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1.
Journal of Biomedical Informatics ; : 104079, 2022.
Article in English | ScienceDirect | ID: covidwho-1804425

ABSTRACT

Objective The Coronavirus Disease 2019 (COVID-19) pandemic has overwhelmed the capacity of healthcare resources and posed a challenge for worldwide hospitals. The ability to distinguish potentially deteriorating patients from the rest helps facilitate reasonable allocation of medical resources, such as ventilators, hospital beds, and human resources. The real-time accurate prediction of a patient's risk scores could also help physicians to provide earlier respiratory support for the patient and reduce the risk of mortality. Methods We propose a robust real-time prediction model for the in-hospital COVID-19 patients' probability of requiring mechanical ventilation (MV). The end-to-end neural network model incorporates the Multi-task Gaussian Process to handle the irregular sampling rate in observational data together with a self-attention neural network for the prediction task. Results We evaluate our model on a large database with 9,532 nationwide in-hospital patients with COVID-19. The model demonstrates significant robustness and consistency improvements compared to conventional machine learning models. The proposed prediction model also shows performance improvements in terms of area under the receiver operating characteristic curve (AUC) and area under the precision-recall curve (AUPRC) compared to various deep learning models, especially at early times after a patient's hospital admission. Conclusion The availability of large and real-time clinical data calls for new methods to make the best use of them for real-time patient risk prediction. It is not ideal for simplifying the data for traditional methods or for making unrealistic assumptions that deviate from observation's true dynamics. We demonstrate a pilot effort to harmonize cross-sectional and longitudinal information for mechanical ventilation needing prediction.

2.
Blood Advances ; 2022.
Article in English | ScienceDirect | ID: covidwho-1799125

ABSTRACT

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.

3.
J Nurs Educ ; 61(4): 205-207, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1780109

ABSTRACT

BACKGROUND: The use of an innovative approach for mental health interviews met unprecedented needs during the coronavirus disease 2019 pandemic for patients and staff at a community health clinic and provided nursing students with a telehealth activity that met patient care education requirements while practicing essential skills. METHOD: The nursing students and instructors worked collaboratively with the clinical team to call patients using an algorithm that incorporates screeners for depression, anxiety, and chronic disease distress. RESULTS: Reports during daily debriefings and feedback obtained from evaluations were summarized by faculty and used to improve the activity. These reports indicated the experience was beneficial to students and clinic staff. CONCLUSION: Providers were able to follow up on vulnerable patients more quickly, students were able to practice essential nursing skills during a time when safety concerns limited direct patient interaction, and patients continued to feel connected to health care providers during a global pandemic. [J Nurs Educ. 2022;61(4):205-207.].


Subject(s)
COVID-19 , Education, Nursing, Baccalaureate , Students, Nursing , Telemedicine , COVID-19/epidemiology , Humans , Mental Health
4.
N Engl J Med ; 2022 Mar 30.
Article in English | MEDLINE | ID: covidwho-1768967

ABSTRACT

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.).

5.
Transfusion ; 2022 Mar 29.
Article in English | MEDLINE | ID: covidwho-1765061

ABSTRACT

Convalescent plasma, collected from donors who have recovered from a pathogen of interest, has been used to treat infectious diseases, particularly in times of outbreak, when alternative therapies were unavailable. The COVID-19 pandemic revived interest in the use of convalescent plasma. Large observational studies and clinical trials that were executed during the pandemic provided insight into how to use convalescent plasma, whereby high levels of antibodies against the pathogen of interest and administration early within the time course of the disease are critical for optimal therapeutic effect. Several studies have shown outpatient administration of COVID-19 convalescent plasma (CCP) to be both safe and effective, preventing clinical progression in patients when administered within the first week of COVID-19. The United States Food and Drug Administration expanded its emergency use authorization (EUA) to allow for the administration of CCP in an outpatient setting in December 2021, at least for immunocompromised patients or those on immunosuppressive therapy. Outpatient transfusion of CCP and infusion of monoclonal antibody therapies for a highly transmissible infectious disease introduces nuanced challenges related to infection prevention. Drawing on our experiences with the clinical and research use of CCP, we describe the logistical considerations and workflow spanning procurement of qualified products, infrastructure, staffing, transfusion, and associated management of adverse events. The purpose of this description is to facilitate the efforts of others intent on establishing outpatient transfusion programs for CCP and other antibody-based therapies.

6.
Healthline, Journal of Indian Association of Preventive and Social Medicine ; 12(2):54-57, 2021.
Article in English | GIM | ID: covidwho-1727552

ABSTRACT

Introduction: The World Health Organization declared the 2019-20 coronavirus outbreak a Public Health Emergency of International Concern (PHEIC) on 30 January 2020 and a pandemic on 11 March 2020. A poor understanding of the disease among healthcare workers may implicate in delayed treatment and the rapid spread of infection.

7.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-325077

ABSTRACT

We propose a robust in-time predictor for in-hospital COVID-19 patient's probability of requiring mechanical ventilation. A challenge in the risk prediction for COVID-19 patients lies in the great variability and irregular sampling of patient's vitals and labs observed in the clinical setting. Existing methods have strong limitations in handling time-dependent features' complex dynamics, either oversimplifying temporal data with summary statistics that lose information or over-engineering features that lead to less robust outcomes. We propose a novel in-time risk trajectory predictive model to handle the irregular sampling rate in the data, which follows the dynamics of risk of performing mechanical ventilation for individual patients. The model incorporates the Multi-task Gaussian Process using observed values to learn the posterior joint multi-variant conditional probability and infer the missing values on a unified time grid. The temporal imputed data is fed into a multi-objective self-attention network for the prediction task. A novel positional encoding layer is proposed and added to the network for producing in-time predictions. The positional layer outputs a risk score at each user-defined time point during the entire hospital stay of an inpatient. We frame the prediction task into a multi-objective learning framework, and the risk scores at all time points are optimized altogether, which adds robustness and consistency to the risk score trajectory prediction. Our experimental evaluation on a large database with nationwide in-hospital patients with COVID-19 also demonstrates that it improved the state-of-the-art performance in terms of AUC (Area Under the receiver operating characteristic Curve) and AUPRC (Area Under the Precision-Recall Curve) performance metrics, especially at early times after hospital admission.

