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1.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-337732

ABSTRACT

Homologous and heterologous booster with COVID-19 mRNA vaccines represent the most effective strategy to prevent the ongoing Omicron pandemic. The additional protection from these prototype SARS-CoV-2 S-targeting vaccine was attributed to the increased RBD-specific memory B cells with expanded potency and breadth. Herein, we show the safety and immunogenicity of heterologous boosting with the RBD-targeting mRNA vaccine AWcorna (also term ARCoV) in Chinese adults who have received two doses inactivated vaccine. The superiority over inactivated vaccine in neutralization antibodies, as well as the safety profile, support the use of AWcorna as heterologous booster in China.

2.
BMC Health Serv Res ; 22(1): 399, 2022 Mar 26.
Article in English | MEDLINE | ID: covidwho-1765452

ABSTRACT

BACKGROUND: During the coronavirus disease 2019 (COVID-19) containment, primary health care (PHC) facilities inChina played an important role in providing both healthcare and public care services to community populations. The tasks of COVID-19 containment facilitated by PHC facilities were different among different regions and during different periods of COVID-19 pandemic. We sought to investigate the gaps on task participation, explore existing problems and provide corresponding solutions. METHODS: Semi-structured face-to-face interviews with COVID-19 prevention and control management teams of PHC facilities were conducted. Purposive stratified sampling was used and 32 team members of 22 PHC facilities were selected from Wuhan (as high-risk city), Shanghai (as medium-risk city) and Zunyi (as low-risk city). Framework analysis was employed to analyze the transcribed recordings. RESULTS: The main tasks of PHC facilities during the early period of the pandemic included assisting in contact tracing and epidemiological investigation, screening of populations at high-risk at travel centers/internals, house-by-house, or pre-examination/triage within PHC facilities; at-home/ centralized quarantine management; the work of fever sentinel clinics. Further analyses revealed the existing problems and suggestions for improvement or resolutions. Regular medical supply reserves were recommended because of the medical supply shortage during the pre-outbreak period. Temporarily converted quarantine wards and centralized quarantine centers could be used to deal with pressures on patients' treatment and management of the febrile patients. Only after strict evaluation of nucleic acid testing (NAT) results and housing conditions, decision on quarantine at-home or centralized quarantine centers could be made. Settings of fever sentinel clinics at PHC facilities allowed fever patients with no COVID-19 infection risks for treatment without being transferred to fever clinics of the designed secondary hospitals. Psychological intervention was sometimes in need and really helped in addressing individuals' mental pressures. CONCLUSIONS: During the COVID-19 containment, PHC facilities in China were responsible for different tasks and several problems were encountered in the working process. Accordingly, specific and feasible suggestions were put forward for different problems. Our findings are highly beneficial for healthcare teams and governments in handling similar situations.


Subject(s)
COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , China/epidemiology , Cities , Humans , Pandemics/prevention & control , Primary Health Care
3.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-311998

ABSTRACT

Objectives: These 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared with SSC alone in outpatients with mild to moderate coronavirus disease 2019 (COVID-19). KB109 is a novel synthetic glycan that was formulated to modulate the gut microbiome composition and metabolic output in order to increase beneficial short-chain fatty acid (SCFA) production in the gut. The K031 study is designed to evaluate the safety of KB109 and characterize its impact on the natural progression of COVID-19 in patients with mild to moderate disease. The K032 study is evaluating the effect of KB109 on the gut microbiota structure and function in this same patient population. Additionally, both studies are evaluating measures of health care utilization, quality of life (QOL), laboratory indices, biomarkers of inflammation, and serological measures of immunity in patients who received SSC alone or with KB109. Noteworthy aspects of these outpatient studies include study design measures aimed at limiting in-person interactions to minimize the risk of infection spread, such as use of online diaries, telemedicine, and at-home sample collection.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-324427

