Background: Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) collection began in two Brazilian hospitals for treatment of severe/ critical patients. Methods and Materials: Mild/moderate COVID-19 convalescents were selected as CCP donors after reverse transcription polymerase chain reaction (RT-PCR) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and absence of symptoms for ≥14 days plus (a) age (18-60 years), body weight greater than 55 kg; (b) immunohematological studies; (c) no infectious markers of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T-lymphotropic virus-1/2, Chagas and syphilis infection; (d) no HLA antibodies (multiparous); (e) second RT-PCR (nasopharyngeal swab and/or blood) negativity; (f) virus neutralization test (cytopathic effect-based virus neutralization test neutralizing antibody) and anti-nucleocapsid protein SARS-CoV-2 IgM, IgG, and IgA enzyme-linked immunosorbent assays. Results: Among 271 donors (41 females, 230 males), 250 presented with neutralizing antibodies. Final RT-PCR was negative on swab (77.0%) or blood (88.4%; P = .46). Final definition of RT-PCR was only defined at more than 28 days after full recovery in 59 of 174 (33.9%) RT-PCR-ve, and 25/69 RT-PCR +ve (36.2%;
Background Current evidence regarding COVID‐19 convalescent plasma (CCP) transfusion practices is limited and heterogeneous. We aimed to determine the impact of the use of CCP transfusion in patients with previous circulating neutralizing antibodies (nAbs) in COVID‐19. Methods Prospective cohort including 102 patients with COVID‐19 transfused with ABO compatible CCP on days 0–2 after enrollment. Clinical status of patients was assessed using the adapted World Health Organization (WHO) ordinal scale on days 0, 5, and 14. The nAbs titration was performed using the cytopathic effect‐based virus neutralization test with SARS‐CoV‐2 (GenBank MT126808.1). The primary outcome was clinical improvement on day 14, defined as a reduction of at least two points on the adapted WHO ordinal scale. Secondary outcomes were the number of intensive care unit (ICU)‐free days and the number of invasive mechanical ventilation‐free days. Results Both nAbs of CCP units transfused (p < 0.001) and nAbs of patients before CCP transfusions (p = 0.028) were associated with clinical improvements by day 14. No significant associations between nAbs of patients or CCP units transfused were observed in the number of ICU or mechanical ventilation‐free days. Administration of CCP units after 10 days of symptom onset resulted in a decrease in ICU‐free days (p < 0.001) and mechanical ventilation‐free days (p < 0.001). Conclusion Transfusion of high titer nAbs CCP units may be a determinant in clinical strategies against COVID‐19. We consider these data as useful parameters to guide future CCP transfusion practices.
INTRODUCTIONCOVID-19 convalescent plasma (CCP) transfusion has emerged in the past months as an alternative approach to treat pneumonia cases of SARS-CoV-2. Current evidence regarding characteristics of the plasma product, the titer of neutralizing antibodies (nAbs) in the transfused units, time to onset of intervention, and impact of nAbs produced by the patient are limited and heterogeneous.MATERIAL AND METHODSWe describe the preliminary results of 104 patients with severe pneumonia due to SARS-CoV-2 transfused with CCP at three medical centers in Brazil. All enrolled patients were transfused with doses between 200 mL through 600mL of ABO compatible CCP on days 0-2 after enrolment. Clinical parameters were monitored and nAbs titration was performed using the cytopathic effect-based virus neutralization test with SARS-CoV-2 (GenBank MT126808.1).RESULTSForty-one patients achieved clinical improvement on day 14, and multivariable logistic regression showed that nAbs T (from CCP units transfused) (p= 0.001), nAbs P0 (on day of enrolment) (p=0.009) and use of other supportive therapies (p<0.001) were associated with higher odds for this clinical improvement. Considering ICU length of stay (LOS) and length of mechanical ventilation, in our analysis, nAbs P0 were associated with a significant reduction in ICU LOS (p=0.018) and duration of mechanical ventilation (p<0.001). Administration of CCP after 10 days of symptom onset was associated with increases in ICU length of stay (p<0.001).DISCUSSION/CONCLUSIONDespite the study limitations, our data have shown an association between patients’ previously acquired nAbs and clinical outcomes. The potential value of timely administration of CCP transfusion before day 10 of disease onset was demonstrated and nAbsP0, but not nAbsT, were associated with ICU LOS, and duration of mechanical ventilation on the improvement of clinical outcomes was also demonstrated. In conclusion, we consider these data are useful parameters to guide future CPP transfusion strategies to COVID-19.
