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1.
Hypertension ; 79(9): 1971-1980, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2009244

ABSTRACT

BACKGROUND: The National Health and Nutrition Examination Survey data indicate that the proportion of US adults with hypertension that had controlled blood pressure (BP) declined from 2013 to 2014 through 2017 to 2018. We analyzed data from National Health and Nutrition Examination Survey 2009 to 2012, 2013 to 2016, and 2017 to 2020 to confirm this finding. METHODS: Hypertension was defined as systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg or antihypertensive medication use. BP control among those with hypertension was defined as systolic BP <140 mm Hg and diastolic BP <90 mm Hg. RESULTS: The age-adjusted prevalence of hypertension was 31.5% (95% CI, 30.3%-32.8%), 32.0% (95% CI, 30.6%-33.3%), and 32.9% (95% CI, 31.0%-34.7%) in 2009 to 2012, 2013 to 2016, and 2017 to 2020, respectively (P trend=0.218). The age-adjusted prevalence of hypertension increased among non-Hispanic Asian adults from 27.0% in 2011 to 2012 to 33.5% in 2017 to 2020 (P trend=0.003). Among Hispanic adults, the age-adjusted prevalence of hypertension increased from 29.4% in 2009 to 2012 to 33.2% in 2017 to 2020 (P trend=0.029). In 2009 to 2012, 2013 to 2016, and 2017 to 2020, 52.8% (95% CI, 50.0%-55.7%), 51.3% (95% CI, 47.9%-54.6%), and 48.2% (95% CI, 45.7%-50.8%) of US adults with hypertension had controlled BP (P trend=0.034). Among US adults taking antihypertensive medication, 69.9% (95% CI, 67.8%-72.0%), 69.3% (95% CI, 66.6%-71.9%), and 67.7% (95% CI, 65.2%-70.3%) had controlled BP in 2009 to 2012, 2013 to 2016, and 2017 to 2020, respectively (P trend=0.189). Among all US adults with hypertension and those taking antihypertensive medication, a decline in BP control between 2009 to 2012 and 2017 to 2020 occurred among those ≥75 years, women, and non-Hispanic black adults. CONCLUSIONS: These data confirm that the proportion of US adults with hypertension who have controlled BP has declined.


Subject(s)
Antihypertensive Agents , Hypertension , Adult , Antihypertensive Agents/pharmacology , Antihypertensive Agents/therapeutic use , Blood Pressure , Female , Humans , Hypertension/drug therapy , Hypertension/epidemiology , Nutrition Surveys , Prevalence
2.
Sleep ; 45(Suppl 1):A287-A287, 2022.
Article in English | EuropePMC | ID: covidwho-1999204

ABSTRACT

Introduction Prolonged exposure to stressful environments is associated with adverse psychological outcomes, including sleep disturbance and burnout. Burnout rates have increased substantially during the unprecedented challenges faced by healthcare workers (HCWs) during the COVID-19 pandemic. Since burnout has been associated with significant health risk and adverse organizational outcomes, it is important to identify factors that inform preventive or therapeutic approaches to mitigate adverse outcomes in HCWs. Methods Participants were HCWs (physicians, nurses, advanced practice providers, technicians etc.) from 4 emergency departments in New York City who completed a cross-sectional electronic survey (completed at study enrollment between November 2020-October 2021). The Pittsburgh Sleep Quality Index (PSQI) assessed global sleep quality. The Maslach Burnout Inventory (MBI) assessed 3 burnout dimensions: emotional exhaustion (EE;feelings of being emotionally overextended and exhausted by one's work);Feelings of depersonalization (DP;unfeeling and impersonal response towards patients);and reduced personal accomplishment (PA;feelings of competence and successful achievement in one's work). Descriptive statistics were calculated and separate binary logistic regressions were used to predict poor global sleep quality (PSQI >5) from individual MBI subscales (dimensions of burnout), while controlling for age, race, ethnicity, and gender. Results Ninety-one participants, studied to date, were included in the analysis (51% non-Hispanic/Latino White, 63% female, mean age: 40 [SD: 9.6] y). Poor global sleep quality was reported by 68%. High EE (score >9), DP (score >6) and reduced PA (score <9) were reported by 44%, 27%, and 18% of participants, respectively. Poor global sleep quality was significantly associated with presence of elevated EE (OR: 3.04, 95% CI: 1.07-8.63, p=0.037), but not with elevated DP (OR: 1.35, 95% CI: 0.44-4.10, p=0.603) or reduced PA (OR: 3.29, 95% CI: 0.65-16.44, p=0.146). Conclusion During the COVID-19 pandemic, poor sleep quality was reported by the majority of participants and associated with increased burnout in HCWs. Poor global sleep appears to have the most influence on the burnout dimension EE, thus suggesting new evidence about associations between sleep and emotional regulation in HCW during the pandemic. Future trials should test whether existing (or novel) interventions can improve sleep and thereby support HCWs in high stress periods. Support (If Any) R01HL146911

