Patterns of Violence and Mental Health Outcomes Before and During the COVID-19 Pandemic: Characterizing Vulnerability in Sexual and Gender Minority College Students (preprint)

Background. Lockdown measures and remote learning during the COVID-19 pandemic have had a large impact on the physical and mental health of college students, especially those with minority identities. Sexual and gender minority (SGM) students are especially at risk for sexual violence and subsequent adverse mental health outcomes on campus. It is worth examining how pandemic-related changes on campus may pose differential types of threat to SGM college students. The present study aimed to juxtapose patterns of violence among college students before and during the pandemic, and explore the risks and consequences of violence/assaults among minority groups.  Methods. The study utilizes the 2018-2019 and 2020-2021 Healthy Minds Study (HMS) datasets. The HMS is a web-based survey data focuses on mental health, health behavior, campus climates and related issues among a nationally representative sample of undergraduate and graduate students from 60 U.S. campuses.  Results. Results demonstrated that violence committed by strangers/acquaintances decreased during the pandemic for all college students, while sexual assaults by ex or current partners remained unchanged.Further, SGM students experienced increased sexual violence and adverse mental health outcomes during the pandemic.  Limitations. While the two cohorts in comparison were collected before and during the pandemic, they were not based on the same sample. Future research should collect longitudinal data to understand the impacts of sexual violence over time.  Conclusions. The present study serves as a starting point to understand the sexual violence and heightened mental health risk experienced by sexual and gender minority college students.

Proteomic Characterization of Acute Kidney Injury in Patients Hospitalized with SARS-CoV2 Infection (preprint)

Background Acute kidney injury (AKI) is a known complication of COVID-19 and is associated with an increased risk of in-hospital mortality. Unbiased proteomics using biological specimens can lead to improved risk stratification and discover pathophysiological mechanisms. Methods Using measurements of ~4000 plasma proteins in two cohorts of patients hospitalized with COVID-19, we discovered and validated markers of COVID-associated AKI (stage 2 or 3) and long-term kidney dysfunction. In the discovery cohort (N= 437), we identified 413 higher plasma abundances of protein targets and 40 lower plasma abundances of protein targets associated with COVID-AKI (adjusted p <0.05). Of these, 62 proteins were validated in an external cohort (p <0.05, N =261). Results We demonstrate that COVID-AKI is associated with increased markers of tubular injury (NGAL) and myocardial injury. Using estimated glomerular filtration (eGFR) measurements taken after discharge, we also find that 25 of the 62 AKI-associated proteins are significantly associated with decreased post-discharge eGFR (adjusted p <0.05). Proteins most strongly associated with decreased post-discharge eGFR included desmocollin-2, trefoil factor 3, transmembrane emp24 domain-containing protein 10, and cystatin-Cindicating tubular dysfunction and injury. Conclusions Using clinical and proteomic data, our results suggest that while both acute and long-term COVID-associated kidney dysfunction are associated with markers of tubular dysfunction, AKI is driven by a largely multifactorial process involving hemodynamic instability and myocardial damage.

How Innovation Ecosystem Synergy Degree Influences Technology Innovation Performance—Evidence from China’s High-Tech Industry

The technology innovation of high-tech industries has become an important support for the innovation-driven strategy. This study introduces innovation ecosystem synergy as a moderating variable from a systemic and holistic perspective based on the traditional perspective of innovation factor input-output, and helps construct a technology innovation performance driving model based on the Cobb–Douglas knowledge production function, which enriches the discussion perspective and theoretical model research on technology innovation performance. With a sample of 28 provinces in mainland China, this study empirically analyzed the moderating mechanism of innovation performance by innovation synergy in high-tech industries during the two stages of technology development and technology transformation. The findings of the study are as follows: (1) Independent research and development has a positive and significant impact on technology development performance;product innovation has a positive and significant impact on technology transformation performance;(2) Technology introduction can weaken technology development performance due to technology dependence and the inhibitory effect on independent innovation, and inefficient technology renovation can negatively and significantly affect technology transformation performance.;(3) The degree of synergy has a positive and significant impact on the performance of technology development innovation and technology transformation innovation. The degree of synergy has a positive moderating effect on the innovation performance of independent R&D and technology development, as well as product innovation and technology renovation, and a negative moderating effect on the innovation performance of technology introduction and technology development, but no significant moderating effect on technology renovation and technology transformation performance. The research results can provide a reference for the improvement of the technology innovation performance of regional high-tech industries.

