses infected with COVID-19 in Shanghai, China. Semi-structured face-to-face interviews were conducted in June 2022. A Seven-step Colaizzi process was used for data analysis. Results: Themes were described and extracted from the experience and insights at different stages during the fight against the virus. Three main themes, i.e., stress period, adjustment period, and growth period, as well as several sub-themes, were identified. Conclusion: First-line emergency nurses infected with COVID-19 are a sensitive group that should be given more attention. Investigating how they achieve psychological adjustment and growth in the case of severe trauma can provide valuable references for nursing management and education in the future. Society, hospital and nursing managers should pay more attention to the PTG of nurses and establish supportive PTG strategies, which will benefit the retention rate and career development of nurses.

Occupational benefit perception of acute and critical care nurses: A qualitative meta-synthesis

Background With the development of society, nurses have an increasingly more important role in the medical team. At the same time, due to various reasons, the number of active nurses is continuously decreasing, and the shortage of nursing personnel is becoming ever more serious. The COVID-19 pandemic made these clinical problems more serious. As the department with the greatest work pressure and the most intense pace, acute and critical care nurses are already facing serious problems related to job burnout and dismission. In the context of the COVID-19 pandemic, these problems should be solved urgently. Furthermore, with the rise of positive psychology, many scholars are turning their research direction to the positive professional experience of nurses so as to get inspiration to encourage nurses to face work with an optimistic attitude and guide nursing managers to better retain nursing talents. Objective The purpose of this paper is to summarize and evaluate the positive emotional experience and professional benefit of acute and critical care specialist nurses in the process of work. So as to better interpret their occupational benefit perception and guide nursing managers in adopting positive measures and promoting the development of high-quality nursing. Methods Cinahl plus, Embase, Medline and other twelve databases were searched for relevant literature. Meta-aggregation was used to synthesize the findings of the included studies. Results From a total of 12 articles included in this study, 55 main results were presented, 8 new categories were integrated, and three themes were formed: professional identity, social support, and personal growth. The professional identity included: being proud of professional ability and increasing professional value;social support included: friends and family support, organizational, environmental support, peer support, and support of patients and their families;personal growth included realizing self-worth and promoting self-development. Conclusion Hospital managers should pay attention to the positive emotional experience of nurses in work and based on this, provide practical and beneficial protection for nurses from the aspects of salary, learning opportunities, working environment, social support and internal personality, stimulate work enthusiasm, guide nurses to correctly face negative emotions and occupational pressure, and improve the sense of professional benefit.

Travel despite the COVID-19 pandemic: Implications for tourism recovery

The COVID-19 pandemic has devastated the global tourism industry. This study explores why some Chinese residents travel during the pandemic. A mixed-methods research design was adopted, guided by the health belief model and relevant literature. Through 21 interviews with Chinese tourists who took an overnight leisure trip in May 2020, and a national survey among Chinese residents, this study explored factors influencing Chinese residents’ travel-related decisions and behaviors during the pandemic. Results outline the influences of health beliefs, government trust, past travel experience, and psychological capital on tourists’ risk-reduction behaviors. Theoretical and practical implications are provided regarding tourism recovery during pandemics.

Prevalence and factors of posttraumatic growth among Hubei residents during the COVID-19 pandemic: A cross-sectional study.

The adverse impact of the COVID-19 pandemic on mental health has been widely concerned, but the research on positive psychological factors is insufficient, this study aims to investigate the prevalence and factors of posttraumatic growth (PTG) among residents in the worst-hit areas of China (Hubei Province). We were conducted in three disaster areas with different severity in Hubei Province three months after the outbreak, and the data were from 575 respondents. Instruments included the simplified Chinese version of the Posttraumatic Growth Inventory (C-PTGI) and the public health emergency psychological questionnaire. Nonparametric tests, Spearman correlation analyses, and multiple linear regression equations were used to analyze the data. The results showed that three months after the outbreak of COVID-19, the PTG of Hubei residents was at a low level, and their sense of fear was the most prominent, with a positive detection rate of 82.09%. According to the results of this study, high PTG levels were associated with high levels of fear, married and healthcare providers, while low levels of PTG were associated with serious chronic diseases, males, good economic status, and poor prevention and control measures. Government departments should strengthen social support for residents, carry out necessary stress management training to help them correctly deal with negative emotions and promote their personal growth.

