David Boulware

David Boulware is a professor of medicine with tenure and a practicing infectious disease physician at the University of Minnesota Medical School. He is a member of the graduate faculty for the University of Minnesota School of Public Health Epidemiology PhD program and for the Microbiology, Immunology, and Cancer Biology (MICaB) graduate program. Boulware was the first Lois & Richard Distinguished Assistant Professorship at the University of Minnesota. Boulware is an active medical researcher engaged in clinical trials in infectious diseases.[1]

David Boulware
Born
David R Boulware

1974 (age 48–49)
United States
NationalityAmerican
CitizenshipAmerican, British
Alma materWabash College
OccupationPhysician infectious diseases (medical specialty)
Years active2004–present
Known forCOVID-19 researcher
TitleProfessor of Medicine at University of Minnesota

Career

Boulware's primary research has been focused on improving the diagnosis, prevention, and treatment of cryptococcal meningitis.[2] However, he is best known for outpatient COVID-19 clinical trials, pioneering remote de-centralized, internet-based clinical trials during the COVID-19 pandemic.

Boulware's team rapidly launched a series of three U.S. nationwide randomized clinical trials testing hydroxychloroquine for post-exposure prophylaxis, early treatment, and pre-exposure prophylaxis for prevention of COVID-19 on March 17, 2020.[3] These were among the first U.S. trials to be launched.[4] The pre-exposure prophylaxis trial was reported June 3, 2020 showing that taking hydroxychloroquine was not effective at preventing COVID-19.[5][6][7] As described, "To say that the recruitment of this post-exposure prophylaxis trial was innovative hardly gives the methods enough credit."[8] These trials were pioneering for being remote internet-based randomized decentralized clinical trials.[9][10]

The hydroxychloroquine early treatment trial was the first large phase III, outpatient randomized clinical trial testing an outpatient therapy for COVID-19.[11][12]

While pre-exposure prophylaxis with hydroxychloroquine for prevention was promoted on May 18, 2020,[13] the subsequent randomized trial did not show any benefit.[14]

Boulware served as senior investigator on other trials testing early treatments for COVID-19 including the TogetherTrial ivermectin;,[15][16] which demonstrated that ivermectin did not have a clinical benefit for early COVID-19.[17] University of Minnesota's COVID-Out randomized trial testing metformin, ivermectin, and fluvoxamine.[18] The Covid-Out trial reported a 42% reduction in COVID-related emergency room visits and hospitalizations with the use of metformin.[19] In December 2021, Boulware took the initiate to apply to the U.S. FDA for an Emergency Use Authorization for fluvoxamine 100 mg twice daily.[20]

Boulware serves as the national co-chair of the trial steering committee for the NIH ACTIV-6 platform clinical trial testing repurposed medicines for COVID-19.[21][22]

