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The ongoing evolution of SARS-Co-V2 variants to omicron severely limits available effective monoclonal antibody therapies. Effective drugs are also supply limited. Covid-19 convalescent plasma (CCP) qualified for high antibody levels effectively reduces immunocompetent outpatient hospitalization. The FDA currently allows outpatient CCP for the immunosuppressed. Viral specific antibody levels in CCP can range ten-to hundred-fold between donors unlike the uniform viral specific monoclonal antibody dosing. Limited data are available on the efficacy of polyclonal CCP to neutralize variants. We examined 108 pre-delta/pre-omicron donor units obtained before March 2021, 20 post-delta COVID-19/post-vaccination units and one pre-delta/pre-omicron hyperimmunoglobulin preparation for variant specific virus (vaccine-related isolate (WA-1), delta and omicron) neutralization correlated to Euroimmun S1 IgG antibody levels. We observed a 2-to 4-fold and 20-to 40-fold drop in virus neutralization from SARS-CoV-2 WA-1 to delta or omicron, respectively. CCP antibody levels in the upper 10% of the 108 donations as well as 100% of the post-delta COVID-19/post-vaccination units and the hyperimmunoglobulin effectively neutralized all three variants. High-titer CCP neutralizes SARS-CoV-2 variants despite no previous donor exposure to the variants. Key pointsAll of the post-delta COVID-19/post vaccination convalescent plasma effectively neutralizes the omicron and delta variants. High-titer CCP and hyperimmunoglobulin neutralizes SARS-CoV-2 variants despite no previous donor exposure to the variants.
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BACKGROUNDThe efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. We hypothesized that CCP might prevent infection when administered before symptoms or laboratory evidence of infection. METHODSThis double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer ([≥]1:320) CCP with standard plasma. Asymptomatic participants aged [≥]18 years with close contact exposure to a person with confirmed COVID-19 in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was development of SARS-CoV-2 infection. RESULTS180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for SARS-CoV-2 RT-PCR positivity at screening. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. There were 28 adverse events in CCP and 58 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs. 25.2 days; p=0.49) and COVID-19 (26.3 vs. 25.9 days; p=0.35) were similar for both groups. CONCLUSIONIn this trial, which enrolled persons with recent exposure to a person with confirmed COVID-19, high titer CCP as post-exposure prophylaxis appeared safe, but did not prevent SARS-CoV-2 infection. Trial RegistrationClinicaltrial.gov number NCT04323800.
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Purpose@#The aim of this study was to assess the performance of a mobile acoustic Uroflowmetry (UFM) application compared with standard UFM in the pediatric population. @*Methods@#A mobile acoustic UFM application represents a noninvasive method to estimate the urine flow rate by recording voiding sounds with a smartphone. Male pediatric patients who were undergoing UFM testing were prospectively recruited, and the voiding sounds were recorded and analyzed. The intraclass correlation coefficient (ICC) was used to compare the maximum flow rate (Qmax), average flow rate (Qavg), voiding time (VT), and voiding volume (VV) as estimated by acoustic UFM with those calculated by standard UFM. Differences in Qmax, Qavg, VT, and VV between the 2 UFM tests were determined using 95% Bland-Altman limits of agreement. @*Results@#A total of 16 male patients were evaluated. Their median age was 9 years. With standard UFM, the median Qmax, Qavg, VT, and VV were 18.7 mL/sec, 11.1 mL/sec, 15.2 seconds, and 157.8 mL, respectively. Strong correlations were observed between the 2 methods for Qmax (ICC=0.755, P=0.005), VT (ICC=0.974, P<0.001), and VV (ICC=0.930, P<0.001), but not for Qavg (ICC=0.442, P=0.135). The Bland-Altman plot showed good agreement between the 2 UFM tests. Flow patterns recorded by acoustic UFM and conventional UFM showed good visual correlations. @*Conclusions@#Acoustic UFM was comparable to standard UFM for male pediatric patients. Further validation of its performance in different toilet settings is necessary for broader use.