3.
J Patient Saf ; 2022 Aug 05.
Article in English | MEDLINE | ID: covidwho-1985192

ABSTRACT

OBJECTIVE: It is unknown how hospital- and systems-level factors have impacted patient safety in the intensive care unit (ICU) during the COVID-19 pandemic. We sought to understand how the pandemic has exacerbated preexisting patient safety issues and created novel patient safety challenges in ICUs in the United States. METHODS: We performed a national, multi-institutional, mixed-methods survey of critical care clinicians to elicit experiences related to patient safety during the pandemic. The survey was disseminated via email through the Society of Critical Care Medicine listserv. Data were reported as valid percentages, compared by COVID caseload and peak of the pandemic; free-text responses were analyzed and coded for themes. RESULTS: We received 335 survey responses. On general patient safety, 61% felt that conditions were more hazardous when compared with the prepandemic period. Those who took care of mostly COVID-19 patients were more likely to perceive that care was more hazardous (odds ratio, 4.89; 95% CI, 2.49-9.59) compared with those who took care of mostly non-COVID-19 or no COVID-19 patients. In free-text responses, providers identified patient safety risks related to pandemic adaptations, such as ventilator-related lung injury, medication and diagnostic errors, oversedation, oxygen device removal, and falls. CONCLUSIONS: Increased COVID-19 case burden was significantly associated with perceptions of a less safe patient care environment by frontline ICU clinicians. Results of the qualitative analysis identified specific patient safety hazards in ICUs across the United States as downstream consequences of hospital and provider strain during periods of the COVID-19 pandemic.

4.
J Gerontol A Biol Sci Med Sci ; 2022 Jun 11.
Article in English | MEDLINE | ID: covidwho-1890932

ABSTRACT

BACKGROUND: COVID-19 social distancing policies resulted in reductions in community movement, however fall rates during this time have not been described. METHODS: This prospective study included adults ≥65 years old participating in the Ambulatory Blood Pressure in Older Adults (AMBROSIA) cohort and who completed ≥1 monthly falls calendar (August 2019-March 2021; n=250). Months were grouped to correspond to the fall 2020 phased re-opening (August-October) and the shelter-in-place policy during the winter 2020 surge (November-January) in Los Angeles, California and compared to the same months, one year earlier (i.e., before the pandemic). RESULTS: Participants had a mean (SD) age of 75.2 (6.1) years, 49.6% were White, and 53.2% were women. We obtained 2,795 falls calendars during follow-up. Overall, 110 (44.0%) participants reported a total of 421 falls (rate 15.1 per 100 calendar months). The highest monthly fall rate during the pandemic was 22.9 (95% CI 16.4-31.1) per 100 calendar-months in August 2020. The lowest fall rate during the pandemic was 8.6 (95% CI 3.5-17.8) per 100 calendar-months in February 2021. During the pandemic, fall rates in August, September, and October 2020 were higher than the previous year (rate ratio 1.8 [95% CI 1.1-2.9]) and fall rates in November and December 2020 and January 2021 were lower than the previous year (rate ratio 0.5 [95% CI 0.4-0.8]). CONCLUSIONS: As the pandemic continues and older adults resume community mobility after a shelter-in-place period, providers should pay attention to the risk of falls.