The Efficiency of Convalescent Plasma Therapy in the Management of Critically Ill Patients Infected With COVID-19: A Matched Cohort Study

Background The convalescent plasma of patients who recover from coronavirus disease 2019 (COVID-19) contains high titers of neutralizing antibodies, which has potential effects on the viral shedding of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and improving the prognosis of patients with COVID-19. The goal of this study was to clarify the effects of convalescent plasma therapy on the 60-day mortality and negative conversion rate of SARS-CoV-2 during the hospitalization of patients with severe and life-threatening COVID-19 infection. Methods This was a retrospective, case-matched cohort study that involved patients with severe COVID-19 infections. The patients who received convalescent plasma therapy were matched by age, sex, diabetes, hypertension, heart failure, the onset of symptoms to hospital admission, respiratory support pattern, lymphocyte count, troponin, Sequential organ failure assessment (SOFA), glucocorticoid, and antiviral agents to no more than three patients with COVID-19 who did not receive convalescent plasma therapy. A Cox regression model and competing risk analysis were used to evaluate the effects of convalescent plasma therapy on these patients. Results Twenty-six patients were in the convalescent plasma therapy group, and 78 patients were in the control group. Demographic characteristics were similar in both groups, except for the SOFA score. Convalescent plasma therapy did not improve 60-day mortality [hazard ratio (HR) 1.44, 95% CI 0.82–2.51, p = 0.20], but the SARS-CoV-2 negative conversion rate for 60 days after admission was higher in the convalescent plasma group (26.9 vs. 65.4%, p = 0.002) than in the control. Then, a competing risk analysis was performed, which considered events of interest (the negative conversion rate of SARS-CoV-2) and competing events (death) in the same model. Convalescent plasma therapy improved events of interest (p = 0.0002). Conclusion Convalescent plasma therapy could improve the SARS-CoV-2 negative conversion rate but could not improve 60-day mortality in patients with severe and life-threatening COVID-19 infection. Clinical Trial Number The study was registered at ClinicalTrials.gov (NCT04616976).

Phenotypes of disease severity in a cohort of hospitalized COVID-19 patients: results from the IMPACC study (preprint)

Background: Better understanding of the association between characteristics of patients hospital-ized with coronavirus disease 2019 (COVID-19) and outcome is needed to further improve upon patient management. Methods: Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) is a prospective, observational study of 1,164 patients from 20 hospitals across the United States. Disease severi-ty was assessed using a 7-point ordinal scale based on degree of respiratory illness. Patients were prospectively surveyed for 1 year after discharge for post-acute sequalae of COVID-19 (PASC) through quarterly surveys. Demographics, comorbidities, radiographic findings, clinical laboratory values, SARS-CoV-2 PCR and serology were captured over a 28-day period. Multi-variable logistic regression was performed. Findings: The median age was 59 years (interquartile range [IQR] 20); 711 (61%) were men; overall mortality was 14%, and 228 (20%) required invasive mechanical ventilation. Unsuper-vised clustering of ordinal score over time revealed distinct disease course trajectories. Risk fac-tors associated with prolonged hospitalization or death by day 28 included age [≥] 65 years (odds ratio [OR], 2.01; 95% CI 1.28-3.17), Hispanic ethnicity (OR, 1.71; 95% CI 1.13-2.57), elevated baseline creatinine (OR 2.80; 95% CI 1.63- 4.80) or troponin (OR 1.89; 95% 1.03-3.47), baseline lymphopenia (OR 2.19; 95% CI 1.61-2.97), presence of infiltrate by chest imaging (OR 3.16; 95% CI 1.96-5.10), and high SARS-CoV2 viral load (OR 1.53; 95% CI 1.17-2.00). Fatal cases had the lowest ratio of SARS-CoV-2 antibody to viral load levels compared to other trajectories over time (p=0.001). 589 survivors (51%) completed at least one survey at follow-up with 305 (52%) hav-ing at least one symptom consistent with PASC, most commonly dyspnea (56% among symp-tomatic patients). Female sex was the only associated risk factor for PASC. Interpretation: Integration of PCR cycle threshold, and antibody values with demographics, comorbidities, and laboratory/radiographic findings identified risk factors for 28-day outcome severity, though only female sex was associated with PASC. Longitudinal clinical phenotyping offers important insights, and provides a framework for immunophenotyping for acute and long COVID-19. Funding: NIH

