Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trial.

BACKGROUND: We assessed the safety and immunogenicity of a core-shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. METHODS: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25µg (n = 20), or SW-BIC-213-45µg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). FINDINGS: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 µg, n = 20, or 45 µg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 µg and 45 µg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45µg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. INTERPRETATION: SW-BIC-213, a core-shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. FUNDING: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai.

Expert consensus on prevention and control of infection in COVID-19 designated hospitals

OBJECTIVE: To further standardize and guide the infection prevention and control(IPC) in designated hospitals so as to effectively ensure the stability, order and safety of medical treatment, ensure the safety of health care workers and patients, and reduce cross infections caused by the transmission of COVID-19. METHODS: The experts who repeatedly participated in the national COVID-19 medical treatment and IPC were invited to compile the consensus based on latest national norms, characteristics of the omicron and situation of epidemic prevention and control. RESULTS: The consensus consisted of two major parts: comprehensive coverage and control of infections in designated hospitals, with 47 recommendations involved. CONCLUSION: The expert consensus will provide guidance for the upcoming prevention and control of infection in designated hospitals.

Association between the overall burden of comorbidity and Ct values among the older patients with Omicron infection: Mediated by inflammation.

Objectives: To investigate the associations between the overall burden of comorbidity, inflammatory indicators in plasma and Ct values among the elderly with COVID-19. Methods: We conducted a retrospective observational study. The results of each nucleic acid test of during hospitalization were obtained. Linear regression models assessed the associations between the overall burden of comorbidity, inflammatory indicators in plasma and Ct values among the elderly. A causal mediation analysis was performed to assess the mediation effects of inflammatory indicators on the association between the overall burden of comorbidity and Ct values. Results: A total of 767 COVID-19 patients aged ≥ 60 years were included between April 2022 and May 2022. Patients with a high burden of comorbidity had significantly lower Ct values of the ORF gene than subjects with a low burden of comorbidity (median, 24.81 VS 26.58, P < 0.05). Linear regression models showed that a high burden of comorbidity was significantly associated with higher inflammatory responses, including white blood cell count, neutrophil count and C-reactive protein. Also, white blood cell count, neutrophil count, C-reactive protein and the overall burden of comorbidity assessed by age-adjusted Charlson comorbidity index were independent risk factors for the Ct values. A mediation analysis detected the mediation effect of white blood cells on the association between the burden of comorbidity and Ct values, with the indirect effect estimates of 0.381 (95% CI: 0.166, 0.632, P < 0.001). Similarly, the indirect effect of C-reactive protein was -0.307 (95% CI: -0.645, -0.064, P = 0.034). White blood cells and C-reactive protein significantly mediated the relationship between the burden of comorbidity and Ct values by 29.56% and 18.13% of the total effect size, respectively. Conclusions: Inflammation mediated the association between the overall burden of comorbidity and Ct values among elderly with COVID-19, which suggests that combined immunomodulatory therapies could reduce the Ct values for such patients with a high burden of comorbidity.

Contamination of personal protective equipment and environmental surfaces in Fangcang shelter hospitals.

BACKGROUND: Fangcang shelter hospitals emerged as a new public health concept after COVID-19. Data regarding contamination of Fangcang shelter environments remains scarce. This study aims to investigate the extent of SARS-CoV-2 contamination on personal protective equipment and surfaces in Fangcang hospitals. METHODS: Between March and May 2022, during wave of omicron variant, a prospective study was conducted in two Fangcang hospitals in Shanghai, China. Swabs of personal protective equipment worn and environmental surfaces of contaminated areas, doffing rooms, and potentially contaminated areas were collected. SARS-CoV-2 RNA was detected by reverse transcription quantitative polymerase chain reaction. If viral RNA was detected, sampling was repeated after cleaning and disinfection. RESULTS: A total of 602 samples were collected. 13.3% of the personal protective equipment were contaminated. Positive rate was higher in the contaminated areas (48.4%) than in the doffing rooms (11.7%) and the potentially contaminated areas (0; P<0.05). Contamination was highest in patient occupied areas 67.5%. After cleaning, samples taken at previously contaminated surfaces are all negative. CONCLUSIONS: SARS-CoV-2 RNA contamination is prevalent in Fangcang hospitals and healthcare workers are under risk of infection. Potentially contaminated areas and surfaces after cleaning and disinfection are negative, underlying the importance of infection control policy.

