Publications

O'Halloran JA, Ko ER, Anstrom KJ, Kedar E, McCarthy MW, Panettieri RA Jr, Maillo M, Nunez PS, Lachiewicz AM, Gonzalez C, Smith PB, de Tai SM, Khan A, Lora AJM, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Wen J, Silverstein A, O'Brien SM, Al-Khalidi HR, Maldonado MA, Melsheimer R, Ferguson WG, McNulty SE, Zakroysky P, Halabi S, Benjamin DK Jr, Butler S, Atkinson JC, Adam SJ, Chang S, LaVange L, Proschan M, Bozzette SA, Powderly WG; ACTIV-1 IM Study Group Members. Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):328-339. doi: 10.1001/jama.2023.11043. PMID: 37428480; PMCID: PMC10334296.

Wang TY, Wahed AS, Morris A, Kreuziger LB, Quigley JG, Lamas GA, Weissman AJ, Lopez-Sendon J, Knudson MM, Siegal DM, Kasthuri RS, Alexander AJ, Wahid L, Atassi B, Miller PJ, Lawson JW, Patel B, Krishnan JA, Shapiro NL, Martin DE, Kindzelski AL, Leifer ES, Joo J, Lyu L, Pennella A, Everett BM, Geraci MW, Anstrom KJ, Ortel TL; ACTIV-4C Study Group. Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization. Ann Intern Med. 2023 Mar 21. doi: 10.7326/M22-3350. Epub ahead of print. PMID: 36940444.

Goligher EC, Lawler PR, Jensen TP, Talisa V, Berry LR, Lorenzi E, McVerry BJ, Chang CH, Leifer E, Bradbury C, Berger J, Hunt BJ, Castellucci LA, Kornblith LZ, Gordon AC, McArthur C, Webb S, Hochman J, Neal MD, Zarychanski R, Berry S, Angus DC; REMAP-CAP, ATTACC, and ACTIV-4a Investigators. Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19. JAMA. 2023 Mar 21. doi: 10.1001/jama.2023.3651. Epub ahead of print. PMID: 36942550.

Deo R, Choudhary MC, Moser C, Ritz J, Daar ES, Wohl DA, Greninger AL, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW, Li JZ; ACTIV-2/A5401 Study Team†. Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection. Ann Intern Med. 2023 Feb 21. doi: 10.7326/M22-2381. Epub ahead of print. PMID: 36802755.

Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial. JAMA. Published online February 20, 2023. doi:10.1001/jama.2023.1650.

Matza LS, Stewart KD, Naegeli AN, Mills KM, Coyne KS, Chew KW, Hughes MD, Smith DM. Qualitative interviews to evaluate content validity of the ACTIV-2 COVID-19 Symptom Diary (ACSD). J Patient Rep Outcomes. 2023 Jan 31;7(1):8. doi: 10.1186/s41687-022-00535-x. PMID: 36719546; PMCID: PMC9888338..

Taiwo BO, Chew KW, Moser C, Wohl DA, Daar ES, Li JZ, Greninger AL, Bausch C, Luke T, Hoover K, Neytman G, Giganti MJ, Olefsky M, Javan AC, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Phase 2 safety and antiviral activity of SAB-185, a novel polyclonal antibody therapy for non-hospitalized adults with COVID-19. J Infect Dis. 2023 Jan 20:jiad013. doi: 10.1093/infdis/jiad013. Epub ahead of print. PMID: 36661240..

McCarthy MW, Naggie S, Boulware DR, et al. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(4):296–305. doi:10.1001/jama.2022.24100

Collins FS, et al. The NIH-led research response to COVID-19. Science. 2023;379(6631):441-444. doi:10.1126/science.adf5167

Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, McCarthy MW, Jayaweera D, Castro M, Sulkowski M, McTigue K, Thicklin F, Felker GM, Ginde AA, Bramante CT, Slandzicki AJ, Gabriel A, Shah NS, Lenert LA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A, Wilder R, Wilson S, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 25;328(16):1595-1603. doi: 10.1001/jama.2022.18590. PMID: 36269852.

Connors JM, Brooks MM, Sciurba FC, Krishnan JA, Bledsoe JR, Kindzelski A, Baucom AL, Kirwan BA, Eng H, Martin D, Zaharris E, Everett B, Castro L, Shapiro NL, Lin JY, Hou PC, Pepine CJ, Handberg E, Haight DO, Wilson JW, Majercik S, Fu Z, Zhong Y, Venugopal V, Beach S, Wisniewski S, Ridker PM; ACTIV-4B Investigators. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1703-1712. doi: 10.1001/jama.2021.17272. PMID: 34633405; PMCID: PMC8506296.

ACTIV-3–Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022 Oct;10(10):972-984. doi: 10.1016/S2213-2600(22)00215-6. Epub 2022 Jul 8. PMID: 35817072; PMCID: PMC9270059.

ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group. 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. Lancet Infect Dis. 2022 May;22(5):622-635. doi: 10.1016/S1473-3099(21)00751-9. Epub 2021 Dec 23. PMID: 34953520; PMCID: PMC8700279.

ACTIV-3/TICO Bamlanivimab Study Group; Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Østergaard L, Chang CC, Goodman AL, Chang W, Dewar RL, Gerry NP, Higgs ES, Highbarger H, Murray DD, Murray TA, Natarajan V, Paredes R, Parmar MKB, Phillips AN, Reilly C, Rupert AW, Sharma S, Shaw-Saliba K, Sherman BT, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Davey VJ, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial. Ann Intern Med. 2022 Feb;175(2):234-243. doi: 10.7326/M21-3507. Epub 2021 Dec 21. PMID: 34928698; PMCID: PMC9334931.

Murray DD, Babiker AG, Baker JV, Barkauskas CE, Brown SM, Chang CC, Davey VJ, Gelijns AC, Ginde AA, Grund B, Higgs E, Hudson F, Kan VL, Lane HC, Murray TA, Paredes R, Parmar MK, Pett S, Phillips AN, Polizzotto MN, Reilly C, Sandkovsky U, Sharma S, Teitelbaum M, Thompson BT, Young BE, Neaton JD, Lundgren JD. Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3). Clin Trials. 2022 Feb;19(1):52-61. doi: 10.1177/17407745211049829. Epub 2021 Oct 10. PMID: 34632800; PMCID: PMC8847314.

Berger JS, Kornblith LZ, Gong MN, et al. Effect of P2Y12 Inhibitors on Survival Free of Organ Support Among Non–Critically Ill Hospitalized Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2022;327(3):227–236. doi:10.1001/jama.2021.23605

Buchman TG, Draghia-Akli R, Adam SJ, Aggarwal NR, Fessel JP, Higgs ES, Menetski JP, Read SW, Hughes EA; Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) Therapeutics Clinical Working Group. Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines-Selecting Compounds for Clinical Evaluation in Coronavirus Disease 2019 Clinical Trials. Crit Care Med. 2021 Nov 1;49(11):1963-1973. doi: 10.1097/CCM.0000000000005295. PMID: 34495876; PMCID: PMC8507598.

Connors JM, Brooks MM, Sciurba FC, et al. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021;326(17):1703–1712. doi:10.1001/jama.2021.17272

REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators, et al. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):777-789. doi: 10.1056/NEJMoa2103417. PMID: 34351722; PMCID: PMC8362592. 

ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators, et al. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):790-802. doi: 10.1056/NEJMoa2105911. PMID: 34351721; PMCID: PMC8362594.

LLevy JH, Iba T, Olson LB, Corey KM, Ghadimi K, Connors JM. COVID-19: Thrombosis, thromboinflammation, and anticoagulation considerations. Int J Lab Hematol. 2021 Jul;43 Suppl 1(Suppl 1):29-35. doi: 10.1111/ijlh.13500. PMID: 34288441; PMCID: PMC8444926.

Lisa LaVange, Stacey J. Adam, Judith S. Currier, et al. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): Designing Master Protocols for Evaluation of Candidate COVID-19 Therapeutics. Ann Intern Med. [Epub ahead of print 29 June 2021]. DOI: 10.7326/M21-1269 

Lundgren JD, Lane HC, Neaton JD. Monoclonal Antibody for Patients with Covid-19. Reply. N Engl J Med. 2021;384(12):1171. doi:10.1056/NEJMc2100221

ACTIV-3/TICO LY-CoV555 Study Group, Lundgren JD, Grund B, et al. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med. 2021;384(10):905-914. doi:10.1056/NEJMoa2033130

Haynes BF, Corey L, Fernandes P, et al. Prospects for a safe COVID-19 vaccine. Sci Transl Med. 2020;12(568):eabe0948. doi:10.1126/scitranslmed.abe0948

Grobler JA, Anderson AS, Fernandes P, et al. Accelerated Preclinical Paths to Support Rapid Development of COVID-19 Therapeutics. Cell Host Microbe. 2020;28(5):638-645. doi:10.1016/j.chom.2020.09.017

Hewitt JA, Lutz C, Florence WC, et al. ACTIVating Resources for the COVID-19 Pandemic: In vivo Models for Vaccines and Therapeutics. Cell Host Microbe. 2020;28(5):646-659. doi:10.1016/j.chom.2020.09.016

Deming ME, Michael NL, Robb M, Cohen MS, Neuzil KM. Accelerating Development of SARS-CoV-2 Vaccines - The Role for Controlled Human Infection Models. N Engl J Med. 2020;383(10):e63. doi:10.1056/NEJMp2020076

Collins FS, Stoffels P. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): An Unprecedented Partnership for Unprecedented Times. JAMA. 2020;323(24):2455-2457. doi:10.1001/jama.2020.8920

Corey L, Mascola JR, Fauci AS, Collins FS. A strategic approach to COVID-19 vaccine R&D. Science. 2020;368(6494):948-950. doi:10.1126/science.abc5312