Chimeric mRNA based COVID-19 vaccine elicits potent neutralizing antibodies and protection against Omicron and Delta (preprint)

The emerging SARS-CoV-2 variants of concern (VOCs) exhibit enhanced transmission and immune escape, reducing the efficacy and effectiveness of the two FDA-approved mRNA vaccines currently in use. Here, we explored various strategies to develop mRNA vaccines that offer potentially safer and wider coverage of VOCs. The initial mouse vaccination results showed that the individual VOC mRNAs carrying furin cleavage mutation induced the generation of neutralizing antibody in a VOC-specific manner. Moreover, we discovered that the antibodies produced from mice immunized with Beta-Furin and Washington (WA)-Furin mRNAs cross-reacted with other VOCs. The broad spectrum of generated nAb was further confirmed when vaccinated mice were challenged with the respective live viruses. However, neither WA-Furin nor Beta-Furin mRNA elicited potent neutralizing activity against the omicron variant. Interestingly, in a mix-and-match booster experiment, omicron-Furin and WA-Furin mRNA elicited comparable protection against omicron. Finally, we tested the concept of bivalent vaccine by introducing the RBD of Delta strain into the intact S antigen of Omicron. The chimeric mRNA induces potent and broadly acting nAb against Omicron and Delta, which paves the way to develop vaccine candidate to target emerging variants in the future.

Proteomic Characterization of Acute Kidney Injury in Patients Hospitalized with SARS-CoV2 Infection (preprint)

Acute kidney injury (AKI) is a known complication of COVID-19 and is associated with an increased risk of in-hospital mortality. Unbiased proteomics using longitudinally collected biological specimens can lead to improved risk stratification and discover pathophysiological mechanisms. Using longitudinal measurements of ~4000 plasma proteins in two cohorts of patients hospitalized with COVID-19, we discovered and validated markers of COVID-associated AKI (stage 2 or 3) and long-term kidney dysfunction. In the discovery cohort (N= 437), we identified 413 upregulated and 40 downregulated proteins associated with COVID-AKI (adjusted p <0.05). Of these, 62 proteins were validated in an external cohort (p <0.05, N =261). We demonstrate that COVID-AKI is associated with increased markers of tubular injury (NGAL) and myocardial injury. Using estimated glomerular filtration (eGFR) measurements taken after discharge, we also find that 25 of the 62 AKI-associated proteins are significantly associated with decreased post-discharge eGFR (adjusted p <0.05). Proteins most strongly associated with decreased post-discharge eGFR included desmocollin-2, trefoil factor 3, transmembrane emp24 domain-containing protein 10, and cystatin-C indicating tubular dysfunction and injury. Using longitudinal clinical and proteomic data, our results suggest that while both acute and long-term COVID-associated kidney dysfunction are associated with markers of tubular dysfunction, AKI is driven by a largely multifactorial process involving hemodynamic instability and myocardial damage.

Auricular Acupressure for Adverse Events Following Immunization Related To COVID-19 Vaccine Injection: Study Protocol for a Multicenter, Three-Arm, Blinded Randomized Controlled Trial (preprint)

Background: Some pain, fatigue, and gastrointestinal adverse reactions were observed in potential association with injection of COVID-19 vaccines. However, there were no preventive intervention for it. We aim to investigate efficacy of auricular acupressure (AA) therapy in preventing and (or) relieving AEFI after injection of COVID-19 vaccine. Methods/design: The study design is a randomized controlled, multicentre, three-arm, single-blind trial. Participants meeting the inclusion criteria will be advertised and enrolled, and assigned randomly in the medical institutions for post-injection observation. No less than 360 participants will be randomized into one of three groups: auricular acupressure group, sham auricular acupressure group and wait-list group. Interventions will be performed immediately, and will happen 4 to 5 times per day for 5 days. The primary clinical outcomes will be quality and quantity evaluation among participants who reported any AEFI and who reported local pain at injection site. Secondary outcomes will concern headache, muscle and (or) joint pain, fatigue, nausea, vomiting, diarrhoea, and other potential events. All the outcomes will be assessed at baseline, 1, 3, 5, 7, and 14 days after the injection. Both intention-to-treat and per-protocol analyses will be performed, with significance level determined at the 5 % level. Discussion Results of this trial will help clarify the value of auricular acupressure therapy in preventing and (or) relieving overall and certain adverse events following immunization after injection of COVID-19 vaccine. Trial registration: This trial was registered in the China Clinical Trial Registry (ChiCTR) (ChiCTR2100043210) on 8th February, 2021.