ABSTRACT

Background: In fulfilling the COVID-19 containment, primary health care (PHC) facilities in China played an important role. We sought to investigate the exact tasks performed at the PHC facilities and the processes of COVID-19 prevention and control. Methods: Semi-structured face-to-face interviews for primary care physicians (PCPs) and a simple survey for residents were conducted in the field survey. Based-on purposive stratified sampling, 32 PCPs were selected from 22 PHC facilities in Wuhan as a high-risk city, in Shanghai as medium-risk city and in Zunyi as low-risk city. In the field survey, semi-structured face-to-face interviews were conducted with PCPs to summarize the tasks of COVID-19 prevention and control at the PHC facilities. A simple survey was used to investigate the local residents’ awareness about COVID-19 prevention and control. Results: In pre-outbreak period, the PHC facilities mainly engaged in storing medical supplies;in out-break period, they were responsible for screening, transferring, quarantine and treatment;in regular prevention and control period, attention was given to the employees and items of cold-chain & fresh food markets, etc. In Wuhan, PHC facilities focused on graded diagnoses and treatments of patients;in Shanghai, they were mainly engaged in at-home/centralized quarantine;in Zunyi, they focused on the screening of high-risk individuals. In urban areas, COVID-19 were more likely to be transmitted;in urban-rural areas, it was difficult to perform screening on the migrant populations;in rural areas, the risk was much lower. The community residents had satisfactory compliance with the preventive measures. Conclusion: We identified differences in the prevention and control tasks performed at the PHC facilities in China. During the different phases of the pandemic, the tasks were adjusted depending on the gradually comprehensive understanding of COVID-19. Among the cities at different risk levels, screening, quarantine, transferring or treatment was chosen to be a priority accordingly. Located in different intra-city geographic locations at different risk levels, the PHC facilities conducted their own tasks accordingly. Additionally, compliance on the part of the local community residents could not be overemphasized in COVID-19 prevention and control.

5.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-318923

ABSTRACT

Background: The COVID-19 pandemic has become a great threat to public health, which has greatly impacted the study and life of undergraduate students in China. Objective: This study aims to perform a survey of their knowledge, attitude and practice (KAP) associated with COVID-19. Methods: A cross-sectional survey was designed to gather information regarding the COVID-19 related KAP among undergraduates during the home isolation in the outbreak. Subjects were recruited from 10 universities in Shaanxi Province, China. Enrollees voluntarily submitted their answers to a pre-designed questionnaire online. Results: A total of 872 subjects (female, 534;male, 338) were enrolled with ages from 17 to 25 years old. This cohort included 430 medical and 442 non-medical students, 580 freshmen and 292 higher school year students. There were 453 from public schools and 442 from private school, residing in 28 regions and provinces at the time of study. Results showed that appropriate knowledge was acquired by 82.34% subjects;the levels were significantly higher in undergraduates from public universities and medical majors than those from private schools and non-medical majors (p<0.05). 73.81% subjects reported positive attitudes;females showed significantly higher levels of positive attitudes than males (p<0.05). Proactive practice was found in 87.94% subjects. Using a common scoring method, the overall scores for Knowledge, Attitude and Practice were 4.12±0.749 (range: 0~5), 8.54±1.201 (range: 0~10), and 8.91±1.431 (range: 0~10), respectively. There was a positive correlation between attitude and practice (r=0.319, p<0.05) in the whole study group. Total KAP score was 21.57±2.291 (range: 0~25), which was significantly different among gender groups and major groups. Conclusions: Most undergraduates acquired necessary knowledge, positive attitude and proactive practice in response to COVID-19 outbreak;but their KAP scores significantly varied by gender, major and school types.

6.
Evolutionary bioinformatics online ; 16, 2020.
Article in English | EuropePMC | ID: covidwho-1679280

ABSTRACT

Monitoring the mutation and evolution of the virus is important for tracing its ongoing transmission and facilitating effective vaccine development. A total of 342 complete genomic sequences of SARS-CoV-2 were analyzed in this study. Compared to the reference genome reported in December 2019, 465 mutations were found, among which, 347 occurred in only 1 sequence, while 26 occurred in more than 5 sequences. For these 26 further identified as SNPs, 14 were closely linked and were grouped into 5 profiles. Phylogenetic analysis revealed the sequences formed 2 major groups. Most of the sequences in late period (March and April) constituted the Cluster II, while the sequences before March in this study and the reported S/L and A/B/C types in previous studies were all in Cluster I. The distributions of some mutations were specific geographically or temporally, the potential effect of which on the transmission and pathogenicity of SARS-CoV-2 deserves further evaluation and monitoring. Two mutations were found in the receptor-binding domain (RBD) but outside the receptor-binding motif (RBM), indicating that mutations may only have marginal biological effects but merit further attention. The observed novel sequence divergence is of great significance to the study of the transmission, pathogenicity, and development of an effective vaccine for SARS-CoV-2.

