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Page 1
Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case.
Ortega-Villa AM, Hynes NA, Levine CB, Yang K, Wiley Z, Jilg N, Wang J, Whitaker JA, Colombo CJ, Nayak SU, Kim HJ, Iovine NM, Ince D, Cohen SH, Langer AJ, Wortham JM, Atmar RL, El Sahly HM, Jain MK, Mehta AK, Wolfe CR, Gomez CA, Beresnev T, Mularski RA, Paules CI, Kalil AC, Branche AR, Luetkemeyer A, Zingman BS, Voell J, Whitaker M, Harkins MS, Davey RT Jr, Grossberg R, George SL, Tapson V, Short WR, Ghazaryan V, Benson CA, Dodd LE, Sweeney DA, Tomashek KM. Ortega-Villa AM, et al. Among authors: colombo cj. Open Forum Infect Dis. 2023 May 27;10(6):ofad290. doi: 10.1093/ofid/ofad290. eCollection 2023 Jun. Open Forum Infect Dis. 2023. PMID: 37383244 Free PMC article.
Remdesivir for the Treatment of Covid-19 - Final Report.
Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fätkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Beigel JH, et al. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8. N Engl J Med. 2020. PMID: 32445440 Free PMC article. Clinical Trial.
Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19.
Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, Marconi VC, Ruiz-Palacios GM, Hsieh L, Kline S, Tapson V, Iovine NM, Jain MK, Sweeney DA, El Sahly HM, Branche AR, Regalado Pineda J, Lye DC, Sandkovsky U, Luetkemeyer AF, Cohen SH, Finberg RW, Jackson PEH, Taiwo B, Paules CI, Arguinchona H, Erdmann N, Ahuja N, Frank M, Oh MD, Kim ES, Tan SY, Mularski RA, Nielsen H, Ponce PO, Taylor BS, Larson L, Rouphael NG, Saklawi Y, Cantos VD, Ko ER, Engemann JJ, Amin AN, Watanabe M, Billings J, Elie MC, Davey RT, Burgess TH, Ferreira J, Green M, Makowski M, Cardoso A, de Bono S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH; ACTT-2 Study Group Members. Kalil AC, et al. N Engl J Med. 2021 Mar 4;384(9):795-807. doi: 10.1056/NEJMoa2031994. Epub 2020 Dec 11. N Engl J Med. 2021. PMID: 33306283 Free PMC article. Clinical Trial.
Performance Analysis of the National Early Warning Score and Modified Early Warning Score in the Adaptive COVID-19 Treatment Trial Cohort.
Colombo CJ, Colombo RE, Maves RC, Branche AR, Cohen SH, Elie MC, George SL, Jang HJ, Kalil AC, Lindholm DA, Mularski RA, Ortiz JR, Tapson V, Liang CJ. Colombo CJ, et al. Among authors: colombo re. Crit Care Explor. 2021 Jul 13;3(7):e0474. doi: 10.1097/CCE.0000000000000474. eCollection 2021 Jul. Crit Care Explor. 2021. PMID: 34278310 Free PMC article.
Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial.
Kalil AC, Mehta AK, Patterson TF, Erdmann N, Gomez CA, Jain MK, Wolfe CR, Ruiz-Palacios GM, Kline S, Regalado Pineda J, Luetkemeyer AF, Harkins MS, Jackson PEH, Iovine NM, Tapson VF, Oh MD, Whitaker JA, Mularski RA, Paules CI, Ince D, Takasaki J, Sweeney DA, Sandkovsky U, Wyles DL, Hohmann E, Grimes KA, Grossberg R, Laguio-Vila M, Lambert AA, Lopez de Castilla D, Kim E, Larson L, Wan CR, Traenkner JJ, Ponce PO, Patterson JE, Goepfert PA, Sofarelli TA, Mocherla S, Ko ER, Ponce de Leon A, Doernberg SB, Atmar RL, Maves RC, Dangond F, Ferreira J, Green M, Makowski M, Bonnett T, Beresnev T, Ghazaryan V, Dempsey W, Nayak SU, Dodd L, Tomashek KM, Beigel JH; ACTT-3 study group members. Kalil AC, et al. Lancet Respir Med. 2021 Dec;9(12):1365-1376. doi: 10.1016/S2213-2600(21)00384-2. Epub 2021 Oct 18. Lancet Respir Med. 2021. PMID: 34672949 Free PMC article. Clinical Trial.
Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.