Circulating proteins to predict adverse COVID-19 outcomes (preprint)

Predicting COVID-19 severity is difficult, and the biological pathways involved are not fully understood. To approach this problem, we measured 4,701 circulating human protein abundances in two independent cohorts totaling 986 individuals. We then trained prediction models including protein abundances and clinical risk factors to predict adverse COVID-19 outcomes in 417 subjects and tested these models in a separate cohort of 569 individuals. For severe COVID-19, a baseline model including age and sex provided an area under the receiver operator curve (AUC) of 65% in the test cohort. Selecting 92 proteins from the 4,701 unique protein abundances improved the AUC to 88% in the training cohort, which remained relatively stable in the testing cohort at 86%, suggesting good generalizability. Proteins selected from different adverse COVID-19 outcomes were enriched for cytokine and cytokine receptors, but more than half of the enriched pathways were not immune-related. Taken together, these findings suggest that circulating proteins measured at early stages of disease progression are reasonably accurate predictors of adverse COVID-19 outcomes. Further research is needed to understand how to incorporate protein measurement into clinical care.

Directing an mRNA-LNP vaccine toward lymph nodes improves humoral and cellular immunity against SARS-CoV-2 (preprint)

The exploration and identification of safe and effective vaccines for the SARS-CoV-2 pandemic has captured the worlds attention and remains an ongoing issue in order to protect against emerging variants of concern (VoCs) while generating long lasting immunity. Here, we report the synthesis of a novel messenger ribonucleic acid (mRNA) encoding the spike protein in a lipid nanoparticle formulation (LNP) (STI-7264) that generates robust humoral and cellular immunity following immunization of C57Bl6 mice. In efforts to continually improve immunity, a lymphatic drug delivery device (MuVaxx) was engineered and tested to modulate immune cells at the injection site (epidermis and dermis) and draining lymph node (LN) to elicit adaptive immunity. Using MuVaxx, immune responses were elicited and maintained at a 10-fold dose reduction compared to traditional intramuscular (IM) administration as measured by anti-spike antibodies, cytokine producing CD8 T cells, and neutralizing antibodies against the Washington (Wild Type, WT) and South African (beta) variants. Remarkably, a 4-fold elevated T cell response was observed in MuVaxx administered vaccination as compared to that of IM administered vaccination. Thus, these data support further investigation into STI-7264 and lymphatic mediated delivery using MuVaxx for SARS-CoV-2 and VoCs vaccines.

Changes in the Pathogenic Spectrum of Acute Respiratory Tract Infections During the COVID-19 Epidemic in Beijing, China (preprint)

Background: Public health measures against COVID-19 may influence other disease epidemics. Many countries have reported significant reductions in influenza activity in 2020–2021, but the prevalence of other respiratory pathogens during the COVID-19 pandemic has rarely been reported, especially in China.Methods: Data from the Respiratory Pathogen Surveillance System in Beijing were analyzed to compare pathogen infection rates before the COVID-19 (from 1 February 2015 to 31 January 2020) and during the COVID-19 (from 1 February 2020 to 31 January 2021).Findings: Among 41630 acute respiratory tract infections 13630 had at least one pathogen positive result, which decreased from 32·16% (95% CI 31·69%, 32·64%) before the COVID-19 to 10·97% (95% CI 10·03%, 11·96%) during the COVID-19, representing a 65·90% decrease (P<0·001). The positivity rate fluctuated with the strictness of public health measures. Before the COVID-19 epidemic, the top five of the pathogenic spectrums were IFV (26·27%), MP (19·30%), HPIV (11·80%), HRV (9·38%), and EV (8·38%), while during the COVID-19, the top five were seasonal HCoV (21·10%), HRV (18·99%), HPIV (14·98%), IFV (13·08%), and RSV (10.76%).Interpretation: The prevalence of respiratory pathogens decreased significantly during the COVID-19, closely relating to public health measures against COVID-19; these measures can serve as useful strategies for the prevention and control of other respiratory tract infections.Funding Statement: The National Major Science and Technology Project for Control and Prevention of Major Infectious Diseases in China (2017ZX10103004).Declaration of Interests: FH received funds from the National Major Science and Technology Project for Control and Prevention of Major Infectious Diseases in China (2017ZX10103004). All other authors declare no competing interests.Ethics Approval Statement: Ethics approval for the protocol of this study was obtained from the Ethics Committee of the BJCDC. Written informed consent was obtained.

