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1. Novel subtypes of severe COVID-19 respiratory failure based on biological heterogeneity: a secondary analysis of a randomized controlled trial

Author: Alipanah-Lechner, Narges, Hurst-Hopf, James, Delucchi, Kevin, Swigart, Lamorna, Willmore, Andrew, LaCombe, Benjamin, Dewar, Robin, Lane, H Clifford, Lallemand, Perrine, Liu, Kathleen D, Esserman, Laura, Matthay, Michael A, and Calfee, Carolyn S
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Coronaviruses, Rare Diseases, Acute Respiratory Distress Syndrome, Emerging Infectious Diseases, Clinical Research, Clinical Trials and Supportive Activities, Infectious Diseases, Lung, 4.1 Discovery and preclinical testing of markers and technologies, 2.1 Biological and endogenous factors, Respiratory, Good Health and Well Being, Adult, Humans, Male, Middle Aged, Aged, Female, COVID-19, SARS-CoV-2, Inflammation, Respiratory Distress Syndrome, Oxygen, Respiratory Insufficiency, Biomarkers, Hypoxemic respiratory failure, Latent class analysis, Phenotyping, Biological heterogeneity, Protein biomarkers, I-SPY COVID Consortium, Medical and Health Sciences, Emergency & Critical Care Medicine, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundDespite evidence associating inflammatory biomarkers with worse outcomes in hospitalized adults with COVID-19, trials of immunomodulatory therapies have met with mixed results, likely due in part to biological heterogeneity of participants. Latent class analysis (LCA) of clinical and protein biomarker data has identified two subtypes of non-COVID acute respiratory distress syndrome (ARDS) with different clinical outcomes and treatment responses. We studied biological heterogeneity and clinical outcomes in a multi-institutional platform randomized controlled trial of adults with severe COVID-19 hypoxemic respiratory failure (I-SPY COVID).MethodsClinical and plasma protein biomarker data were analyzed from 400 trial participants enrolled from September 2020 until October 2021 with severe COVID-19 requiring ≥ 6 L/min supplemental oxygen. Seventeen hypothesis-directed protein biomarkers were measured at enrollment using multiplex Luminex panels or single analyte enzyme linked immunoassay methods (ELISA). Biomarkers and clinical variables were used to test for latent subtypes and longitudinal biomarker changes by subtype were explored. A validated parsimonious model using interleukin-8, bicarbonate, and protein C was used for comparison with non-COVID hyper- and hypo-inflammatory ARDS subtypes.ResultsAverage participant age was 60 ± 14 years; 67% were male, and 28-day mortality was 25%. At trial enrollment, 85% of participants required high flow oxygen or non-invasive ventilation, and 97% were receiving dexamethasone. Several biomarkers of inflammation (IL-6, IL-8, IL-10, sTNFR-1, TREM-1), epithelial injury (sRAGE), and endothelial injury (Ang-1, thrombomodulin) were associated with 28- and 60-day mortality. Two latent subtypes were identified. Subtype 2 (27% of participants) was characterized by persistent derangements in biomarkers of inflammation, endothelial and epithelial injury, and disordered coagulation and had twice the mortality rate compared with Subtype 1. Only one person was classified as hyper-inflammatory using the previously validated non-COVID ARDS model.ConclusionsWe discovered evidence of two novel biological subtypes of severe COVID-19 with significantly different clinical outcomes. These subtypes differed from previously established hyper- and hypo-inflammatory non-COVID subtypes of ARDS. Biological heterogeneity may explain inconsistent findings from trials of hospitalized patients with COVID-19 and guide treatment approaches.
Published: 2024

2. Association of SARS-CoV-2 nucleocapsid viral antigen and the receptor for advanced glycation end products with development of severe disease in patients presenting to the emergency department with COVID-19

Author: Matthay, Zachary A, Fields, Alexander T, Wick, Katherine D, Jones, Chayse, Lane, H Clifford, Herrera, Kimberly, Nuñez-Garcia, Brenda, Gennatas, Efstathios, Hendrickson, Carolyn M, Kornblith, Aaron E, Matthay, Michael A, Kornblith, Lucy Z, Group, the COVID-19 Associated Coagulopathy Inflammation Thrombosis Study, Ambachew, Biniam, Bainton, Roland J, Cary, Sarah, Chalwell, Lauren, Colwell, Christopher, Josephy, Clayton, Kurien, Philip, Lee, Deanna, LeGrand, Matthieu, Montoy, Juan Carlos, Nguyen, Viet, Park, John J, Prakash, Arun, Robinson, Brittany, and India, Shelley
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Autoimmune Disease, Infectious Diseases, Coronaviruses, Emerging Infectious Diseases, Coronaviruses Disparities and At-Risk Populations, 4.1 Discovery and preclinical testing of markers and technologies, Infection, Good Health and Well Being, Humans, COVID-19, SARS-CoV-2, Receptor for Advanced Glycation End Products, Nucleocapsid, Antigens, Biomarkers, Antigens, Viral, biomarkers, thromboinflammation, receptor for advanced glycation end products, triage, COVID-19 Associated Coagulopathy Inflammation Thrombosis (Co-ACIT) Study Group, Immunology, Medical Microbiology, Biochemistry and cell biology, Genetics
Abstract: IntroductionThere remains a need to better identify patients at highest risk for developing severe Coronavirus Disease 2019 (COVID-19) as additional waves of the pandemic continue to impact hospital systems. We sought to characterize the association of receptor for advanced glycation end products (RAGE), SARS-CoV-2 nucleocapsid viral antigen, and a panel of thromboinflammatory biomarkers with development of severe disease in patients presenting to the emergency department with symptomatic COVID-19.MethodsBlood samples were collected on arrival from 77 patients with symptomatic COVID-19, and plasma levels of thromboinflammatory biomarkers were measured.ResultsDifferences in biomarkers between those who did and did not develop severe disease or death 7 days after presentation were analyzed. After adjustment for multiple comparisons, RAGE, SARS-CoV-2 nucleocapsid viral antigen, interleukin (IL)-6, IL-10 and tumor necrosis factor receptor (TNFR)-1 were significantly elevated in the group who developed severe disease (all p80% on cut-point analysis.DiscussionElevated RAGE and SARS-CoV-2 nucleocapsid viral antigen on emergency department presentation are strongly associated with development of severe disease at 7 days. These findings are of clinical relevance for patient prognostication and triage as hospital systems continue to be overwhelmed. Further studies are warranted to determine the feasibility and utility of point-of care measurements of these biomarkers in the emergency department setting to improve patient prognostication and triage.
Published: 2023

3. The Association of Baseline Plasma SARS-CoV-2 Nucleocapsid Antigen Level and Outcomes in Patients Hospitalized With COVID-19

Author: Rogers, Angela J, Wentworth, Deborah, Phillips, Andrew, Shaw-Saliba, Katy, Dewar, Robin L, Aggarwal, Neil R, Babiker, Abdel G, Chang, Weizhong, Dharan, Nila J, Davey, Victoria J, Higgs, Elizabeth S, Gerry, Norman, Ginde, Adit A, Hayanga, JW Awori, Highbarger, Helene, Highbarger, Jeroen L, Jain, Mamta K, Kan, Virginia, Kim, Kami, Lallemand, Perrine, Leshnower, Bradley G, Lutaakome, Joseph K, Matthews, Gail, Mourad, Ahmad, Mylonakis, Eleftherios, Natarajan, Ven, Padilla, Maria L, Pandit, Lavannya M, Paredes, Roger, Pett, Sarah, Ramachandruni, Srikanth, Rehman, M Tauseef, Sherman, Brad T, Files, D Clark, Brown, Samuel M, Matthay, Michael A, Thompson, B Taylor, Neaton, James D, Lane, H Clifford, Lundgren, Jens D, Sahner, David, Tierney, John, Vogel, Susan E, Herpin, Betsey R, Smolskis, Mary C, McKay, Laura A, Cahill, Kelly, Crew, Page, Sardana, Ratna, Raim, Sharon Segal, Hensely, Lisa, Lorenzo, Johsua, Mock, Rebecca, Zuckerman, Judith, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Kang, Nayon, and Barrett, Kevin
Subjects: Prevention, Vaccine Related, Emerging Infectious Diseases, Infectious Diseases, Clinical Research, Lung, Biodefense, Inflammatory and immune system, Infection, Good Health and Well Being, Adult, COVID-19, Cross-Sectional Studies, Humans, Male, Nucleocapsid, SARS-CoV-2, ACTIV-3/TICO Study Group, Clinical Sciences, Public Health and Health Services
Abstract: BackgroundLevels of plasma SARS-CoV-2 nucleocapsid (N) antigen may be an important biomarker in patients with COVID-19 and enhance our understanding of the pathogenesis of COVID-19.ObjectiveTo evaluate whether levels of plasma antigen can predict short-term clinical outcomes and identify clinical and viral factors associated with plasma antigen levels in hospitalized patients with SARS-CoV-2.DesignCross-sectional study of baseline plasma antigen level from 2540 participants enrolled in the TICO (Therapeutics for Inpatients With COVID-19) platform trial from August 2020 to November 2021, with additional data on day 5 outcome and time to discharge.Setting114 centers in 10 countries.ParticipantsAdults hospitalized for acute SARS-CoV-2 infection with 12 days or less of symptoms.MeasurementsBaseline plasma viral N antigen level was measured at a central laboratory. Delta variant status was determined from baseline nasal swabs using reverse transcriptase polymerase chain reaction. Associations between baseline patient characteristics and viral factors and baseline plasma antigen levels were assessed using both unadjusted and multivariable modeling. Association between elevated baseline antigen level of 1000 ng/L or greater and outcomes, including worsening of ordinal pulmonary scale at day 5 and time to hospital discharge, were evaluated using logistic regression and Fine-Gray regression models, respectively.ResultsPlasma antigen was below the level of quantification in 5% of participants at enrollment, and 1000 ng/L or greater in 57%. Baseline pulmonary severity of illness was strongly associated with plasma antigen level, with mean plasma antigen level 3.10-fold higher among those requiring noninvasive ventilation or high-flow nasal cannula compared with room air (95% CI, 2.22 to 4.34). Plasma antigen level was higher in those who lacked antispike antibodies (6.42 fold; CI, 5.37 to 7.66) and in those with the Delta variant (1.73 fold; CI, 1.41 to 2.13). Additional factors associated with higher baseline antigen level included male sex, shorter time since hospital admission, decreased days of remdesivir, and renal impairment. In contrast, race, ethnicity, body mass index, and immunocompromising conditions were not associated with plasma antigen levels. Plasma antigen level of 1000 ng/L or greater was associated with a markedly higher odds of worsened pulmonary status at day 5 (odds ratio, 5.06 [CI, 3.41 to 7.50]) and longer time to hospital discharge (median, 7 vs. 4 days; subhazard ratio, 0.51 [CI, 0.45 to 0.57]), with subhazard ratios similar across all levels of baseline pulmonary severity.LimitationsPlasma samples were drawn at enrollment, not hospital presentation. No point-of-care test to measure plasma antigen is currently available.ConclusionElevated plasma antigen is highly associated with both severity of pulmonary illness and clinically important patient outcomes. Multiple clinical and viral factors are associated with plasma antigen level at presentation. These data support a potential role of ongoing viral replication in the pathogenesis of SARS-CoV-2 in hospitalized patients.Primary funding sourceU.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.
Published: 2022

