Jin-Zhen oral liquid for pediatric coronavirus disease (COVID-19): A randomly controlled, open-label, and non-inferiority trial at multiple clinical centers.

Background: As the coronavirus disease 2019 (COVID-19) pandemic progressed, especially with the emergence of the Omicron variant, the proportion of infected children and adolescents increased significantly. Some treatment such as Chinese herbal medicine has been administered for COVID-19 as a therapeutic option. Jin-Zhen Oral Liquid is widely used for pediatric acute bronchitis, while the efficacy and safety in the treatment of pediatric COVID-19 are unclear. Methods: We conducted a randomized controlled, open-label, multicenter, non-inferiority clinical study involving hospitalized children with mild to moderate COVID-19. Children eligible for enrollment were randomly assigned in a 1:1 ratio to Jin-Zhen Oral Liquid (the treatment group) and Jinhua Qinggan Granules (the positive control group) and received the respective agent for 14 days, followed by a 14-day follow-up after discontinuation of the treatment. The primary efficacy endpoint was the time to first negative viral testing. The secondary endpoints were the time and rate of major symptoms disappearance, duration of hospitalization, and the proportion of symptoms changed from asymptomatic or mild to moderate or severe/critical illness. In addition, the safety end points of any adverse events were observed. Results: A total of 240 child patients were assigned randomly into the Jin-Zhen Oral Liquid (117 patients) and Jinhua Qinggan Granules (123 patients) groups. There was no significant difference of the baselines in terms of the clinical characteristics and initial symptoms between the two groups. After 14-day administration, the time to first negative viral testing in the Jin-Zhen group (median 6.0 days, 95% CI 5.0-6.0) was significantly shorter compared with the positive control Jinhua Qinggan Granules group (median 7.0 days, 95% CI 7.0-8.0). The time and rate of major clinical symptoms disappearance were comparable to the positive control. The symptom disappearance time of pharyngalgia and hospitalization duration were significantly shortened in the Jin-zhen Oral Liquid group. No participants in either group experienced post-treatment exacerbation to severe or critical illness. No adverse events were observed in the Jin-Zhen Oral Liquid treatment group (0.0%) while 1 patient with adverse events occurred in the positive control Jinhua Qinggan granules group (0.8%). No serious adverse events were observed during the study period in both groups. Conclusion: Jin-Zhen Oral Liquid is safe and effective in the treatment of mild to medium COVID-19 in children. It is non-inferior to Jinhua Qinggan granules in shortening the time to first negative viral testing, the time and rate of major clinical symptoms disappearance, and the hospitalization duration. The results suggest that Jin-Zhen Oral Liquid can be a recommended drug for treatment of pediatric COVID-19 patients.

Information technology and artificial intelligence support in management experiences of the pediatric designated hospital during the COVID-19 2022 epidemic in Shanghai.

Objective: To describe the information technology and artificial intelligence support in management experiences of the pediatric designated hospital in the wave of COVID-19 in Shanghai. Methods: : We retrospectively concluded the management experiences at the largest pediatric designated hospital from March 1st to May 11th in Shanghai. We summarized the application of Internet hospital, face recognition technology in outpatient department, critical illness warning system and remote consultation system in the ward and the structed electronic medical record in the inpatient system. We illustrated the role of the information system through the number and prognosis of patients treated. Results: The COVID-19 designated hospitals were built particularly for critical patients requiring high-level medical care, responded quickly and scientifically to prevent and control the epidemic situation. From March 1st to May 11th 2022, we received and treated 768 children confirmed by positive RT-PCR and treated at our center. In our management, we use Internet Information on the Internet Hospital, face recognition technology in outpatient department, critical illness warning system and remote consultation system in the ward, structed electronic medical record in the inpatient system. No deaths or nosocomial infections occurred. The number of offline outpatient visits dropped, from March to May 2022, 146,106, 48,379, 57,686 respectively. But the outpatient volume on the internet hospital increased significantly (3,347 in March 2022 vs. 372 in March 2021; 4,465 in April 2022 vs. 409 in April 2021; 4,677 in May 2022 vs. 538 in May 2021). Conclusions: Information technology and artificial intelligence has provided significant supports in the management. The system optimizes the admission screening process, increases the communication inside and outside the ward, achieves early detection and diagnosis, timely isolates patients, and timely treatment of various types of children.

Epidemiological and clinical features of SARS-CoV-2 infection in children during the outbreak of Omicron variant in Shanghai, March 7-31, 2022.

