Neutralizing monoclonal antibody in patients with coronavirus disease 2019: an observational study.

BACKGROUND: Clinical data on patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) delta variant are limited, especially on clinical status after the application of antibody therapy. METHODS: We evaluated clinical status in patients with the SARS-CoV-2 delta variant after BRII-196 and BRII-198 treatment in an infectious disease hospital in China. We collected data on clinical symptoms, laboratory tests, radiological characteristics, viral load, anti-SARS-CoV-2 antibodies, treatment, and outcome. RESULTS: In mid-June 2021, 36 patients with delta variant infection were identified in Shenzhen. The most common symptoms at illness onset were cough (30.6%), fever (22.2%), myalgia (16.7%), and fatigue (16.7%). A small number of patients in this study had underlying diseases, including diabetes (5.6%) and hypertension (8.3%). The application of BRII-196 and BRII-198 can rapidly increase anti-SARS-CoV-2 IgG. The median peak IgG levels in the antibody treatment group were 32 times higher than those in the control group (P < 0.001). The time from admission to peak IgG levels in the antibody treatment group (mean: 10.2 days) was significantly shorter than that in the control group (mean: 17.7 days). Chest CT score dropped rapidly after antibody therapy, with a mean duration of 5.74 days from admission to peak levels. CONCLUSION: The results of this study suggest that the application of BRII-196 and BRII-198 antibody therapy improved clinical status in patients with SARS-CoV-2 delta variant infection.

Proof-of-concept for speedy development of rapid and simple at-home method for potential diagnosis of early COVID-19 mutant infections using nanogold and aptamer.

The positive single-stranded nature of COVID-19 mRNA led to the low proof-reading efficacy for its genome authentication. Thus mutant covid-19 strains have been rapidly evolving. Besides Alpha, Beta, Gamma, Delta, and Omicron variants, currently, subvariants of omicron are circulating, including BA.4, BA.5, and BA.2.12.1. Therefore, the speedy development of a rapid, simple, and easier diagnosis method to deal with new mutant covid viral infection is critically important. Many diagnosis methods have been developed for COVID-19 detection such as RT-PCR and antibodies detection. However, the former is time-consuming, laborious, and expensive, and the latter relies on the production of antibodies making it not suitable for the early diagnosis of viral infection. Many lateral-flow methods are available but might not be suitable for detecting the mutants, Here we proved the concept for the speedy development of a simple, rapid, and cost-effective early at-home diagnosis method for mutant Covid-19 infection by combining a new aptamer. The idea is to use the current lateral flow Covid-19 diagnosis system available in the market or to use one existing antibody for the Lateral Flow Nitrocellulose filter. To prove the concept, the DNA aptamer specific to spike proteins (S-proteins) was conjugated to gold nanoparticles and served as a detection probe. An antibody that is specific to spike proteins overexpressed on COVID viral particles was used as a second probe immobilized to the nitrocellulose membrane. The aptamer conjugated nanoparticles were incubated with spike proteins for half an hour and tested for their ability to bind to antibodies anchored on the nitrocellulose membrane. The gold nanoparticles were visualized on the nitrocellulose membrane due to interaction between the antigen (S-protein) with both the aptamer and the antibody. Thus, the detection of viral antigen can be obtained within 2 h, with a cost of less than $5 for the diagnosis reagent. In the future, as long as the mutant of the newly emerged viral surface protein is reported, a peptide or protein corresponding to the mutation can be produced by peptide synthesis or gene cloning within several days. An RNA or DNA aptamer can be generated quickly via SELEX. A gold-labeled aptamer specific to spike proteins (S-proteins) will serve as a detection probe. Any available lateral-flow diagnosis kits with an immobilized antibody that has been available on the market, or simply an antibody that binds COVID-19 virus might be used as a second probe immobilized on the nitrocellulose. The diagnosis method can be carried out by patients at home if a clinical trial verifies the feasibility and specificity of this method.

Antiviral Efficacy and Safety of Molnupiravir Against Omicron Variant Infection: A Randomized Controlled Clinical Trial.

Background: The rapid worldwide spread of the Omicron variant of SARS-CoV-2 has unleashed a new wave of COVID-19 outbreaks. The efficacy of molnupiravir, an approved drug, is still unknown in patients infected with the Omicron variant. Objective: Evaluated the antiviral efficacy and safety of molnupiravir in patients infected with SARS-CoV-2 Omicron variant, with symptom duration within 5 days. Methods: We conducted a randomized, controlled trial involving patients with mild or moderate COVID-19. Patients were randomized to orally receive molnupiravir (800 mg) plus basic treatment or only basic treatment for 5 days (BID). The antiviral efficacy of the drug was evaluated using reverse transcriptase polymerase chain reaction. Results: Results showed that the time of viral RNA clearance (primary endpoint) was significantly decreased in the molnupiravir group (median, 9 days) compared to the control group (median, 10 days) (Log-Rank p = 0.0092). Of patients receiving molnupiravir, 18.42% achieved viral RNA clearance on day 5 of treatment, compared to the control group (0%) (p = 0.0092). On day 7, 40.79%, and 6.45% of patients in the molnupiravir and control groups, respectively, achieved viral RNA clearance (p = 0.0004). In addition, molnupiravir has a good safety profile, and no serious adverse events were reported. Conclusion: Molnupiravir significantly accelerated the SARS-CoV-2 Omicron RNA clearance in patients with COVID-19. Clinical Trial Registration: [chictr.org.cn], identifier [ChiCTR2200056817].

