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Background: Nearly 30,000 patients with coronavirus disease-2019 have been hospitalized in New York City as of April 14 th , 2020. Data on the epidemiology, clinical course, and outcomes of critically ill patients with COVID-19 in this setting are needed. Methods:We prospectively collected clinical, biomarker, and treatment data on critically ill adults with laboratory-confirmed-COVID-19 admitted to two hospitals in northern Manhattan between March 2 nd and April 1 st , 2020. The primary outcome was in-hospital mortality.Secondary outcomes included frequency and duration of invasive mechanical ventilation, frequency of vasopressor use and renal-replacement-therapy, and time to clinical deterioration following hospital admission. The relationship between clinical risk factors, biomarkers, and inhospital mortality was modeled using Cox-proportional-hazards regression. Each patient had at least 14 days of observation. Results:Of 1,150 adults hospitalized with COVID-19 during the study period, 257 (22%) were critically ill. The median age was 62 years (interquartile range [IQR] 51-72); 170 (66%) were male. Two-hundred twelve (82%) had at least one chronic illness, the most common of which were hypertension (63%; 162/257) and diabetes mellitus (36%; 92/257). One-hundred-thirtyeight patients (54%) were obese, and 13 (5%) were healthcare workers. As of April 14 th , 2020, in-hospital mortality was 33% (86/257); 47% (122/257) of patients remained hospitalized. Twohundred-one (79%) patients received invasive mechanical ventilation (median 13 days [IQR 9-17]), and 54% (138/257) and 29% (75/257) required vasopressors and renal-replacementtherapy, respectively. The median time to clinical deterioration following hospital admission was 3 days (IQR 1-6). Older age, hypertension, chronic lung disease, and higher concentrations of interleukin-6 and d-dimer at admission were independently associated with in-hospital mortality. All rights reserved. No reuse allowed without permission.(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
Background: Although convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited. Objective: To evaluate the clinical efficacy and safety of convalescent plasma among adults hospitalized with severe and critical COVID-19. Design: Randomized, double-blind, controlled, multicenter, phase 2 trial conducted from April 21st to November 27th, 2020. Setting: Five hospitals in New York City (NY, USA) and Rio de Janeiro (Brazil). Participants: Hospitalized patients aged ≥18 years with laboratory-confirmed COVID-19, infiltrates on chest imaging and oxygen saturation ≤ 94% on room air or requirement for supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Intervention: Participants were randomized 2:1 to a single transfusion of either 1 unit of convalescent or normal control plasma. Measurements: The primary outcome was clinical status at 28 days, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population (with an odds ratio (OR) >1.0 indicating improved clinical status in the convalescent plasma group). Results: Of 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to normal control plasma. At 28 days, no significant improvement in clinical status was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval (CI) 0.83-2.68, p=0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, p=0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected. Serious adverse events occurred in 39/147 (27%) participants who received convalescent plasma and 26/72 (36%) participants who received control plasma. Limitations: Some participants did not receive high-titer convalescent plasma. Conclusion: In adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in 28 days clinical status. However, a significant improvement in mortality was observed, which warrants further evaluation. Registration: ClinicalTrials.gov, NCT04359810 Funding: Amazon Foundation
What does this study add to the field?Using latent class analysis (LCA), we identified two subgroups among a cohort of 483 patients with COVID-19-related ARDS. Class 2 patients had higher inflammatory markers and lactate and corresponded with the previously identified hyperinflammatory subphenotype, whereas Class 1 corresponded with the hypoinflammatory subphenotype. Class 2 had significantly higher 90-day mortality compared with Class 1 (75% vs 48%; p<0•0001). Differential response to corticosteroid treatment was observed, with decreased mortality in steroid-treated patients in Class 2 but not Class 1. SARS-CoV-2 polymerase chain reaction cycle threshold was a predictor of mortality in Class 1, but not Class 2, suggesting distinct drivers of mortality among classes.
Background: Although convalescent plasma has been widely used to treat severe coronavirus disease 2019 , data from randomized controlled trials that support its efficacy are limited. Methods:We conducted a randomized, double-blind, placebo-controlled trial among adults hospitalized with severe and critical COVID-19 at five sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or placebo (normal control plasma). The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.Results: Of 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval (CI) 0.83-2.68, p=0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, p=0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected. Conclusion:In adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.
The coronavirus disease 2019 (COVID-19) can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections, but their benefit has not been assessed in COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1st through May 12th, 2020 with study period ending on June 11th, 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline sociodemographic and clinical characteristics, and outpatient medications. The primary endpoint includes in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, statin use is significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.47, 95% CI 0.36–0.62, p < 0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 is associated with lower inpatient mortality.
The coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections and ARDS, but their benefit has not been assessed in COVID-19. Thus, we sought to determine whether antecedent statin use is associated with lower in-hospital mortality in patients hospitalized for COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1st through May 12th, 2020 with study period ending on June 11th, 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline socio-demographic and clinical characteristics, and outpatient medications. The primary endpoint included in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, demographic, baseline, and outpatient medication information were well balanced. Statin use was significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.48, 95% CI 0.36 – 0.64, p<0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 was associated with lower inpatient mortality. Randomized clinical trials evaluating the utility of statin therapy in patients with COVID-19 are needed.
In sub-Saharan Africa, many nomadic pastoralists have begun to settle in permanent communities as a result of long-term water, food, and civil insecurity. Little is known about the epidemiology of cholera in these emerging semi-nomadic populations. We report the results of a case-control study conducted during a cholera outbreak among semi-nomadic pastoralists in the Karamoja sub-region of northeastern Uganda in 2010. Data from 99 cases and 99 controls were analysed. In multivariate analyses, risk factors identified were: residing in the same household as another cholera case [adjusted odds ratio (aOR) 6·67, 95% confidence interval (CI) 2·83-15·70], eating roadside food (aOR 2·91, 95% CI 1·24-6·81), not disposing of children's faeces in a latrine (aOR 15·76, 95% CI 1·54-161·25), not treating drinking water with chlorine (aOR 3·86, 95% CI 1·63-9·14), female gender (aOR 2·43, 95% CI 1·09-5·43), and childhood age (10-17 years) (aOR 7·14, 95% CI 1·97-25·83). This is the first epidemiological study of cholera reported from a setting of semi-nomadic pastoralism in sub-Saharan Africa. Public health interventions among semi-nomadic pastoralists should include a two-faceted approach to cholera prevention: intensive health education programmes to address behaviours inherited from insecure nomadic lifestyles, as well as improvements in water and sanitation infrastructure. The utilization of community-based village health teams provides an important method of implementing such activities.
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