OBJECTIVES: This study aimed to understand the epidemiological and clinical characteristics of pediatric SARS-CoV-2 infection during the early stage of Omicron variant outbreak in Shanghai. METHODS: This study included local COVID-19 cases <18 years in Shanghai referred to the exclusively designated hospital from March 7 to March 31, 2022. Clinical data, epidemiological exposure, and COVID-19 vaccination status were collected. Relative risks (RRs) were calculated to assess the effect of vaccination on symptomatic infection and febrile disease. RESULTS: A total of 376 pediatric cases of COVID-19 (median age: 6.0 ± 4.2 years) were referred to the designated hospital, including 257 (68.4%) symptomatic cases and 119 (31.6%) asymptomatic cases. Of the 307 (81.6%) children ≥3 years eligible for COVID-19 vaccination, 110 (35.8%) received two doses of vaccines. The median interval between the completion of two-dose vaccination and infection was 3.5 (interquartile range [IQR]: 3, 4.5) months. Compared with no vaccination, two-dose COVID-19 vaccination reduced the risks of symptomatic infection and febrile disease by 35% (RR 0.65, 95% confidence interval [CI]: 0.53-0.79) and 33% (RR 0.64, 95% CI: 0.51-0.81) among confirmed cases. Eighty-four percent of symptomatic cases had fever (mean duration: 1.7 ± 1.0.8 days), 40.5% had cough, and 16.4% had transient leukopenia. Three hundred and seven (81.6%) had an epidemiological exposure in household (69.1%), school (21.8%), and residential area (8.8%). CONCLUSION: The surge of pediatric COVID-19 cases and multiple transmission model reflect wide dissemination of Omicron variant in the community. Asymptomatic infection is common among Omicron-infected children. COVID-19 vaccination can offer some protection against symptomatic infection and febrile disease.

COVID-19 vaccine counseling and safety assessment in children and teenagers with underlying medical conditions in China: a single center study.

Safety concerns about novel vaccines and necessity of COVID-19 vaccination for children, especially with underlying medical conditions, are the obstacle of COVID-19 vaccination program among pediatric population. The study was conducted to investigate the vaccine hesitancy reasons among the parents, and to monitor the adverse events of inactivated COVID-19 vaccines in children and teenagers with underlying medical conditions in China. Children with underlying medical conditions encountered to the Immunization Advisory Clinic for COVID-19 vaccine counseling were enrolled. They were given immunization recommendation and followed up at 72 h and 28 d after immunization to monitor the immunization compliance after consultation and adverse events. A total of 324 children aged 3-17 y were included. The top three primary medical conditions for counseling were allergy (33.6%), neurological diseases (31.2%) and rheumatic diseases (8.3%). COVID-19 vaccination was promptly recommended for 242 (74.7%) children. Seventy-one (65.7%) children who had allergy issues were recommend to take vaccination, which was significantly lower than that of other medical conditions (p < .05). The follow-up record showed that 180 children received 340 doses of inactivated COVID-19 vaccine after consultation. Overall, 39 (21.6%) children reported at least one adverse event within 28 d of either vaccination. No serious adverse reactions were observed. No difference of adverse effects between the first dose and the second dose of vaccination except fever. Parents' hesitancy in COVID-19 vaccination for children with underling medical conditions are mainly due to the safety concerns. Specialist consultation is helpful to improve the vaccine uptake.

Comparison of Clinical and Epidemiological Characteristics of Asymptomatic and Symptomatic SARS-CoV-2 Infection in Children.

To understand the epidemiological and clinical features of the symptomatic and asymptomatic pediatric cases of COVID-19, we carried out a prospective study in Shanghai during the period of January 19 to April 30, 2020. A total of 49 children (mean age 11.5 ± 5.12 years) confirmed with SARS-CoV-2 infection were enrolled in the study, including 11 (22.4%) domestic cases and 38 (77.6%) imported cases. Nine (81.8%) local cases and 12 (31.6%) imported cases had a definitive epidemiological exposure. Twenty-eight (57.1%) were symptomatic and 21 (42.9%) were asymptomatic. Neither asymptomatic nor symptomatic cases progressed to severe diseases. The mean duration of viral shedding for SARS-CoV-2 in upper respiratory tract was 14.1 ± 6.4 days in asymptomatic cases and 14.8 ± 8.4 days in symptomatic cases (P > 0.05). Forty-five (91.8%) cases had viral RNA detected in stool. The mean duration of viral shedding in stool was 28.1 ± 13.3 days in asymptomatic cases and 30.8 ± 18.6 days in symptomatic participants (P > 0.05). Children < 7 years shed viral RNA in stool for a longer duration than school-aged children (P < 0.05). Forty-three (87.8%) cases had seropositivity for antibodies against SARS-CoV-2 within 1-3 weeks after confirmation with infection. In conclusion, asymptomatic SARS-CoV-2 infection may be common in children in the community during the COVID-19 pandemic wave. Asymptomatic cases shed viral RNA in a similar pattern as symptomatic cases do. It is of particular concern that asymptomatic individuals are potentially seed transmission of SARS-CoV-2 and pose a challenge to disease control.

