Transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection: a double-blinded, phase 2 randomized, controlled trial.

BACKGROUND: The efficacy of SARS-CoV-2 convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection. METHODS: This double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) 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 new SARS-CoV-2 infection. RESULTS: 180 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 screening SARS-CoV-2 RT-PCR positivity. 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. 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) was similar for both groups. CONCLUSIONS: Administration of high-titer CCP as post-exposure prophylaxis, while appearing safe, did not prevent SARS-CoV-2 infection.

Early Outpatient Treatment for Covid-19 with Convalescent Plasma.

BACKGROUND: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain. METHODS: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion. RESULTS: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized. CONCLUSIONS: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).

Emergency department utilization for mental health conditions before and after the COVID-19 outbreak.

INTRODUCTION: The outbreak of COVID-19 disrupted lives across the United States. Evidence shows that such a climate is deleterious to mental health and may increase demand for mental health services in emergency departments. The purpose of this study was to determine the difference in emergency department utilization for mental health diagnoses before and after the COVID-19 surge. METHODS: We conducted a cross-sectional study between January-August 2019 and January-August 2020 with emergency department encounter as the sampling unit. The primary outcome was the proportion of all emergency department encounters attributed to mental health. We performed chi-square analyses to evaluate the differences between 2019 and 2020. RESULTS: We found that overall emergency department volume declined between 2019 and 2020, while the proportion attributable to mental health conditions increased (p < 0.01). Substance abuse, anxiety, and mood disorders accounted for nearly 90% of mental health diagnoses during both periods. When stratified by sex, substance abuse was the leading mental health diagnosis for males and anxiety and substance abuse disorders combined accounted for the largest proportion for females. DISCUSSION: The emergency department is an important community resource for the identification and triage of mental health emergencies. This role is even more important during disasters and extended crises, making it imperative that emergency departments employ experienced mental health staff. This study provides a comparison of emergency department utilization for mental health diagnoses before the pandemic and during the spring 2020 surge and may serve as a useful guide for hospitals, health systems and communities in future planning.

A matched cohort study of convalescent plasma therapy for COVID-19.

INTRODUCTION: COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a public health crisis. Prior studies demonstrated successful use of convalescent plasma therapy for treatment of other viral illnesses. Our primary objective was to evaluate treatment efficacy of convalescent plasma in patients with COVID-19. MATERIALS AND METHODS: In this retrospective matched cohort study, we enrolled recipients of convalescent plasma collected from donors recovered from laboratory-confirmed SARS-CoV-2 infection under the single patient eIND process. We individually matched 35 cases with 61 controls based on age, gender, supplemental oxygen requirements, and C-reactive protein level at the time of hospital admission. We compared the outcomes of in-hospital mortality and hospital length of stay between the groups. RESULTS: In-hospital mortality was 20% among the cases and 24.6% among the controls (P = .61). A multivariable logistic regression model that included age, gender, duration of symptoms, need for mechanical ventilation, and pharmacologic interventions revealed no significant difference in mortality by study group (P = .71). The median length of stay was significantly greater among convalescent plasma recipients compared with controls, 10 (IQR, 6-17) vs 7 (IQR, 4-11) days, P < .01. The difference was not significant after controlling for covariates (P > .1). CONCLUSIONS: We did not find convalescent plasma reduced in-hospital mortality in our sample, nor did it reduce length of stay. Further investigation is warranted to determine the efficacy of this treatment in patients with COVID-19, particularly early in the disease process.

Clinical Outcomes With the Use of Prophylactic Versus Therapeutic Anticoagulation in Coronavirus Disease 2019.

OBJECTIVES: To determine the impact of anticoagulation on inhospital mortality among coronavirus disease 2019-positive patients with the a priori hypothesis that there would be a lower risk of inhospital mortality with use of preemptive therapeutic over prophylactic dose enoxaparin or heparin. DESIGN SETTING: Retrospective cohort study from April 1, 2020, to April 25, 2020. The date of final follow-up was June 12, 2020 Two large, acute-care hospitals in Western Connecticut. PATIENTS: Five hundred and one inpatients were identified after discharge as 18 years or older and positive for severe acute respiratory syndrome coronavirus 2. The final sample size included 374 patients after applying exclusion criteria. Demographic variables were collected via hospital billing inquiries, whereas the clinical variables were abstracted from patients' medical records. EXPOSURE: Preemptive enoxaparin or heparin at a therapeutic or prophylactic dose. MAIN RESULTS: When comparing treatments through multivariable analysis, risk of inhospital mortality was 2.3 times greater in patients receiving preemptive therapeutic anticoagulation (95% CI = 1.0-4.9; p = 0.04). Additionally, the average treatment effects were higher (ß = 0.11, p = 0.01) in the therapeutic group. CONCLUSIONS: An increase in inhospital mortality was observed among patients on preemptive therapeutic anticoagulation. Thus, in the management of coronavirus disease 2019 and its complications, we recommend further research and cautious use of preemptive therapeutic over prophylactic anticoagulation.

Initial review of pregnancy and neonatal outcomes of pregnant women with COVID-19 infection.

OBJECTIVES: Data regarding the pathogenesis and clinical manifestations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge, however, there's limited data in regard to maternal and neonatal outcomes. Therefore, we conducted a retrospective analysis of all pregnant women who tested positive for SARS-CoV-2 within Nuvance Health system. METHODS: Data were abstracted from the medical records of each patient and descriptive analysis was performed. Variables included demographics, COVID testing results, symptoms, management, labor course, neonatal information, and complications. RESULTS: Total of 40 patients were identified. Average age was 29.6 years old, 35% were Hispanic, and approximately one in three patients had comorbidities. Of the patients who had repeated testing, the average number of days between first positive test and negative test was 36.8 days (± 19.9 days). Three out of four women reported symptoms. Of the 40 pregnant women who were positive for SARS-CoV-2, 25 of them delivered. About 84% of the women delivered after 37 weeks. Twelve percent of the women delivered under 33 and 6/7 weeks. Most patients had vaginal deliveries (68%) and the remaining had cesarean deliveries. Neonatal outcomes included: mean 1 and 5 min Apgar scores of 8 and 8.8, respectively and the mean birth weight was 3212 g. Twenty neonates were tested for SARS-CoV-2 and were all found to be negative. CONCLUSIONS: Overall, with routine prenatal care and preventive measures, pregnant patients and neonates in our study had good outcomes. At this time, there appears to be no evidence of vertical transmission.