Background: Hospital-acquired pneumonia (HAP) is one of the most common healthcare-associated infections (HAIs). Interventions based on the identification of patients at risk for aspiration with subsequent application of multidisciplinary measures, such as speech therapy follow-up, head elevation, oral hygiene, and patient and family education can be effective in reducing the incidence of HAP. In 2016, the step-down unit of our institution experienced an increase in the incidence of HAP with 21 cases. A root-cause analysis showed that most of them were related to comorbidities that increased aspiration risk. We conducted an study to decrease the incidence of HAP through a multidisciplinary bundled intervention. Methods: We conducted a quasi-experimental study in a 45-bed step-down unit from January 2016 to June 2019. In January 2017, we conducted an educational intervention with all the unit team, reinforcing practices of bed head elevation and oral hygiene. In June 2018, we observed inconsistencies in practice and conducted a second intervention with another round of educational training and a bundled intervention consisting of the following elements: identification of patients at risk for aspiration at admission by a speech therapy evaluation, bed-head elevation, oral hygiene, feeding guidance individualized to each patient by a nutritionist and a speech therapist, patient and family education with a printed material, signaling of aspiration risk in a care plan board within the room and development of a sialorrhea treatment protocol. HAP surveillance was conducted in accordance to CDC definitions and was reported as number of HAP cases per 1,000 patient days. Results: Our first intervention decreased the incidence of HAP in the first semester of 2017 from 1.03 to 0.29 (graph) but was not sustained. The incidence started to increase in the second semester of 2017 and reached a high incidence of 1.87 HAP per 1,000 patient days in the first semester of 2018. The second bundled intervention succeeded in decreasing HAP incidence to 0.57 in the second semester of 2018 and 0.23 in the first semester of 2019. Conclusions: An educational intervention combined with a bundled intervention focused on strategies to reduce the risk of aspiration succeeded in decreasing the incidence of HAP in a step-down unit. However, the sustainability of improvements remains challenging.Funding: NoneDisclosures: None
Background: The use of real-time polymerase chain reaction (RT-PCR) as a first-line test for the diagnosis of Clostridioides difficile may result in overdiagnosis and overtreatment because the test is not capable of distinguishing infection from carriage. Toxin EIA assays have impeditive low sensitivity. Some algorithms using enzyme immunoassay for glutamate dehydrogenase (GDH) antigen and toxins A and B as the first step have been proposed to increase diagnostic performance. However, cost-effectiveness of different diagnostic algorithms would depend on the cost of each test and on the pretest probability in different settings. The objective of the present study was to evaluate the cost-effectiveness of 2 algorithms proposed by current guidelines to diagnose C. difficile infection by developing a mathematical model that would take into account the epidemiology and costs in our hospital. Methods: The study was conducted in a 480-bed tertiary-care teaching hospital in So Paulo, Brazil. All suspected C. difficile infection cases from January to December of 2017 were evaluated for pretest probability analysis. All stools collected from patients with a requested PCR test for suspected C. difficile infection were selected for additional testing to measure the specificity and sensitivity of each different test: C. diff GDH/Toxin A/B combined test, Toxin A/B Microplate Assay, GDH, and PCR. Toxigenic stool culture for C. difficile was considered the gold standard. A mathematical model was developed and simulations were done. The outcomes evaluated were: final annual costs with diagnostic tests in US dollars and number of patients receiving a false-positive or a false-negative diagnosis in a year simulation. Results: In total, 1,441 stool samples were tested by PCR for C. difficile in our institution from January 2017 to December 2017. Overall, 206 had a positive result, with a pretest probability of 14.3%. In our simulations, the PCR-based algorithm had an annual cost of US$279,914.25, with 4 false-negative results and 8 false-positive results. The implementation of a GDH/Toxin/PCR stepwise algorithm would have reduced the annual cost to US$160,488.75, with 6 false-negative results and 1 false-positive result. Simulations of annual cost and performance of the 2 algorithms have shown that the stepwise algorithm would still be advantageous in settings with higher pretest probabilities (Fig. 1). Conclusions: A stepwise algorithm based on GDH/Toxin before PCR seems to be more cost-effective, even in settings with higher pretest probabilities.Funding: NoneDisclosures: None
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