![]() ![]() Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. San Francisco, California and other locations Specifically, the investigators will test a COVID-19 Vaccine Acceptance Intervention (Motivational Interviewing) plus Implementation Facilitation. The overall goal of this study is to increase COVID-19 vaccination in Veterans of VISNs 16 and 21 who remain unvaccinated either because of vaccine hesitancy or lack of access to COVID-19 vaccine. Thus, there is a critical need for evidence-based interventions to increase COVID-19 vaccine acceptance and access among Veterans, many of whom are vulnerable to poor outcomes of COVID-19. Veterans have been vaccinated to date, largely owing to vaccine hesitancy and lack of access to vaccination. ![]() Nevertheless, according to VA data sources, only 56% of all U.S. COVID-19 vaccines have proven highly effective in preventing severe illness, hospitalization, and death. The COVID-19 pandemic has resulted in significant loss of life and suffering with total case and death counts increasing daily, particularly with the emergence of the delta variant. Given, this extensive body of evidence we believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality. EB05 has demonstrated safety in two clinical studies (>120 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. We hypothesis that targeting the initial step in the signalling pathways of these DAMPs in innate immunity offers the best hope for controlling the exaggerated host response to SARS-CoV-2 infection. Taken together the DAMP-TLR4 interaction forms a central axis in the innate immune system and is a key driver of the pathological inflammation observed in COVID-19. Several recent studies have shown that S100A8/A9 serum levels in hospitalized COVID-19 patients positively correlate with both neutrophil count and disease severity. ![]() ![]() These damage-associated molecular patterns (DAMPs) are recognized by the pattern recognition receptor Toll-Like Receptor 4 (TLR4) found on macrophages, dendritic cells and other innate immune cells and result in additional release of pro-inflammatory molecules. This proinflammatory cascade is activated when viral-mediated cell damage occurs in the lungs, resulting in the release of damage-signaling alarmin molecules such as S100A8/A9 (Calprotectin), HMGB1, Resistin, and oxidized phospholipids. This in turn stimulates a pro-inflammatory cascade ("cytokine storm") as well as emergency myelopoiesis. COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response. ![]()
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