Mild Cytokine Elevation, Moderate CD4+ T Cell Response and Abundant Antibody Production in Children with COVID-19.

Children with Coronavirus Disease 2019 (COVID-19) were reported to show milder symptoms and better prognosis than their adult counterparts, but the difference of immune response against SARS-CoV-2 between children and adults hasn't been reported. Therefore we initiated this study to figure out the features of immune response in children with COVID-19. Sera and whole blood cells from 19 children with COVID-19 during different phases after disease onset were collected. The cytokine concentrations, SARS-CoV-2 S-RBD or N-specific antibodies and T cell immune responses were detected respectively. In children with COVID-19, only 3 of 12 cytokines were increased in acute sera, including interferon (IFN)-γ-induced protein 10 (IP10), interleukin (IL)-10 and IL-16. We observed an increase in T helper (Th)-2 cells and a suppression in regulatory T cells (Treg) in patients during acute phase, but no significant response was found in the IFN-γ-producing or tumor necrosis factor (TNF)-α-producing CD8+ T cells in patients. S-RBD and N IgM showed an early induction, while S-RBD and N IgG were prominently induced later in convalescent phase. Potent S-RBD IgA response was observed but N IgA seemed to be inconspicuous. Children with COVID-19 displayed an immunophenotype that is less inflammatory than adults, including unremarkable cytokine elevation, moderate CD4+ T cell response and inactive CD8+ T cell response, but their humoral immunity against SARS-CoV-2 were as strong as adults. Our finding presented immunological characteristics of children with COVID-19 and might give some clues as to why children develop less severe disease than adults.

Dynamic surveillance of SARS-CoV-2 shedding and neutralizing antibody in children with COVID-19.

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in China and quickly spread globally. In this study, we investigated the characteristics of viral shedding from different sites and the neutralizing antibody (NAb) response during the acute and convalescent phases of nine children with COVID-19. SARS-CoV-2 was detected in their nasopharyngeal swabs (9/9, 100%), stool samples (8/9, 89%), and oropharyngeal swabs (3/9, 33%) but was not detected in their serum and urine samples. The median duration of viral shedding detected in nasopharyngeal swabs, oropharyngeal swabs, and stools was 13, 4, and 43 days respectively, and the maximum duration of viral shedding detected from stools was 46 days after discharge. In children, nasopharyngeal swabs appear to be a more sensitive specimen type for the diagnosis of COVID-19 compared with oropharyngeal swabs. Three of eight patients produced NAbs in the acute phase, and NAbs were detected in all eight patients with convalescent sera. The results of this study provide valuable information for the diagnosis and surveillance of COVID-19 and development of SARS-CoV-2 vaccines for use in children.

A quickly, effectively screening process of novel corona virus disease 2019 (COVID-19) in children in Shanghai, China.

BACKGROUND: A recent cluster of pneumonia cases in China was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report the screening and diagnosis of corona virus disease 2019 (COVID-19) in our hospital. METHODS: Developed a procedure for the identification of children cases with COVID-19 in outpatient and emergency department of our hospital, then we observed how this process works. RESULTS: (I) There were 56 cases considered suspected cases, and 10 cases were confirmed as COVID-19. (II) Of the 10 confirmed COVID-19 cases admitted in our hospital, 5 were males and 5 were females, aged from 7 months to 11 years, the average age is 6.0±4.2 years, 6 cases were mild pneumonia, the others were upper respiratory tract infection. (III) We followed up 68 patients in isolation at home until symptoms disappeared. Non were missed in the patient's first visit. The sensitivity of this method is 100% and the specificity is 71.3%. CONCLUSIONS: Our screening process works well, and it is also necessary to establish a screening network in the hospital.