Chinese Public Perception of Climate Change on Social Media: An Investigation Based on Data Mining and Text Analysis.

Climate change is a serious threat to humankind. As broad public participation is required in climate change mitigation efforts, it is critical to understand how the public talk about climate change on social media. This study sets out to increase the understanding of Chinese public awareness of climate change, as well as explore the potential and limitations of social media for public engagement on climate change issues. It examines the Chinese public's discussion about climate change on social media Weibo during the last six years through data mining and text analysis. The analyses include volume analysis, keyword extraction, topic modeling, and sentiment analysis. The results indicate three main aspects of public awareness and concern regarding climate change. First, public awareness of climate change is growing in China. Second, the sentiment analysis shows that the general sentiment toward climate change is becoming more positive over time. Third, based on keyword extraction and topic modeling, the discussion on climate change shows a top-down perspective, an optimistic economic perspective, and a preference for celebrity content. The study provides a comprehensive picture of Chinese social media users' views on climate change issues, based on large-scale research data. It contributes to a better understanding of what Chinese people think about climate change on social media generally. These findings may provide government and environmental organizations with valuable insights for better climate change campaigns on social media.

Lessons Learned from an Embedded Palliative Care Model in the Medical Intensive Care Unit

Outcomes 1. Examine impact of an embedded model of palliative care delivery in the ICU 2. Brainstorm how to adapt this model of delivery into other ICU settings Background When palliative care is embedded in the medical intensive care unit (MICU), more critically ill patients with unmet palliative care needs can receive an earlier consultation and more value-aligned medical care. Aim Statement To describe an embedded physician (MD) + registered nurse (RN)-led palliative care consultation team in the MICU. To compare timing of consultation, goals of care documentation, and in-ICU mortality before and after the embedded team is implemented. Methods In a retrospective cohort study, we compared patients who received a referral-based MICU consult (pre-embedded) from 01/01/2019 to 06/30/2019, an MD/RN consult (embedded) from 09/01/2019 to 02/28/2020 and an adapted COVID MICU consult from 03/1/2020 to 8/31/2020. Using the electronic health record, we collected sociodemographic and clinical data to compare the consultation volume, patient sociodemographics, rates of documentation of medical decision makers and goals of care, and in-ICU deaths. Results The number of patients who received a MICU palliative care consult increased by 2.4 times (63 patients [pre] vs 169 patients [embedded]) As compared to pre-embedded, there was a significant increase in the documentation of medical decision makers (39% vs 90%, p < .001) and goals of care (34% vs. 90%, p < .001) during the embedded period. Patients were seen earlier in the hospitalization (median 9 days [pre-embedded] vs 3 days [embedded], p < .001);the rate of in-ICU death decreased (75% vs 43%, p < .001). During COVID, there was no change in documentation of decision makers (90% [embedded] vs 93% [COVID], p = .24), goals of care (98% vs 99%, p = 0.63), or time to consult (3 days vs 4 days, p = .08), yet, the rate of in-ICU death increased (43% vs 58%, p = .01). Conclusions and Implications The embedded model provided earlier consultation, increased medical decision maker and goals of care documentation, and decreased in-ICU mortality for MICU patients. Future work will examine how to adapt this model to other ICUs to improve palliative care access for critically ill patients.

Social Distancing, Gathering, Search Games: Mobile Agents on Simple Networks.

