ABSTRACT
Background: Intravenous (IV) and subcutaneous (SC) Immunoglobulin G (IG) replacement products are in wide use in patients with primary antibody deficiency syndrome (PAD). There is limited data on the levels of anti-SARS-CoV-2 spike antibodies in IG products or their ability to neutralize emerging SARS-CoV-2 variants. There is lack of data on the impact of IG therapy on serum anti-SARS-CoV-2 spike or neutralizing antibody titers in PAD patients. Method(s): We measured anti-SARS-CoV-2 anti-spike antibody levels and neutralizing titers against historical (WA1/2020) and variant (B.1.617.2 [Delta] and BA.1 [Omicron]) strains in 158 lots of 6 different IG products, collected between August 2021 to April 2022 and manufactured between December 2019 to December 2021. IG products were compared to serum from 20 healthy donors vaccinated with 2 doses of Pfizer-BioNTech mRNA vaccine. Serum anti-spike antibody level and SARS-CoV-2 neutralization activity were measured in 27 PAD patients treated with the tested IG products. Result(s): Anti-spike antibody titers started to increase in products manufactured in March 2021 and reached peak level, comparable to vaccinated healthy donors, in products manufactured in August 2021 (Fig. 1). The neutralization activity against WA1/2020 and Delta strains showed a similar pattern (Fig. 2). However, 95% of the tested products had no neutralization activity against Omicron. Until November 2021, IVIG products infused to patients in the study had anti-spike titers comparable to unvaccinated healthy donors (Fig. 3). Beginning in February 2022, IVIG products had anti-spike titers comparable to vaccinated healthy controls. Concurrent with a rise in anti-spike antibodies in IG products, PAD patients showed an increase in serum levels of anti-spike antibody and neutralizing activity against WA1/202 and Delta but not against Omicron variants. Testing of immunoglobulin replacement products neutralization activity against emerging variants BQ.1 and BQ.1.1 is underway.[Formula presented][Formula presented][Formula presented] Conclusion(s): The anti-SARS spike antibody and neutralization activity of IVIG products lags after the emergence of COVID-19 variants and currently have poor activity against Omicron strain. Because of the protracted manufacturing process, this is expected to be an ongoing challenge. As variants emerge, clinicians should consider additional means of protection for PAD patients such as vaccination, or prophylaxis with monoclonal antibodies.Copyright © 2023 Elsevier Inc.
ABSTRACT
Providing home care to individuals with intellectual and developmental disabilities can be challenging in the best of times. Communication and relationships, which are both critical to the care provided by Direct Support Professionals (DSPs), were impacted significantly during the COVID-19 pandemic. Using interpretive research methods with DSPs at a Midwestern agency, this study identifies communication and relationship challenges brought on by the COVID-19 pandemic and strategies used to manage those challenges. COVID-19 protocols like masking, cleaning procedures, and cared-for individuals' home confinement created significant relational challenges including misunderstandings, changing routines, and fluctuating roles. DSPs also discussed how those challenges were overcome, including communication adaptation, creativity, and empathy. By examining the strategies DSPs used to negotiate the challenges and their changing roles, insight can be gained into how organizations might best support direct care workers in times of significant stress and uncertainty. This study builds on the growing scholarship exploring the impact of COVID-19 on health care communication. © 2023 Central States Communication Association.
ABSTRACT
Background: The COVID-19 pandemic highlighted plasma as a strategic resource with continually increasing demand. Demographic data for plasma donors are limited compared with blood donors. Increased information regarding pre-pandemic donor demographics may serve as a baseline for evaluation of post-pandemic practices. OBJECTIVES: This study asked the question, "What were the demographics of source plasma donors in the US compared to the general population and how did these change over a five-year period preceding the pandemic?" STUDY DESIGN: Donor demographic data were retrospectively analyzed for the years 2014, 2016 and 2018 from a network of US plasma centers. METHODS: Routine demographic data obtained prior to source plasma collection from all plasma donors at Grifols US centers were retrospectively analyzed. Donor screening and eligibility requirements were standardized across all donor sites and met all donor eligibility requirements (Code of Federal Regulations: 21 CFR part 600). During each calendar year, only data from the first donation in that year were included with each cohort year. RESULTS: This study included 1,303,049 unique donors. Donors were predominantly young adult males, although females increased from 37.4% to 41.6%. Caucasians constituted the highest proportion, followed by African American and Hispanic donors. Demographics were generally stable, but the 2018 cohort and the US population exhibited significantly different age, race/ethnicity, and sex profiles. Of 2014 donors, 9.0% returned in all three years studied (2014-2016-2018), with a higher return rate of 16.0% observed for donors returning in just two of the years (2014-2016). Multiyear donors were predominantly male and African American. CONCLUSION: US plasma donor demographics over a five-year period (2014-2018) showed generally consistent characteristics but differed from the general US population. Multiyear donors were demographically distinct from single-year donors. These data serve as a snapshot of the US source plasma donor base prior to the COVID-19 pandemic. [ FROM AUTHOR]
ABSTRACT
BACKGROUND: Although frequently used in the early pandemic, data on the effectiveness of COVID-19 convalescent plasma (CCP) remain mixed. We investigated the effectiveness and safety of CCP in hospitalized COVID-19 patients in real-world practices during the first two waves of the pandemic in a multi-hospital healthcare system in Texas. METHODS AND FINDINGS: Among 11,322 hospitalized patients with confirmed COVID-19 infection from July 1, 2020 to April 15, 2021, we included patients who received CCP and matched them with those who did not receive CCP within ±2 days of the transfusion date across sites within strata of sex, age groups, days and use of dexamethasone from hospital admission to the match date, and oxygen requirements 4-12 hours prior to the match date. Cox proportional hazards model estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for effectiveness outcomes in a propensity score 1:1 matched cohort. Pre-defined safety outcomes were described. We included 1,245 patients each in the CCP treated and untreated groups. Oxygen support was required by 93% of patients at the baseline. The pre-defined primary effectiveness outcome of 28-day in-hospital all-cause mortality (HR = 0.85; 95%CI: 0.66,1.10) were similar between treatment groups. Sensitivity and stratified analyses found similar null results. CCP-treated patients were less likely to be discharged alive (HR = 0.82; 95%CI: 0.74, 0.91), and more likely to receive mechanical ventilation (HR = 1.48; 95%CI: 1.12, 1.96). Safety outcomes were rare and similar between treatment groups. CONCLUSION: The findings in this large, matched cohort of patients hospitalized with COVID-19 and mostly requiring oxygen support at the time of treatment, do not support a clinical benefit in 28-day in-hospital all-cause mortality for CCP. Future studies should assess the potential benefits with specifically high-titer units in perhaps certain subgroups of patients (e.g. those with early disease or immunocompromised).