7.
BMC Med ; 20(1): 24, 2022 01 20.
Article in English | MEDLINE | ID: covidwho-1638127

ABSTRACT

BACKGROUND: COVID-19 is an infectious disease characterized by multiple respiratory and extrapulmonary manifestations, including gastrointestinal symptoms. Although recent studies have linked gut microbiota to infectious diseases such as influenza, little is known about the role of the gut microbiota in COVID-19 pathophysiology. METHODS: To better understand the host-gut microbiota interactions in COVID-19, we characterized the gut microbial community and gut barrier function using metagenomic and metaproteomic approaches in 63 COVID-19 patients and 8 non-infected controls. Both immunohematological parameters and transcriptional profiles were measured to reflect the immune response in COVID-19 patients. RESULTS: Altered gut microbial composition was observed in COVID-19 patients, which was characterized by decreased commensal species and increased opportunistic pathogenic species. Severe illness was associated with higher abundance of four microbial species (i.e., Burkholderia contaminans, Bacteroides nordii, Bifidobacterium longum, and Blautia sp. CAG 257), six microbial pathways (e.g., glycolysis and fermentation), and 10 virulence genes. These severity-related microbial features were further associated with host immune response. For example, the abundance of Bu. contaminans was associated with higher levels of inflammation biomarkers and lower levels of immune cells. Furthermore, human-origin proteins identified from both blood and fecal samples suggested gut barrier dysfunction in COVID-19 patients. The circulating levels of lipopolysaccharide-binding protein increased in patients with severe illness and were associated with circulating inflammation biomarkers and immune cells. Besides, proteins of disease-related bacteria (e.g., B. longum) were detectable in blood samples from patients. CONCLUSIONS: Our results suggest that the dysbiosis of the gut microbiome and the dysfunction of the gut barrier might play a role in the pathophysiology of COVID-19 by affecting host immune homeostasis.


Subject(s)
COVID-19 , Gastrointestinal Microbiome , Dysbiosis , Homeostasis , Humans , SARS-CoV-2
8.
Clin Infect Dis ; 73(11): e3949-e3955, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1561940

ABSTRACT

BACKGROUND: We evaluated an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine for immunogenicity and safety in adults aged 18-59 years. METHODS: In this randomized, double-blinded, controlled trial, healthy adults received a medium dose (MD) or a high dose (HD) of the vaccine at an interval of either 14 days or 28 days. Neutralizing antibody (NAb) and anti-S and anti-N antibodies were detected at different times, and adverse reactions were monitored for 28 days after full immunization. RESULTS: A total of 742 adults were enrolled in the immunogenicity and safety analysis. Among subjects in the 0, 14 procedure, the seroconversion rates of NAb in MD and HD groups were 89% and 96% with geometric mean titers (GMTs) of 23 and 30, respectively, at day 14 and 92% and 96% with GMTs of 19 and 21, respectively, at day 28 after immunization. Anti-S antibodies had GMTs of 1883 and 2370 in the MD group and 2295 and 2432 in the HD group. Anti-N antibodies had GMTs of 387 and 434 in the MD group and 342 and 380 in the HD group. Among subjects in the 0, 28 procedure, seroconversion rates for NAb at both doses were both 95% with GMTs of 19 at day 28 after immunization. Anti-S antibodies had GMTs of 937 and 929 for the MD and HD groups, and anti-N antibodies had GMTs of 570 and 494 for the MD and HD groups, respectively. No serious adverse events were observed during the study period. CONCLUSIONS: Adults vaccinated with inactivated SARS-CoV-2 vaccine had NAb as well as anti-S/N antibody and had a low rate of adverse reactions. CLINICAL TRIALS REGISTRATION: NCT04412538.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Antibodies, Neutralizing , Antibodies, Viral , COVID-19 Vaccines , Double-Blind Method , Humans , Immunogenicity, Vaccine
9.
Int J Environ Res Public Health ; 18(22)2021 11 13.
Article in English | MEDLINE | ID: covidwho-1512361

ABSTRACT

The rapid spread of preliminary scientific evidence is raising concerns on its role in producing misinformation during the COVID-19 pandemic. This research investigated how the communication of uncertainty about preliminary evidence affects the spread of its inferred misinformation in a Weibo case study. In total, 3439 Weibo posts and 10,380 reposts regarding the misinformation of pets transmitting COVID-19 were analyzed. The results showed that attitude ambiguity toward the preliminary evidence and the stage when the evidence was first released with uncertainty were associated with higher numbers of likes and retweets of misinformation posts. Our study highlights the internal sources of misinformation and revisits the contextual perspective in misinformation studies.


Subject(s)
COVID-19 , Social Media , Communication , Humans , Pandemics , SARS-CoV-2 , Uncertainty
10.
Front Psychol ; 12: 628342, 2021.
Article in English | MEDLINE | ID: covidwho-1497119

