ABSTRACT
Background. BRII-196 and BRII-198 are two anti-SARS-CoV-2 monoclonal neutralizing antibodies with modified Fc region that extends half-life and are being developed as cocktail therapy for the treatment of COVID-19. Safety, tolerability, pharmacokinetics, and immunogenicity of BRII-196 and BRII-198 were investigated in healthy adults. Methods. Single ascending doses of BRII-196 and BRII-198 were evaluated in parallel in the first-in-human, placebo-controlled phase 1 studies. A total of 32 healthy adults were randomized and received a single intravenous infusion of 750, 1500, and 3000 mg of BRII-196 (n=12), BRII-198 (n=12), or placebo (n=8) and were followed for 180 days. Results. All infusions were well tolerated at infusion rates between 0.5 mL/min to 4 mL/min with no dose-limiting adverse events, deaths, serious adverse events, or any systemic or local infusion reactions. Most treatment-emergent adverse events were isolated asymptomatic laboratory abnormalities of Grade 1-2 in severity. Each mAb displayed pharmacokinetics expected of Fc-engineered human IgG1 with mean terminal half-lives of approximately 46 days and 76 days, respectively, with no evidence of significant anti-drug antibody development. Conclusions. BRII-196 and BRII-198 were well-tolerated. Clinical results support further development as therapeutic or prophylactic options for SARS-CoV-2 infection.
Subject(s)
COVID-19ABSTRACT
Background There are very few studies focusing on the relationship between COVID-19 and pre-infection lifestyle. In the absence of effective vaccines and special-effect medicines, it is very meaningful to actively respond to the disease pandemic by improving lifestyle habits.Methods This is a multicenter, retrospective cohort study enrolled 431 adult people including 228 normal people and 203 confirmed infects in Wubei, Henan and Shandong Provinces. Questionnaires were used to collect information on physical activity and lifestyle by competent doctors. The univariate logistic regression models and multiple regression models were used in risk factor analysis. Kruskal-Wallis H test were used to test the correlation.Results Lifestyle habits including exercise, smoking, sedentary behavior and physical activity intensity can significantly affect the probability of getting COVID-19 (P < 0.05). The MET (Metabolic Equivalent) intensity classification and sleep status are found to be the potential influencing factors of prognosis in both all infects and symptomatic patients. In all infects, taking the high MET intensity level as a reference, inpatient days would increase by 1.812 times (95% CI: 0.887–3.701) with no significance when the level is moderate (P > 0.05) and significantly increase by 6.674 times (95% CI: 1.613–27.613) when the level is low (P < 0.05). Kruskal-Wallis H test results showed moderate activity MET*min promoted shorter hospital stay (P < 0.05) mainly.Conclusions Sleep status and physical activity influenced the susceptibility and prognosis of COVID-19. Lack of sleep and low MET intensity level may prolong the hospital stay, which means a relatively slow recovery. This encourages the public to have moderate physical activity and adequate sleep to respond to the COVID-19 pandemic actively.
Subject(s)
COVID-19 , InfectionsABSTRACT
Background There are very few studies focusing on the relationship between COVID-19 and pre-infection lifestyle. In the absence of effective vaccines and special-effect medicines, it is very meaningful to actively respond to the disease pandemic by improving lifestyle habits.Methods This is a multicenter, retrospective cohort study enrolled 431 adult people including 228 normal people and 203 confirmed infects in Wubei, Henan and Shandong Provinces. Questionnaires were used to collect information on physical activity and lifestyle by competent doctors. The univariate logistic regression models and multiple regression models were used in risk factor analysis. Kruskal-Wallis H test were used to test the correlation.Results Lifestyle habits including exercise, smoking, sleep and physical activity can significantly affect the probability of getting COVID-19(P < 0.05). The MET (Metabolic Equivalent) intensity classification and sleep status are found to be the potential influencing factors of prognosis in both all infects and symptomatic patients. In all infects, taking the high MET intensity level as a reference, inpatient days would increase by 1.812 times (95% CI: 0.887–3.701) with no significance when the level is moderate (P > 0.05) and significantly increase by 6.674 times (95% CI: 1.613–27.613) when the level is low (P < 0.05). Kruskal-Wallis H test results showed moderate activity MET*min promoted shorter hospital stay (P < 0.05) mainly.Conclusions Sleep status and physical activity influenced the susceptibility and prognosis of COVID-19. Lack of sleep and low MET intensity level may prolong the hospital stay, which means a relatively slow recovery. This encourages the public to have moderate physical activity and adequate sleep to respond to the COVID-19 pandemic actively.