4. Evaluating Primary Endpoints for COVID-19 Therapeutic Trials to Assess Recovery.

Author: Douin, David J, Siegel, Lianne, Grandits, Greg, Phillips, Andrew, Aggarwal, Neil R, Baker, Jason, Brown, Samuel M, Chang, Christina C, Goodman, Anna L, Grund, Birgit, Higgs, Elizabeth S, Hough, Catherine L, Murray, Daniel D, Paredes, Roger, Parmar, Mahesh, Pett, Sarah, Polizzotto, Mark N, Sandkovsky, Uriel, Self, Wesley H, Young, Barnaby E, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Gelijns, Annetine C, Matthews, Gail, Thompson, B Taylor, Lane, H Clifford, Neaton, James D, Lundgren, Jens D, and Ginde, Adit A
Subjects: Humans, Antibodies, Monoclonal, Treatment Outcome, Aftercare, Patient Discharge, Aged, COVID-19, SARS-CoV-2, monoclonal antibodies, outcomes assessment, Clinical Trials and Supportive Activities, Clinical Research, Good Health and Well Being, Medical and Health Sciences, Respiratory System
Abstract: Rationale: Uncertainty regarding the natural history of coronavirus disease (COVID-19) led to difficulty in efficacy endpoint selection for therapeutic trials. Capturing outcomes that occur after hospital discharge may improve assessment of clinical recovery among hospitalized patients with COVID-19. Objectives: Evaluate 90-day clinical course of patients hospitalized with COVID-19, comparing three distinct definitions of recovery. Methods: We used pooled data from three clinical trials of neutralizing monoclonal antibodies to compare: 1) the hospital discharge approach; 2) the TICO (Therapeutics for Inpatients with COVID-19) trials sustained recovery approach; and 3) a comprehensive approach. At the time of enrollment, all patients were hospitalized in a non-ICU setting without organ failure or major extrapulmonary manifestations of COVID-19. We defined discordance as a difference between time to recovery. Measurements and Main Results: Discordance between the hospital discharge and comprehensive approaches occurred in 170 (20%) of 850 enrolled participants, including 126 hospital readmissions and 24 deaths after initial hospital discharge. Discordant participants were older (median age, 68 vs. 59 years; P
Published: 2022

5. Dolutegravir plus boosted darunavir versus recommended standard-of-care antiretroviral regimens in people with HIV-1 for whom recommended first-line non-nucleoside reverse transcriptase inhibitor therapy has failed (D2EFT): an open-label, randomised, phase 3b/4 trial

Author: Matthews, Gail, Jacoby, Simone, Borok, Margaret, Eriobu, Nnakelu, Kaplan, Richard, Kumarasamy, Nagalingeswaran, Bennet, Jaclyn Ann, Avihingsanon, Anchalee, Chetchotisakd, Ploenchan, Wagner Cardoso, Sandra, Azwa, Iskandar, Losso, Marcelo, Brown, Dannae, Arlinda, Dona, Hutchinson, Jolie, Kelleher, Anthony, Cisse, Mohamed, Dao, Sounkalo, Polizzotto, Mark, Emery, Sean, Law, Matthew, Papot, Emmanuelle, Karyana, Muhammad, Lupo, Sergio, Solari, Ana Melisa, Grinsztejn, Beatriz, Wolff, Marcello, Andrade-Villanueva, Jaime, Mosqueda Gómez, Juan Luis, Chow, Ting Soo, Mohapi, Lerato, Yunihastuti, Evy, Hadi, Usman, Katu, Sudirman, Subronto, Yanri Wijayanti, Lane, H. Clifford, and Perelis, Leonardo
Published: 2024
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6. RAGE has potential pathogenetic and prognostic value in non-intubated hospitalized patients with COVID-19

Author: Wick, Katherine D, Siegel, Lianne, Neaton, James D, Oldmixon, Cathryn, Lundgren, Jens, Dewar, Robin L, Lane, H Clifford, Thompson, B Taylor, and Matthay, Michael A
Subjects: Clinical Research, Clinical Trials and Supportive Activities, Good Health and Well Being, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Biomarkers, COVID-19, Humans, Interleukin-6, Prognosis, Receptor for Advanced Glycation End Products, ACTIV-3/TICO study group, Antigen, Clinical practice, Cytokines, Pulmonology
Abstract: BackgroundThe value of the soluble receptor for advanced glycation end-products (sRAGE) as a biomarker in COVID-19 is not well understood. We tested the association between plasma sRAGE and illness severity, viral burden, and clinical outcomes in hospitalized patients with COVID-19 who were not mechanically ventilated.MethodsBaseline sRAGE was measured among participants enrolled in the ACTIV-3/TICO trial of bamlanivimab for hospitalized patients with COVID-19. Spearman's rank correlation was used to assess the relationship between sRAGE and other plasma biomarkers, including viral nucleocapsid antigen. Fine-Gray models adjusted for baseline supplemental oxygen requirement, antigen level, positive endogenous anti-nucleocapsid antibody response, sex, age, BMI, diabetes mellitus, renal impairment, corticosteroid treatment, and log2-transformed IL-6 level were used to assess the association between baseline sRAGE and time to sustained recovery. Cox regression adjusted for the same factors was used to assess the association between sRAGE and mortality.ResultsAmong 277 participants, baseline sRAGE was strongly correlated with viral plasma antigen concentration (ρ = 0.57). There was a weaker correlation between sRAGE and biomarkers of systemic inflammation, such as IL-6 (ρ = 0.36) and CRP (ρ = 0.20). Participants with plasma sRAGE in the highest quartile had a significantly lower rate of sustained recovery (adjusted recovery rate ratio, 0.64 [95% CI, 0.43-0.90]) and a higher unadjusted risk of death (HR, 4.70 [95% CI, 2.01-10.99]) compared with participants in the lower quartiles.ConclusionElevated plasma sRAGE in hospitalized, nonventilated patients with COVID-19 was an indicator of both clinical illness severity and plasma viral load. Plasma sRAGE in the highest quartile was associated with a lower likelihood of sustained recovery and higher unadjusted risk of death. These findings, which we believe to be novel, indicate that plasma sRAGE may be a promising biomarker for COVID-19 prognostication and clinical trial enrichment.Trial RegistrationClinicalTrials.gov NCT04501978.FundingNIH (5T32GM008440-24, 18X107CF6, HHSN261201500003I, R35HL140026, and OT2HL156812).
Published: 2022

7. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author: Group, ACTIV-3 Therapeutics for Inpatients with COVID-19 Study, Self, Wesley H, Sandkovsky, Uriel, Reilly, Cavan S, Vock, David M, Gottlieb, Robert L, Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R, Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R, Hibbert, Kathryn A, Rice, Todd W, Casey, Jonathan D, Hayanga, J Awori, Badhwar, Vinay, Leshnower, Bradley G, Sharifpour, Milad, Knowlton, Kirk U, Peltan, Ithan D, Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E, Sturek, Jeffrey M, Rogers, Angela J, Files, D Clark, Mosier, Jarrod M, Gong, Michelle N, Douin, David J, Hite, R Duncan, Trautner, Barbara W, Jain, Mamta K, Gardner, Edward M, Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A, Ginde, Adit A, Brown, Samuel M, Higgs, Elizabeth S, Pett, Sarah, Weintrob, Amy C, Chang, Christina C, Murrary, Daniel D, Günthard, Huldrych F, Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Thompson, B Taylor, Gelijns, Annetine C, Neaton, James D, Lane, H Clifford, Jundgren, Jens D, Tierney, John, Barrett, Kevin, Herpin, Betsey R, Smolskis, Mary C, Voge, Susan E, McNay, Laura A, Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J, Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, and Murray, Thomas
Subjects: Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Double-Blind Method, Female, Humans, Male, Middle Aged, SARS-CoV-2, Treatment Outcome, COVID-19 Drug Treatment, ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group, Clinical Sciences, Medical Microbiology, Public Health and Health Services, Microbiology
Abstract: BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed.
Published: 2022

8. Association of Lower Exposure Risk With Paucisymptomatic/Asymptomatic Infection, Less Severe Disease, and Unrecognized Ebola Virus Disease: A Seroepidemiological Study

Author: Kelly, J Daniel, Frankfurter, Raphael G, Tavs, Jacqueline M, Barrie, Mohamed Bailor, McGinnis, Timothy, Kamara, Mohamed, Freeman, Adams, Quiwah, Komba, Davidson, Michelle C, Dighero-Kemp, Bonnie, Gichini, Harrison, Elliott, Elizabeth, Reilly, Cavan, Hensley, Lisa E, Lane, H Clifford, Weiser, Sheri D, Porco, Travis C, Rutherford, George W, and Richardson, Eugene T
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Infectious Diseases, Prevention, Biodefense, Emerging Infectious Diseases, Vaccine Related, Infection, Good Health and Well Being, Ebola virus, exposure risk, epidemiology, public health, transmission, Clinical sciences, Medical microbiology
Abstract: BackgroundIt remains unclear if there is a dose-dependent relationship between exposure risk to Ebola virus (EBOV) and severity of illness.MethodsFrom September 2016 to July 2017, we conducted a cross-sectional, community-based study of Ebola virus disease (EVD) cases and household contacts of several transmission chains in Kono District, Sierra Leone. We analyzed 154 quarantined households, comprising both reported EVD cases and their close contacts. We used epidemiological surveys and blood samples to define severity of illness as no infection, pauci-/asymptomatic infection, unrecognized EVD, reported EVD cases who survived, or reported EVD decedents. We determine seropositivity with the Filovirus Animal Nonclinical Group EBOV glycoprotein immunoglobulin G antibody test. We defined levels of exposure risk from 8 questions and considered contact with body fluid as maximum exposure risk.ResultsOur analysis included 76 reported EVD cases (both decedents and survivors) and 421 close contacts. Among these contacts, 40 were seropositive (22 paucisymptomatic and 18 unrecognized EVD), accounting for 34% of the total 116 EBOV infections. Higher exposure risks were associated with having had EBOV infection (maximum risk: adjusted odds ratio [AOR], 12.1 [95% confidence interval {CI}, 5.8-25.4; trend test: P
Published: 2022

9. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

Author: Group, The ITAC Study, Polizzotto, Mark N, Nordwall, Jacqueline, Babiker, Abdel G, Phillips, Andrew, Vock, David M, Eriobu, Nnakelu, Kwaghe, Vivian, Paredes, Roger, Mateu, Lourdes, Ramachandruni, Srikanth, Narang, Rajeev, Jain, Mamta K, Lazarte, Susana M, Baker, Jason V, Frosch, Anne EP, Poulakou, Garyfallia, Syrigos, Konstantinos N, Arnoczy, Gretchen S, McBride, Natalie A, Robinson, Philip A, Sarafian, Farjad, Bhagani, Sanjay, Taha, Hassan S, Benfield, Thomas, Liu, Sean TH, Antoniadou, Anastasia, Jensen, Jens Ulrik Stæhr, Kalomenidis, Ioannis, Susilo, Adityo, Hariadi, Prasetyo, Jensen, Tomas O, Morales-Rull, Jose Luis, Helleberg, Marie, Meegada, Sreenath, Johansen, Isik S, Canario, Daniel, Fernández-Cruz, Eduardo, Metallidis, Simeon, Shah, Amish, Sakurai, Aki, Koulouris, Nikolaos G, Trotman, Robin, Weintrob, Amy C, Podlekareva, Daria, Hadi, Usman, Lloyd, Kathryn M, Røge, Birgit Thorup, Saito, Sho, Sweerus, Kelly, Malin, Jakob J, Lübbert, Christoph, Muñoz, Jose, Cummings, Matthew J, Losso, Marcelo H, Turner, Dan, Shaw-Saliba, Kathryn, Dewar, Robin, Highbarger, Helene, Lallemand, Perrine, Rehman, Tauseef, Gerry, Norman, Arlinda, Dona, Chang, Christina C, Grund, Birgit, Holbrook, Michael R, Holley, Horace P, Hudson, Fleur, McNay, Laura A, Murray, Daniel D, Pett, Sarah L, Shaughnessy, Megan, Smolskis, Mary C, Touloumi, Giota, Wright, Mary E, Doyle, Mittie K, Popik, Sharon, Hall, Christine, Ramanathan, Roshan, Cao, Huyen, Mondou, Elsa, Willis, Todd, Thakuria, Joseph V, Yel, Leman, Higgs, Elizabeth, Kan, Virginia L, Lundgren, Jens D, Neaton, James D, and Lane, H Clifford
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Emerging Infectious Diseases, Clinical Research, Vaccine Related, Clinical Trials and Supportive Activities, Lung, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenosine Monophosphate, Alanine, Antibodies, Neutralizing, Antiviral Agents, COVID-19, COVID-19 Vaccines, Double-Blind Method, Female, Hospitalization, Humans, Inpatients, Internationality, Male, Middle Aged, Treatment Outcome, Vaccines, Inactivated, ITAC (INSIGHT 013) Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundPassive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.MethodsIn this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581.FindingsFrom Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77-1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66-1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14-4·29); for patients who were antibody negative, the OR was 0·51 (0·29-0·90; pinteraction=0·001).InterpretationWhen administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry.FundingUS National Institutes of Health.
Published: 2022

