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mBio ; : e0175122, 2022.
Article in English | MEDLINE | ID: covidwho-2038241


COVID-19 convalescent plasma (CCP) was an early and widely adopted putative therapy for severe COVID-19. Results from randomized control trials and observational studies have failed to demonstrate a clear therapeutic role for CCP for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Underlying these inconclusive findings is a broad heterogeneity in the concentrations of neutralizing antibodies (nAbs) between different CCP donors. We conducted this study to evaluate the effectiveness and safety of nAb titer-defined CCP in adults admitted to an academic referral hospital. Patients positive by a SARS-CoV-2 nucleic acid amplification test and with symptoms for <10 days were eligible. Participants received either CCP with nAb titers of >1:640 (high-titer group) or >=1:160 to 1:640 (standard-titer group) in addition to standard of care treatments. The primary clinical outcome was time to hospital discharge, with mortality and respiratory support evaluated as secondary outcomes. Adverse events were contrasted by CCP titer. Between 28 August and 4 December 2020, 316 participants were screened, and 55 received CCP, with 14 and 41 receiving high- versus standard-titer CCP, respectively. Time to hospital discharge was shorter among participants receiving high- versus standard-titer CCP, accounting for death as a competing event (hazard ratio, 1.94;95% confidence interval [CI], 1.05 to 3.58;Gray's P = 0.02). Severe adverse events (SAEs) (>=grade 3) occurred in 4 (29%) and 23 (56%) of participants receiving the high versus standard titer, respectively, by day 28 (risk ratio, 0.51;95% CI, 0.21 to 1.22;Fisher's P = 0.12). There were no observed treatment-related AEs. (This study has been registered at under registration no. NCT04524507). IMPORTANCE In this study, in a high-risk population of patients admitted for COVID-19, we found an earlier time to hospital discharge among participants receiving CCP with nAb titers of >1:640 compared with participants receiving CCP with a lower nAb titer and no CCP-related AEs. The significance of our research is in identifying a dose response of CCP and clinical outcomes based on nAb titer. Although limited by a small study size, these findings support further study of high-nAb-titer CCP defined as >1:640 in the treatment of COVID-19.

PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-333686


The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) has now caused over 2 million deaths worldwide and continues to expand. Currently, much is unknown about functionally neutralizing human antibody responses and durability to SARS-CoV-2. Using convalescent sera collected from 101 COVID-19 recovered individuals 21-212 days after symptom onset with forty-eight additional longitudinal samples, we measured functionality and durability of serum antibodies. We also evaluated associations between individual demographic and clinical parameters with functional neutralizing antibody responses to COVID-19. We found robust antibody durability out to six months, as well as significant positive associations with the magnitude of the neutralizing antibody response and male sex. We also show that SARS-CoV-2 convalescent neutralizing antibodies are higher in individuals with cardio-metabolic comorbidities. SIGNIFICANCE: In this study we found that neutralizing antibody responses in COVID-19 convalescent individuals vary in magnitude but are durable and correlate well with RBD Ig binding antibody levels compared to other SARS-CoV-2 antigen responses. In our cohort, higher neutralizing antibody titers are independently and significantly associated with male sex compared to female sex. We also show for the first time, that higher convalescent antibody titers in male donors are associated with increased age and symptom grade. Furthermore, cardio-metabolic co-morbidities are associated with higher antibody titers independently of sex. Here, we present an in-depth evaluation of serologic, demographic, and clinical correlates of functional antibody responses and durability to SARS-CoV-2.

Internet J. Allied Health Sci. Pract. ; 19(4):17, 2021.
Article in English | Web of Science | ID: covidwho-1473022


Purpose: The purpose of this study was to explore the role of intercollegiate head athletic trainers in the process of planning to resume sport, as well as their experiences across the course of the pandemic to identify key strategies, challenges, and future considerations during the Covid-19 pandemic. Method: This exploratory, descriptive qualitative study was conducted via one-on-one semi structured interviews through the Zoom video conference technology. Twenty-four head athletic trainers across NCAA Division I, II, and III institutions participated in the study. Results: Emerging themes included the development of detailed, institution-specific plans with shared elements such as policies for testing and screening, modifications to facilities and cleaning, and incorporation of coach and athlete education. Athletic trainers discussed the processes they used to create their return-to-sport policies, which included professional development and interprofessional collaborations. While participants were confident in their plans, they acknowledged the need to overcome logistical and psychosocial challenges, such as the recognition that the success of their plans relied on numerous variables that could not be completely controlled. Conclusion: It is clear that NCAA ATs have played - and will continue to play - an integral role in overcoming challenges to promote a safe return-to-sports amidst the COVID-19 pandemic via education, policy making, and delivery of healthcare services. The challenges imposed by the accompanying set of circumstances have strained these ATs' practical tendencies and procedures. ATs have met these challenges through collaboration, information-seeking, and acceptance of the situation. NCAA ATs have embraced the opportunity to lead the way towards safe, successful campus reopening and resumption of competition.