Prolonged Use of Surgical Masks and Respirators Affects the Protection and Comfort for Healthcare Workers.

This study explored the ideal period for wearing masks to prevent the physiological and psychological problems associated with long-term face mask use during respiratory infections by healthcare workers. Breathing simulators, surgical masks (SM) and medical respirators (PM) were prepared for two to eight hours. Changes in the comfort of masks (facial skin temperature, breathing resistance, and moisture permeability) and protection (filtration efficiency, resistance to blood penetration, and colony count) were assessed. The results demonstrated that the masks offered efficient liquid-particle filtering even after eight hours of use. However, the number of bacterial colonies using PM and SM grew significantly after two and four hours, respectively. Concerning comfort, the inspiratory resistance of masks rose dramatically after two hours, whereas the moisture permeability declined considerably after four hours. In addition, skin temperature had a significant increase within two hours, which may result in facial discomfort. When conditions permitted, the hospital staff was instructed to replace their masks every two hours.

Current situation of construction and management of infectious diseases department and fever clinics in medical institutions in Jiangsu Province

OBJECTIVE: To analyze theconstruction of infectious diseases departments and fever clinics in medical institutions at all levels in Jiangsu Province after the COVID-19 epidemic, and to provide a basis for promoting their standardized construction. METHODS: A questionnaire survey was conducted on the construction of infectious diseases departments and fever clinics in 429 medical institutions of Jiangsu Province from July to December 2020, including the overview of medical institutions, the construction status of infectious diseases departments, the construction status and future construction plans of fever clinics, etc. RESULTS: The construction rate of infectious diseases department and fever clinics in medical institutions of Jiangsu province were 33.3% and 75.3% respectively. Ventilation by opening window for was the main form of airflow organization in infectious diseases department and fever clinics, and independent ICUs and negative pressure wards were not set up in most of infectious diseases departments. The setting rate of "three zones and two channels" in fever clinics was high(96.9%), but most of them were not equipped with special CT for fever clinics patients. The proportion of air conditioning and ventilation system without air disinfection devices in the of fever clinics of medical institutions at all levels was higher than 90%. Considering the both hardware construction and quality management, the situation in tertiary medical institutions were superior to secondary medical institutions, and secondary medical institutions were superior to primary medical institutions. Various construction indicators and management systems failed to fully meet the requirements of documents and standards. CONCLUSION: Jiangsu province actively promotes the construction of infectious diseases department and fever clinic layout, but there is still a gap with the construction standard, which is necessary to further promote standardized construction. We should mend the shortages, strengthen the weakness, expand the bases, comprehensively improve the service and anti-epidemic capacity of infectious diseases departments, fever clinics and even the entire medical and health system, so as to better serve the health and life safety of the people.

Research progress on characteristics, epidemiology and control measure of SARS-CoV-2 Delta VOC

COVID-2019 has become a global pandemic, and a variety of SARS-CoV-2 variants have emerged with the continuous evolution and variation. SARS-CoV-2 Delta VOC (B.1.617.2) has the characteristics of strong transmission, short incubation period of infection, high pathogenicity and rapid disease progression, which has gradually become the main epidemic strain in India and even in the world, leading to countries and regions of the epidemic rebound. In this paper, the current epidemic characteristics and core control measures of SARS-CoV-2 Delta VOC was reviewed.

Incidence and outcomes of patients with COVID-19 associated pulmonary aspergillosis (CAPA) in intensive care units: a systematic review and meta-analysis of 31 cohort studies.