Pulmonary Sequelae in Patients After Recovery From Coronavirus Disease 2019: A Follow-Up Study With Chest CT.

Objective: The pulmonary sequelae of coronavirus disease 2019 (COVID-19) have not been comprehensively evaluated. We performed a follow-up study analyzing chest computed tomography (CT) findings of COVID-19 patients at 3 and 6 months after hospital discharge. Methods: Between February 2020 and May 2020, a total of 273 patients with COVID-19 at the Shenzhen Third People's Hospital were recruited and followed for 6 months after discharge. Chest CT scanning was performed with the patient in the supine position at end-inspiration. A total of 957 chest CT scans was obtained at different timepoints. A semi-quantitative score was used to assess the degree of lung involvement. Results: Most chest CT scans showed bilateral lung involvement with peripheral location at 3 and 6 months follow-up. The most common CT findings were ground-glass opacity and parenchymal band, which were found in 136 (55.3%) and 94 (38.2%) of the 246 patients at 3 months follow-up, and 82 (48.2%) and 76 (44.7%) of 170 patients at 6 months follow-up, respectively. The number of lobes involved and the total CT severity score declined over time. The total CT score gradually increased with the increasement of disease severity at both 3 months follow-up (trend test P < 0.001) and 6 months follow-up (trend test P < 0.001). Patients with different disease severity represented diverse CT patterns over time. Conclusions: The most common CT findings were ground-glass opacity and parenchymal bands at the 3 and 6 months follow-up. Patients with different disease severity represent diverse CT manifestations, indicating the necessary for long-term follow-up monitoring of patients with severe and critical conditions.

Parental Self-Efficacy and Behavioral Problems in Children with Autism During COVID-19: A Moderated Mediation Model of Parenting Stress and Perceived Social Support.

PURPOSE: COVID-19 pandemic has been verified as a public health emergency of international concern. During the special period, the health of vulnerable groups, such as children with autism, should be concerned. Some studies have been carried out to investigate the behavioral problems of children with autism during the COVID-19, but underlying mechanisms behind it is not clear. This study examines the role of parenting stress as a mediator in the relationship between parental self-efficacy and behavioral problems in Chinese children as well as the role of perceived social support as a moderator for this mediation effect. METHODS: A total of 439 parents of children with autism (mean age=40.17, SD=5.26) were surveyed and completed five questionnaires (Conners Parent Symptom Questionnaire, Parental Self-Efficacy Questionnaire, Parenting Stress Index-Short Form 15, Perceived Social Support Questionnaire, and Neuroticism Extraversion Openness Five Factor Inventory). The statistical analyses were conducted by SPSS 26.0 and SPSS PROCESS macro. RESULTS: Controlling for neuroticism, which is highly associated with psychological changes in parents, the study found that parental self-efficacy was significantly and negatively correlated with behavioral problems in children with autism. In addition, the relationship between parental self-efficacy and behavioral problems was mediated by parenting stress. Furthermore, parenting stress moderated the indirect relationship between parental self-efficacy and behavioral problems via perceived social support. CONCLUSION: These results provide direct evidences for the inextricable relationship between family, social factors and behavioral problems of children with autism. It suggest that improving perceived social support to enhance parental self-efficacy is critical to buffering against parenting stress and stabilizing children with autism during the COVID-19 pandemic.

Is chemoprophylaxis necessary for all latent tuberculosis infection patients receiving IL-17 inhibitors? A cohort study.

The tuberculosis (TB) burden is high in China, with a 32% prevalence of latent tuberculosis infection (LTBI) in Beijing. Screening for LTBI and the chemoprophylaxis of positive patients are recommended prior to biologic therapy. To evaluate the TB-related safety of secukinumab (SEC) in a cohort of plaque psoriasis patients with LTBI receiving different treatments. Plaque psoriasis patients eligible for SEC treatment were screened for TB. LTBI patients (QuantiFeron-TB test positive, QFT+) receiving SEC were closely monitored by chest radiograph, ESR or hs-CRP, and blood counts every 12 to 20 weeks for active TB infection. QFT_patients receiving SEC treatment were screened for LTBI every 6 to 12 months. Of 42 patients treated with SEC, 19 were QFT+ (45.24%). A QFT_patient became QFT+ after 6 months treatment. Two patients started SEC treatment from 2015 to 2016 and were followed up 268 and 216 weeks later, respectively. Three patients received chemoprophylaxis, 17 did not because of safety concerns or being unable to complete the process. During the 16- to 268-week follow-up, no signs of TB reactivation were observed in the 20 LTBI patients receiving SEC. Plaque psoriasis patients with LTBI who received no chemoprophylaxis could be safely treated with SEC.

Mental Health of Parents of Special Needs Children in China during the COVID-19 Pandemic.

