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HGNC Genes

SARS-CoV-2 proteins

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    LENZILUMAB EFFICACY AND SAFETY IN NEWLY HOSPITALIZED MESHD COVID-19 MESHD SUBJECTS: RESULTS FROM THE LIVE-AIR PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

    Authors: Zelalem Temesgen; Charles D. Burger; Jason Baker; Christopher Polk; Claudia Libertin; Colleen Kelley; Vincent C Marconi; Robert Orenstein; Cameron Durrant; Dale Chappell; Omar Ahmed; Gabrielle Chappell; Andrew Badley

    doi:10.1101/2021.05.01.21256470 Date: 2021-05-05 Source: medRxiv

    BACKGROUND: Severe COVID19 MESHD pneumonia MESHD results from a hyperinflammatory immune response (cytokine storm, CS), characterized by GM CSF HGNC mediated activation and trafficking of myeloid cells, leading to elevation of downstream inflammatory chemokines ( MCP1 HGNC, IL8 HGNC, IP10 HGNC), cytokines ( IL6 HGNC, IL1 HGNC), and other markers of systemic inflammation MESHD ( CRP HGNC, D dimer, ferritin). CS leads to fever MESHD, hypotension MESHD, coagulopathy MESHD, respiratory failure MESHD, ARDS, and death MESHD. Lenzilumab is a novel Humaneered anti-human GM CSF HGNC monoclonal antibody that directly binds GM CSF HGNC and prevents signaling through its receptor. The LIVE AIR Phase 3 randomized, double blind, placebo controlled trial investigated the efficacy and safety of lenzilumab to assess the potential for lenzilumab to improve the likelihood of ventilator free survival (referred to herein as survival without ventilation, SWOV), beyond standard supportive care, in hospitalized subjects with severe COVID-19 MESHD. METHODS: Subjects with COVID-19 MESHD (n=520), >18 years <94% oxygen saturation on room air and/or requiring supplemental oxygen, but not invasive mechanical ventilation, were randomized to receive lenzilumab (600 mg, n=261) or placebo (n=259) via three intravenous infusions administered 8 hours apart. Subjects were followed through Day 28 following treatment. RESULTS: Baseline demographics were comparable between the two treatment groups: male, 64.7%; mean age, 60.5 years; mean BMI, 32.5 kg/m2; mean CRP HGNC, 98.36 mg/L; CRP HGNC was <150 mg/L in 77.9% of subjects. The most common comorbidities were obesity MESHD (55.1%), diabetes MESHD (53.4%), chronic kidney disease MESHD (14.0%), and coronary artery disease MESHD (13.6%). Subjects received steroids (93.7%), remdesivir (72.4%), or both (69.1%). Lenzilumab improved the likelihood of SWOV by 54% in the mITT population (HR: 1.54; 95% CI: 1.02 to 2.31, p=0.041) and by 90% in the ITT population (HR: 1.90; 1.02 to 3.52, nominal p=0.043) compared to placebo. SWOV also relatively improved by 92% in subjects who received both corticosteroids and remdesivir (1.92; 1.20 to 3.07, nominal p=0.0067); by 2.96-fold in subjects with CRP HGNC<150 mg/L and age <85 years (2.96; 1.63 to 5.37, nominal p=0.0003); and by 88% in subjects hospitalized <2 days prior to randomization (1.88; 1.13 to 3.12, nominal p=0.015). Survival was improved by 2.17-fold in subjects with CRP HGNC<150 mg/L and age <85 years (2.17; 1.04 to 4.54, nominal p=0.040). CONCLUSION: Lenzilumab significantly improved SWOV in hospitalized, hypoxic subjects with COVID-19 MESHD pneumonia MESHD over and above treatment with remdesivir and/or corticosteroids. Subjects with CRP HGNC<150 mg/L and age <85 years demonstrated an improvement in survival and had the greatest benefit from lenzilumab. NCT04351152

