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A Phase 3 Safety and Efficacy Study of Baloxavir Marboxil in Children Less Than 1 Year Old With Suspected or Confirmed Influenza
Here are the results of a phase 3, global, multicenter, single-arm study to evaluate patients <1 year of age who received a single dose of baloxavir (age ≥3 months: 2 mg/kg; <3 months 1 mg/kg). The primary endpoint was safety; secondary endpoints included pharmacokinetics and efficacy (time to alleviation of signs and symptoms, duration of fever and symptoms, antibiotic use and cessation of viral shedding). 48/49 enrolled patients received baloxavir, of whom 15 had positive centralized influenza reverse transcription polymerase chain reaction tests and comprised the intent-to-treat influenza-infected population. The median age was 6 months and 79.2% of patients were not influenza-vaccinated. Overall, 51 adverse events (AEs) were reported in 23 patients; most were grade 1–2. The most common AEs were diarrhea (16.7%) and vomiting (12.5%). Two patients experienced serious AEs unrelated to treatment. In the intent-to-treat influenza-infected population, median time to alleviation of signs and symptoms was 163.7 hours [95% confidence interval (CI): 122.5–not estimable], median duration of fever was 23.1 hours (95% CI: 22.3–44.6) and median time to cessation of viral shedding was 24.5 hours (95% CI: 24.2–68.6).
COVID-19 Infection History as a Risk Factor for Early Pregnancy Loss: Results from the Electronic Health Record-based Southeast Texas COVID and Pregnancy Cohort Study
In the Southeast Texas Pregnancy and COVID Cohort (26,783 pregnancy episodes), the risk of miscarriage among pregnancy episodes with a miscarriage, live birth, or delivery outcome was 6.3% (1,514/ 24,119). In multivariable modeling, history of both mild and moderate to severe COVID-19 before pregnancy were associated with miscarriage (adjusted odds ratio (aOR) 2.48, confidence interval (CI) 2.21–2.78 and aOR 2.81, CI 1.8–4.38, respectively). Additionally, in the same model, both mild and moderate to severe COVID-19 in the first trimester were associated with miscarriage (aOR 2.31, CI 1.96–2.72 and aOR 2.45, CI 1.12–5.35, respectively). So in this study that looked at nearly 27,000 pregnancies, women infected with COVID-19 before or during pregnancy are at two to three times the risk for miscarriage before 20 weeks' gestation.
Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial
These results are from a phase 3 study, mRNA-1083 elicited noninferior immune responses against standard care immunization: licensed standard-dose or high-dose seasonal influenza vaccine (A/H1N1, A/H3N2, B/Victoria, B/Yamagata) coadministered with licensed SARS-CoV-2 (Omicron XBB.1.5) vaccine. The multicomponent vaccine mRNA-1083 had an acceptable tolerability and safety profile. This mRNA-1083 vaccine comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate targeting Omicron XBB.1.5. Here participants in two age cohorts (≥65 years and 50-64 years) were randomly assigned (1:1) to receive mRNA-1083 plus placebo (so combo COVID/Flu mRNA shot) or -mRNA-1273 and the licensed quadrivalent seasonal influenza (so the COVID vaccine and an age appropriate flu shot). For those (≥65 years: high-dose quadrivalent inactivated influenza vaccine [HD-IIV4]; For those (50-64 years: standard-dose IIV4 [SD-IIV4]). 8,015 participants were enrolled and vaccinated (4,017 aged ≥65 y and 3,998 aged 50-64 y). Noninferior immunogenicity of mRNA-1083 was demonstrated against all vaccine-matched influenza and SARS-CoV-2 strains. Solicited adverse reactions were numerically higher in frequency and severity after mRNA-1083 vaccination than comparators in both age cohorts (≥65 y: 83.5% and 78.1%; 50-64 y: 85.2% and 81.8%); most were grade 1 or 2 in severity and of short duration. No safety concerns were identified. For all ages, mRNA-1083, the combined vaccine, elicited higher immune responses.
Remdesivir Associated with Reduced Mortality in Hospitalized COVID-19 Patients: Treatment Effectiveness Using Real-world Data and Natural Language Processing
Investigators use real-world evidence (RWE) generated by artificial intelligence techniques to assess the impact of remdesivir (RDV) on COVID-19-associated outcomes including in-hospital mortality. Using EHRead®, an NLP technology including SNOMED-CT terminology that extracts unstructured clinical information from electronic health records (EHR), they retrospectively examined hospitalized COVID-19 patients with moderate-to-severe pneumonia in three Spanish hospitals between January 2021 and March 2022. Among RDV eligible patients, treated (RDV+) vs untreated (RDV‒) patients were compared after propensity score matching (PSM; 1:3.3 ratio) based on age, sex, Charlson comorbidity index, COVID-19 vaccination status, other COVID-19 treatment, hospital, and variant period. Among 7,651,773 EHRs from 84,408 patients, 6,756 patients were detected with moderate-to-severe COVID-19 pneumonia during the study period. The study population was defined with 4,882 (72.3%) RDV eligible patients. The median age was 72 years and 57.3% were male. A total of 812 (16.6%) patients were classified as RDV+ and were matched to 2,703 RDV‒ patients (from a total of 4,070 RDV‒). The hazard ratio for in-hospital mortality at 28 days was 0.73 (95% confidence interval, CI, 0.56 to 0.96, p = 0.022) with RDV‒ as the reference group. RDV treatment was associated with a statistically significant 37% reduction in inpatient mortality compared with propensity score-matched controls who did not receive RDV.
Excess Weight is Associated with Neurological and Neuropsychiatric Symptoms in Post-COVID-19 Condition: A Systematic Review and Meta-analysis
Investigators conducted a comprehensive search of eight databases (PubMed, Embase, Scopus, Web of Science, VHL, Google Scholar, ProQuest, and medRxiv) for studies published up to July 2023. Studies were included if they assessed PCC symptoms in relation to nutritional status, specifically the development of neurological and neuropsychiatric symptoms more than 12 weeks post-infection. 18 studies (n = 139,091 adults) were included. These studies included 79,050 individuals with excess weight vs 57,926 normal-weight individuals and 30,694 individuals with obesity vs 107,612 non-obese individuals. The presence of excess weight in PCC was significantly associated with persistent depression (RR = 1.21; 95% CI: 1.03–1.42), headache (OR = 1.23; 95% CI: 1.10–1.37), memory issues (RR = 1.43; 95% CI: 1.24–1.65), sleep disturbance (RR = 1.31; 95% CI: 1.16–1.48), and vertigo (RR = 1.21; 95% CI: 1.04–1.41).
Identification of Soluble Biomarkers that Associate with Distinct Manifestations of Long COVID
Investigators looked at geographically independent cohorts from Sweden and the United Kingdom and identified a shared plasma biomarker signature of disease linking breathlessness with apoptotic inflammatory networks centered on various proteins, including CCL3, CD40, IKBKG, IL-18 and IRAK1, and dysregulated pathways associated with cell cycle progression, lung injury and platelet activation, which could potentially inform the diagnosis and treatment of Long COVID.
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