BACKGROUND: We aimed to identify studies systematically that describe the incidence and outcome of COVID-19-related pulmonary aspergillosis (CAPA). METHODS: We searched ScienceDirect, PubMed, CNKI, and MEDLINE (OVID) from December 31, 2019 to November 20, 2021 for all eligible studies. Random-model was used to reported the incidence, all-cause case fatality rate (CFR) and 95% confidence intervals (CIs). The meta-analysis was registered with PROSPERO (CRD42021242179). RESULTS: In all, thirty-one cohort studies were included in this study. A total of 3,441 patients with severe COVID-19 admitted to an intensive care unit (ICU) were investigated and 442 cases of CAPA were reported (30 studies). The pooled incidence rate of CAPA was 0.14 (95% CI: 0.11-0.17, I2=0.0%). Twenty-eight studies reported 287 deceased patients and 269 surviving patients. The pooled CFR of CAPA was 0.52 (95% CI: 0.47-0.56, I2=3.9%). Interestingly, patients with COVID19 would develop CAPA at 7.28 days after mechanical ventilation (range, 5.48-9.08 days). No significant publication bias was detected in this meta-analysis. DISCUSSION: Patients with COVID-19 admitted to an ICU might develop CAPA and have high all-cause CFR. We recommend conducting prospective screening for CAPA among patients with severe COVID-19, especially for those who receive mechanical ventilation over 7 days.

Persistence and clearance of viral RNA in 2019 novel coronavirus disease rehabilitation patients.

BACKGROUND: A patient's infectivity is determined by the presence of the virus in different body fluids, secretions, and excreta. The persistence and clearance of viral RNA from different specimens of patients with 2019 novel coronavirus disease (COVID-19) remain unclear. This study analyzed the clearance time and factors influencing 2019 novel coronavirus (2019-nCoV) RNA in different samples from patients with COVID-19, providing further evidence to improve the management of patients during convalescence. METHODS: The clinical data and laboratory test results of convalescent patients with COVID-19 who were admitted to from January 20, 2020 to February 10, 2020 were collected retrospectively. The reverse transcription polymerase chain reaction (RT-PCR) results for patients' oropharyngeal swab, stool, urine, and serum samples were collected and analyzed. Convalescent patients refer to recovered non-febrile patients without respiratory symptoms who had two successive (minimum 24 h sampling interval) negative RT-PCR results for viral RNA from oropharyngeal swabs. The effects of cluster of differentiation 4 (CD4)+ T lymphocytes, inflammatory indicators, and glucocorticoid treatment on viral nucleic acid clearance were analyzed. RESULTS: In the 292 confirmed cases, 66 patients recovered after treatment and were included in our study. In total, 28 (42.4%) women and 38 men (57.6%) with a median age of 44.0 (34.0-62.0) years were analyzed. After in-hospital treatment, patients' inflammatory indicators decreased with improved clinical condition. The median time from the onset of symptoms to first negative RT-PCR results for oropharyngeal swabs in convalescent patients was 9.5 (6.0-11.0) days. By February 10, 2020, 11 convalescent patients (16.7%) still tested positive for viral RNA from stool specimens and the other 55 patients' stool specimens were negative for 2019-nCoV following a median duration of 11.0 (9.0-16.0) days after symptom onset. Among these 55 patients, 43 had a longer duration until stool specimens were negative for viral RNA than for throat swabs, with a median delay of 2.0 (1.0-4.0) days. Results for only four (6.9%) urine samples were positive for viral nucleic acid out of 58 cases; viral RNA was still present in three patients' urine specimens after throat swabs were negative. Using a multiple linear regression model (F = 2.669, P = 0.044, and adjusted R = 0.122), the analysis showed that the CD4+ T lymphocyte count may help predict the duration of viral RNA detection in patients' stools (t = -2.699, P = 0.010). The duration of viral RNA detection from oropharyngeal swabs and fecal samples in the glucocorticoid treatment group was longer than that in the non-glucocorticoid treatment group (15 days vs. 8.0 days, respectively; t = 2.550, P = 0.013) and the duration of viral RNA detection in fecal samples in the glucocorticoid treatment group was longer than that in the non-glucocorticoid treatment group (20 days vs. 11 days, respectively; t = 4.631, P < 0.001). There was no statistically significant difference in inflammatory indicators between patients with positive fecal viral RNA test results and those with negative results (P > 0.05). CONCLUSIONS: In brief, as the clearance of viral RNA in patients' stools was delayed compared to that in oropharyngeal swabs, it is important to identify viral RNA in feces during convalescence. Because of the delayed clearance of viral RNA in the glucocorticoid treatment group, glucocorticoids are not recommended in the treatment of COVID-19, especially for mild disease. The duration of RNA detection may relate to host cell immunity.