ABSTRACT

Due to the influence of COVID-19, people pay more attention to the balance between human and nature and pursue more healthy, environmental and nutritional sustainable products (such as organic food). However, the mainstream consumption of organic food is far less, especially in developing countries like China. Therefore, it is urgent to take effective measures to promote the development of China's organic food market. This current study investigated the relationships between consumers' similarity (i.e., information anxiety, uncertainty, and sustainable consumption attitude), perceived values (i.e., functional value, health value, and environmental value) and organic purchasing behavior based on the Stimulus-Organism-Response (S-O-R) theoretical model and information similarity effect. And considering gender differences in consumers' similarity, perceived values and organic purchasing behavior. Meanwhile, the mediating effects of perceived values on the relationship between consumers' similarity and purchasing behavior were also discussed, considering the background of COVID-19. Data were collected using structured questionnaire survey in first-tier cities in China. A total of 344 consumers of organic foods participated in the study. Structural equation modeling was employed for data analysis. The results indicated the significant association of information anxiety, uncertainty and sustainable consumption attitude with perceived values. And perceived values and sustainable consumption attitude had a positively significant influence on purchase behavior. In addition, environmental value played mediating effects in the relationships between organic purchasing behavior and information anxiety, uncertainty and sustainable consumption attitude. And the impact of sustainable consumption attitude and environmental value on organic purchasing behavior differed in gender. The research not only provides novel insights for understanding organic consumption, but also provides reference for organic sellers to develop sales strategies and policy makers to formulate policies to guide organic consumption, which are conducive to promoting China's organic food industry.

11.
Front Microbiol ; 12: 750725, 2021.
Article in English | MEDLINE | ID: covidwho-1485077

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants have been emerging and circulating globally since the start of the COVID-19 pandemic, of which B.1.617 lineage that was first reported in India at the end of 2020, soon became predominant. Tracing genomic variations and understanding their impact on the viral properties are the foundations for the vaccine and drug development and for the mitigation measures to be taken or lifted. In this study, 1,051 near-complete genomes and 1,559 spike (S) sequences belonging to the B.1.617 were analyzed. A genome-wide spread of single nucleotide polymorphisms (SNPs) was identified. Of the high frequency mutations identified, 61% (11/18) involved structural proteins, despite two third of the viral genome encoding nonstructural proteins. There were 22 positive selection sites, mostly distributed across the S protein, of which 16 were led by non-C to U transition and should be of a special attention. Haplotype network revealed that a large number of daughter haplotypes were continually derived throughout the pandemic, of which H177, H181 H219 and H286 from the ancestor haplotype H176 of B.1.617.2 were widely prevalent. Besides the well known substitutions of L452R, P681R and deletions of E156 and F157, as well as the potential biological significance, structural analysis in this study still indicated that new amino acid changes in B.1.617, such as E484Q and N501Y, had reshaped the viral bonding network, and increasingly sequenced N501Y mutant with a potential enhanced binding ability was detected in many other countries in the follow-up monitoring. Although we can't conclude the properties of all the mutants including N501Y thoroughly, it merits focusing on their spread epidemically and biologically.

14.
Chemical Engineering Journal ; : 130869, 2021.
Article in English | ScienceDirect | ID: covidwho-1271587

ABSTRACT

Wearable strain sensors have generated considerable recent research interest due to their huge potential in the real-time detection of human body deformation. State-of-the-art strain sensors are normally fabricated through conductive networks with a single sensing element, which always faces the challenge of either limited stretchability or inferior quality in sensitivity. In this work, we report a highly sensitive strain sensor based on a multi-functionalized fabric through carbonization and polymer-assisted copper deposition. The sensor shows high sensitivity (Gauge factor∼3557.6 in the strain range from 0 to 48%), and outstanding stretchability up to the strain of 300%, which is capable of detecting different types of deformation of the human body. By integrating the high-performance sensor with a deep learning network, we demonstrate a high accuracy of respiration monitoring and emergency alarm system, showing the enormous application potential of the sensor in personal and public healthcare.

15.
Expert Rev Vaccines ; 20(7): 891-898, 2021 07.
Article in English | MEDLINE | ID: covidwho-1209986

ABSTRACT

Background: Although the inactivated SARS-CoV-2 vaccine (CoronaVac) has undergone preclinical tests and clinical trials evaluating its efficacy and safety, few data have been reported in the post-licensure real-world setting. We aimed to assess the safety of the vaccine among healthcare workers.Methods: A self-administered online survey on monitoring adverse reactions post vaccination was conducted among the staff who worked at and were vaccinated in a tertiary hospital in Taizhou, China, from February 24 to 7 March 2021. A total of 1526 subjects responded to the questionnaire when they received an e-mail or an e-poster on WeChat.Results: The incidences of overall adverse reactions after the first and second injections were 15.6% (238/1526) and 14.6% (204/1397), respectively. The most common adverse reaction was localized pain at the injection site, with an incidence of 9.6% and 10.7% after each dose, accounting for 61.8% and 73.0% of adverse reactions, respectively. Fatigue, muscle pain, and headache were the most common systemic adverse reactions.Conclusions: These findings implied that the inactivated CoronaVac vaccine has an acceptable safety profile among healthcare workers due to the low incidence of self-reported adverse reactions. This may boost public confidence in nationwide mass vaccination campaigns.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Health Personnel , Self Report , Vaccines, Inactivated/administration & dosage , Adolescent , Adult , COVID-19/epidemiology , COVID-19 Vaccines/adverse effects , China/epidemiology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Vaccines, Inactivated/adverse effects , Young Adult
16.
Trials ; 22(1): 245, 2021 Apr 02.
Article in English | MEDLINE | ID: covidwho-1166927