Wolfe CR, Tomashek KM, Patterson TF, Gomez CA, Marconi VC, Jain MK, Yang OO, Paules CI, Palacios GMR, Grossberg R, Harkins MS, Mularski RA, Erdmann N, Sandkovsky U, Almasri E, Pineda JR, Dretler AW, de Castilla DL, Branche AR, Park PK, Mehta AK, Short WR, McLellan SLF, Kline S, Iovine NM, El Sahly HM, Doernberg SB, Oh MD, Huprikar N, Hohmann E, Kelley CF, Holodniy M, Kim ES, Sweeney DA, Finberg RW, Grimes KA, Maves RC, Ko ER, Engemann JJ, Taylor BS, Ponce PO, Larson L, Melendez DP, Seibert AM, Rouphael NG, Strebe J, Clark JL, Julian KG, de Leon AP, Cardoso A, de Bono S, Atmar RL, Ganesan A, Ferreira JL, Green M, Makowski M, Bonnett T, Beresnev T, Ghazaryan V, Dempsey W, Nayak SU, Dodd LE, Beigel JH, Kalil AC; ACTT-4 Study Group. Wolfe CR, et al. Lancet Respir Med. 2022 Sep;10(9):888-899. doi: 10.1016/S2213-2600(22)00088-1. Epub 2022 May 23. Lancet Respir Med. 2022. PMID: 35617986 Free PMC article. Clinical Trial.
Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial.
Potter GE, Bonnett T, Rubenstein K, Lindholm DA, Rapaka RR, Doernberg SB, Lye DC, Mularski RA, Hynes NA, Kline S, Paules CI, Wolfe CR, Frank MG, Rouphael NG, Deye GA, Sweeney DA, Colombo RE, Davey RT Jr, Mehta AK, Whitaker JA, Castro JG, Amin AN, Colombo CJ, Levine CB, Jain MK, Maves RC, Marconi VC, Grossberg R, Hozayen S, Burgess TH, Atmar RL, Ganesan A, Gomez CA, Benson CA, Lopez de Castilla D, Ahuja N, George SL, Nayak SU, Cohen SH, Lalani T, Short WR, Erdmann N, Tomashek KM, Tebas P. Potter GE, et al. Among authors: colombo cj, colombo re. Ann Intern Med. 2022 Dec;175(12):1716-1727. doi: 10.7326/M22-2116. Epub 2022 Nov 29. Ann Intern Med. 2022. PMID: 36442063 Free PMC article.
SARS-CoV-2 RNA and nucleocapsid antigen are blood biomarkers associated with severe disease outcomes that improve in response to remdesivir.
Singh K, Rubenstein K, Callier V, Shaw-Saliba K, Rupert A, Dewar R, Laverdure S, Highbarger H, Lallemand P, Huang ML, Jerome KR, Sampoleo R, Mills MG, Greninger AL, Juneja K, Porter D, Benson CA, Dempsey W, El Sahly HM, Focht C, Jilg N, Paules CI, Rapaka RR, Uyeki TM, Lane HC, Beigel J, Dodd LE; Adaptive COVID-19 Treatment Trial (ACTT-1) Study Group Members. Singh K, et al. J Infect Dis. 2024 Apr 24:jiae198. doi: 10.1093/infdis/jiae198. Online ahead of print. J Infect Dis. 2024. PMID: 38657001
Clinical, Immunological, and Virological SARS-CoV-2 Phenotypes in Obese and Nonobese Military Health System Beneficiaries.
Epsi NJ, Richard SA, Laing ED, Fries AC, Millar E, Simons MP, English C, Colombo CJ, Colombo RE, Lindholm DA, Ganesan A, Maves RC, Huprikar N, Larson D, Mende K, Chi SW, Madar C, Lalani T, Broder CC, Tribble D, Agan BK, Burgess TH, Pollett SD; EPICC COVID-19 Cohort Study Group. Epsi NJ, et al. Among authors: colombo cj, colombo re. J Infect Dis. 2021 Nov 16;224(9):1462-1472. doi: 10.1093/infdis/jiab396. J Infect Dis. 2021. PMID: 34331541 Free PMC article.
Durability of SARS-CoV-2-Specific T-Cell Responses at 12 Months Postinfection.
Lu Z, Laing ED, Pena DaMata J, Pohida K, Tso MS, Samuels EC, Epsi NJ, Dorjbal B, Lake C, Richard SA, Maves RC, Lindholm DA, Rozman JS, English C, Huprikar N, Mende K, Colombo RE, Colombo CJ, Broder CC, Ganesan A, Lanteri CA, Agan BK, Tribble D, Simons MP, Dalgard CL, Blair PW, Chenoweth J, Pollett SD, Snow AL, Burgess TH, Malloy AMW; EPICC COVID-19 Cohort Study Group. Lu Z, et al. Among authors: colombo cj, colombo re. J Infect Dis. 2021 Dec 15;224(12):2010-2019. doi: 10.1093/infdis/jiab543. J Infect Dis. 2021. PMID: 34673956 Free PMC article.
49 results