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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: nayak su. 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. Among authors: nayak su. 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.
Heterologous SARS-CoV-2 Booster Vaccinations - Preliminary Report.
Atmar RL, Lyke KE, Deming ME, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Bäcker M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobryzynski D, Posavad CM, Archer JI, Crandon S, Nayak SU, Szydlo D, Zemanek J, Dominguez Islas CP, Brown ER, Suthar MS, McElrath MJ, McDermott AB, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Roberts PC, Beigel JH; DMID 21-0012 Study Group. Atmar RL, et al. Among authors: nayak su. medRxiv [Preprint]. 2021 Oct 15:2021.10.10.21264827. doi: 10.1101/2021.10.10.21264827. medRxiv. 2021. PMID: 34671773 Free PMC article. Updated. Preprint.
Homologous and Heterologous Covid-19 Booster Vaccinations.
Atmar RL, Lyke KE, Deming ME, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Bäcker M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobrzynski D, Coler RN, Posavad CM, Archer JI, Crandon S, Nayak SU, Szydlo D, Zemanek JA, Dominguez Islas CP, Brown ER, Suthar MS, McElrath MJ, McDermott AB, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Roberts PC, Beigel JH; DMID 21-0012 Study Group. Atmar RL, et al. Among authors: nayak su. N Engl J Med. 2022 Mar 17;386(11):1046-1057. doi: 10.1056/NEJMoa2116414. Epub 2022 Jan 26. N Engl J Med. 2022. PMID: 35081293 Free PMC article. Clinical Trial.
SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses.
Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Rostad CA, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Türeli S, Makhene M, Crandon S, Lee M, Nayak SU, Montefiori DC, Makowski M, Smith DJ, Roberts PC, Beigel JH; COVAIL Study Group. Branche AR, et al. Among authors: nayak su. medRxiv [Preprint]. 2022 Jul 15:2022.07.12.22277336. doi: 10.1101/2022.07.12.22277336. medRxiv. 2022. PMID: 35898343 Free PMC article. Preprint.
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: nayak su. 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.
Bivalent and Monovalent SARS-CoV-2 Variant Vaccine Boosters Improve coverage of the known Antigenic Landscape: Results of the COVID-19 Variant Immunologic Landscape (COVAIL) Trial.
Branche A, Rouphael N, Diemert D, Falsey A, Losada C, Baden LR, Frey S, Whitaker J, Little S, Anderson E, Walter E, Novak R, Rupp R, Jackson L, Babu T, Kottkamp A, Luetkemeyer A, Immergluck L, Presti R, Backer M, Winokur P, Mahgoub S, Goepfert P, Fusco D, Malkin E, Bethony J, Walsh E, Graciaa D, Samaha H, Sherman A, Walsh S, Abate G, Oikonomopoulou Z, El Sahly H, Martin T, Kamidani S, Smith M, Ladner B, Porterfield L, Dunstan M, Wald A, Davis T, Atmar R, Mulligan M, Lyke K, Posavad C, Meagher M, Stephens D, Neuzil K, Abebe K, Hill H, Albert J, Telu K, Mu J, Lewis T, Giebeig L, Eaton A, Netzl A, Wilks S, Tureli S, Makhene M, Crandon S, Montefiori D, Makowski M, Smith D, Nayak S, Roberts P, Beigel J. Branche A, et al. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2653179. doi: 10.21203/rs.3.rs-2653179/v1. Res Sq. 2023. PMID: 37205592 Free PMC article. Updated. Preprint.
Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants.
Lyke KE, Atmar RL, Dominguez Islas C, Posavad CM, Deming ME, Branche AR, Johnston C, El Sahly HM, Edupuganti S, Mulligan MJ, Jackson LA, Rupp RE, Rostad CA, Coler RN, Bäcker M, Kottkamp AC, Babu TM, Dobrzynski D, Martin JM, Brady RC, Frenck RW Jr, Rajakumar K, Kotloff K, Rouphael N, Szydlo D, PaulChoudhury R, Archer JI, Crandon S, Ingersoll B, Eaton A, Brown ER, McElrath MJ, Neuzil KM, Stephens DS, Post DJ, Lin BC, Serebryannyy L, Beigel JH, Montefiori DC, Roberts PC; DMID 21-0012 Study Group. Lyke KE, et al. NPJ Vaccines. 2023 Jul 11;8(1):98. doi: 10.1038/s41541-023-00693-z. NPJ Vaccines. 2023. PMID: 37433788 Free PMC article.
Immunogenicity of a 2-Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial.
Rouphael NG, Branche AR, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Kamidani S, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Bäcker M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Atmar RL, Posavad CM, Netzl A, Smith DJ, Telu K, Mu J, McQuarrie LJ, Makowski M, Makhene MK, Crandon S, Montefiori DC, Roberts PC, Beigel JH; Coronavirus Variant Immunologic Landscape Trial (COVAIL) Study Team. Rouphael NG, et al. J Infect Dis. 2023 Dec 20;228(12):1662-1666. doi: 10.1093/infdis/jiad323. J Infect Dis. 2023. PMID: 37561027 Clinical Trial.
75 results