During epidemics, the population is asked to socially distance, with pairs of individuals keeping two meters apart. We model this as a new optimization problem by considering a team of agents placed on the nodes of a network. Their common aim is to achieve pairwise graph distances of at least D,  a state we call socially distanced. (If D = 1 , they want to be at distinct nodes; if D = 2 they want to be non-adjacent.) We allow only a simple type of motion called a lazy random walk: with probability p (called the laziness parameter), they remain at their current node next period; with complementary probability 1 - p , they move to a random adjacent node. The team seeks the common value of p which achieves social distance in the least expected time, which is the absorption time of a Markov chain. We observe that the same Markov chain, with different goals (absorbing states), models the gathering, or multi-rendezvous problem (all agents at the same node). Allowing distinct laziness for two types of agents (searchers and hider) extends the existing literature on predator-prey search games to multiple searchers. We consider only special networks: line, cycle and grid.

Psychological Symptoms and Posttraumatic Growth Among the General Population in Wuhan, China During the COVID-19 Pandemic: A Cross-Sectional Study.

The aim of the current study was to investigate psychological symptoms and post-traumatic growth (PTG) among the general population in Wuhan, China during the coronavirus disease 2019 (COVID-19) pandemic. An online survey was conducted using convenience sampling. Participants were invited to fill out this questionnaire, which included information on sociodemographic characteristics and other survey objectives. The Psychological Questionnaire for Emergent Events of Public Health (PQEEPH) and the Chinese version of the Posttraumatic Growth Inventory (PTGI) were used. The prevalence of depression, neurasthenia, fear, obsessive-anxiety, and hypochondriasis among 311 participants were 61.1%, 69.8%, 97.8%, 57.2%, and 45%, respectively. Results indicated that a substantial proportion of the general population may have experienced psychological symptoms as well as PTG, due to the COVID-19 pandemic. Findings demonstrate the importance of developing targeted psychological interventions for those at risk for mental health symptoms. [Journal of Psychosocial Nursing and Mental Health Services, 60(4), 39-46.].

[Moxibustion on mental disorder in close contacts of coronavirus disease 2019: a randomized controlled trial].

OBJECTIVE: To observe the effect of moxibustion combined with Daiwenjiu plaster on mental disorder and self rating symptoms in close contacts of coronavirus disease 2019 (COVID-19) during quarantine. METHODS: A total of 240 close contacts of COVID-19 were randomized into an observation group (120 cases, 18 cases dropped off) and a control group (120 cases, 58 cases dropped off). Conventional observation was adopted in the control group. Moxibustion combined with Daiwenjiu plaster was given in the observation group, moxibustion was applied at Zusanli (ST 36), Hegu (LI 4) and Shenque (CV 8), 10 min each acupoint, once a day; Daiwenjiu plaster was applied at Dazhui (GV 14) and Feishu (BL 13) for 3 to 6 h each time, once every 2 days, the treatment was required for 2 weeks. Before and after treatment and in the follow-up of 2 weeks after treatment, self-reporting questionnaire 20 (SRQ-20), self-rating anxiety scale (SAS) scores and self rating symptoms were evaluated in the two groups. RESULTS: In the follow-up, SRQ-20 score was decreased compared before treatment (P<0.01), SAS score was decreased compared before and after treatment (P<0.01, P<0.05) in the observation group. After treatment and in the follow-up, SRQ-20 scores in the observation group were lower than those in the control group (P<0.05, P<0.01). After treatment, the case proportion of fatigue in the observation group was higher than that in the control group (P<0.05). In the follow-up, the case proportion of tension was lower than that in the control group (P<0.05). CONCLUSION: Moxibustion combined with Daiwenjiu plaster can effectively improve the mental disorder in close contacts of COVID-19.

Access to Palliative Care Consultation for Hospitalized Adults with COVID-19 in an Urban Health System: Were There Disparities at the Peak of the Pandemic?