Notable contributions and honors

References
  1. "David R Boulware". University of Minnesota.
  2. Adams, Patrick (4 January 2016). "Crushing Crypto, the deadly, neglected disease that kills 300K every year". Newsweek.
  3. Boulware, David R.; Pullen, Matthew F.; Bangdiwala, Ananta S.; Pastick, Katelyn A.; Lofgren, Sarah M.; Okafor, Elizabeth C.; Skipper, Caleb P.; Nascene, Alanna A.; Nicol, Melanie R.; Abassi, Mahsa; Engen, Nicole W.; Cheng, Matthew P.; LaBar, Derek; Lother, Sylvain A.; MacKenzie, Lauren J.; Drobot, Glen; Marten, Nicole; Zarychanski, Ryan; Kelly, Lauren E.; Schwartz, Ilan S.; McDonald, Emily G.; Rajasingham, Radha; Lee, Todd C.; Hullsiek, Kathy H. (6 August 2020). "A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for COVID-19". New England Journal of Medicine. 383 (6): 517–525. doi:10.1056/NEJMoa2016638. PMC 7289276. PMID 32492293.
  4. Palca, Joe (31 March 2020). "Clinical Trials Set To Determine If Anti-Malaria Drug Effective Against COVID-19". NPR.
  5. Grady, Denise (3 June 2020). "Malaria Drug Promoted by Trump Did Not Prevent COVID Infections, Study Finds". The New York Times.
  6. "Hydroxychloroquine, a drug promoted by Trump, failed to prevent healthy people from getting covid-19 in trial". Washington Post.
  7. "White House asked for Dr. Boulware's advice on hydroxychloroquine. This is what he said - CNN Video". CNN.
  8. Sax, Paul (7 June 2020). "Hydroxychloroquine Not Effective in Preventing COVID-19 -- In Praise of a Negative Clinical Trial". HIV and ID Observations. NEJM Journal Watch.
  9. Adam, Rogers. "The Strange and Twisted Tale of Hydroxychloroquine". Wired.
  10. "How to Conduct a Clinical Trial During a Pandemic—An Interview with Dr. David Boulware". Open Forum Infectious Diseases. 7 (7): ofaa277. 1 July 2020. doi:10.1093/ofid/ofaa277. PMC 7534549. PMID 33043070.
  11. "Hydroxychloroquine studies show drug is not effective for early treatment of mild covid-19". Washington Post.
  12. Skipper, Caleb P.; Pastick, Katelyn A.; Engen, Nicole W.; Bangdiwala, Ananta S.; Abassi, Mahsa; Lofgren, Sarah M.; Williams, Darlisha A.; Okafor, Elizabeth C.; Pullen, Matthew F.; Nicol, Melanie R.; Nascene, Alanna A.; Hullsiek, Kathy H.; Cheng, Matthew P.; Luke, Darlette; Lother, Sylvain A.; MacKenzie, Lauren J.; Drobot, Glen; Kelly, Lauren E.; Schwartz, Ilan S.; Zarychanski, Ryan; McDonald, Emily G.; Lee, Todd C.; Rajasingham, Radha; Boulware, David R. (20 October 2020). "Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial". Annals of Internal Medicine. 173 (8): 623–631. doi:10.7326/M20-4207. PMC 7384270. PMID 32673060.
  13. McDonald, Jessica; Rieder, Rem (21 May 2020). "Trump Misleads on Hydroxychloroquine, Again". FactCheck.org.
  14. Rajasingham, Radha; Bangdiwala, Ananta S; Nicol, Melanie R; Skipper, Caleb P; Pastick, Katelyn A; Axelrod, Margaret L; Pullen, Matthew F; Nascene, Alanna A; Williams, Darlisha A; Engen, Nicole W; Okafor, Elizabeth C; Rini, Brian I; Mayer, Ingrid A; McDonald, Emily G; Lee, Todd C; Li, Peter; MacKenzie, Lauren J; Balko, Justin M; Dunlop, Stephen J; Hullsiek, Katherine H; Boulware, David R; Lofgren, Sarah M; Abassi, Mahsa; Balster, Andrew; Collins, Lindsey B; Drobot, Glen; Krakower, Douglas S; Lother, Sylvain A; MacKay, Dylan S; Meyer-Mueller, Cameron; Selinsky, Stephen; Solvason, Dayna; Zarychanski, Ryan; Zash, Rebecca (1 June 2021). "Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial". Clinical Infectious Diseases. 72 (11): e835–e843. doi:10.1093/cid/ciaa1571. PMC 7665393. PMID 33068425.
  15. "TOGETHER Trial". TOGETHER Trial.
  16. Reis, Gilmar; Silva, Eduardo A.S.M.; Silva, Daniela C.M.; Thabane, Lehana; Milagres, Aline C.; Ferreira, Thiago S.; dos Santos, Castilho V.Q.; Campos, Vitoria H.S.; Nogueira, Ana M.R.; de Almeida, Ana P.F.G.; Callegari, Eduardo D.; Neto, Adhemar D.F.; Savassi, Leonardo C.M.; Simplicio, Maria I.C.; Ribeiro, Luciene B.; Oliveira, Rosemary; Harari, Ofir; Forrest, Jamie I.; Ruton, Hinda; Sprague, Sheila; McKay, Paula; Guo, Christina M.; Rowland-Yeo, Karen; Guyatt, Gordon H.; Boulware, David R.; Rayner, Craig R.; Mills, Edward J. (5 May 2022). "Effect of Early Treatment with Ivermectin among Patients with COVID-19". New England Journal of Medicine. 386 (18): 1721–1731. doi:10.1056/NEJMoa2115869. PMC 9006771. PMID 35353979.
  17. Zimmer, Carl (30 March 2022). "Ivermectin Does Not Reduce Risk of COVID Hospitalization, Large Study Finds". The New York Times.
  18. "COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)". ClinicalTrials.gov. clinicaltrials.gov. 2 March 2022.
  19. Bramante, Carolyn T.; Huling, Jared D.; Tignanelli, Christopher J.; Buse, John B.; Liebovitz, David M.; Nicklas, Jacinda M.; Cohen, Kenneth; Puskarich, Michael A.; Belani, Hrishikesh K.; Proper, Jennifer L.; Siegel, Lianne K.; Klatt, Nichole R.; Odde, David J.; Luke, Darlette G.; Anderson, Blake; Karger, Amy B.; Ingraham, Nicholas E.; Hartman, Katrina M.; Rao, Via; Hagen, Aubrey A.; Patel, Barkha; Fenno, Sarah L.; Avula, Nandini; Reddy, Neha V.; Erickson, Spencer M.; Lindberg, Sarah; Fricton, Regina; Lee, Samuel; Zaman, Adnin; Saveraid, Hanna G.; Tordsen, Walker J.; Pullen, Matthew F.; Biros, Michelle; Sherwood, Nancy E.; Thompson, Jennifer L.; Boulware, David R.; Murray, Thomas A. (18 August 2022). "Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19". New England Journal of Medicine. 387 (7): 599–610. doi:10.1056/NEJMoa2201662. PMID 36070710. S2CID 251659997.
  20. "Doctor Submits Fluvoxamine EUA Application to FDA". www.medpagetoday.com. 29 December 2021.
  21. "Activ-6 Study".
  22. "ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications". clinicaltrials.gov. 22 March 2022.
  23. "Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy". www.who.int. World Health Organization.
  24. "Guidelines for the diagnosis, prevention and management of cryptococcal disease in HIV-infected adults, adolescents and children". www.who.int. World Health Organization.
  25. "US HHS/NIH/CDC HIV Opportunistic Infection Guidelines | NIH". clinicalinfo.hiv.gov. US HHS.
  26. "David R. Boulware, MD, MPH". The American Society for Clinical Investigation.
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