5.
JMIR Form Res ; 6(3): e32403, 2022 Mar 23.
Article in English | MEDLINE | ID: covidwho-1770900

ABSTRACT

BACKGROUND: Telemedicine visit use vastly expanded during the COVID-19 pandemic, and this has had an uncertain impact on cardiovascular care quality. OBJECTIVE: We sought to examine the association between telemedicine visits and the failure to meet the Controlling High Blood Pressure (BP) quality measure from the Centers for Medicare & Medicaid Services. METHODS: This was a retrospective cohort study of 32,727 adult patients with hypertension who were seen in primary care and cardiology clinics at an urban, academic medical center from February to December 2020. The primary outcome was a failure to meet the Controlling High Blood Pressure quality measure, which was defined as having no BP recorded or having a last recorded BP of ≥140/90 mm Hg (ie, poor BP control). Multivariable logistic regression was used to assess the association between telemedicine visit use during the study period (none, 1 telemedicine visit, or ≥2 telemedicine visits) and poor BP control; we adjusted for demographic and clinical characteristics. RESULTS: During the study period, no BP was recorded for 2.3% (486/20,745) of patients with in-person visits only, 27.1% (1863/6878) of patients with 1 telemedicine visit, and 25% (1277/5104) of patients with ≥2 telemedicine visits. After adjustment, telemedicine use was associated with poor BP control (1 telemedicine visit: odds ratio [OR] 2.06, 95% CI 1.94-2.18; P<.001; ≥2 telemedicine visits: OR 2.49, 95% CI 2.31-2.68; P<.001; reference: in-person visits only). This effect disappeared when the analysis was restricted to patients with at least 1 recorded BP (1 telemedicine visit: OR 0.89, 95% CI 0.83-0.95; P=.001; ≥2 telemedicine visits: OR 0.91, 95% CI 0.83-0.99; P=.03). CONCLUSIONS: Increased telemedicine visit use is associated with poorer performance on the Controlling High Blood Pressure quality measure. However, telemedicine visit use may not negatively impact BP control when BP is recorded.

6.
J Affect Disord ; 298(Pt A): 618-624, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1536624

ABSTRACT

BACKGROUND: Healthcare workers (HCWs) treating patients with COVID-19 report psychological distress. We examined whether disturbed sleep was associated with psychological distress in New York City (NYC) HCWs during the initial peak of the COVID-19 pandemic (April-May 2020). METHODS: HCWs completed a survey screening for acute stress (4-item Primary Care PTSD screen), depressive (Patient Health Questionaire-2), and anxiety (2-item Generalized Anxiety Disorder scale) symptoms. Insomnia symptoms (modified item from the Insomnia Severity Index) and short sleep (SS, sleep duration <6 h/day) were assessed. Poisson regression analyses predicting psychological distress from SS and insomnia symptoms, adjusting for demographics, clinical role/setting, redeployment status, shifts worked, and multiple comparisons were performed. RESULTS: Among 813 HCWs (80.6% female, 59.0% white) mean sleep duration was 5.8 ± 1.2 h/night. Prevalence of SS, insomnia, acute stress, depressive, and anxiety symptoms were 38.8%, 72.8%, 57.9%, 33.8%, and 48.2%, respectively. Insomnia symptoms was associated with acute stress (adjusted prevalence ratio [PR]: 1.51, 95% CI: 1.35, 1.69), depressive (PR: 2.04, 95% CI: 1.78, 2.33), and anxiety (PR: 1.74, 95% CI: 1.55, 1.94) symptoms. SS was also associated with acute stress (PR: 1.17, 95% CI: 1.07, 1.29), depressive (PR: 1.36, 95% CI: 1.233, 1.51), and anxiety (PR: 1.38, 95% CI: 1.26, 1.50) symptoms. LIMITATIONS: Our cross-sectional analysis may preclude the identification of temporal associations and limit causal claims. CONCLUSIONS: In our study, SS and insomnia were associated with psychological distress symptoms in NYC HCWs during the COVID-19 pandemic. Sleep may be a target for interventions to decrease psychological distress among HCWs.