8.
JCI Insight ; 7(5)2022 03 08.
Article in English | MEDLINE | ID: covidwho-1662370

ABSTRACT

Benchmarks for protective immunity from infection or severe disease after SARS-CoV-2 vaccination are still being defined. Here, we characterized virus neutralizing and ELISA antibody levels, cellular immune responses, and viral variants in 4 separate groups: healthy controls (HCs) weeks (early) or months (late) following vaccination in comparison with symptomatic patients with SARS-CoV-2 after partial or full mRNA vaccination. During the period of the study, most symptomatic breakthrough infections were caused by the SARS-CoV-2 Alpha variant. Neutralizing antibody levels in the HCs were sustained over time against the vaccine parent virus but decreased against the Alpha variant, whereas IgG titers and T cell responses against the parent virus and Alpha variant declined over time. Both partially and fully vaccinated patients with symptomatic infections had lower virus neutralizing antibody levels against the parent virus than the HCs, similar IgG antibody titers, and similar virus-specific T cell responses measured by IFN-γ. Compared with HCs, neutralization activity against the Alpha variant was lower in the partially vaccinated infected patients and tended to be lower in the fully vaccinated infected patients. In this cohort of breakthrough infections, parent virus neutralization was the superior predictor of breakthrough infections with the Alpha variant of SARS-CoV-2.


Subject(s)
Adaptive Immunity , Antibodies, Viral/immunology , COVID-19 Vaccines/pharmacology , COVID-19/virology , SARS-CoV-2/immunology , Vaccination/methods , Vaccines, Synthetic/pharmacology , /pharmacology , Adult , Aged , COVID-19/epidemiology , COVID-19/prevention & control , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pandemics , Population Surveillance , Retrospective Studies , United States/epidemiology , Young Adult
9.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-296989

ABSTRACT

BACKGROUND: The 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. METHODS: This 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. 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 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. CONCLUSION: In 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 Registration: Clinicaltrial.gov number NCT04323800 .

10.
JAMA Intern Med ; 182(2): 115-126, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1567885

ABSTRACT

Importance: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants: CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions: A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures: The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results: Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). Conclusions and Relevance: In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. Trial Registration: ClinicalTrials.gov Identifier: NCT04364737.


Subject(s)
Blood Component Transfusion , COVID-19/therapy , Critical Illness/therapy , Adult , Aged , Double-Blind Method , Female , Hospitalization/statistics & numerical data , Humans , Immunization, Passive , Male , Middle Aged , Respiration, Artificial/statistics & numerical data , Treatment Outcome , United States
11.
Transfusion ; 61(4): 1047-1052, 2021 04.
Article in English | MEDLINE | ID: covidwho-999171

ABSTRACT

BACKGROUND: Convalescent plasma is used as a treatment for COVID-19. Only limited data describe the efforts to recruit COVID-19 convalescent plasma (CCP) donors. We describe our experience engaging persons recovered from COVID-19 to donate CCP. STUDY DESIGN AND METHODS: We performed a retrospective analysis of the CCP recruitment for an 11-hospital health system in Houston, Texas. We sought CCP donations from: a) "volunteers" responding to advertisements in social media, press releases, and websites and b) "referred" individuals directed to the program or identified from hospitalization records. We determined the proportions of donor candidates who passed initial telephone health screening, who qualified after diagnostic testing, who presented to the regional CCP donation center, and who completed CCP donation. RESULTS: There were 900 CCP donor candidates, including 363 volunteers and 537 referred donors. Of 360 contacted volunteers, 186 (5.7%) were excluded by interview; 133 were referred for additional diagnostic screening, 97 completed donor antibody and antigen testing, and 87 were qualified for CCP donation, resulting in 35 CCP donations (9.7% of initial telephone contacts). Among 533 referred donors, 448 (84.1%) were excluded by interview, 71 were referred for additional screening, 48 completed donor antibody and antigen testing, and 40 were qualified for CCP donation, resulting in one CCP donation (0.2% of initial telephone contacts). CONCLUSION: In this community, screening of a high number of candidates yielded a limited number of CCP donations. These observations have important implications for CCP donor recruitment and community pandemic planning.


Subject(s)
Blood Donors , COVID-19/immunology , COVID-19/therapy , Convalescence , Donor Selection , Pandemics , SARS-CoV-2/immunology , Adult , Humans , Immunization, Passive , Male , Middle Aged , Retrospective Studies
12.
Am J Infect Control ; 49(4): 508-511, 2021 04.
Article in English | MEDLINE | ID: covidwho-880384

ABSTRACT

The SARS-CoV2 pandemic has created extreme shortages of N95 mask necessitating the need for rapid development of reuse and reprocessing plans. Our aim was to create a process to recapture, reprocess, and redistribute N95 masks using hydrogen peroxide vapor as a real time disinfection method within a large hospital system. We were able to recapture and reprocess 29, 706 N95 masks using hydrogen peroxide vapor with approximately 25% loss due to damage.


Subject(s)
COVID-19/prevention & control , Equipment Reuse , Gases , Hydrogen Peroxide/pharmacology , N95 Respirators/standards , SARS-CoV-2 , Disinfectants/pharmacology , Disinfection/methods , Hospitals , Humans
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