Caregiving experiences of older family caregivers of persons with heart failure: A mixed methods study.

Older family caregivers of persons with heart failure (HF-FCGs) are an understudied and vulnerable population, who are at heightened risk for age-related physical and cognitive declines. We explored caregiving experiences of older HF-FCGs and examined levels of their caregiver burden, psychological distress, caregiving self-efficacy and quality of life (QoL) using descriptive mixed methods. We conducted telephone-based surveys and semi-structured interviews (N=13). Low levels of caregiver burden, psychological distress, and high levels of caregiving self-efficacy and QoL were reported. Through qualitative interviews, three qualitative themes emerged: (1) Impact of Being a Caregiver, (2) Managing Caregiver Distress, and (3) Embracing the Caregiver Role. Psychological distress was the most frequently reported. Physical, psychological, and social distress experienced by older HF-FCGs might be offset by their coping strategies and willingness to accept their caregiver role. FCG-centered support programs that help older HF-FCGs develop and apply their own coping strategies should be considered.

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

BACKGROUNDSevere COVID-19 pneumonia results from a hyperinflammatory immune response (cytokine storm, CS), characterized by GM-CSF mediated activation and trafficking of myeloid cells, leading to elevation of downstream inflammatory chemokines (MCP-1, IL-8, IP-10), cytokines (IL-6, IL-1), and other markers of systemic inflammation (CRP, D-dimer, ferritin). CS leads to fever, hypotension, coagulopathy, respiratory failure, ARDS, and death. Lenzilumab is a novel Humaneered(R) anti-human GM-CSF monoclonal antibody that directly binds GM-CSF 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. METHODSSubjects with COVID-19 (n=520), [≥]18 years, and [≤]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. RESULTSBaseline demographics were comparable between the two treatment groups: male, 64.7%; mean age, 60.5 years; mean BMI, 32.5 kg/m2; mean CRP, 98.36 mg/L; CRP was <150 mg/L in 77.9% of subjects. The most common comorbidities were obesity (55.1%), diabetes (53.4%), chronic kidney disease (14.0%), and coronary artery disease (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: 1.02-2.31, p=0.041) and by 90% in the ITT population (HR: 1.90; 1.02-3.52, nominal p=0.043) compared to placebo. SWOV also relatively improved by 92% in subjects who received both corticosteroids and remdesivir (1.92; 1.20-3.07, nominal p=0.0067); by 2.96-fold in subjects with CRP<150 mg/L and age <85 years (2.96; 1.63-5.37, nominal p=0.0003); and by 88% in subjects hospitalized [≤]2 days prior to randomization (1.88; 1.13-3.12, nominal p=0.015). Survival was improved by 2.17-fold in subjects with CRP<150 mg/L and age <85 years (2.17; 1.04-4.54, nominal p=0.040). CONCLUSIONLenzilumab significantly improved SWOV in hospitalized, hypoxic subjects with COVID-19 pneumonia over and above treatment with remdesivir and/or corticosteroids. Subjects with CRP<150 mg/L and age <85 years demonstrated an improvement in survival and had the greatest benefit from lenzilumab. NCT04351152

Early Release Estimates for SARS-CoV-2 Prevalence and Antibody Response Interim Weighting for Probability-Based Sample Surveys

Many months into the SARS-CoV-2 pandemic, basic epidemiologic parameters describing burden of disease are lacking. To reduce selection bias in current burden of disease estimates derived from diagnostic testing data or serologic testing in convenience samples, we are conducting a national probability-based sample SARS-CoV-2 serosurvey. Sampling from a national address-based frame and using mailed recruitment materials and test kits will allow us to estimate national prevalence of SARS-CoV-2 infection and antibodies, overall and by demographic, behavioral, and clinical characteristics. Data will be weighted for unequal selection probabilities and non-response and will be adjusted to population benchmarks. Due to the urgent need for these estimates, expedited interim weighting of serosurvey responses will be undertaken to produce early release estimates, which will be published on the study website, COVIDVu.org. Here, we describe a process for computing interim survey weights and guidelines for release of interim estimates.