Background: Palliative care (PC) services expanded rapidly to meet the needs of coronavirus disease 2019 (COVID-19) patients, yet little is known about which patients were referred for PC consultation during the pandemic. Objective: Examine factors predictive of PC consultation for COVID-19 patients. Design: Retrospective cohort study of COVID-19 patients discharged from four hospitals (March 1-June 30, 2020). Exposures: Patient demographic, socioeconomic, and clinical factors and hospital-level characteristics. Outcome Measurement: Inpatient PC consultation. Results: Of 4319 hospitalized COVID-19 patients, 581 (14%) received PC consultation. Increasing age, serious illness (cancer, chronic obstructive pulmonary disease, and dementia), greater illness severity, and admission to the quaternary hospital were associated with receipt of PC consultation. There was no association between PC consultation and race/ethnicity, household crowding, insurance status, or hospital-factors, including inpatient, emergency department, and intensive care unit census. Conclusions: Although site variation existed, the highest acuity patients were most likely to receive PC consultation without racial/ethnic or socioeconomic disparities.

Biochemical features and mutations of key proteins in SARS-CoV-2 and their impacts on RNA therapeutics.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a global pandemic. Three viral proteins, the spike protein (S) for attachment of virus to host cells, 3-chymotrypsin-like cysteine protease (Mpro) for digestion of viral polyproteins to functional proteins, and RNA-dependent-RNA-polymerase (RdRp) for RNA synthesis are the most critical proteins for virus infection and replication, rendering them the most important drug targets for both antibody and chemical drugs. Due to its low-fidelity polymerase, the virus is subject to frequent mutations. To date, the sequence data from tens of thousands of virus isolates have revealed hundreds of mutations. Although most mutations have a minimum consequence, a small number of non-synonymous mutations may alter the virulence and antigenicity of the mutants. To evaluate the effects of viral mutations on drug safety and efficacy, we reviewed the biochemical features of the three main proteins and their potentials as drug targets, and analyzed the mutation profiles and their impacts on RNA therapeutics. We believe that monitoring and predicting mutation-introduced protein conformational changes in the three key viral proteins and evaluating their binding affinities and enzymatic activities with the U.S. Food and Drug Administration (FDA) regulated drugs by using computational modeling and machine learning processes can provide valuable information for the consideration of drug efficacy and drug safety for drug developers and drug reviewers. Finally, we propose an interactive database for drug developers and reviewers to use in evaluating the safety and efficacy of U.S. FDA regulated drugs with regard to viral mutations.

Administration Timing and Efficacy of Tocilizumab in Patients With COVID-19 and Elevated IL-6.

BACKGROUND: Tocilizumab (TCZ), an interleukin-6 receptor antibody, has previously been used for treating patients with the coronavirus disease 2019 (COVID-19), but there is a lack of data regarding the administration timing of TCZ. OBJECTIVES: This study aimed to evaluate the timing and efficacy of TCZ in the treatment of patients with COVID-19. METHODS: Laboratory-confirmed patients with COVID-19 with an elevated interleukin-6 (IL-6) level (>10 pg/ml) were offered TCZ intravenously for compassionate use. Clinical characteristics, laboratory tests, and chest imaging before and after the administration of TCZ were retrospectively analyzed. RESULTS: A total of 58 consecutive patients who met the inclusion criteria and with no compliance to the exclusion criteria were included. Of these 58 patients, 39 patients received TCZ treatment, and 19 patients who declined TCZ treatment were used as the control cohort. In the TCZ-treatment group, 6 patients (15.4%) were in mild condition, 16 (41.0%) were in severe condition, and 17 (43.6%) were in critical condition. After TCZ treatment, the condition of 27 patients (69.2%) improved and 12 (30.8%) died. Compared with the improvement group, patients in the death group had higher baseline levels of IL-6 (P = 0.0191) and procalcitonin (PCT) (P = 0.0003) and lower lymphocyte percentage (LYM) (P = 0.0059). Patients receiving TCZ treatment had better prognoses than those without TCZ treatment (P = 0.0273). Furthermore, patients with a baseline IL-6 level of ≥100 pg/ml in the TCZ-treatment group had poorer clinical outcomes than those with an IL-6 level of <100 pg/ml (P = 0.0051). CONCLUSION: The administration of TCZ in an early stage of cytokine storm (IL-6 level < 100 pg/ml) may effectively improve the clinical prognosis of patients with COVID-19 by blocking the IL-6 signal pathway.