Research on control and prevention strategy of COVID-19 in metropolis

OBJECTIVE To discuss the core control strategy for the possible COVID-19 pandemic in the metropolis. METHODS Based on the national technical guidelines for COVID-19 Prevention and Control, this study summarized the experience in the fighting against the COVID-19 epidemic in Guangdong Province and explored the core strategy for the infection prevention and control under the new dynamic and precise' model. RESULTS Five key points played a great role in the control and prevention of COVID-19 epidemic in the metropolis, including the control of imported cases, management of isolation points, designated medical institutions,non-designated metical institutions and community control. The bundle measures of seven core measures may be effective, including strengthening the strict control over goods and staff of inbound personnel, management of designated hospitals, isolation points and residence, improving the construction of the associated teams, deploying tight check at the entrance of the community, enhancing comprehensive social governance, encouraging vaccination and propagating health education. CONCLUSION The epidemic COVID-19 seriously affects the economic and social life in the metropolis.We must rapidly control the situation by taking comprehensive measures decisively in order to achieve the fastest response.We expected that the most precise strategy, the shortest time and the minimum cost of control and prevention strategy can result in the optima effect on the COVID-19 prevention and control.

Low CD4 T cell count predicts radiological progression in severe and critically ill COVID-19 patients: a case control study.

BACKGROUND: Novel coronavirus disease (COVID-19) has spread globally and caused over 3 million deaths, posing great challenge on public health and medical systems. Limited data are available predictive factors for disease progression. We aim to assess clinical and radiological predictors for pulmonary aggravation in severe and critically ill COVID-19 patients. METHODS: Patients with confirmed COVID-19 in Renmin Hospital of Wuhan University, China, between Feb. 6th, 2020 and Feb. 21st, 2020 were retrospectively collected. Enrolled patients were divided into non-progression group and progression group based on initial and follow-up chest CTs. Clinical, laboratory, and radiological variables were analyzed. RESULTS: During the study period, 162 patients were identified and a total of 126 patients, including 97 (77.0%) severe cases and 29 (23.0%) critically ill cases were included in the final analysis. Median age was 66.0 (IQR, 56.0-71.3) years. Median time from onset to initial chest CT was 15.0 (IQR, 12.0-20.0) days and median interval to follow-up was 7.0 (IQR, 5.0-7.0) days. Compared with those who did not progress (n=111, 88.1%), patients in the progression group (n=15, 11.9%) had significantly higher percentage of peak body temperature >38 °C (P=0.002), lower platelet count (P=0.011), lower CD4 T cell count (P=0.002), lower CD8 count (P=0.011), higher creatine kinase level (P=0.002), and lower glomerular filtration rate (P=0.018). On both univariate and multivariable analysis, only CD4 T cell count <200/µL was significant (OR, 6.804; 95% CI, 1.450-31.934; P=0.015) for predicting pulmonary progression. CONCLUSIONS: Low CD4 T cell count predicts progression of pulmonary change in severe and critically ill patients with COVID-19.