ABSTRACT

OBJECTIVES: These 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared with SSC alone in outpatients with mild to moderate coronavirus disease 2019 (COVID-19). KB109 is a novel synthetic glycan that was formulated to modulate the gut microbiome composition and metabolic output in order to increase beneficial short-chain fatty acid (SCFA) production in the gut. The K031 study is designed to evaluate the safety of KB109 and characterize its impact on the natural progression of COVID-19 in patients with mild to moderate disease. The K032 study is evaluating the effect of KB109 on the gut microbiota structure and function in this same patient population. Additionally, both studies are evaluating measures of health care utilization, quality of life (QOL), laboratory indices, biomarkers of inflammation, and serological measures of immunity in patients who received SSC alone or with KB109. Noteworthy aspects of these outpatient studies include study design measures aimed at limiting in-person interactions to minimize the risk of infection spread, such as use of online diaries, telemedicine, and at-home sample collection. STUDY DESIGN: K031 and K032 are randomized, controlled, open-label, clinical food studies. PARTICIPANTS: Inclusion Criteria: • Adults ≥18 years of age • Patients willing and able to give informed consent • Screening/randomization telemedicine visit within 2 days of testing positive test for COVID-19 ○ In K031 study, symptomatic patients at COVID-19 testing must report new or worsening symptoms at baseline that have not been present for more than 5 days ▪ Cardinal COVID-19 symptoms include fever, chills/repeated shaking with chills, cough, shortness of breath, headache, muscle pain, anosmia/ageusia, and sore throat. The 5 additional symptoms include gastrointestinal (GI) disturbance/symptoms (other than diarrhea), diarrhea, fatigue, nasal congestion, and chest tightness ○ In K031, at COVID-19 testing, pre-symptomatic patients must report new cardinal COVID-19 symptoms within 7 days of a positive test and they must be screened and randomized within 5 days of developing symptoms • Mild to moderate COVID-19 and self-reported outpatient management ○ In K032, mild to moderate COVID-19 was defined as having the following symptoms for no more than 72 hours before COVID-19 testing: a self- reported fever or cough (new or exacerbated) or presence of at least 2 of the following: anosmia, sore throat, or nasal congestion • Ability to adhere to the study visit schedule and other protocol requirements • Consistent internet or cell phone access with a data plan and access to a smartphone, tablet, or computer • The K031 and K032 studies are currently being conducted at 17 clinical institutions throughout the United States. EXCLUSION CRITERIA: • In the primary investigator's (PI) judgement, patients likely to require hospitalization for COVID-19 • Patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID-19 • History of chronic lung disease with chronic hypoxia • History of documented cirrhosis or end-stage liver disease • Ongoing requirement for oxygen therapy • Shortness of breath in resting position • Diagnosis of sleep apnea requiring bilevel positive airway pressure (BIPAP)/continuous positive airway pressure (CPAP) • Female patients who are pregnant, trying to become pregnant, or lactating • Concurrent use of immunomodulatory agent within 12 months; systemic antibiotics, antifungals, or antivirals for treatment of active infection within 28 days; systemic immunosuppressive therapy within 3 months; or drugs or other compounds that modulate GI motility (eg, stool softeners, laxatives, or fiber supplements) taken currently, or within 7 days. Antacid (histamine 2 blockers and proton pump inhibitors) and antidiarrheal agents are not prohibited • History of GI surgery (6 months prior to randomization), including but not limited to bariatric surgery and bowel resection, or history of, or active GI disease(s) that may affect assessment of tolerability, including but not limited to inflammatory bowel disease, irritable bowel syndrome, autoimmune disease, or GI malignancy • Participation in an interventional clinical trial or use of any investigational agent within 30 days before randomization • Clinically significant or uncontrolled concomitant medical condition that would put the patient at risk or jeopardize the objectives of the study in the opinion of the PI • In the opinion of the PI, patient unlikely for any reason to be able to comply with study procedures • Contraindications, sensitivities, or known allergy to the use of the study product or its components INTERVENTION AND COMPARATOR: Patients will be randomized (1,1) to receive either SSC and KB109 or SSC alone. During SSC, patients should follow the steps as instructed by their healthcare provider to care for themselves and protect other people in the home and community from potentially contracting COVID-19. Management of COVID-19-related symptoms with over-the-counter cough, cold, and anti-pyretic medications by patients is permitted in accordance with the medications' respective drug facts label or as instructed by the patient's healthcare provider. Following randomization, patients assigned to receive KB109 and SSC will receive a Kaleido Biosciences, Inc at-home study kit including a thermometer, pulse oximeter, and KB109. During the Intake Period (days 1-14), KB109 will be reconstituted in water by the patient and consumed by the patient twice daily (at least 8 hours apart), following an up-titration dosing schedule: Days 1 to 2: 9 g twice daily for a total daily dose of 18 g Days 3 to 4: 18 g twice daily for a total daily dose of 36 g Days 5 to 14: 36 g twice daily for a total daily dose of 72 g During the intake period, patients will