10. Plasma SARS-CoV-2 nucleocapsid antigen levels are associated with progression to severe disease in hospitalized COVID-19

Author: Wick, Katherine D, Leligdowicz, Aleksandra, Willmore, Andrew, Carrillo, Sidney A, Ghale, Rajani, Jauregui, Alejandra, Chak, Suzanna S, Nguyen, Viet, Lee, Deanna, Jones, Chayse, Dewar, Robin, Lane, H Clifford, Kangelaris, Kirsten N, Hendrickson, Carolyn M, Liu, Kathleen D, Sinha, Pratik, Erle, David J, Langelier, Charles R, Krummell, Matthew F, Woodruff, Prescott G, Calfee, Carolyn S, and Matthay, Michael A
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Emerging Infectious Diseases, Lung, Infectious Diseases, Prevention, Clinical Research, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Infection, Good Health and Well Being, COVID-19, Humans, Nucleocapsid, RNA, Viral, SARS-CoV-2, COMET Consortium, Medical and Health Sciences, Emergency & Critical Care Medicine, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundStudies quantifying SARS-CoV-2 have focused on upper respiratory tract or plasma viral RNA with inconsistent association with clinical outcomes. The association between plasma viral antigen levels and clinical outcomes has not been previously studied. Our aim was to investigate the relationship between plasma SARS-CoV-2 nucleocapsid antigen (N-antigen) concentration and both markers of host response and clinical outcomes.MethodsSARS-CoV-2 N-antigen concentrations were measured in the first study plasma sample (D0), collected within 72 h of hospital admission, from 256 subjects admitted between March 2020 and August 2021 in a prospective observational cohort of hospitalized patients with COVID-19. The rank correlations between plasma N-antigen and plasma biomarkers of tissue damage, coagulation, and inflammation were assessed. Multiple ordinal regression was used to test the association between enrollment N-antigen plasma concentration and the primary outcome of clinical deterioration at one week as measured by a modified World Health Organization (WHO) ordinal scale. Multiple logistic regression was used to test the association between enrollment plasma N-antigen concentration and the secondary outcomes of ICU admission, mechanical ventilation at 28 days, and death at 28 days. The prognostic discrimination of an externally derived "high antigen" cutoff of N-antigen ≥ 1000 pg/mL was also tested.ResultsN-antigen on D0 was detectable in 84% of study participants. Plasma N-antigen levels significantly correlated with RAGE (r = 0.61), IL-10 (r = 0.59), and IP-10 (r = 0.59, adjusted p = 0.01 for all correlations). For the primary outcome of clinical status at one week, each 500 pg/mL increase in plasma N-antigen level was associated with an adjusted OR of 1.05 (95% CI 1.03-1.08) for worse WHO ordinal status. D0 plasma N-antigen ≥ 1000 pg/mL was 77% sensitive and 59% specific (AUROC 0.68) with a positive predictive value of 23% and a negative predictive value of 93% for a worse WHO ordinal scale at day 7 compared to baseline. D0 N-antigen concentration was independently associated with ICU admission and 28-day mechanical ventilation, but not with death at 28 days.ConclusionsPlasma N-antigen levels are readily measured and provide important insight into the pathogenesis and prognosis of COVID-19. The measurement of N-antigen levels early in-hospital course may improve risk stratification, especially for identifying patients who are unlikely to progress to severe disease.
Published: 2022

11. Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19

Author: Kuriakose, Safia, Singh, Kanal, Pau, Alice K, Daar, Eric, Gandhi, Rajesh, Tebas, Pablo, Evans, Laura, Gulick, Roy M, Lane, H Clifford, Masur, Henry, Aberg, Judith A, Adimora, Adaora A, Baker, Jason, Kreuziger, Lisa Baumann, Bedimo, Roger, Belperio, Pamela S, Cantrill, Stephen V, Coopersmith, Craig M, Davis, Susan L, Dzierba, Amy L, Gallagher, John J, Glidden, David V, Grund, Birgit, Hardy, Erica J, Hinkson, Carl, Hughes, Brenna L, Johnson, Steven, Keller, Marla J, Kim, Arthur Y, Lennox, Jeffrey L, Levy, Mitchell M, Li, Jonathan Z, Martin, Greg S, Naggie, Susanna, Pavia, Andrew T, Seam, Nitin, Simpson, Steven Q, Swindells, Susan, Tien, Phyllis, Waghmare, Alpana A, Wilson, Kevin C, Yazdany, Jinoos, Zachariah, Philip, Campbell, Danielle M, Harrison, Carly, Burgess, Timothy, Francis, Joseph, Sheikh, Virginia, Uyeki, Timothy M, Walker, Robert, Brooks, John T, Ortiz, Laura Bosque, Davey, Richard T, Doepel, Laurie K, Eisinger, Robert W, Han, Alison, Higgs, Elizabeth S, Nason, Martha C, Crew, Page, Lerner, Andrea M, Lund, Claire, and Worthington, Christopher
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Health Services, Clinical Research, Generic health relevance, Good Health and Well Being, Advisory Committees, COVID-19, Child, Data Interpretation, Statistical, Drug Approval, Evidence-Based Medicine, Female, Humans, Interprofessional Relations, National Institutes of Health (U.S.), Pandemics, Practice Guidelines as Topic, Pregnancy, SARS-CoV-2, Stakeholder Participation, United States, COVID-19 Drug Treatment, NIH COVID-19 Treatment Guidelines Panel, Medical and Health Sciences, General & Internal Medicine, Clinical sciences
Abstract: The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.
Published: 2021

12. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author: Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford
Published: 2023
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13. Convalescent Plasma for the Treatment of COVID-19: Perspectives of the National Institutes of Health COVID-19 Treatment Guidelines Panel

Author: Pau, Alice K, Aberg, Judith, Baker, Jason, Belperio, Pamela S, Coopersmith, Craig, Crew, Page, Glidden, David V, Grund, Birgit, Gulick, Roy M, Harrison, Carly, Kim, Arthur, Lane, H Clifford, Masur, Henry, Sheikh, Virginia, Singh, Kanal, Yazdany, Jinoos, and Tebas, Pablo
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Emerging Infectious Diseases, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, COVID-19, Humans, Immunization, Passive, National Institutes of Health (U.S.), Plasma, SARS-CoV-2, United States, COVID-19 Serotherapy, National Institutes of Health COVID-19 Treatment Guidelines Panel, Medical and Health Sciences, General & Internal Medicine, Clinical sciences
Abstract: In the United States, the efficacy and safety of convalescent plasma for treating coronavirus disease 2019 (COVID-19) is currently being tested in randomized placebo-controlled clinical trials. Treatment of individual patients with COVID-19 with convalescent plasma outside such trials is also now permitted through U.S. Food and Drug Administration Emergency Use Authorization. Here, members of the National Institutes of Health COVID-19 Treatment Guidelines Panel provide their views regarding use of convalescent plasma for treating COVID-19.
Published: 2021

14. Quantitative PET imaging of the CD4 pool in nonhuman primates

Author: Kim, Insook, Srinivasula, Sharat, DeGrange, Paula, Long, Brad, Jang, Hyukjin, Carrasquillo, Jorge A., Lane, H. Clifford, and Di Mascio, Michele
Published: 2022
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15. Pregnancy, pregnancy outcomes, and infant growth and development after recovery from Ebola virus disease in Liberia: an observational cohort study

Author: Fallah, Mosoka P, Reilly, Cavan, Van Ryn, Collin, Badio, Moses, Camanor, Sia Wata, Kaler, Stephen G, Johnson, Billy, Orone, Romeo, Flumo, Hilary, Moses, Soka J, Johnson, Kumblytee L, Gorpudolo, Nowiah, Gayedyu-Dennis, Dehkontee, Dighero-Kemp, Bonnie, Fayiah, John, Marron, Lindsay, Hensley, Lisa E, Taylor, Robert J, Higgs, Elizabeth S, Lane, H Clifford, Neaton, James D, and Sneller, Michael C
Published: 2023
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16. Remdesivir for the Treatment of Covid-19 — Final Report

Author: Beigel, John H, Tomashek, Kay M, Dodd, Lori E, Mehta, Aneesh K, Zingman, Barry S, Kalil, Andre C, Hohmann, Elizabeth, Chu, Helen Y, Luetkemeyer, Annie, Kline, Susan, Lopez de Castilla, Diego, Finberg, Robert W, Dierberg, Kerry, Tapson, Victor, Hsieh, Lanny, Patterson, Thomas F, Paredes, Roger, Sweeney, Daniel A, Short, William R, Touloumi, Giota, Lye, David Chien, Ohmagari, Norio, Oh, Myoung-Don, Ruiz-Palacios, Guillermo M, Benfield, Thomas, Fätkenheuer, Gerd, Kortepeter, Mark G, Atmar, Robert L, Creech, C Buddy, Lundgren, Jens, Babiker, Abdel G, Pett, Sarah, Neaton, James D, Burgess, Timothy H, Bonnett, Tyler, Green, Michelle, Makowski, Mat, Osinusi, Anu, Nayak, Seema, and Lane, H Clifford
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Clinical Trials and Supportive Activities, Clinical Research, Rehabilitation, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adenosine Monophosphate, Administration, Intravenous, Adult, Aged, Alanine, Antiviral Agents, Betacoronavirus, COVID-19, Coronavirus Infections, Double-Blind Method, Extracorporeal Membrane Oxygenation, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Oxygen Inhalation Therapy, Pandemics, Pneumonia, Viral, Respiration, Artificial, SARS-CoV-2, Time Factors, Young Adult, COVID-19 Drug Treatment, ACTT-1 Study Group Members, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract: BackgroundAlthough several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.MethodsWe conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.ResultsA total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P
Published: 2020

17. Dynamics of SARS-CoV-2 variants characterized during different COVID-19 waves in Mali

Author: Koné, Amadou, Diallo, Dramane, Kané, Fousseyni, Diarra, Bassirou, Coulibaly, Tenin Aminatou, Sameroff, Stephen C., Diarra, Hawa B., Diakité, Mahamane T., Camara, Fatoumata, Maiga, Oumou, Keita, Daouda, Dolo, Oumar, Somboro, Amadou, Coulibaly, Youssouf, Bane, Sidy, Togo, Antieme C.G., Somboro, Anou M., Togo, Josué, Coulibaly, Mariam, Coulibaly, Gagni, Kone, Mahamadou, Degoga, Boureima, Dramé, Hawa Baye, Traoré, Fah Gaoussou, Diallo, Fatimata, Sanogo, Fanta, Kone, Kadidia, Diallo, Ibrahima B., Sanogo, Moumine, Diakité, Mahamadou, Mishra, Nischay, Neal, Aaron, Saliba-Shaw, Katy, Sow, Ydrissa, Hensley, Lisa, Lane, H. Clifford, Briese, Thomas, Lipkin, W. Ian, and Doumbia, Seydou
Published: 2023
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18. Long-term persistence of transcriptionally active ‘defective’ HIV-1 proviruses: implications for persistent immune activation during antiretroviral therapy