Use of antibacterial drugs in 616 COVID-19 patients in Shanghai

OBJECTIVE: To analyze the use of antibiotics in patients with coronavirus disease 2019(COVID-19) in Shanghai and to provide evidence for the treatment of COVID-19 and the management of antibacterial drugs. METHODS: The clinical data of 616 patients with COVID-19 in Shanghai Public Health Clinical Center from 20 th, Jan. 2020 to 30 th Apr., 2020 were collected retrospectively, including demographic data, time of admission, time of discharge, and use of antibacterial drugs. All patients were followed up until they were discharged. The frequency of antibacterial drug usage, AUD and the situation of antibacterial using were analyzed. RESULTS: Among 616 patients, 137 were mild, 382 were common, 79 were severe and 18 were critical severe. There were 343 males with an average age of 41.1 years and a median length of stay of 16 days, 273 female cases with an average age of 42.8 years and a median length of stay of 14 days. A total of 165 patients(26.8%) received antibiotics therapy. The usage rates of antibiotics in the mild, common, severe and critical severe subgroups were 4.3%, 21.7%, 73.4% and 100.0%, respectively, which was closely related to clinical classification. The overall usage rates of antibacterial drugs in hospitalized patients gradually decreased with the increase of months. In common patients, the usage rates of antibacterial drugs in March and April were significantly lower than that in January and February. The AUD in all patients was 25.3. As the clinical classification worsened, the AUD in each subgroup gradually increased(0.9, 11.9, 46.2, and 143.8). In total, mild and common patients, the AUD showed a downward trend in January, February, March and April. The total frequency of antibacterial drugs was 286 times, and the top 5 most frequently used drugs were fluoroquinolones, beta-lactamase/beta-lactamase inhibitors, carbapenems, cephalosporins, and linezolid. In severe patients, the antibacterial drugs were mainly restricted use grade antibiotics, and in critical severe patients were mainly special use grade antibiotics. CONCLUSION: In the treatment of COVID-19 patients, the usage rates of antibacterial drugs and AUD were related to clinical classification. As our knowledge and understanding of COVID-19 deepen, our usage rates and strategies of antibacterial drugs are being adjusted, in order to avoid inappropriate use of antibacterial drugs as much as possible.

Evaluation of superinfection, antimicrobial usage, and airway microbiome with metagenomic sequencing in COVID-19 patients: A cohort study in Shanghai.

BACKGROUND: In COVID-19 patients, information regarding superinfection, antimicrobial assessment, and the value of metagenomic sequencing (MS) could help develop antimicrobial stewardship. METHOD: This retrospective study analyzed 323 laboratory-confirmed COVID-19 patients for co-infection rate and antimicrobial usage in the Shanghai Public Health Clinical Center (SPHCC) from January 23rd to March 14th 2020. The microbiota composition was also investigated in patients with critically severe COVID-19. RESULTS: The total population co-infection rate was 17/323 (5.3%) and 0/229 (0), 4/78 (5.1%), and 13/16 (81.3%) for the mild, severe, and critically severe subgroups, respectively. Proven fungal infection was significantly associated with a higher mortality rate (p = 0.029). In critically severe patients, the rate of antimicrobials and carbapenem usage were 16/16 (100%) and 13/16 (81.3%), respectively, in which the preemptive and empiric antimicrobial days accounted for 51.6% and 30.1%, respectively. Targeted therapy only accounted for 18.3%. MS was implemented to detect non-COVID-19 virus co-existence and the semi-quantitative surveillance of bacteremia, with clear clinical benefit seen in cases with MS-based precision antimicrobial management. Airway microbiome analysis suggested that the microbiota compositions in critically severe COVID-19 patients were likely due to intubation and mechanical ventilation. CONCLUSIONS: In the SPHCC cohort, we observed a non-negligible rate of super-infection, especially for the critically ill COVID-19 patients. Fungal co-infection requires intensive attention due to the high risk of mortality, and the clinical benefit of MS in guiding antimicrobial management warrants further investigation.