Subject(s)
COVID-19 , Psychological Distress , Anxiety , Cross-Sectional Studies , Depression , Female , Health Personnel , Humans , Male , Mental Health , New York City/epidemiology , Pandemics , SARS-CoV-2 , Sleep
7.
Journal of affective disorders ; 2021.
Article in English | EuropePMC | ID: covidwho-1479164

ABSTRACT

Background Healthcare workers (HCWs) treating patients with COVID-19 report psychological distress. We examined whether disturbed sleep was associated with psychological distress in New York City (NYC) HCWs during the initial peak of the COVID-19 pandemic (April-May 2020). Methods HCWs completed a survey screening for acute stress (4-item Primary Care PTSD screen), depressive (Patient Health Questionaire-2), and anxiety (2-item Generalized Anxiety Disorder scale) symptoms. Insomnia symptoms (modified item from the Insomnia Severity Index) and short sleep (SS, sleep duration <6 hours/day) were assessed. Poisson regression analyses predicting psychological distress from SS and insomnia symptoms, adjusting for demographics, clinical role/setting, redeployment status, shifts worked, and multiple comparisons were performed. Results Among 813 HCWs (80.6% female, 59.0% white) mean sleep duration was 5.8±1.2 hours/night. Prevalence of SS, insomnia, acute stress, depressive, and anxiety symptoms were 38.8%, 72.8%, 57.9%, 33.8%, and 48.2%, respectively. Insomnia symptoms was associated with acute stress (adjusted prevalence ratio [PR]: 1.51, 95% CI: 1.35, 1.69), depressive (PR: 2.04, 95% CI: 1.78, 2.33), and anxiety (PR: 1.74, 95% CI: 1.55, 1.94) symptoms. SS was also associated with acute stress (PR: 1.17, 95% CI: 1.07, 1.29), depressive (PR: 1.36, 95% CI: 1.233, 1.51), and anxiety (PR: 1.38, 95% CI: 1.26, 1.50) symptoms. Limitations Our cross-sectional analysis may preclude the identification of temporal associations and limit causal claims. Conclusions In our study, SS and insomnia were associated with psychological distress symptoms in NYC HCWs during the COVID-19 pandemic. Sleep may be a target for interventions to decrease psychological distress among HCWs.

8.
J Health Psychol ; : 13591053211042075, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-1374083

ABSTRACT

In a sample of 28 individuals cohabiting with a partner in NYC, Boston, or Chicago, this study tested whether implementation of stay-home orders to combat the spread of COVID-19 disrupted physical activity and whether high-quality romantic relationships buffered adverse effects. Participants provided FitBit data between February and October, 2020. Stay-home orders were associated with a reduction in daily step counts, B = -1595.72, p = 0.018, increased sedentary minutes, B = 33.75, p = 0.002, and reduced daily minutes of light and moderate physical activity, B = -25.01, p = 0.011; B = -0.72, p = 0.021. No moderation effects emerged.

9.
Am J Hypertens ; 35(1): 103-110, 2022 01 05.
Article in English | MEDLINE | ID: covidwho-1354271

ABSTRACT

BACKGROUND: Blood pressure (BP) control was only 43.7% in the National Health and Nutrition Survey (NHANES) survey in 2017-2018. Scalable, nonclinic-based strategies to control BP are needed. We therefore conducted a pilot trial of a text-messaging intervention in a national network of retail outlet health kiosks with BP devices. All study procedures were conducted remotely. METHODS: Eligible individuals (N = 140), based on average BP greater than or equal to 140/90 mm Hg at kiosks during the prior year, were randomized to intervention vs. usual care. Intervention consisted of tailored text messages providing educational information with embedded links to educational videos on topics related to BP control. BP measurements were obtained at kiosks at 3, 6, and 12 months following randomization; control was defined as BP < 140/90 mm Hg. Follow-up at 12 months was curtailed due to SARS-CoV-2. We therefore combined 12-month (N = 62) or carried forward 6-month (N = 61) data as the primary end point. RESULTS: Participants were 51.4% male, 70.7% white/Caucasian, had mean age of 52.1 years, and mean baseline BP 145.5/91.8 mm Hg. At the end point, 37.7% intervention vs. 27.4% usual care subjects achieved BP control (difference, 10.3%, 95% confidence interval -6.2%, 26.8%). In an intention-to-treat analysis with multiple imputation of missing data, 12-month BP control was 29.0% vs. 19.8% favoring intervention (difference, 9.2%. 95% confidence interval -7.3%, 25.7%); intervention vs. control differences in adjusted mean BP levels were systolic BP: -5.4 mm Hg (95% confidence interval: -13.5, 2.7) and diastolic BP: +0.6 mm Hg (95% confidence interval: -4.2, 5.4). CONCLUSIONS: These pilot results support the potential for a highly scalable text-messaging intervention to improve BP. CLINICAL TRIALS REGISTRATION: Trial Number NCT03515681.