Research on pregnant women suspected of having COVID-19 in the epidemic outbreak area (preprint)

Background COVID-19 has become a major public health problem around the world. There are limited data on maternal and neonatal outcomes of pregnant women with COVID-19 pneumonia. The purpose of this study is to investigate and analysis the clinical features, imaging findings, related laboratory indicators, treatments and outcomes of maternal-fetal for cases of suspected infection COVID-19 pregnant women in outbreak area in order to provide reference for clinical work.Methods A case-control study was conducted to compare clinical features, treatment, maternal and neonatal outcomes of pregnant women with and without COVID-19 pneumonia.Results One confirmed patient who was discharged from hospital after a negative RT-PCR result, was readmitted and subsequently tested positive on RT-PCR. The vaginal delivery rate and gestational week of confirmed case group showed significantly lower than 2019 control group. Pulmonary CT images were initially same between confirmed group and suspected group, but changed over time with different trends. The two case groups shared similar dynamic profiles on blood routine test. Four confirmed cases which had COVID-19 antibody test were all positive for IgG antibody and negative for IgM antibody, via both umbilical cord blood and the newborns. Fifteen of newborns (three confirmed and twelve suspected cases) at nearly three months old were tested negative by antibodies.Conclusions Pulmonary CT images showed different trends with the extending of time between confirmed group and suspected group. Blood test results weren’t strong enough to make differential diagnosis between two case groups. Perform antibody test can understand the antibody responses mounted in response to the virus, and to identify individuals who are potentially immune to re-infection. Infant obtain COVID-19 IgG antibody from maternal that only may last for less than three months.

Cytotoxic lymphocytes are dysregulated in multisystem inflammatory syndrome in children (preprint)

Multisystem inflammatory syndrome in children (MIS-C) presents with fever, inflammation and multiple organ involvement in individuals under 21 years following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To identify genes, pathways and cell types driving MIS-C, we sequenced the blood transcriptomes of MIS-C cases, pediatric cases of coronavirus disease 2019, and healthy controls. We define a MIS-C transcriptional signature partially shared with the transcriptional response to SARS-CoV-2 infection and with the signature of Kawasaki disease, a clinically similar condition. By projecting the MIS-C signature onto a co-expression network, we identified disease gene modules and found genes downregulated in MIS-C clustered in a module enriched for the transcriptional signatures of exhausted CD8+ T-cells and CD56dimCD57+ NK cells. Bayesian network analyses revealed nine key regulators of this module, including TBX21, a central coordinator of exhausted CD8+ T-cell differentiation. Together, these findings suggest dysregulated cytotoxic lymphocyte response to SARS-Cov-2 infection in MIS-C.

SARS-CoV-2 causes severe alveolar inflammation and barrier dysfunction (preprint)

Infections with SARS-CoV-2 lead to mild to severe coronavirus disease-19 (COVID-19) with systemic symptoms. Although the viral infection originates in the respiratory system, it is unclear how the virus can overcome the alveolar barrier, which is observed in severe COVID-19 disease courses. To elucidate the viral effects on the barrier integrity and immune reactions, we used mono-cell culture systems and a complex human alveolus-on-a-chip model composed of epithelial, endothelial, and mononuclear cells. Our data show that SARS-CoV-2 efficiently infected epithelial cells with high viral loads and inflammatory response, including the interferon expression. By contrast, the adjacent endothelial layer was no infected and did neither show productive virus replication or interferon release. With prolonged infection, both cell types are damaged, and the barrier function is deteriorated, allowing the viral particles to overbear. In our study, we demonstrate that although SARS-CoV-2 is dependent on the epithelium for efficient replication, the neighboring endothelial cells are affected, e.g., by the epithelial cytokine release, which results in the damage of the alveolar barrier function and viral dissemination.