Author: Singh, Kanal, Natarajan, Ven, Dewar, Robin, Rupert, Adam, Badralmaa, Yuden, Zhai, Tracey, Winchester, Nicole, Scrimieri, Francesca, Smith, Mindy, Davis, Ivery, Lallemand, Perrine, Giglietti, Aude, Hensien, Jack, Buerkert, Thomas, Goshu, Bruktawit, Rehm, Catherine A., Hu, Zonghui, Lane, H. Clifford, and Imamichi, Hiromi
Published: 2023
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19. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Author: Ginde, Adit A., Paredes, Roger, Murray, Thomas A., Engen, Nicole, Grandits, Greg, Vekstein, Andrew, Ivey, Noel, Mourad, Ahmad, Sandkovsky, Uriel, Gottlieb, Robert L., Berhe, Mezgebe, Jain, Mamta K., Marines-Price, Rubria, Agbor Agbor, Barbine Tchamba, Mateu, Lourdes, España-Cueto, Sergio, Lladós, Gemma, Mylonakis, Eleftherios, Rogers, Ralph, Shehadeh, Fadi, Filbin, Michael R., Hibbert, Kathryn A., Kim, Kami, Tran, Thanh, Morris, Peter E., Cassity, Evan P., Trautner, Barbara, Pandit, Lavannya M., Knowlton, Kirk U., Leither, Lindsay, Matthay, Michael A., Rogers, Angela J., Drake, Wonder, Jones, Beatrice, Poulakou, Garyfallia, Syrigos, Konstantinos N., Fernández-Cruz, Eduardo, Natale, Marisa Di, Almasri, Eyad, Balerdi-Sarasola, Leire, Bhagani, Sanjay R., Boyle, Katherine L., Casey, Jonathan D., Chen, Peter, Douin, David J., Files, D. Clark, Günthard, Huldrych F., Hite, R. Duncan, Hyzy, Robert C., Khan, Akram, Kibirige, Moses, Kidega, Robert, Kiweewa, Francis, Jensen, Jens-Ulrik, Leshnower, Bradley G., Lutaakome, Joseph K., Manian, Prasad, Menon, Vidya, Morales-Rull, Jose Luis, O'Mahony, D. Shane, Overcash, J. Scott, Ramachandruni, Srikant, Steingrub, Jay S., Taha, Hassan S., Waters, Michael, Young, Barnaby E., Phillips, Andrew N., Murray, Daniel D., Jensen, Tomas O., Padilla, Maria L., Sahner, David, Shaw-Saliba, Katy, Dewar, Robin L., Teitelbaum, Marc, Natarajan, Ven, Rehman, M. Tauseef, Pett, Sarah, Hudson, Fleur, Touloumi, Giota, Brown, Samuel M., Self, Wesley H., Chang, Christina C., Sánchez, Adriana, Weintrob, Amy C., Hatlen, Timothy, Grund, Birgit, Sharma, Shweta, Reilly, Cavan S., Garbes, Pedro, Esser, Mark T., Templeton, Alison, Babiker, Abdel G., Davey, Victoria J., Gelijns, Annetine C., Higgs, Elizabeth S., Kan, Virginia, Matthews, Gail, Thompson, B. Taylor, Neaton, James D., Lane, H. Clifford, and Lundgren, Jens D.
Published: 2022
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20. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author: Self, Wesley H., Sandkovsky, Uriel, Reilly, Cavan S., Vock, David M., Gottlieb, Robert L., Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R., Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R., Hibbert, Kathryn A., Rice, Todd W., Casey, Jonathan D., Hayanga, J. Awori, Badhwar, Vinay, Leshnower, Bradley G., Sharifpour, Milad, Knowlton, Kirk U., Peltan, Ithan D., Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E., Sturek, Jeffrey M., Rogers, Angela J., Files, D. Clark, Mosier, Jarrod M., Gong, Michelle N., Douin, David J., Hite, R. Duncan, Trautner, Barbara W., Jain, Mamta K., Gardner, Edward M., Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A., Ginde, Adit A., Brown, Samuel M., Higgs, Elizabeth S., Pett, Sarah, Weintrob, Amy C., Chang, Christina C., Murrary, Daniel D., Günthard, Huldrych F., Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N., Babiker, Abdel G., Davey, Victoria J., Kan, Virginia, Thompson, B. Taylor, Gelijns, Annetine C., Neaton, James D., Lane, H. Clifford, Jundgren, Jens D., Tierney, John, Barrett, Kevin, Herpin, Betsey R., Smolskis, Mary C., Voge, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J., Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, Murray, Thomas, Quan, Kien, Quan, Siu Fun, Thompson, Greg, Walski, Jamie, Wentworth, Deborah, Moskowitz, Alan J., Bagiella, Emilia, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Berhe, Mezgebe, Haley, Clinton, Bettacchi, Christopher, Duhaime, Erin, Ryan, Madison, Burris, Sarah, Jones, Felecia, Villa, Samantha, Want, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Marian, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Dreyer, Grace R., Witte, Marie, Mosaly, Nilima, Mourad, Ahmad, Holland, Thomas L., Lane, Kathleen, Bouffler, Andrew, McGowan, Lauren M., Motta, Marry, Tipton, Gregory, Stallings, Ben, Stout, Gennifer, McLendon-Arvik, Beth, Hollister, Beth A., Giangiacomo, Dana M., Sharma, Sunil, Pappers, Brian, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresio, Lisa, Glaze, Chad, Evans, Raquel, Preamble, Katarina, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Bartolo, Elizabeth Berry, Williams, Roger, Bunner, Robin, Bender, William, Miller, Jeffrey, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elizabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, May M., Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Lozano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Possemato, Tammie, Escobar, Jose, Chiu, Charlene, Weissman, Kevin, Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Jonathan, Vonderhaar, Derek, Nossaman, Bobby, Laudun, Sylvia, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Maroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberley, Audette, Matthew, Fleischmann, Emily, Akbari, Freshta, Lee, Maia, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Caccia, Taylor, Johnson, Haley, Newton, Crystallee, Parr, Doug, Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Fitzgerald, Laura, Morin, Haley D., Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Aggarwal, Neil R., Bienstock, Karen, Hou, Peter, Steingrub, Jay, Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Banner-Goodspeed, Valerie, Boyle, Katherine L., Hayes, Sharon, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah K., Parry, Blair Alden, Margolin, Justin D., Brait, Kelsey, Beakes, Caroline, Kangelaris, Kirsten N., Yee, Kimberly J., Ashktorab, Kimia, Jauregui, Alejandra E., Zhuo, Hanjing, Hendey, Gregory, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Wilson, Jennifer G., Vojnik, Rosemary, Roque, Jonasel, Perez, Cynthia, Lim, George W., Chang, Steven Y., Beutler, Rebecca, Agarwal, Trisha, Vargas, Julia, Moss, Marc, Baduashvili, Amiran, Chauhan, Lakshmi, Finck, Lani L., Howell, Michelle, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jia, Shijing, Sullins, Barbara, Hanna, Sinan, Olbrich, Norman, Richardson, Lynne D., Nair, Rahul, Offor, Obiageli, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Terndrup, Thomas E., Wiedemann, Herbert P., Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Hudock, Kristin, Kiran, Simra, More, Harshada, Roads, Tammy, Martinkovic, Jamie, Kennedy, Sarah, Robinson, Bryce H., Hough, Catherine L., Krol, Olivia F., Kinjal, Mistry, Mills, Emmanuel, McDougal, Madeline, Deshmukh, Rupali, Chen, Peter, Torbati, Sam S., Matusov, Yuri, Choe, June, Hindoyan, Niree A., Jackman, Susan E., Bayoumi, Emad, Wynter, Timothy, Caudill, Antonina, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Mehdikhani, Shaunt, O'Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Miller, Chadwick, Gibbs, Keven W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sara N., Mayer, Kirby P., Bissel, Brittany, Bledsoe, Joseph, Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Armbruster, Brent P., Montgomery, Quinn, Applegate, Darrin, Kumar, Naresh, Fergus, Melissa, Serezlic, Erna, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Aston, Valerie T., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Sánchez, Adriana, Popielski, Laura, Rivasplata, Heather, Turner, Melissa, Vjecha, Michael, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Lucas, Claudia Sanchez, DellaValle, Natalie, Gonzales, Sonia, Scott, James, Wyles, David, Douglas, Ivor, Haukoos, Jason, Kamis, Kevin, Robinson, Caitlin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Markowitz, Norman, Pastor, Erika, Ramesh, Mayur, Brar, Indira, Rivers, Emanuel, Kumar, Princy, Menna, Maximiliano, Biswas, Kousick, Harrington, Cristin, Delp, Alex, Pandit, Lavannya, Hines-Munson, Casey, Van, John, Dillon, Laura, Want, Yiqun, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Roller, Brentin, Nguyen, Chinh, Mikail, Amani, Raben, Dorthe, Jensen, Tomas O., Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esmann, Frederik V.L., Clausen, Clara Lundetoft, Hovmand, Nichlas, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Høgsberg, Dorthe S., Rastoder, Ema, Kamstrup, Thobias, Bergsøe, Christina Marisa, Østergaard, Lars, Stærke, Nina Breinholt, Johansen, Isik S., Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Helleberg, Marie, Gerstoft, Jan, Jensen, Tomas Østergaard, Lindegaard, Birgitte, Pedersen, Thomas Ingemann, Røge, Birgit Thorup, Løfberg, Sandra Valborg, Hansen, Thomas Michael, Nielsen, Ariella Denize, von Huth, Sebastian Leicht, Nielsen, Henrik, Thisted, Rikke Krog, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Lindnér, Cecilia Ebba Clara Ellinor, Wiese, Lothar, Knudsen, Lene Surland, Nytofte, Nikolaj Julian Skrøder, Havmøller, Signe Ravn, Paredes, Roger, Exposito, Maria, Fernández-Cruz, Eduardo, Muñoz, José, Arribas, Jose R., Estrada, Vicente, Horcajada, Juan P., Burgos, Joaquin, Morales-Rull, Jose Luis, Braun, Dominique L., West, Emily, M'Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, Horban, Andrzej, Bednarska, Agnieszka, Jurek, Natalia, Fätkenheuer, Gerd, Malinm, Jakob J., Matthews, Gail, Kelleher, Anthony, Cabrera, Gesalit, Carey, Catherine, Hough, Sally, Virachit, Sophie, Zhong, Amy, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David, Ong, Sean, Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Hudson, Fleur, Parmar, Mahesh KB, Goodman, Anna, Badrock, Jonathan, Gregory, Adam, Harris, Nicola, Touloumi, Giota, Pantaz, Nikos, Gioukari, Vicky, Lutaakome, Joseph, Kityo, Cissy M., Mugerwa, Henry, Kiweewa, Francis, Osinusi, Anu, Tipple, Craig, Willis, Angela, Peppercorn, Amanda, Watson, Helen, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Adams, Amy, Albert, Sara, Balde, Abby, Baracz, Michelle, Baseler, Beth, Becker, Nancy, Bielica, Mona, Billouin-Frazier, Shere, Cash, Jennifer, Choudhary, Jay, Dolney, Suzanne, Dixon, Mary, Eyler, Carolyn, Frye, Leanna, Galcik, Michael, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hissey, Debbie, Hogarty, Debi, Hohn, Matt, Holley, H Preston, Hoopengardner, Lisa, Huber, Lynda, Jankelevich, Shirley, Krauss, Gary, Lake, Eileen, Linton, Jessica, MacDonald, Leah, Manandhar, Meryan, Spinelli-Nadzam, Mary, Oluremi, Charles, Proffitt, Calvin, Rudzinski, Erin, Sandrus, Jen, Schaffhauser, Marylu, Schechner, Adam, Suders, Connie, Gerry, Norman P., Smith, Kenneth, Solomon, Courtney, Kubernac, Amanda, Rashid, Marium, Patel, Bhakti, Kubernac, Robert, Murphy, Joseph, Hoover, Marie L., Brown, Craig, DuChateau, Nadine, Flosi, Adam, Johnson, Les, Treagus, Amy, and Wenner, Christine
Published: 2022
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21. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