Subject(s)
Hypertension , Text Messaging , Blood Pressure , Female , Humans , Hypertension/prevention & control , Male , Middle Aged , Nutrition Surveys , Pilot Projects
10.
J Clin Invest ; 131(13)2021 07 01.
Article in English | MEDLINE | ID: covidwho-1291316

ABSTRACT

BACKGROUNDAlthough 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.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 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 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.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive 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.CONCLUSIONIn 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.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.


Subject(s)
COVID-19/therapy , SARS-CoV-2 , Adult , Aged , Aged, 80 and over , Brazil/epidemiology , COVID-19/immunology , COVID-19/mortality , Double-Blind Method , Female , Humans , Immunization, Passive , Kaplan-Meier Estimate , Male , Middle Aged , New York City/epidemiology , Pandemics , SARS-CoV-2/immunology , Severity of Illness Index , Treatment Outcome
11.
Fam Syst Health ; 39(3): 499-504, 2021 09.
Article in English | MEDLINE | ID: covidwho-1275878

ABSTRACT

BACKGROUND: Health care workers (HCWs) during the COVID-19 pandemic report high levels of psychological distress. We examined whether concerns regarding transmission of COVID-19 to loved ones and social distancing from loved ones were associated with HCWs' distress. We tested whether living with others modified these associations. METHOD: HCWs at a New York City academic medical center (N = 767; 80.7% female, 58.5% White) enrolled in the COVID-19 Health Care Provider Study and completed a web-based survey between April 9, 2020 and May 11, 2020. RESULTS: Controlling for demographics, distress regarding potential transmission to loved ones and social distancing from loved ones were each significantly associated with higher odds of a positive screen for acute stress, depression, and anxiety (ORs = 1.29-1.59, all ps < .01). Living with others was associated with lower odds of a positive screen for depression and anxiety, though the protective effect for anxiety was evident only for HCWs with no distress regarding transmission concerns. CONCLUSIONS: Transmission concerns and social distancing from loved ones were associated with greater odds of psychological distress, whereas living with others was associated with lower odds of distress. Interventions should consider ways to facilitate the ability of HCWs to receive social support from loved ones, while simultaneously protecting their family's health. (PsycInfo Database Record (c) 2021 APA, all rights reserved).


Subject(s)
COVID-19 , Pandemics , Female , Health Personnel , Humans , Male , New York City/epidemiology , SARS-CoV-2
12.
Transplant Cell Ther ; 27(3): 270.e1-270.e6, 2021 03.
Article in English | MEDLINE | ID: covidwho-1108498

ABSTRACT

SARS-CoV-2 has spread rapidly worldwide, but the full impact of the COVID-19 pandemic on the field of hematopoietic cell transplantation (HCT) remains unknown. To understand this better, an 18-item online survey was disseminated by the Worldwide Network for Blood & Marrow Transplantation with questions exploring SARS-CoV-2 testing algorithms, mobilization, and cryopreservation strategies and COVID-19 infections in allogeneic related and autologous hematopoietic progenitor cell (HPC) donors. The aim of this survey was to assess the impact of the outbreak on policies relating to HPC mobilization, collection, and processing with respect to changes in daily routine. A total of 91 individual responses from distinct centers in 6 continents were available for analysis. In these centers, the majority (72%) of allogeneic related and autologous donors are routinely tested for SARS-CoV-2 before HPC collection, and 80% of centers implement cryopreservation of allogeneic HPC grafts before commencing conditioning regimens in patients. Five related and 14 autologous donors who tested positive for COVID-19 did not experience any unexpected adverse events or reactions during growth factor administration (eg, hyperinflammatory syndrome). These data are limited by the small number of survey respondents but nonetheless suggest that centers are following the recommendations of appropriate scientific organizations and provide some preliminary data to suggest areas of further study.