Efficacy of early hydroxychloroquine treatment in preventing COVID-19 pneumonia aggravation, the experience from Shanghai, China.

The aim of this study is to assess the efficacy of multiple treatments, especially hydroxychloroquine, used in different disease stages of coronavirus disease 2019 (COVID-19). All consecutive patients with COVID-19 admitted to Shanghai Public Health Clinical Center (Shanghai, China) between January 20, 2020, and April 30, 2020, were enrolled, and their clinical data were retrospectively collected. Binary logistic regression was used to screen the factors associated with disease aggravation, and multivariable analyses with the Cox proportional hazards model were used to estimate the effects of prognostic factors on the improvement time and PCR conversion days in throat swabs and stool swabs. A total of 616 patients, including 50 (8.11%) severe and 18 (2.92%) critical patients, were enrolled in our retrospective cohort study. The early use of hydroxychloroquine was a protective factor associated with disease aggravation (95% CI: 0.040-0.575, p = 0.006). Clinical improvement by 20 days was significantly different between patients with hydroxychloroquine used early and those with hydroxychloroquine not used (p = 0.016, 95% CI: 1.052-1.647). The median time to clinical improvement was 6 days in the hydroxychloroquine used early group, compared with 9 days in the without hydroxychloroquine used group and 8 days in the with hydroxychloroquine not used early group (p < 0.001). Hydroxychloroquine used early was associated with earlier PCR conversion in both throat swabs (HR = 1.558, p = 0.001) and stool swabs (HR = 1.400, p = 0.028). The use of hydroxychloroquine at an early stage is a potential therapeutic strategy for treating patients before irreversible severe respiratory complications occur. The early use of hydroxychloroquine decreased the improvement time and the duration of COVID-19 detection in throat and stool swabs.

Beneficial aspects of high dose intravenous vitamin C on patients with COVID-19 pneumonia in severe condition: a retrospective case series study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a global public health event without specific therapeutic agents till now. We aim to determine if high dose intravenous vitamin C (HDIVC) was effective for COVID-19 patients in severe condition. METHODS: COVID-19 patients admitted in Shanghai Public Health Clinical Center from January 22, 2020 to April 11, 2020 were retrospectively scrolled. The enrolled patients were those with confirmed diagnosis of severe or critical COVID-19 pneumonia, who received HDIVC within 24 hours after disease aggravation. Main clinical outcomes obtained from 3-5 days (day 3) and 7-10 days (day 7) after HDIVC were compared to the ones just before (day 0) HDIVC. RESULTS: Totally, twelve patients were enrolled including six severe [age of mean, 56; interquartile range (IQR), 32-65 years, 3 men] and six critical (age of mean, 63; IQR, 60-82 years, 4 men) patients. The dosage of vitamin C [median (IQR), mg/kg (body weight)/day] were [162.7 (71.1-328.6)] for severe and [178.6 (133.3-350.6)] for critical patients. By Generalized estimating equation (GEE) model, C-reactive protein (CRP) was found to decrease significantly from day 0 to 3 and 7 (severe: 59.01±37.9, 12.36±22.12, 8.95±20.4; critical: 92.5±41.21, 33.9±30.2, 59.56±41.4 mg/L). Lymphocyte and CD4+ T cell counts in severe patients reached to normal level since day 3. Similar improving trends were observed for PaO2/FiO2 (severe: 209.3±111.7, 313.4±146, 423.3±140.8; critical: 119.9±52.7, 201.8±86.64, 190.5±51.99) and sequential organ failure assessment score (severe: 2.83±1.72, 1.33±1.63, 0.67±1.03; critical: 6.67±2.34, 4.17±2.32, 3.83±2.56). Better improving effect was observed in severe than critical patients after HDIVC. CONCLUSIONS: HDIVC might be beneficial in aspects of inflammatory response, immune and organ function for aggravation of COVID-19 patients. Further clinical trials are in warrant. TRIAL REGISTRATION: This trial has been retrospectively registered in Chinese Clinical Trail Registry (ChiCTR2000032716) on May 8, 2020. http://www.chictr.org.cn/showproj.aspx?proj=53389.