Focusing on the Treatment of COVID-19: A Comprehensive Analysis of 226 Trials Registered on Clinicaltrials.gov and ChiCTR (preprint)

Background: The purpose of this study is to analyze the registered clinical trials of COVID-19, and to provide a reference for the clinical treatment of COVID-19. Methods: Chinese ClinicalTrial Registry (ChiCTR) and Clinicaltrials.gov databases were searched for clinical trials of COVID-19, which were registered from inception to February 29, 2020, to screen out the clinical trials on the treatment of COVID-19, and the research units and regions, sample size, study types, study stages, and intervention measures were analyzed. Results: There were 226 clinical trials on COVID-19 in the 2 databases, and all of them were registered by research units in China. The top five registered areas were Hubei, Beijing, Shanghai, Guangdong, and Zhejiang. The study type was as follows: interventional study (207, 91.6%) and observational study (18, 8.0%). Clinical trial staging was as follows: exploratory studies/preliminary trials (91, 40.3%), phase I trials (4, 1.8%), phase II trials (12, 5.3%), phase III trials (12, 5.3%), phase IV trials (47, 20.8%), phase I/II trials (2, 0.9%), phase II/III trials (5, 2.2%), and other trials (57, 25.2%). Intervention measures were as follows: there were 143 (63.3%) trials of western medicine treatment, 50 (22.1%) trials of Chinese medicine treatment, and 21 (9.3%) trials of integrated Chinese medicine treatment and western medicine treatment. Conclusion: Researchers have registered a large number of clinical trials in a short time. The number of existing patients of COVID-19 is not enough to support hundreds of clinical trials. There is a lack of multicenter, randomized, double-blind, placebo-controlled trials.

An inflammatory cytokine signature helps predict COVID-19 severity and death (preprint)

The COVID-19 pandemic caused by infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has led to more than 100,000 deaths in the United States. Several studies have revealed that the hyper-inflammatory response induced by SARS-CoV-2 is a major cause of disease severity and death in infected patients. However, predictive biomarkers of pathogenic inflammation to help guide targetable immune pathways are critically lacking. We implemented a rapid multiplex cytokine assay to measure serum IL-6, IL-8, TNF-, and IL-1{beta} in hospitalized COVID-19 patients upon admission to the Mount Sinai Health System in New York. Patients (n=1484) were followed up to 41 days (median 8 days) and clinical information, laboratory test results and patient outcomes were collected. In 244 patients, cytokine measurements were repeated over time, and effect of drugs could be assessed. Kaplan-Meier methods were used to compare survival by cytokine strata, followed by Cox regression models to evaluate the independent predictive value of baseline cytokines. We found that high serum IL-6, IL-8, and TNF- levels at the time of hospitalization were strong and independent predictors of patient survival. Importantly, when adjusting for disease severity score, common laboratory inflammation markers, hypoxia and other vitals, demographics, and a range of comorbidities, IL-6 and TNF- serum levels remained independent and significant predictors of disease severity and death. We propose that serum IL-6 and TNF- levels should be considered in the management and treatment of COVID-19 patients to stratify prospective clinical trials, guide resource allocation and inform therapeutic options. We also propose that patients with high IL-6 and TNF- levels should be assessed for combinatorial blockade of pathogenic inflammation in this disease.

Treatment for breast cancer patients during the special period of novel coronavirus pneumonia outbreak (preprint)

Purpose: The outbreak of novel coronavirus pneumonia occurred worldwide. 2019 novel coronavirus disease (COVID-19) can be transmitted from human to human, cause hospital infection, and seriously threatens surgical staffs and inpatients. The treatment of patients with breast cancer may be affected in this special period. Methods: From 24th January to 8th March 2020, patients diagnosed with breast cancer were enrolled from 16 hospitals in Jiangsu Province, and patients, who were candidates for surgery after neoadjuvant chemotherapy, were also enrolled. Patients from 24th January to 8th March 2019 were included as control with the same criteria. Results: In 2019, 520 patients were diagnosed with breast cancer in these 16 hospital; however, only 229 patients (decreased by 56%) were diagnosed with breast cancer in the same period of 2020. The clinical characteristics were similar between the two groups, and core biopsy was performed to more patients in 2020 than that in 2019 (4.1 days ±3.2 vs 3.2 days ±2.6, P < 0.001), and more patients underwent mastectomy and axillary lymph node dissection in 2020. After neoadjuvant chemotherapy, the mean interval between last time of neoadjuvant chemotherapy and surgery in 2020 was significantly longer than that in 2019 (29.2 days ±11.1 vs 17.7 days ±8.2, P < 0.001). After examinations to rule out COVID-19, no COVID-19 was found in any patient. Conclusions: In the special period of novel coronavirus pneumonia outbreak, the treatment of patients with breast cancer was delayed, but the treatment was safe after strict exclusions of COVID-19.