We assessed the mental health of parents (N = 1450, Mage = 40.76) of special needs children during the COVID-19 pandemic. We conducted an online survey comprising items on demographic data; two self-designed questionnaires (children's behavioral problems/psychological demand of parents during COVID-19); and four standardized questionnaires, including the General Health Questionnaire, Perceived Social Support, Parenting Stress Index, and Neuroticism Extraversion Openness Five Factor Inventory. The results showed that there were significant differences among parents of children with different challenges. Parents of children with autism spectrum disorder were more likely to have mental health problems compared to parents whose children had an intellectual disability or a visual or hearing impairment. Behavioral problems of children and psychological demands of parents were common factors predicting the mental health of all parents. Parent-child dysfunctional interactions and parenting distress were associated with parents of children with autism spectrum disorder. Family support, having a difficult child, and parenting distress were associated with having children with an intellectual disability. It is necessary to pay attention to the parents' mental health, provide more social and family support, and reduce parenting pressures.

Mental Health of Parents of Special Needs Children in China during the COVID-19 Pandemic

We assessed the mental health of parents (N = 1450, Mage = 40.76) of special needs children during the COVID-19 pandemic. We conducted an online survey comprising items on demographic data;two self-designed questionnaires (children’s behavioral problems/psychological demand of parents during COVID-19);and four standardized questionnaires, including the General Health Questionnaire, Perceived Social Support, Parenting Stress Index, and Neuroticism Extraversion Openness Five Factor Inventory. The results showed that there were significant differences among parents of children with different challenges. Parents of children with autism spectrum disorder were more likely to have mental health problems compared to parents whose children had an intellectual disability or a visual or hearing impairment. Behavioral problems of children and psychological demands of parents were common factors predicting the mental health of all parents. Parent–child dysfunctional interactions and parenting distress were associated with parents of children with autism spectrum disorder. Family support, having a difficult child, and parenting distress were associated with having children with an intellectual disability. It is necessary to pay attention to the parents’mental health, provide more social and family support, and reduce parenting pressures.

Characteristics of mortal COVID-19 cases compared to the survivors.

The outbreak of coronavirus disease 2019 (COVID-19) initially occurred in December 2019 and triggered a public health emergency. The increasing number of deaths due to this disease was of great concern. Therefore, our study aimed to explore risk factors associated with COVID-19 deaths. After having searched the PubMed, EMBASE, and CNKI for studies published as of August 10, 2020, we selected articles and extracted data. The meta-analysis was performed using Stata 16.0 software. Nineteen studies were used in our meta-analysis. The proportions of comorbidities such as diabetes, hypertension, malignancies, chronic obstructive pulmonary disease, cardio-cerebrovascular disease, and chronic liver disease were statistically significantly higher in mortal COVID-19 cases. Coagulation and inflammatory markers, such as platelet count, D-dimer, prothrombin time, C-reactive protein, procalcitonin, and interleukin 6, predicted the deterioration of the disease. In addition, extracorporeal membrane oxygenation and mechanical ventilation predicted the poor prognosis during its progression. The COVID-19 pandemic is still evolving, placing a huge burden on healthcare facilities. Certain coagulation indicators, inflammatory indicators, and comorbidities contribute to the prognosis of patients. Our study results may help clinicians optimize the treatment and ultimately reduce the mortality rate.

Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study.

There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes has been named coronavirus disease 2019 (COVID-19). More than 16% of patients developed acute respiratory distress syndrome, and the fatality ratio was 1%-2%. No specific treatment has been reported. Herein, we examined the effects of favipiravir (FPV) versus lopinavir (LPV)/ritonavir (RTV) for the treatment of COVID-19. Patients with laboratory-confirmed COVID-19 who received oral FPV (Day 1: 1600 mg twice daily; Days 2-14: 600 mg twice daily) plus interferon (IFN)-α by aerosol inhalation (5 million international unit (IU) twice daily) were included in the FPV arm of this study, whereas patients who were treated with LPV/RTV (Days 1-14: 400 mg/100 mg twice daily) plus IFN-α by aerosol inhalation (5 million IU twice daily) were included in the control arm. Changes in chest computed tomography (CT), viral clearance, and drug safety were compared between the two groups. For the 35 patients enrolled in the FPV arm and the 45 patients in the control arm, all baseline characteristics were comparable between the two arms. A shorter viral clearance median time was found for the FPV arm versus the control arm (4 d (interquartile range (IQR): 2.5-9) versus 11 d (IQR: 8-13), P < 0.001). The FPV arm also showed significant improvement in chest CT compared with the control arm, with an improvement rate of 91.43% versus 62.22% (P = 0.004). After adjustment for potential confounders, the FPV arm also showed a significantly higher improvement rate in chest CT. Multivariable Cox regression showed that FPV was independently associated with faster viral clearance. In addition, fewer adverse events were found in the FPV arm than in the control arm. In this open-label before-after controlled study, FPV showed better therapeutic responses on COVID-19 in terms of disease progression and viral clearance. These preliminary clinical results provide useful information of treatments for SARS-CoV-2 infection.