Profile: Investigator

C. Buddy Creech, MD, MPH

"The IDCRC has clearly continued the legacy of the VTEUs – collaboration and collegiality. Coming together under the stress of the pandemic has shown again the power of our robust clinical trial network.”

IDCRC Year-End Infographics & ACTT Year-End Metrics

ACTT Metrics

Since January 15, 2020, the ACTT studies have:

• Established 4 high-quality randomized, placebo-controlled trials
  • Completed 3 trials
    • ACTT-1 – 1,062 participants enrolled in 58 days
    • ACTT-2 – 1,033 participants enrolled in 54 days
    • ACTT-3 – 969 participants enrolled in 98 days.
  • And we are over 10% enrolled into ACTT-4

• The studies were opened at 103 sites in 10 different countries
• A total of:
  • 3,247 subjects enrolled
  • 42,110 visits
  • 180,896 CRFs completed
  • 272,863 specimens collected
• 2 NEJM papers that have been cited 817 times
• These efforts have supported:
  • The licensure of remdesivir (approved in approximately 50 countries)
  • The EUA of baricitinib

By any account, this has been a remarkably productive trial and collaboration. It only happens because of the countless people working tirelessly to make these studies successful – the teams at all the sites, groups coordinating implementation in each country, multiple networks that have come together for this trial, our partners at Emmes, Leidos Biomed, TRI, ICON, FHI, Fisher Bioservices and all the work across multiple divisions at NIAID. Thanks to everyone involved – it is remarkable what a motivated group can accomplish in such a short amount of time. 

Manual of Procedures Sections

View approved IDCRC Manual of Procedures (MOP) sections which describe structure, operating policies, roles and responsibilities of entities and individuals within the unit/consortium:

• Advisory Boards
• Network Meetings and Communications

In The News

Atlanta Business Chronicle: "Capital of public health"

Published January 22, 2021

Emory’s Hope Clinic was one of just three sites in the U.S. that launched a phase one trial of the Moderna vaccine in March 2020. This was due in part to the fact that Emory is home to a Vaccine Trial Evaluation Unit (VTEU) — one of 10 NIH-funded sites across the country engaged in cutting-edge vaccine research and prepared to rapidly conduct large-scale trials. 

"Ride Health and COVID-19 Prevention Trials Network (CoVPN) Partner to Provide Transportation for Vaccine Trial Participants"

Published January 20, 2021

"Gritstone Advances Second Generation COVID-19 Vaccine 'CORAL' Program with Support from NIAID; Program has Potential to Protect Against Mutant Variants of SARS-CoV-2"

Published January 19, 2021

"Brotman Baty Institute's Helen Chu named 'Washingtonian of the Year'"

Published January 15, 2021

"Fenway Health deploys mobile health clinic to increase access to and representation in COVID-19 research"

Published January 14, 2021

Lab Land: "The blind is off: Moderna COVID-19 vaccine study update"

Published January 7, 2021

“IDCRC PI Neuzil Named Marylander of the Year”​

Published January 2, 2021

NIH: "Peer-reviewed report on Moderna COVID-19 vaccine publishes"

Published December 30, 2020

The investigational vaccine known as mRNA-1273 was 94.1 percent efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19. Investigators identified no safety concerns and no evidence of vaccine-associated enhanced respiratory disease (VAERD).

NIH: "Phase 3 trial of Novavax investigational COVID-19 vaccine opens"

Published December 28, 2020

The Phase 3 trial of another investigational coronavirus disease 2019 (COVID-19) vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people at approximately 115 sites in the United States and Mexico. It will evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax is leading the trial as the regulatory sponsor.

Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine

Published December 18, 2020

The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID).

National Academy of Inventors names IDCRC PI David S. Stephens as fellow

Published December 8, 2020

Publications

View recent journal articles featuring IDCRC-supported work below:

• Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination
• Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
• Vaccine optimization for COVID-19: who to vaccinate first?
• Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19
• A Geroscience Approach to Preventing Pathologic Consequences of COVID-19
• Rapid generation of neutralizing antibody responses in COVID-19 patients

IDCRC-CoVPN Studies

Communication Resources: New Zoom Backgrounds 

Click the button below to access IDCRC communication resources, including five new IDCRC Zoom backgrounds.

Event

Thank you to the more than 200 attendees of the 2nd Annual IDCRC Meeting, held January 19, 2021.

IDCRC Concept Quick Stats

Please submit IDCRC news to epthomp@emory.edu for inclusion in the monthly newsletter and IDCRC.org.