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Clin Infect Dis ; 75(1): e630-e644, 2022 08 24.
Article in English | MEDLINE | ID: covidwho-1886372


BACKGROUND: We studied humoral responses after coronavirus disease 2019 (COVID-19) vaccination across varying causes of immunodeficiency. METHODS: Prospective study of fully vaccinated immunocompromised adults (solid organ transplant [SOT], hematologic malignancy, solid cancers, autoimmune conditions, human immunodeficiency virus [HIV]) versus nonimmunocompromised healthcare workers (HCWs). The primary outcome was the proportion with a reactive test (seropositive) for immunoglobulin G to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain. Secondary outcomes were comparisons of antibody levels and their correlation with pseudovirus neutralization titers. Stepwise logistic regression was used to identify factors associated with seropositivity. RESULTS: A total of 1271 participants enrolled: 1099 immunocompromised and 172 HCW. Compared with HCW (92.4% seropositive), seropositivity was lower among participants with SOT (30.7%), hematological malignancies (50.0%), autoimmune conditions (79.1%), solid tumors (78.7%), and HIV (79.8%) (P < .01). Factors associated with poor seropositivity included age, greater immunosuppression, time since vaccination, anti-CD20 monoclonal antibodies, and vaccination with BNT162b2 (Pfizer) or adenovirus vector vaccines versus messenger RNA (mRNA)-1273 (Moderna). mRNA-1273 was associated with higher antibody levels than BNT162b2 or adenovirus vector vaccines after adjusting for time since vaccination, age, and underlying condition. Antibody levels were strongly correlated with pseudovirus neutralization titers (Spearman r = 0.89, P < .0001), but in seropositive participants with intermediate antibody levels, neutralization titers were significantly lower in immunocompromised individuals versus HCW. CONCLUSIONS: Antibody responses to COVID-19 vaccines were lowest among SOT and anti-CD20 monoclonal recipients, and recipients of vaccines other than mRNA-1273. Among those with intermediate antibody levels, pseudovirus neutralization titers were lower in immunocompromised patients than HCWs. Additional SARS-CoV-2 preventive approaches are needed for immunocompromised persons, which may need to be tailored to the cause of immunodeficiency.

COVID-19 , HIV Infections , Adult , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines , HIV Infections/complications , Humans , Immunocompromised Host , Prospective Studies , SARS-CoV-2 , Vaccination
J Thorac Dis ; 13(4): 2081-2086, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1224393
Contemp Clin Trials ; 105: 106407, 2021 06.
Article in English | MEDLINE | ID: covidwho-1193252


The coronavirus disease-2019 (COVID-19) pandemic has changed the conduct of clinical trials. For studies with physical function and physical activity outcomes that require in-person participation, thoughtful approaches in transitioning to the remote research environment are critical. Here, we share our experiences in transitioning from in-person to remote assessments of physical function and activity during the pandemic and highlight key considerations for success. Details on the development of the remote assessment protocol, integration of a two-way video platform, and implementation of remote assessments are addressed. In particular, procedural challenges and considerations in transitioning and conducting remote assessments will be discussed in terms of efforts to maintain participant safety, maximize study efficiency, and sustain trial integrity. Plans for triangulation and analysis are also discussed. Although the role of telehealth platforms and research activities in remote settings are still growing, our experiences suggest that adopting remote assessment strategies are useful and convenient in assessing study outcomes during, and possibly even beyond, the current pandemic. Trial register and number: [NCT03728257].

COVID-19/epidemiology , Exercise/physiology , Lung Transplantation/rehabilitation , Research Design , Actigraphy , Clinical Protocols , Exercise Test/methods , Humans , Pandemics , Patient Safety , Postural Balance/physiology , Quality of Life , SARS-CoV-2 , Telemedicine , Videoconferencing
Transplantation ; 105(1): 187-192, 2021 01 01.
Article in English | MEDLINE | ID: covidwho-991001


BACKGROUND: The purpose of this study is to examine the effects of the coronavirus disease 2019 (COVID-19) pandemic on adult lung transplants and report practice changes in the United States. METHODS: A retrospective analysis of a public dataset from the United Network for Organ Sharing was performed regarding adult lung transplantation (January 19, 2020-June 30, 2020). Data were stratified into 3 periods: pre-COVID-19 (January 19, 2020-March 14, 2020), first COVID-19 era (March 15, 2020-May 8, 2020), and second COVID-19 era (May 9, 2020-June 30, 2020). Weekly changes in waitlist inactivations (COVID-19 precautions or not), waitlist additions, transplant volume, and donor recovery were examined across eras and changes across era were correlated. RESULTS: During the first COVID-19 era, 301 patients were added to the waitlist, representing a 40% decrease when compared to the prior 8-week period. This was followed by a significant increase in listing during the second COVID-19 era (t = 2.16, P = 0.032). Waitlist inactivations decreased in the second COVID-19 era from the first COVID-19 era (t = 3.60, P < 0.001). There was no difference in waitlist inactivations between the pre-COVID era and the second COVID-19 era (P = 0.10). Weekly volume was not associated with trends in COVID-19 cases across any era, but was negatively associated with waitlist inactivations due to COVID-19 precautions entering the first COVID-19 era (r = -0.73, P = 0.04) and second COVID-19 era (r = -0.89, P = 0.003). CONCLUSIONS: Due to the COVID-19 pandemic, the United States experienced a decrease in lung transplant volume. While overall volume has returned to normal, additional studies are needed to identify areas of improvement to better prepare for future pandemics.

COVID-19/epidemiology , Lung Transplantation/trends , SARS-CoV-2 , Cross-Sectional Studies , Humans , Lung Transplantation/statistics & numerical data , Retrospective Studies , Tissue Donors , United States/epidemiology , Waiting Lists