record their daily COVID-19-related symptoms, selected COVID-19 signs (as self-measured using the provided thermometer and pulse oximeter), responses to questions related to QOL measures, health care use measures, and concomitant medications taken in the previous 24 hours. Wellness visits by telephone will be conducted between days 1 and 14 to follow up on patient's health status and to ascertain compliance with KB109 and completion of questions. On day 14, all patients will undergo a telemedicine visit where the following will be conducted: abbreviated physical examination, assessment of safety and other protocol-specified measures of health, and an evaluation of whether follow-up treatment is recommended owing to a progression of COVID-19 symptoms. If feasible, blood samples for clinical chemistries, biomarkers and serological measure of immunity, and nasal/oropharyngeal swabs for quantitative viral load assessments will be collected. Beginning on day 15, patients in both groups will enter the follow-up period (days 15-35) where COVID-19 signs, symptoms, and health care use indices will be collected. Wellness visits by telephone will be conducted on days 21, 28, and 35 to follow-up on the patient's health status. On day 35, all patients will undergo a telemedicine visit where the same information as the day 14 telemedicine visit will be collected, including any blood samples. MAIN OUTCOMES: The primary outcome for the K031 and K032 studies is to evaluate the safety of KB109 in addition to SSC compared with SSC alone in outpatients with mild to moderate COVID-19 by assessing the number of patients experiencing KB109-related treatment-emergent adverse events (TEAEs) during the study. K031 will also evaluate duration of symptoms among outpatients with mild to moderate COVID-19. This will be as an assessment made during the intake and/or follow-up periods of the following: • Time to resolution of the 13 overall and the 8 cardinal COVID-19-related symptoms from day 1 until the day at which the composite score of the 13 overall and 8 cardinal COVID-19-related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the intake period and for the follow-up period • Proportion of patients with a reduction from baseline in each of the 13 overall COVID-19-related symptoms • Proportion of patients in whom symptoms (present at baseline) become absent for each of the 13 overall COVID-19-related symptoms • Change from baseline in the overall composite score of the 13 overall COVID-19-related symptoms and the 8 cardinal COVID-19-related symptoms • Time to resolution of fever (defined as from day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4°F without antipyretic medication) • Proportion of patients with oxygen saturation <95% and <98% on days 14 and 35 • Measures collected from the health care provider wellness visits • Proportion of patients experiencing hospital admissions (all cause and COVID-19-related) • Health care use K032 will evaluate the effect of KB109 in addition to SSC compared with SSC alone on the gut microbiota structure and function in outpatients with mild to moderate COVID-19. Before days 1, 14, and 35, microbiota structure (eg, magnitude of change in gut microbiome structure, composition of gut microbiome) will be analysed by methods such as nucleic acid sequencing and gut microbiome function will be analysed via levels of stool inflammatory biomarkers (eg, lipocalin) and gut microbiome metabolites (eg, SCFA). The health of outpatients with mild to moderate COVID-19 will be evaluated during the intake and follow- up periods by: measures of QOL; measures collected from the healthcare provider wellness visits; the proportion of patients experiencing hospital admissions; health care use, the proportions of patients with oxygen saturation <95% and <98%, and the proportionof patients with temperature below 100.4 °F without an anti-pyretic medication. Potential exploratory outcome measures may include: changes from baseline (day 1) in laboratory measures, specific biomarkers of infection, serology, inflammation (eg, D-dimer, lipocalin, cytokines, IgM/IgG sero-conversion, and neutralization assays), and viral load in outpatients with mild to moderate COVID-19 in the presence and absence of KB109. RANDOMISATION: All patients deemed eligible for the studies will be randomized in a 1:1 ratio to KB109 in addition to SSC or SSC alone group using an interactive response technology system. Randomization will be stratified by study site/center, age groups (≥18-<45 years, ≥45-<65 years, ≥65 years), and comorbidity status (yes, no). BLINDING (MASKING): These studies are open-label; therefore, no blinding is necessary. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): K031 will enroll approximately 350 to 400 (175-200 patients per group) whereas K032 will enroll approximately 50 patients (25 per group). STUDY STATUS: K031 protocol version 4, December 9, 2020; recruitment started in August, 2020, and the study is estimated to be completed in March 2021. This study is active and enrollment was completed in January, 2021. K032 protocol version 2, June 30, 2020; recruitment is estimated to start in July, 2020. This study is recruiting and the study is estimated to be completed in March 2021. STUDY REGISTRATION: K031 is registered with the US National Library of Medicine, Identifier NCT04414124 as of June 4, 2020. K032 is registered with the US National Library of Medicine, Identifier NCT04486482 as of July 24, 2020. FULL PROTOCOL: The full protocols are attached as additional files (Additional files 1 and 2), accessible from the ClinicalTrials.gov website. In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocols. The study protocols have been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files 3 and 4).