Subject(s)
Bone Marrow Transplantation/statistics & numerical data , COVID-19/epidemiology , Hematopoietic Stem Cell Transplantation/statistics & numerical data , Pandemics , SARS-CoV-2 , Algorithms , Allografts , Bone Marrow Transplantation/trends , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19 Testing/methods , COVID-19 Testing/statistics & numerical data , Cryopreservation/methods , Donor Selection/standards , Global Health , Health Care Surveys , Hematopoietic Stem Cell Mobilization/statistics & numerical data , Hematopoietic Stem Cell Transplantation/trends , Practice Patterns, Physicians'/statistics & numerical data , Procedures and Techniques Utilization/statistics & numerical data , Tissue Preservation/methods , Transplantation, Autologous , Unrelated Donors/statistics & numerical data
14.
Transfusion ; 61(3): 692-698, 2021 03.
Article in English | MEDLINE | ID: covidwho-936858

ABSTRACT

BACKGROUND: Blood suppliers and transfusion services have worked diligently to maintain an adequate blood supply during the COVID-19 pandemic. Our experience has shown that some COVID-19 inpatients require transfusion support; understanding this need is critical to blood product inventory management. STUDY DESIGN AND METHODS: Hospital-wide and COVID-19 specific inpatient blood product utilization data were collected retrospectively for our network's two tertiary academic medical centers over a 9-week period (March 1, 2020-May 2, 2020), when most inpatients had COVID-19. Utilization data were merged with a COVID-19 patient database to investigate clinical demographic characteristics of transfused COVID-19 inpatients relative to non-transfused ones. RESULTS: Overall, 11 041 COVID-19 patients were admitted and 364 received blood product transfusions for an overall transfusion rate of 3.3%. COVID-19 patients received 1746 blood components in total, the majority of which were red blood cells. COVID-19 patients' weekly transfusion rate increased as the pandemic progressed, possibly reflecting their increased severity of illness. Transfusion was significantly associated with several indicators of severe disease, including mortality, intubation, thrombosis, longer hospital admission, lower hemoglobin and platelet nadirs, and longer prothrombin and activated partial thromboplastin times. As the pandemic progressed, institutional adherence to transfusion guidelines improved for RBC transfusions compared to prior year trends but did not improve for platelets or plasma. CONCLUSION: There is a need to closely monitor the blood product inventory and demand throughout the COVID-19 pandemic as patients' transfusion needs may increase over time. Daily or weekly trending of patients' clinical status and laboratory values may assist blood banks in inventory management.


Subject(s)
Blood Component Transfusion/trends , COVID-19/therapy , Facilities and Services Utilization/trends , Adult , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Critical Illness , Female , Hospitalization , Humans , Linear Models , Male , Middle Aged , Needs Assessment , New York City/epidemiology , Pandemics , Retrospective Studies , Severity of Illness Index
16.
Transfusion ; 60:85A-86A, 2020.
Article in English | Web of Science | ID: covidwho-836956
18.
Trials ; 21(1): 499, 2020 06 08.
Article in English | MEDLINE | ID: covidwho-768581

ABSTRACT

OBJECTIVES: The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. TRIAL DESIGN: This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. PARTICIPANTS: Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. INTERVENTION AND COMPARATOR: The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. MAIN OUTCOMES: The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. RANDOMIZATION: Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. BLINDING (MASKING): The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. TRIAL STATUS: Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Betacoronavirus/immunology , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , Adult , Antibodies, Viral/blood , Antibodies, Viral/immunology , COVID-19 , Clinical Trials, Phase II as Topic , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Pandemics , Prospective Studies , SARS-CoV-2
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