Progress in cognition of revised and updated 'guidelines for diagnosis and treatment of COVID-19'

OBJECTIVE: To systematically review the key pints of updated 'Guidelines for Diagnosis and Treatment of COVID-19' and sort out the knowledge about the disease in combination with relevant literatures so as to provide guidance for clinical practice. METHODS: The similarities and differences among the 7 trial editions of 'Guidelines for Diagnosis and Treatment of COVID-19' that were issued by the National Health Commission of the People's Republic of China(NHC) from Jan. 15, 2020 to Mar. 3, 2020 were observed and compared. The features, epidemiological characteristics, diagnosis and treatment programs and prevention strategies for COVID-19 were sorted out in combination with the published literatures that were included in the databases such as Pubmed and CNKI and the latest data of COVID-19 that were released by the authorities like World Health Organization and the Centers for Disease Control and Prevention. RESULTS: In China, COVID-19 has been included in class B notifiable infectious disease, and the prevention and control measures were taken as class A. At present, there is no effective treatment drug, and the supportive treatment is the major treatment strategy, and the oxygen therapy is an extremely important treatment strategy for severe cases. CONCLUSION: Each edition of the Guidelines is drawn on the latest advance in frontier research of the diseases and plays a positive role in guiding the prevention of the epidemic. The high-frequency and large-scale update of the guidelines for diagnosis and treatment may reflect the constantly deepening understanding of the disease.

D-dimer as a biomarker for disease severity and mortality in COVID-19 patients: a case control study.

BACKGROUND: Over 5,488,000 cases of coronavirus disease-19 (COVID-19) have been reported since December 2019. We aim to explore risk factors associated with mortality in COVID-19 patients and assess the use of D-dimer as a biomarker for disease severity and clinical outcome. METHODS: We retrospectively analyzed the clinical, laboratory, and radiological characteristics of 248 consecutive cases of COVID-19 in Renmin Hospital of Wuhan University, Wuhan, China from January 28 to March 08, 2020. Univariable and multivariable logistic regression methods were used to explore risk factors associated with in-hospital mortality. Correlations of D-dimer upon admission with disease severity and in-hospital mortality were analyzed. Receiver operating characteristic curve was used to determine the optimal cutoff level for D-dimer that discriminated those survivors versus non-survivors during hospitalization. RESULTS: Multivariable regression that showed D-dimer > 2.0 mg/L at admission was the only variable associated with increased odds of mortality [OR 10.17 (95% CI 1.10-94.38), P = 0.041]. D-dimer elevation (≥ 0.50 mg/L) was seen in 74.6% (185/248) of the patients. Pulmonary embolism and deep vein thrombosis were ruled out in patients with high probability of thrombosis. D-dimer levels significantly increased with increasing severity of COVID-19 as determined by clinical staging (Kendall's tau-b = 0.374, P = 0.000) and chest CT staging (Kendall's tau-b = 0.378, P = 0.000). In-hospital mortality rate was 6.9%. Median D-dimer level in non-survivors (n = 17) was significantly higher than in survivors (n = 231) [6.21 (3.79-16.01) mg/L versus 1.02 (0.47-2.66) mg/L, P = 0.000]. D-dimer level of > 2.14 mg/L predicted in-hospital mortality with a sensitivity of 88.2% and specificity of 71.3% (AUC 0.85; 95% CI = 0.77-0.92). CONCLUSIONS: D-dimer is commonly elevated in patients with COVID-19. D-dimer levels correlate with disease severity and are a reliable prognostic marker for in-hospital mortality in patients admitted for COVID-19.