Subject(s)
COVID-19/therapy , Gastrointestinal Microbiome , Polysaccharides/therapeutic use , Randomized Controlled Trials as Topic , Ambulatory Care , COVID-19/metabolism , COVID-19/microbiology , Fatty Acids, Volatile/metabolism , Humans , SARS-CoV-2 , Self Care , Severity of Illness Index , Telemedicine , Treatment Outcome
17.
Med Sci Monit ; 27: e929708, 2021 Apr 11.
Article in English | MEDLINE | ID: covidwho-1148368

ABSTRACT

BACKGROUND Since the outbreak of COVID-19 in December 2019, there have been 96 623 laboratory-confirmed cases and 4784 deaths by December 29 in China. We aimed to analyze the risk factors and the incidence of thrombosis from patients with confirmed COVID-19 pneumonia. MATERIAL AND METHODS Eighty-eight inpatients with confirmed COVID-19 pneumonia were reported (31 critical cases, 33 severe cases, and 24 common cases). The thrombosis risk factor assessment, laboratory results, ultrasonographic findings, and prognoses of these patients were analyzed, and compared among groups with different severity. RESULTS Nineteen of the 88 cases developed DVT (12 critical cases, 7 severe cases, and no common cases). In addition, among the 18 patients who died, 5 were diagnosed with DVT. Positive correlations were observed between the increase in D-dimer level (≥5 µg/mL) and the severity of COVID-19 pneumonia (r=0.679, P<0.01), and between the high Padua score (≥4) and the severity (r=0.799, P<0.01). In addition, the CRP and LDH levels on admission had positive correlations with the severity of illness (CRP: r=0.522, P<0.01; LDH: r=0.600, P<0.01). A negative correlation was observed between the lymphocyte count on admission and the severity of illness (r=-0.523, P<0.01). There was also a negative correlation between the lymphocyte count on admission and mortality in critical patients (r=-0.499, P<0.01). Univariable logistic regression analysis showed that the occurrence of DVT was positively correlated with disease severity (crude odds ratio: 3.643, 95% CI: 1.218-10.896, P<0.05). CONCLUSIONS Our report illustrates that critically or severely ill patients have an associated high D-dimer value and high Padua score, and illustrates that a low threshold to screen for DVT may help improve detection of thromboembolism in these groups of patients, especially in asymptomatic patients. Our results suggest that early administration of prophylactic anticoagulant would benefit the prognosis of critical patients with COVID-19 pneumonia and would likely reduce thromboembolic rates.


Subject(s)
COVID-19/complications , Fibrin Fibrinogen Degradation Products/analysis , Venous Thrombosis/epidemiology , Adult , Aged , Asymptomatic Diseases , COVID-19/blood , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , China/epidemiology , Female , Hospital Mortality , Humans , Incidence , Lower Extremity/blood supply , Lower Extremity/diagnostic imaging , Male , Middle Aged , Patient Admission , Prognosis , Retrospective Studies , Risk Assessment/methods , Risk Assessment/statistics & numerical data , Risk Factors , SARS-CoV-2/isolation & purification , Severity of Illness Index , Ultrasonography , Venous Thrombosis/blood , Venous Thrombosis/diagnosis , Venous Thrombosis/etiology
18.
Hu Li Za Zhi ; 68(1): 43-53, 2021 Feb.
Article in Chinese | MEDLINE | ID: covidwho-1100322