    Viral shedding and immunological features of children COVID-19 MESHD patients

    Authors: Yang Yang; Haixia Zheng; Ling Peng; Jinli Wei; Yanrong Wang; Xiaohe Li; Bo Peng; Shisong Fang; Mingxia Zhang; Hui Liu; Yanjie Li; Kai Feng; Li Xing; Jun Wang; Mengli Cao; Fuxiang Wang; Yingxia Liu; Lei Liu; Jing Yuan

    doi:10.1101/2020.08.25.20181446 Date: 2020-08-31 Source: medRxiv

    Abstract Background SARS-CoV-2 could infect people at all ages, and the viral shedding and immunological features of children COVID-19 MESHD patients were analyzed. Methods Epidemiological information and clinical data were collected from 35 children patients. Viral RNAs in respiratory and fecal samples were detected. Plasma of 11 patients were collected and measured for 48 cytokines. Results 40% (14/35) of the children COVID-19 MESHD patients showed asymptomatic infections, while pneumonia shown by CT scan occurred in most of the cases (32/35, 91.43%). Elevated LDH, AST HGNC, CRP HGNC, neutropenia, leukopenia, lymphopenia and thrombocytopenia occurred in some cases, and CD4 HGNC and CD8 HGNC counts were normal. A total of 22 cytokines were significantly higher than the healthy control, and IP-10 HGNC, IFN-2 of them in children were significantly lower than the adult patients. Meanwhile, MCP-3 HGNC, HGF HGNC, MIP-1 HGNC, and IL-1ra HGNC were similar or lower than healthy control, while significantly lower than adult patients. Viral RNAs were detected as early as the first day after illness onset (d.a.o) in both the respiratory and fecal samples. Viral RNAs decreased as the disease progression and mostly became negative in respiratory samples within 18 d.a.o, while maintained relatively stable during the disease progression and still detectable in some cases during 36~42 d.a.o. Conclusion COVID-19 MESHD in children was mild, and asymptomatic infection was common. Immune responses were relatively normal in children COVID-19 MESHD patients. Cytokine storm also occurred in children patients, while much weaker than adult patients. Positive rate of viral RNAs in fecal samples was high, and profile of viral shedding were different between respiratory and gastrointestinal tract.

    Viral shedding and immunological features of children COVID-19 MESHD patients

    Authors: Yang Yang; Haixia Zheng; Ling Peng; Jinli Wei; Yanrong Wang; Hexiao Li; Bo Peng; Shisong Fang; Mingxia Zhang; Yanjie Li; Hui Liu; Kai Feng; Li Xing; Jun Wang; Mengli Cao; Fuxiang Wang; Lei Liu; Yingxia Liu; Jing Yuan

    doi:10.21203/rs.3.rs-48544/v2 Date: 2020-07-24 Source: ResearchSquare

    Background SARS-CoV-2 could infect people at all ages, and the viral shedding and immunological features of children COVID-19 MESHD patients were analyzed.Methods Epidemiological information and clinical data were collected from 35 children patients. Viral RNAs in respiratory and fecal samples were detected. Plasma of 11 patients were collected and measured for 48 cytokines.Results 40% (14/35) of the children COVID-19 MESHD patients showed asymptomatic infections, while pneumonia MESHD shown by CT scan occurred in most of the cases (32/35, 91.43%). Elevated LDH, AST HGNC, CRP HGNC, neutropenia MESHD, leukopenia MESHD, lymphopenia MESHD and thrombocytopenia MESHD occurred in some cases, and CD4 HGNC and CD8 HGNC counts were normal. A total of 22 cytokines were significantly higher than the healthy control, and IP-10 HGNC, IFN-α2 HGNC of them in children were significantly lower than the adult patients. Meanwhile, MCP-3 HGNC, HGF HGNC, MIP-1α HGNC, and IL-1ra HGNC were similar or lower than healthy control, while significantly lower than adult patients. Viral RNAs were detected as early as the first day after illness onset (d.a.o) in both the respiratory and fecal samples. Viral RNAs decreased as the disease progression and mostly became negative in respiratory samples within 18 d.a.o, while maintained relatively stable during the disease progression and still detectable in some cases during 36~42 d.a.o. Conclusion COVID-19 MESHD in children was mild, and asymptomatic infection was common. Immune responses were relatively normal in children COVID-19 MESHD patients. Cytokine storm also occurred in children patients, while much weaker than adult patients. Positive rate of viral RNAs in fecal samples was high, and profile of viral shedding were different between respiratory and gastrointestinal tract.

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MeSH Disease
HGNC Genes
SARS-CoV-2 Proteins


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