Author: Polizzotto, Mark N., Nordwall, Jacqueline, Babiker, Abdel G., Phillips, Andrew, Vock, David M., Eriobu, Nnakelu, Kwaghe, Vivian, Paredes, Roger, Mateu, Lourdes, Ramachandruni, Srikanth, Narang, Rajeev, Jain, Mamta K., Lazarte, Susana M., Baker, Jason V., Frosch, Anne E.P., Poulakou, Garyfallia, Syrigos, Konstantinos N., Arnoczy, Gretchen S., McBride, Natalie A., Robinson, Philip A., Sarafian, Farjad, Bhagani, Sanjay, Taha, Hassan S., Benfield, Thomas, Liu, Sean T.H., Antoniadou, Anastasia, Jensen, Jens Ulrik Stæhr, Kalomenidis, Ioannis, Susilo, Adityo, Hariadi, Prasetyo, Jensen MD, Tomas O., Morales-Rull, Jose Luis, Helleberg, Marie, Meegada, Sreenath, Johansen, Isik S., Canario, Daniel, Fernández-Cruz, Eduardo, Metallidis, Simeon, Shah, Amish, Sakurai, Aki, Koulouris, Nikolaos G., Trotman, Robin, Weintrob, Amy C., Podlekareva, Daria, Hadi, Usman, Lloyd, Kathryn M., Røge, Birgit Thorup, Saito, Sho, Sweerus, Kelly, Malin, Jakob J., Lübbert, Christoph, Muñoz, Jose, Cummings, Matthew J., Losso, Marcelo H., Turner, Dan, Shaw-Saliba, Kathryn, Dewar, Robin, Highbarger, Helene, Lallemand, Perrine, Rehman, Tauseef, Gerry, Norman, Arlinda, Dona, Chang, Christina C., Grund, Birgit, Holbrook, Michael R., Holley, Horace P., Hudson, Fleur, McNay, Laura A., Murray, Daniel D., Pett, Sarah L., Shaughnessy, Megan, Smolskis, Mary C., Touloumi, Giota, Wright, Mary E., Doyle, Mittie K., Popik, Sharon, Hall, Christine, Ramanathan, Roshan, Cao, Huyen, Mondou, Elsa, Willis, Todd, Thakuria, Joseph V., Yel, Leman, Higgs, Elizabeth, Kan, Virginia L., Lundgren, Jens D., Neaton, James D., and Lane, H. Clifford
Published: 2022
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22. Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial

Author: Beigel, John H, Aga, Evgenia, Elie-Turenne, Marie-Carmelle, Cho, Josalyn, Tebas, Pablo, Clark, Carol L, Metcalf, Jordan P, Ozment, Caroline, Raviprakash, Kanakatte, Beeler, Joy, Holley, H. Preston, Jr., Warner, Stephanie, Chorley, Carla, Lane, H. Clifford, Hughes, Michael D, Davey, Richard T, Barron, Michelle, Bastani, Aveh, Bauer, Philippe, Borkowsky, William, Cairns, Charles, Deville, Jaime, Elie, Marie-Carmelle, Fichtenbaum, Carl, Finberg, Robert, Jain, Mamta, Kaufman, David, Lin, Michael, Lin, John, Maves, Ryan, Morrow, Lee, Nguyen, Minh-Hong, Park, Pauline, Polk, Christopher, Randolph, Adrienne, Rao, Suchitra, Rubinson, Lewis, Schofield, Christina, Shoham, Shmuel, Stalets, Erika, Stapleton, Renee D, Holley, H Preston, Jr, Lane, H Clifford, and Davey, Richard T, Jr
Published: 2019
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23. Defective HIV-1 proviruses produce viral proteins

Author: Imamichi, Hiromi, Smith, Mindy, Adelsberger, Joseph W., Izumi, Taisuke, Scrimieri, Francesca, Sherman, Brad T., Rehm, Catherine A., Imamichi, Tomozumi, Pau, Alice, Catalfamo, Marta, Fauci, Anthony S., and Lane, H. Clifford
Published: 2020

24. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Author: Beigel, John H, Tebas, Pablo, Elie-Turenne, Marie-Carmelle, Bajwa, Ednan, Bell, Todd E, Cairns, Charles B, Shoham, Shmuel, Deville, Jaime G, Feucht, Eric, Feinberg, Judith, Luke, Thomas, Raviprakash, Kanakatte, Danko, Janine, O'Neil, Dorothy, Metcalf, Julia A, King, Karen, Burgess, Timothy H, Aga, Evgenia, Lane, H Clifford, Hughes, Michael D, Davey, Richard T, Team, IRC002 Study, Quinn, Joseph, Jiang, Yan, Hoelle, Robyn, Iovine, Nicole, Wills, Robert Shawn, Pata, Socorro, Huggins, Monique, Manukian, Belinda, Holland, Carrie, Brait, Kelsey, Hunt, Taylor, Stowell, Christopher, Slater, Amy, Townsends, Mary, Quackenbush, Eugenia B, Park, Yara A, Jordan, Paul Gaither, Blanchet, Cherie, Chronowski, Kevin, Alvarez, Kathleen, Ostrander, Darin, Woessner, Terry, Thoman, Sandra, Lin, James, Ziman, Alyssa, Shankar, Kavita, Blok, Tom, Batts, Don, Beck, Bob, Massey, Gail, Bradley, Carol, Carey, Patricia, Baer, Jenifer, Whitehead, Eva Moore, Kohrs, Sharon, Giulitto, Robert, Schofield, Christina, Fairchok, Mary, Chambers, Susan, Baker, Cindy, RN, Parker, Michelle, Harshbarger, Marta, Nguyen, M Hong, Carey, Mary Ellen, Paronish, Julie, Cornell, Frank, Cramer, Jim, Pakstis, Diana Lynn, Ison, Michael G, Wunderink, Richard, Glesby, Marshall, Ham, Kirsis, Hughes, Valery, Cushing, Melissa, Goss, Cheryl, Grenade, Joanne, Park, Pauline K, Napolitano, Lena M, Raghavendran, Krishnan, Hyzy, Robert C, Davenport, Robertson, Brierley, Kristin, Downs, Theresa, Gong, Michelle Ng, Uehlinger, Joan, Lin, Michael, Fritsche, Janice, and Green, Tondria
Subjects: Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Health Services, Clinical Research, Influenza, Pneumonia & Influenza, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Aged, Blood Component Transfusion, Case-Control Studies, Female, Humans, Influenza, Human, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Plasma, Respiration, Artificial, Treatment Outcome, IRC002 Study Team, Public Health and Health Services, Other Medical and Health Sciences, Cardiovascular medicine and haematology, Clinical sciences
Abstract: BackgroundInfluenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza.MethodsIn this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20-38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480.FindingsBetween Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96-3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02-1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4-16] vs 11 days [5-25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0-6] vs 3 days [0-14], p=0·14). Fewer plasma plus standard care participants had serious adverse events compared with standard care alone recipients (nine [20%] of 46 vs 20 [38%] of 52, p=0·041), the most frequent of which were acute respiratory distress syndrome (one [2%] vs two [4%] patients) and stroke (one [2%] vs two [4%] patients).InterpretationAlthough there was no significant effect of plasma treatment on the primary endpoint, the treatment seemed safe and well tolerated. A phase 3 randomised trial is now underway to further assess this intervention.FundingNational Institute of Allergy and Infectious Diseases, US National Institutes of Health.
Published: 2017

25. Transcriptionally Active Defective HIV-1 Proviruses and Their Association With Immunological Nonresponse to Antiretroviral Therapy.

Author: Scrimieri, Francesca, Bastian, Estella, Smith, Mindy, Rehm, Catherine A, Morse, Caryn, Kuruppu, Janaki, McLaughlin, Mary, Chang, Weizhong, Sereti, Irini, Kovacs, Joseph A, Lane, H Clifford, and Imamichi, Hiromi
Subjects: ANTIRETROVIRAL agents, HIV, NEGATIVE regulatory factor, T cells
Abstract: A subset of antiretroviral therapy-treated persons with human immunodeficiency virus (HIV), referred to as immunological nonresponders (INRs), fails to normalize CD4+ T-cell numbers. In a case-control study involving 26 INRs (CD4 < 250 cells/µL) and 25 immunological responders (IRs; CD4 ≥ 250 cells/µL), we evaluated the potential contribution of transcriptionally competent defective HIV-1 proviruses to poor CD4+ T-cell recovery. Compared to the responders, the INRs had higher levels of cell-associated HIV RNA (P =.034) and higher percentages of HLA-DR+ CD4+ T cells (P <.001). While not encoding replication-competent viruses, the RNA transcripts frequently encoded HIV-1 Gag-p17 and Nef proteins. These transcripts and/or resulting proteins may activate pathway(s) leading to the immunological nonresponse phenotype. [ABSTRACT FROM AUTHOR]
Published: 2024
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26. Vaccines for Mpox — An Unmet Global Need

Author: Dodd, Lori E., primary, Lane, H. Clifford, additional, and Muyembe-Tamfum, Jean-Jacques, additional
Published: 2024
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27. Expanded Access of Unproven Drugs: Not the Final Word.

Author: Lane, H. Clifford and Fauci, Anthony S.
Subjects: PREVENTION of epidemics, HEALTH services accessibility, MONKEYPOX, INFECTIOUS disease transmission
Abstract: Mpox caught the attention of the general public following the global outbreak of clade IIb disease that began in 2022. This outbreak, predominantly due to human-to-human transmission of clade IIb infection, with a high proportion of cases occurring in men who have sex with men, led to the World Health Organization (WHO) classifying it as a public health emergency of international concern (PHEIC) from July 2022 to May 2023. A second PHEIC due to mpox was declared in August 2024 due to the increased spread of clade Ib disease in Africa, again related to an increase in cases due to sexual transmission. [ABSTRACT FROM AUTHOR]
Published: 2024
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28. The Past Need Not Be Prologue : Recommendations for Testing and Positioning the Most-Promising Medical Countermeasures for the Next Outbreak of Ebola Virus Infection

Author: Davey, Richard T., Dodd, Lori, Proschan, Michael, Jahrling, Peter, Hensley, Lisa, Higgs, Elizabeth, and Lane, H. Clifford
Published: 2018

29. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

Author: Davey, Richard T, Fernández-Cruz, Eduardo, Markowitz, Norman, Pett, Sarah, Babiker, Abdel G, Wentworth, Deborah, Khurana, Surender, Engen, Nicole, Gordin, Fred, Jain, Mamta K, Kan, Virginia, Polizzotto, Mark N, Riska, Paul, Ruxrungtham, Kiat, Temesgen, Zelalem, Lundgren, Jens, Beigel, John H, Lane, H Clifford, Neaton, James D, Butts, Jessica, Denning, Eileen, DuChene, Alain, Krum, Eric, Harrison, Merrie, Meger, Sue, Peterson, Ross, Quan, Kien, Shaughnessy, Megan, Thompson, Greg, Vock, David, Metcalf, Julia, Dewar, Robin, Rehman, Tauseef, Natarajan, Ven, McConnell, Rose, Flowers, Emily, Smith, Kenny, Hoover, Marie, Coyle, Elizabeth M, Munroe, David, Aagaard, Bitten, Pearson, Mary, Cursley, Adam, Webb, Helen, Hudson, Fleur, Russell, Charlotte, Sy, Aminata, Purvis, Cara, Jackson, Brooke, Collaco-Moraes, Yolanda, Carey, Dianne, Robson, Rosemary, Sánchez, Adriana, Finley, Elizabeth, Conwell, Donna, Losso, Marcelo H, Gambardella, Luciana, Abela, Cecilia, Lopez, Paco, Alonso, Helena, Touloumi, Giota, Gioukari, Vicky, Anagnostou, Olga, Avihingsanon, Anchalee, Pussadee, Kanitta, Ubolyam, Sasiwimol, Omotosho, Bola, Solórzano, Clemencia, Petersen, Tianna, Vysyaraju, Kranthi, Rizza, Stacey A, Whitaker, Jennifer A, Nahra, Raquel, Baxter, John, Coburn, Patricia, Gardner, Edward M, Scott, James A, Faber, Leslie, Pastor, Erica, Makohon, Linda, MacArthur, Rodger A, Hillman, L Monique, Farrough, Marti J, Polenakovik, Hari M, Clark, Linda A, Colon, Roberto J, Kunisaki, Ken M, DeConcini, Miranda, Johnson, Susan A, Wolfe, Cameron R, Mkumba, Laura, Carbonneau, June Y, Morris, Alison, Fitzpatrick, Meghan E, Kessinger, Cathy J, Salata, Robert A, Arters, Karen A, Tasi, Catherine M, Panos, Ralph J, Lach, Laura A, Glesby, Marshall J, Ham, Kirsis A, Hughes, Valery G, Schooley, Robert T, Crouch, Daniel, Muttera, Leticia, Novak, Richard M, Bleasdale, Susan C, Zuckerman, Ariel E, Manosuthi, Weerawat, Thaonyen, Supeda, Chiewcharn, Thaniya, Suwanpimolkul, Gompol, Gatechumpol, Sivaporn, Bunpasang, Sirikunya, Angus, Brian J, Anderson, Monique, Morgan, Marcus, Minton, Jane, Gkamaletsou, Maria N, Hambleton, Joe, Price, David A, Llewelyn, Martin J, Sweetman, Jonathan, Carbone, Javier, Arribas, Jose R, Montejano, Rocio, Lobo Beristain, Jose L, Martinez, Iñaki Z, Barberan, Jose, Hernandez, Paola, Dwyer, Dominic E, Kok, Jen, Borges, Alvaro, Brandt, Christian T, Knudsen, Lene S, Sypsas, Nikolaos, Constantinou, Costas, Markogiannakis, Antonios, Zakynthinos, Spyros, Katsaounou, Paraskevi, Kalomenidis, Ioannis, Mykietiuk, Analia, Alzogaray, Maria F, Obed, Mora, Macias, Laura M, Ebensrtejin, Juan, Burgoa, Patricia, Nannini, Esteban, Lahitte, Matias, Perez-Patrigeon, Santiago, Martínez-Orozco, José Arturo, Ramírez-Hinojosa, Juan Pablo, and Davey, Richard T, Jr
Published: 2019
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30. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author: Brown, Samuel M, primary, Barkauskas, Christina E, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Phillips, Andrew N, additional, Leither, Lindsay, additional, Peltan, Ithan D, additional, Lanspa, Michael, additional, Gilstrap, Daniel L, additional, Mourad, Ahmad, additional, Lane, Kathleen, additional, Beitler, Jeremy R, additional, Serra, Alexis L, additional, Garcia, Ivan, additional, Almasri, Eyad, additional, Fayed, Mohamed, additional, Hubel, Kinsley, additional, Harris, Estelle S, additional, Middleton, Elizabeth A, additional, Barrios, Macy A G, additional, Mathews, Kusum S, additional, Goel, Neha N, additional, Acquah, Samuel, additional, Mosier, Jarrod, additional, Hypes, Cameron, additional, Salvagio Campbell, Elizabeth, additional, Khan, Akram, additional, Hough, Catherine L, additional, Wilson, Jennifer G, additional, Levitt, Joseph E, additional, Duggal, Abhijit, additional, Dugar, Siddharth, additional, Goodwin, Andrew J, additional, Terry, Charles, additional, Chen, Peter, additional, Torbati, Sam, additional, Iyer, Nithya, additional, Sandkovsky, Uriel S, additional, Johnson, Nicholas J, additional, Robinson, Bryce R H, additional, Matthay, Michael A, additional, Aggarwal, Neil R, additional, Douglas, Ivor S, additional, Casey, Jonathan D, additional, Hache-Marliere, Manuel, additional, Georges Youssef, J, additional, Nkemdirim, William, additional, Leshnower, Brad, additional, Awan, Omar, additional, Pannu, Sonal, additional, O'Mahony, Darragh Shane, additional, Manian, Prasad, additional, Awori Hayanga, J W, additional, Wortmann, Glenn W, additional, Tomazini, Bruno M, additional, Miller, Robert F, additional, Jensen, Jens-Ulrik, additional, Murray, Daniel D, additional, Bickell, Nina A, additional, Zatakia, Jigna, additional, Burris, Sarah, additional, Higgs, Elizabeth S, additional, Natarajan, Ven, additional, Dewar, Robin L, additional, Schechner, Adam, additional, Kang, Nayon, additional, Arenas-Pinto, Alejandro, additional, Hudson, Fleur, additional, Ginde, Adit A, additional, Self, Wesley H, additional, Rogers, Angela J, additional, Oldmixon, Cathryn F, additional, Morin, Haley, additional, Sanchez, Adriana, additional, Weintrob, Amy C, additional, Cavalcanti, Alexandre Biasi, additional, Davis-Karim, Anne, additional, Engen, Nicole, additional, Denning, Eileen, additional, Taylor Thompson, B, additional, Gelijns, Annetine C, additional, Kan, Virginia, additional, Davey, Victoria J, additional, Lundgren, Jens D, additional, Babiker, Abdel G, additional, Neaton, James D, additional, Lane, H Clifford, additional, Tierney, John, additional, Vogel, Susan E., additional, McNay, Laura A., additional, Cahill, Kelly, additional, Crew, Page, additional, Sardana, Ratna, additional, Segal Raim, Sharo, additional, Shaw-Saliba, Katy, additional, Atri, Negin, additional, Miller, Mark, additional, Vallee, David, additional, Chung, Lucy, additional, Delph, Yvette, additional, Adam, Stacey J., additional, Read, Sarah, additional, Draghia-Akli, Ruxandra, additional, Harrigan, Rachel, additional, Carlsen, Amy, additional, Carter, Anita, additional, DuChene, Alain, additional, Eckroth, Kate, additional, Frase, Alex, additional, Harrison, Merrie, additional, Meger, Sue, additional, Quan, Kien, additional, Quan, Siu Fun, additional, Reilly, Cavan, additional, Thompson, Greg, additional, Walski, Jamie, additional, Moskowitz, Alan J., additional, Bagiella, Emilia, additional, Moquete, Ellen, additional, O'Sullivan, Karen, additional, Marks, Mary E., additional, Accardi, Evan, additional, Kinzel, Emily, additional, Bedoya, Gabriela, additional, Gupta, Lopa, additional, Overbey, Jessica R., additional, Padillia, Maria L., additional, Santos, Milerva, additional, Gillinov, Marc A., additional, Miller, Marissa A., additional, Taddei-Peters, Wendy C., additional, Fenton, Kathleen, additional, Smith, Peter K., additional, Vekstein, Andrew M., additional, Ko, Emily R., additional, Al-Hegelan, Mashael S., additional, McGowan, Lauren M., additional, Motta, Mary, additional, Howell, Shauna, additional, Bent, Francine, additional, Kalager, Rachel, additional, Chan, Emmanuel, additional, Aloor, Heather L., additional, Griffin, S. Michelle, additional, Covington, Anna, additional, McLendon-Arvik, Beth, additional, Bussadori, Barbara, additional, Miller-Bell, Mary, additional, Sampey, Cathy, additional, Gaver, Vincent, additional, Hollister, Beth A., additional, Giangiacomo, Dana M., additional, Pauley, Alena, additional, Patel, Aashay, additional, Classon, Chris, additional, Frazier, Madison, additional, Osborne, Robyn, additional, Conlon, Debbi H., additional, Joshi, Marybeth, additional, Gottlieb, Robert L., additional, Mack, Michael, additional, Berhe, Mezgebe, additional, Haley, Clinton, additional, Dishner, Emma, additional, Bettacchi, Christopher, additional, Golden, Kevin, additional, Duhaime, Erin, additional, Ryan, Madison, additional, Tallmadge, Catherine, additional, Estrada, Lorie, additional, Jones, Felecia, additional, Villa, Samantha, additional, Wang, Samantha, additional, Robert, Raven, additional, Coleman, Tanquinisha, additional, Clariday, Laura, additional, Baker, Rebecca, additional, Hurutado-Rodriguez, Mariana, additional, Iram, Nazia, additional, Fresnedo, Michelle, additional, Davis, Allyson, additional, Leonard, Kiara, additional, Ramierez, Noelia, additional, Thammavong, Jon, additional, Duque, Krizia, additional, Turner, Emma, additional, Fisher, Tammy, additional, Robinson, Dianna, additional, Ransom, Desirae, additional, Maldonado, Nicholas, additional, Lusk, Erica, additional, Killian, Aaron, additional, Palacios, Adriana, additional, Solis, Edilia, additional, Jerrow, Janet, additional, Watts, Matthew, additional, Whitacre, Heather, additional, Cothran, Elizabeth, additional, Bender, William, additional, Miller, Jeffrey, additional, Nugent, Katherine, additional, Farrington, Woodrow, additional, Baio, Kim T., additional, McBride, Mary K., additional, Fielding, Michele, additional, Mathewson, Sonya, additional, Porte, Kristina, additional, Haley, Elizabeth, additional, Rogers, Susan, additional, Tyler, Derrick, additional, Perin, Emerson, additional, Costello, Briana, additional, Postalian, Alexander, additional, Sohail, Rizwan, additional, Hinsu, Punit, additional, Watson, Carolyn, additional, Kappenman, Casey, additional, Chen, James, additional, Walker, Kim, additional, Fink, Melyssa, additional, Phillip, Gabrielle, additional, Mahon, Kim, additional, Sturgis, Lydia, additional, Maher, Patrick, additional, Rogers, Linda, additional, Ng, Nicole, additional, Marshall, Jason, additional, Bassily-Marcus, Adel, additional, Cohen, Ivy, additional, Ramoo, Shamini, additional, Malhotra, Aryan, additional, Kessler, Jonathan, additional, Goetz, Rebekah, additional, Badhwar, Vinay, additional, Hayanga, Jeremiah, additional, Giblin Sutton, Lisa, additional, Williams, Roger, additional, Berry Bartolo, Elizabeth, additional, Walker, Dmitry, additional, Bunner, Robin, additional, Glaze, Chad, additional, Aucremanne, Tanja, additional, Bishop, James, additional, Kelley, Macey, additional, Peterson, Autumn, additional, Sauerborn, Erica, additional, Reckart, Robin, additional, Miller, Brittany, additional, Mittel, Aaron, additional, Darmanian, Anita, additional, Rosen, Amanda, additional, Madahar, Purnema, additional, Schicchi, John, additional, Gosek, Katarzyna, additional, Dzierba, Amy, additional, Wahab, Romina, additional, Eng, Connie, additional, Al-Saadi, Mukhtar, additional, Zahiruddin, Faisal, additional, Syed, Mohi, additional, George, Michael, additional, Patel, Varsha, additional, Onwunyi, Chisom, additional, Barroso da Costa, Rosa, additional, North, Crystal, additional, Ringwood, Nancy, additional, Fitzgerald, Laura, additional, Muzikansky, Ariela, additional, Morse, Richard, additional, Brower, Roy G., additional, Reineck, Lora A., additional, Bienstock, Karen, additional, Hou, Peter, additional, Steingrub, Jay S., additional, Tidswell, Mark A., additional, Kozikowski, Lori-Ann, additional, Kardos, Cynthia, additional, De Souza, Leslie, additional, Talmor, Daniel, additional, Shapiro, Nathan, additional, Hibbert, Kathryn, additional, Brait, Kelsey, additional, Kone, Mamary, additional, Hendey, Gregory, additional, Kangelaris, Kirsten N., additional, Ashktorab, Kimia, additional, Gropper, Rachel, additional, Agrawal, Anika, additional, Timothy, Kelly, additional, Zhou, Hanjing, additional, Hughes, Alyssa, additional, Garcia, Rebekah, additional, Torres, Adrian, additional, Hernandez-Almaraz, Maria Elena, additional, Vojnik, Rosemary, additional, Perez, Cynthia, additional, McDowell, Jordan, additional, Chang, Steven Y., additional, Vargas, Julia, additional, Moss, Marc, additional, McKeehan, Jeffrey, additional, Higgins, Carrie, additional, Johnson, Emily, additional, Slaughter, Suzanne, additional, Wyles, David, additional, Hiller, Terra, additional, Oakes, Judy, additional, Garcia, Ana, additional, Gravitz, Stephanie, additional, Lyle, Carolynn, additional, Swanson, Diandra, additional, Gong, Michelle Ng., additional, Richardson, Lynnne D., additional, Chen, Jen-Ting, additional, Moskowitz, Ari, additional, Mohamed, Amira, additional, Lopez, Brenda, additional, Amosu, Omowunmi, additional, Tzehaie, Hiwet, additional, Boujid, Sabah, additional, Bixby, Billie, additional, Lopez, Anitza A., additional, Durley, JaVon, additional, Gilson, Boris, additional, Hite, R. Duncan, additional, Wang, Henry, additional, Wiedemann, Hebert P., additional, Mehkri, Omar, additional, Ashok, Kiran, additional, King, Alexander, additional, Brennan, Connery, additional, Exline, Matthew C., additional, Englert, Joshua A., additional, Karow, Sarah, additional, Schwartz, Elizabeth, additional, So, Preston, additional, So, Madison, additional, Krol, Olivia F., additional, Briceno Parra, Genesis I., additional, Mills, Emmanuel Nii Lantei, additional, Oh, Minn, additional, Pena, Jose, additional, Martínez, Jesús Alejandro, additional, Jackman, Susan E., additional, Bayoumi, Emad, additional, Pascual, Ethan, additional, Caudill, Antonina, additional, Chen, Po-En, additional, Richardson, Tabia, additional, Clapham, Gregg J., additional, Herrera, Lisa, additional, Ojukwu, Cristabelle, additional, Fine, Devin, additional, Gomez, Millie J., additional, Choi-Kuaea, Yunhee, additional, Weissberg, Gwendolyn, additional, Isip, Katherine, additional, Mattison, Brittany, additional, Tran, Dana, additional, Emilov Dukov, Jennifer, additional, Chung, Paul, additional, Kang, Bo Ran, additional, Escobar, Lauren, additional, Tran, Trung, additional, Baig, Saba, additional, Wallick, Julie A., additional, Duven, Alexandria M., additional, Fletcher, Dakota D., additional, Gundel, Stephanie, additional, Fuentes, Megan, additional, Newton, Maranda, additional, Peterson, Emily, additional, Jiang, Kelsey, additional, Files, D. Clark, additional, Miller, Chadwick, additional, Lematty, Caitlin, additional, Rasberry, April, additional, Warden, Ashley, additional, Bledsoe, Joseph, additional, Knowlton, Kirk, additional, Knox, Daniel B., additional, Klippel, Carolyn, additional, Armbruster, Brent P., additional, Applegate, Darrin, additional, Imel, Karah, additional, Fergus, Melissa, additional, Rahmati, Kasra, additional, Jensen, Hannah, additional, Aston, Valerie T., additional, Jeppson, Joshua, additional, Marshall, J. Hunter, additional, Lumpkin, Jenna, additional, Smith, Cassie, additional, Burke, Tyler, additional, Gray, Andrew, additional, Paine, Robert, additional, Callahan, Sean, additional, Yamane, Misty, additional, Waddoups, Lindsey, additional, Rice, Todd W., additional, Johnson, Jakea, additional, Gray, Christopher, additional, Hays, Margaret, additional, Roth, Megan, additional, Musick, Sarah, additional, Miller, Karen, additional, Semler, Matthew W., additional, Popielski, Laura, additional, Kambo, Amy, additional, Viens, Kimberly, additional, Turner, Melissa, additional, Vjecha, Michael J., additional, Denyer, Rachel, additional, Khosla, Rahul, additional, Rajendran, Bindu, additional, Gonzales, Melissa, additional, Moriarty, Theresa, additional, Biswas, Kousick, additional, Harrington, Cristin, additional, Garcia, Amanda, additional, Bremer, Tammy, additional, Burke, Tara, additional, Koker, Brittany, additional, Pittman, David, additional, Vasudeva, Shikha S., additional, Anholm, James D., additional, Specht, Lennard, additional, Rodriguez, Aimee, additional, Ngo, Han, additional, Duong, Lien, additional, Previte, Matthew, additional, Raben, Dorthe, additional, Nielsen, Charlotte B., additional, Friis Larsen, Jakob, additional, Peters, Lars, additional, Matthews, Gail, additional, Kelleher, Anthony, additional, Polizzotto, Mark, additional, Carey, Catherine, additional, Chang, Christina, additional, Dharan, Nila, additional, Hough, Sally, additional, Virachit, Sophie, additional, Davidson, Sarah, additional, Bice, Daniel J., additional, Ognenovska, Katherine, additional, Cabrera, Gesalit, additional, Flynn, Ruth, additional, Abdelghany, Mazin, additional, Baseler, Beth, additional, Teitelbaum, Marc, additional, Holley, H. Preston, additional, Jankelevich, Shirley, additional, Adams, Amy, additional, Becker, Nancy, additional, Doleny, Suzanne, additional, Hissey, Debbie, additional, Simpson, Shelly, additional, Kim, Mi Ha, additional, Beeler, Joy, additional, Harmon, Liam, additional, Vanderpuye, Sharon, additional, Yeon, Lindsey, additional, Frye, Leanna, additional, Rudzinski, Erin, additional, Buehn, Molly, additional, Eccard-Koons, Vanessa, additional, Frary, Sadie, additional, MacDonalad, Leah, additional, Cash, Jennifer, additional, Hoopengardner, Lisa, additional, Linton, Jessica, additional, Nelson, Michaela, additional, Spinelli-Nadzam, Mary, additional, Proffitt, Calvin, additional, Lee, Christopher, additional, Engel, Theresa, additional, Fontaine, Laura, additional, Osborne, CK, additional, Hohn, Matt, additional, Galcik, Michael, additional, Thompson, DeeDee, additional, Sandrus, Jen, additional, Manchard, Jon, additional, Giri, Jiwan, additional, Kopka, Stacy, additional, Chang, Weizhong, additional, Sherman, Brad T., additional, Rupert, Adam W., additional, Highbarger, Helene, additional, Baseler, Michael, additional, Lallemand, Perrine, additional, Rehman, Tauseef, additional, Imamichi, Tom, additional, Laverdure, Sylvain, additional, Paudel, Sharada, additional, Cook, Kyndal, additional, Haupt, Kendra, additional, Hazen, Allison, additional, Badralmaa, Yunden, additional, Highbarger, Jeroen, additional, McCormack, Ashley, additional, Gerry, Norman P., additional, Smith, Kenneth, additional, Patel, Bhakti, additional, Domeraski, Nadia, additional, Hoover, Marie L., additional, DuChateau, Nadine, additional, Flosi, Adam, additional, Nelson, Rich, additional, Stojanovic, Jelena, additional, and Wenner, Christine, additional
Published: 2023
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31. Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial

Author: Winnie, Michael, Dinh, Dinh V, Seethala, Raghu, Garcia, Hiram, Pouzar, Joe, Seep, Michael, Riffer, Ernie, Bart, Belinda, Dar, Sadia, Hoppers, Melanie, Panuto, John, Rowe, Heather, Slandzicki, Alex, Wolfe, Cameron, Desantis, Donna, Baynton, Barr, Beasley, Richard L, Markowitz, Norman, Stearns, Zebediah A, Cho, Josalyn, Goisse, Marcy, Wolf, Thomas A, Kay, Jennifer, Dharan, Nila, Fitzgibbons, William, Woodruff, Mark, Bell, Todd, Lenzmeier, Thomas, Schooley, Robert, Elie, Marie-Carmelle, Winokur, Patricia, Finberg, Robert, Hurt, Christopher, Tebas, Pablo, Sattler, Fred R, Ampajwala, Madhavi, Batts, Donald, Bloch, Mark, Moore, Richard, Dwyer, Dominic, Romo-Garcia, Javier, Patrigeon, Santiago Perez, Zulueta, Ana Patricia Rodríguez, Manosuthi, Weerawat, Chetchotisakd, Ploenchan, Ruxrungtham, Kiat, Avihingsanon, Anchalee, Suwanpimolkul, Gompol, Ratanasuwan, Winai, Lupo, Sergio, Trape, Liliana, Losso, Marcelo H, Macias, Laura M, Lopardo, Gustavo, Barcelona, Laura, Mykietuk, Analia, Alzogaray, Maria F, Beigel, John H, Bao, Yajing, Beeler, Joy, Dar, Sadia M, Perez-Patrigeon, Santiago, McClure, Natalie, Bozzolo, Dawn R, Myers, Christopher, Holley, H Preston, Jr, Hoopes, Justin, Lane, H Clifford, Hughes, Michael D, and Davey, Richard T
Published: 2017
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32. Genome-wide association study of high-sensitivity C-reactive protein, D-dimer, and interleukin-6 levels in multiethnic HIV+ cohorts

Author: Sherman, Brad T., Hu, Xiaojun, Singh, Kanal, Haine, Lillian, Rupert, Adam W., Neaton, James D., Lundgren, Jens D., Imamichi, Tomozumi, Chang, Weizhong, and Lane, H. Clifford
Published: 2021
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33. CD4 Cell Response to 3 Doses of Subcutaneous Interleukin 2: Meta-Analysis of 3 Vanguard Studies

Author: Fosdick, Lisa, Tavel, Jorge A., Davey, Richard T., and Lane, H. Clifford
Published: 2004

34. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Author: Tebas, Pablo, Quinn, Joseph, Jiang, Yan, Elie-Turenne, Marie-Carmelle, Hoelle, Robyn, Iovine, Nicole, Wills, Robert Shawn, Pata, Socorro, Huggins, Monique, Manukian, Belinda, Bajwa, Ednan, Holland, Carrie, Brait, Kelsey, Hunt, Taylor, Stowell, Christopher, Slater, Amy, Bell, Todd E, Townsends, Mary, Cairns, Charles B, Quackenbush, Eugenia B, Park, Yara A, Jordan, Paul Gaither, Blanchet, Cherie, Chronowski, Kevin, Alvarez, Kathleen, Shoham, Shmuel, Ostrander, Darin, Woessner, Terry, Thoman, Sandra, Deville, Jaime G, Lin, James, Ziman, Alyssa, Shankar, Kavita, Feucht, Eric, Blok, Tom, Batts, Don, Beck, Bob, Massey, Gail, Bradley, Carol, Feinberg, Judith, Carey, Patricia, Baer, Jenifer, Whitehead, Eva Moore, Kohrs, Sharon, Giulitto, Robert, Schofield, Christina, Fairchok, Mary, Chambers, Susan, Baker, Cindy, RN, Parker, Michelle, Harshbarger, Marta, Nguyen, M Hong, Carey, Mary Ellen, Paronish, Julie, Cornell, Frank, Cramer, Jim, Pakstis, Diana Lynn, Ison, Michael G, Wunderink, Richard, Glesby, Marshall, Ham, Kirsis, Hughes, Valery, Cushing, Melissa, Goss, Cheryl, Grenade, Joanne, Park, Pauline K, Napolitano, Lena M, Raghavendran, Krishnan, Hyzy, Robert C, Davenport, Robertson, Brierley, Kristin, Downs, Theresa, Gong, Michelle Ng, Uehlinger, Joan, Lin, Michael, Fritsche, Janice, Green, Tondria, McLeod, Bruce, Patel, Deena, Bavaro, Mary F, Deiss, Robert, Brandt, Carolyn, Cammarata, Stephanie, Kremp, Allan, Hollis-Perry, Karine, Lalani, Tahaniyat, Banks, Susan, Johnson, Jacqueline, Maguire, Jason, McNiff, Janet, Rigg, Leslie E, Ganesan, Anuradha, Barahona, Irma, Danko, Janine, Spencer, Steven, Stagliano, David, Burgess, Timothy, Talmor, Daniel, Mohammed, Monique, Banner-Goodspeed, Valerie, Salata, Robert, Finberg, Robert, Wang, Jennifer, Longtine, Karen, Longtine, Jaclyn, O'Neil, Mellissa, Bauer, Philippe R, Gajic, Ognjen, Weist, Suanne M, Sevransky, Jonathan, Brown, Mona, Roback, John, Oropello, John, Twohig, Bridget, Jhang, Jeffrey, Seethala, Rahgu, Chen, Wilbur H, Fontaine, Magali, Saharia, Kapil, Husson, Jennifer, DeBiasi, Roberta, Wilson, Jurran L, Criss, Valli Ree, Voell, Jocelyn, Leitman, Susan, Atkins, James Wade, Patel, Hemaxi, Paige, Traci, Cantilena, Cathy, Siegel, Donald, DeMuth, Faye, Fletcher, Craig H, Pelletier, J Peter R, Alnuaimat, Hassan, Pourde, Michelle, Beigel, John H, Luke, Thomas, Raviprakash, Kanakatte, O'Neil, Dorothy, Metcalf, Julia A, King, Karen, Burgess, Timothy H, Aga, Evgenia, Lane, H Clifford, Hughes, Michael D, and Davey, Richard T
Published: 2017
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35. Amino Acid Deletions Are Introduced into the V2 Region of gp120 during Independent Pathogenic Simian Immunodeficiency Virus/HIV Chimeric Virus (SHIV) Infections of Rhesus Monkeys Generating Variants That Are Macrophage Tropic