ABSTRACT

BACKGROUND: Because of the COVID-19 epidemic, people are mostly isolated at home and must seek medical advice over the internet. In addition, government authorities are currently investing greater efforts in developing internet hospitals. PURPOSE: The purpose of this essay was to assess how outpatients feel about online outpatient clinics and to analyze the factors that affect their satisfaction and willingness to return to these clinics. The results provide advice regarding how to more effectively encourage patients to use online outpatient clinics. METHODS: A self-developed questionnaire was used to survey 191 patients who had visited the online outpatient clinic of a tertiary hospital in Sichuan Province from January to July 2019. A descriptive analysis was conducted on the collected data, and factors influencing satisfaction were identified. RESULTS: The majority of the surveyed patients were young or middle-aged (92.7%) and 42.9% held a college degree or higher. Nearly three-quarters (72.2%) expressed feeling satisfied or better with the online outpatient clinic, with 31.4% of these expressing feeling very satisfied. Nearly all (91.1%) expressed the opinion that the online outpatient clinic had improved their awareness of health self-management . Furthermore, 176 (92.1%) were willing to use the online outpatient clinic again. The results of univariate analysis showed that the main factors negatively influencing re-use of the online outpatient clinic were: failure to solve the problem in a timely manner (χ2 = 8.603, p = .045), the complicated process of online registration (χ2 = 8.322, p = .016), the failure of the online physical examination (χ2 = 8.958, p = .015), and unreliable quality (χ2 = 15.373, p = .004). CONCLUSIONS: The participants surveyed in this study reported a lower satisfaction for their online outpatient clinic experience than reported in similar surveys of traditional outpatient services. However, many reported that their health-related self-management awareness had improved after use, indicating that they feel better about the online outpatient clinic. The factors that affected willingness to reuse to the online outpatient clinic related mainly to imperfections related to the clinic and its inability to adequately meet patient needs. Online outpatient clinics should simplify the process of registration, improve functions, and increase service functions such as online examination appointments and follow-up visits to improve patient satisfaction.


Subject(s)
COVID-19 , Aged , Ambulatory Care Facilities , Humans , Middle Aged , Patient Satisfaction , Retreatment , SARS-CoV-2 , Surveys and Questionnaires
19.
Biosens Bioelectron ; 172: 112766, 2021 Jan 15.
Article in English | MEDLINE | ID: covidwho-893625

ABSTRACT

The 2019 novel coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected all aspects of human life. Rapid, accurate, sensitive and user friendly detection method is urgently needed to facilitate early intervention and control the spread of SARS-CoV-2. Here, we propose a one-pot visual SARS-CoV-2 detection system named "opvCRISPR" by integrating reverse transcription loop-mediated isothermal amplification (RT-LAMP) and Cas12a cleavage in a single reaction system. We demonstrate that the collateral activity against single-stranded DNA (ssDNA) reporters of activated Cas12a triggered by RT-LAMP amplicon increases detection sensitivity and makes detection results observable with naked eye. The opvCRISPR enables detection at nearly single molecule level in 45 min. We validate this method with 50 SARS-CoV-2 potentially infected clinical samples. The opvCRISPR diagnostic results provide 100% agreement with the Centers for Disease Control and Prevention (CDC)-approved quantitative RT-PCR assay. The opvCRISPR holds great potential for SARS-CoV-2 detection in next-generation point-of-care molecular diagnostics.


Subject(s)
COVID-19 Nucleic Acid Testing/methods , COVID-19/diagnosis , CRISPR-Cas Systems , Molecular Diagnostic Techniques/methods , Nucleic Acid Amplification Techniques/methods , SARS-CoV-2/genetics , Base Sequence , COVID-19/virology , COVID-19 Nucleic Acid Testing/instrumentation , COVID-19 Nucleic Acid Testing/statistics & numerical data , Humans , Molecular Diagnostic Techniques/instrumentation , Molecular Diagnostic Techniques/statistics & numerical data , Nucleic Acid Amplification Techniques/instrumentation , Nucleic Acid Amplification Techniques/statistics & numerical data , Pandemics , RNA, Viral/genetics , SARS-CoV-2/isolation & purification , Sensitivity and Specificity
20.
Evol Bioinform Online ; 16: 1176934320954870, 2020.
Article in English | MEDLINE | ID: covidwho-835730

ABSTRACT

Monitoring the mutation and evolution of the virus is important for tracing its ongoing transmission and facilitating effective vaccine development. A total of 342 complete genomic sequences of SARS-CoV-2 were analyzed in this study. Compared to the reference genome reported in December 2019, 465 mutations were found, among which, 347 occurred in only 1 sequence, while 26 occurred in more than 5 sequences. For these 26 further identified as SNPs, 14 were closely linked and were grouped into 5 profiles. Phylogenetic analysis revealed the sequences formed 2 major groups. Most of the sequences in late period (March and April) constituted the Cluster II, while the sequences before March in this study and the reported S/L and A/B/C types in previous studies were all in Cluster I. The distributions of some mutations were specific geographically or temporally, the potential effect of which on the transmission and pathogenicity of SARS-CoV-2 deserves further evaluation and monitoring. Two mutations were found in the receptor-binding domain (RBD) but outside the receptor-binding motif (RBM), indicating that mutations may only have marginal biological effects but merit further attention. The observed novel sequence divergence is of great significance to the study of the transmission, pathogenicity, and development of an effective vaccine for SARS-CoV-2.

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