Author: Imamichi, Hiromi, Igarashi, Tatsuhiko, Imamichi, Tomozumi, Donau, Olivia K., Endo, Yasuyuki, Nishimura, Yoshiaki, Willey, Ronald L., Suffredini, Anthony F., Lane, H. Clifford, and Martin, Malcolm A.
Published: 2002

36. Increased Peripheral Expansion of Naive CD4+ T Cells in vivo after IL-2 Treatment of Patients with HIV Infection

Author: Natarajan, Ven, Lempicki, Richard A., Sereti, Irini, Badralmaa, Yunden, Adelsberger, Joseph W., Metcalf, Julia A., Prieto, Darue A., Stevens, Randy, Baseler, Michael W., Kovacs, Joseph A., and Lane, H. Clifford
Published: 2002

37. Immunopathogenesis of Human Immunodeficiency Virus: Implications for Immune-Based Therapies

Author: Sereti, Irini and Lane, H. Clifford
Published: 2001

38. Combination Therapy with Amprenavir, Abacavir, and Efavirenz in Human Immunodeficiency Virus (HIV)-Infected Patients Failing a Protease-Inhibitor Regimen: Pharmacokinetic Drug Interactions and Antiviral Activity

Author: Falloon, Judith, Vogel, Susan, Mitsuya, Hiroaki, Kavlick, Mark F., Yoshimura, Kazuhisa, Rogers, Michael, Lane, H. Clifford, and Masur, Henry
Published: 2000

39. HIV-1 and T Cell Dynamics after Interruption of Highly Active Antiretroviral Therapy (HAART) in Patients with a History of Sustained Viral Suppression

Author: Davey,, Richard T., Bhat, Niranjan, Yoder, Christian, Chun, Tae-Wook, Metcalf, Julia A., Dewar, Robin, Natarajan, Ven, Lempicki, Richard A., Adelsberger, Joseph W., Miller, Kirk D., Kovacs, Joseph A., Polis, Michael A., Walker, Robert E., Falloon, Judith, Masur, Henry, Gee, Dennis, Baseler, Michael, Dimitrov, Dimiter S., Fauci, Anthony S., and Lane, H. Clifford
Published: 1999

40. Epidemiologic, clinical, and serum markers may improve discrimination between bacterial and viral etiologies of childhood pneumonia

Author: Farida, Helmia, primary, Triasih, Rina, additional, Lokida, Dewi, additional, Mardian, Yan, additional, Salim, Gustiani, additional, Wulan, Wahyu Nawang, additional, Butar-butar, Deni P., additional, Sari, Rizki Amalia, additional, Budiman, Arif, additional, Hayuningsih, Chakrawati, additional, Anam, Moh Syarofil, additional, Dipayana, Setya, additional, Mujahidah, Mujahidah, additional, Setyati, Amalia, additional, Aman, Abu Tholib, additional, Naysilla, Adhella Menur, additional, Lukman, Nurhayati, additional, Diana, Aly, additional, Karyana, Muhammad, additional, Kline, Ahnika, additional, Neal, Aaron, additional, Lane, H. Clifford, additional, Kosasih, Herman, additional, and Lau, Chuen-Yen, additional
Published: 2023
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41. Clinical evaluation of commercial SARS-CoV-2 serological assays in a malaria endemic setting

Author: Dabitao, Djeneba, primary, Shaw-Saliba, Kathryn, additional, Konate, Drissa S., additional, Highbarger, Helene C., additional, Lallemand, Perrine, additional, Sanogo, Ibrahim, additional, Rehman, Tauseef, additional, Wague, Mamadou, additional, Coulibaly, Nadie, additional, Kone, Bourahima, additional, Baya, Bocar, additional, Diakite, Seidina A.S., additional, Samake, Seydou, additional, Akpa, Esther, additional, Tounkara, Moctar, additional, Laverdure, Sylvain, additional, Doumbia, Seydou, additional, Lane, H. Clifford, additional, Diakite, Mahamadou, additional, and Dewar, Robin L., additional
Published: 2023
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42. Clinical research as a critical component of epidemic response: the case of PREVAIL in Liberia

Author: Fallah, Mosoka P, primary, Lane, H Clifford, additional, Higgs, Elizabeth S, additional, Kennedy, Stephen B, additional, Massaquoi, Moses B F, additional, Kieh, Mark W S, additional, Neaton, James D, additional, Hensley, Lisa E, additional, McNay, Laura, additional, Njoh, Wissedi, additional, and Doe-Anderson, Jestina, additional
Published: 2023
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43. Guide to Major Clinical Trials of Antiretroviral Therapy Administered to Patients Infected with Human Immunodeficiency Virus

Author: Lane, H. Clifford and Masur, Henry
Published: 1996

44. Investigation of Causal Effects of Protein Biomarkers on Cardiovascular Disease in Persons With HIV

Author: Reilly, Cavan S., Borges, Álvaro H., Baker, Jason V., Safo, Sandra E., Sharma, Shweta, Polizzotto, Mark N., Pankow, James S., Hu, Xiaojun, Sherman, Brad T., Babiker, Abdel G., Lundgren, Jens D., Lane, H. Clifford, Reilly, Cavan S., Borges, Álvaro H., Baker, Jason V., Safo, Sandra E., Sharma, Shweta, Polizzotto, Mark N., Pankow, James S., Hu, Xiaojun, Sherman, Brad T., Babiker, Abdel G., Lundgren, Jens D., and Lane, H. Clifford
Abstract: BACKGROUND: There is an incompletely understood increased risk for cardiovascular disease (CVD) among people with HIV (PWH). We investigated if a collection of biomarkers were associated with CVD among PWH. Mendelian randomization (MR) was used to identify potentially causal associations. METHODS: Data from follow-up in 4 large trials among PWH were used to identify 131 incident CVD cases and they were matched to 259 participants without incident CVD (controls). Tests of associations between 460 baseline protein levels and case status were conducted. RESULTS: Univariate analysis found CLEC6A, HGF, IL-6, IL-10RB, and IGFBP7 as being associated with case status and a multivariate model identified 3 of these: CLEC6A (odds ratio [OR] = 1.48, P = .037), HGF (OR = 1.83, P = .012), and IL-6 (OR = 1.45, P = .016). MR methods identified 5 significantly associated proteins: AXL, CHI3L1, GAS6, IL-6RA, and SCGB3A2. CONCLUSIONS: These results implicate inflammatory and fibrotic processes as contributing to CVD. While some of these biomarkers are well established in the general population and in PWH (IL-6 and its receptor), some are novel to PWH (HGF, AXL, and GAS6) and some are novel overall (CLEC6A). Further investigation into the uniqueness of these biomarkers in PWH and the role of these biomarkers as targets among PWH is warranted.
Published: 2023

45. Defective HIV-1 proviruses produce novel protein-coding RNA species in HIV-infected patients on combination antiretroviral therapy

Author: Imamichi, Hiromi, Dewar, Robin L., Adelsberger, Joseph W., Rehm, Catherine A., O’Doherty, Una, Paxinos, Ellen E., Fauci, Anthony S., and Lane, H. Clifford
Published: 2016

46. Discordance in lymphoid tissue recovery following stem cell transplantation in rhesus macaques: an in vivo imaging study

Author: Donahue, Robert E., Srinivasula, Sharat, Uchida, Naoya, Kim, Insook, St. Claire, Alexis, Duralde, Gorka, DeGrange, Paula, St. Claire, Marisa, Reba, Richard C., Bonifacino, Aylin C., Krouse, Allen E., Metzger, Mark E., Paik, Chang H., Lane, H. Clifford, Tisdale, John F., and Di Mascio, Michele
Published: 2015
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47. Predicting Virological Response to HIV Treatment Over Time: A Tool for Settings With Different Definitions of Virological Response

Author: Revell, Andrew D., Wang, Dechao, Perez-Elias, Maria-Jesus, Wood, Robin, Tempelman, Hugo, Clotet, Bonaventura, Reiss, Peter, van Sighem, Ard I., Alvarez-Uria, Gerardo, Nelson, Mark, Montaner, Julio S. G., Lane, H. Clifford, and Larder, Brendan A.
Published: 2019
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48. Molecular Imaging of Infections: Advancing the Search for the Hidden Enemy.

Author: Hammoud, Dima A, Lane, H Clifford, and Jain, Sanjay K
Subjects: *CORONAVIRUS diseases, *COVID-19 pandemic, *NANOTECHNOLOGY
Abstract: Even before the coronavirus disease 2019 pandemic, infections were a major threat to human health, as the third leading cause of death and the leading cause of morbidity among all human diseases. Although conventional imaging studies are routinely used for patients with infections, they provide structural or anatomic information only. Molecular imaging technologies enable noninvasive visualization of molecular processes at the cellular level within intact living subjects, including patients, and hold great potential for infections. We hope that this supplement will spur interest in the field and establish new collaborations to develop and translate novel molecular imaging approaches to the clinic. [ABSTRACT FROM AUTHOR]
Published: 2023
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49. The NIH-led research response to COVID-19

Author: Collins, Francis, primary, Adam, Stacey, additional, Colvis, Christine, additional, Desrosiers, Elizabeth, additional, Draghia-Akli, Ruxandra, additional, Fauci, Anthony, additional, Freire, Maria, additional, Gibbons, Gary, additional, Hall, Matthew, additional, Hughes, Eric, additional, Jansen, Kathrin, additional, Kurilla, Michael, additional, Lane, H. Clifford, additional, Lowy, Douglas, additional, Marks, Peter, additional, Menetski, Joseph, additional, Pao, William, additional, Pérez-Stable, Eliseo, additional, Purcell, Lisa, additional, Read, Sarah, additional, Rutter, Joni, additional, Santos, Michael, additional, Schwetz, Tara, additional, Shuren, Jeffrey, additional, Stenzel, Timothy, additional, Stoffels, Paul, additional, Tabak, Lawrence, additional, Tountas, Karen, additional, Tromberg, Bruce, additional, Wholley, David, additional, Woodcock, Janet, additional, and Young, John, additional
Published: 2023
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50. Systemic Inflammation, Coagulation, and Clinical Risk in the START Trial

Author: Baker, Jason V, Sharma, Shweta, Grund, Birgit, Rupert, Adam, Metcalf, Julia A, Schechter, Mauro, Munderi, Paula, Aho, Inka, Emery, Sean, Babiker, Abdel, Phillips, Andrew, Lundgren, Jens D, Neaton, James D, and Lane, H Clifford
Published: 2017
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