IDCRC-VTEU Sites Supported ACTT 1-4 Studies: Contributing to Advance COVID-19 Therapeutics

Nine Infectious Diseases Clinical Research Consortium (IDCRC) and Vaccine and Treatment Evaluation Unit (VTEU) sites or protocol specific sites across the U.S. participated in the Adaptive COVID-19 Treatment Trials (ACTT) 1-4 enrolling almost 20% of participants. Results from these clinical trials identified remdesivir as an agent to treat hospitalized COVID patients; found baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with COVID-19, notably among those receiving high-flow oxygen or noninvasive ventilation; found Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalized patients with COVID-19 pneumonia; and found that both baricitinib and dexamethasone when added to remdesivir in those hospitalized on low flow or high flow oxygen had similar outcomes with baricitinib having fewer adverse events.

John Beigel, MD, associate director for clinical research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), NIH, presented the accomplishments of the ACTT program during the final ACTT COVID-19 Treatment Study (DMID 20-0006) Protocol Team/Site Call in late October.

The ACTT studies were conducted over 21 months at 93 sites in 10 countries, enrolling 4,074 participants and completing 53,572 total visits. The studies have led to an impressive public health and science impact. Remdesivir is now approved/authorized for use in 49 countries worldwide – most of which have scientific or government guidelines recommending use in hospitalized patients. More than 9 million people worldwide have been treated with remdesivir to date. “We have shown that high-quality trials, capable of supporting regulatory decisions, can be done during a pandemic/public health emergency,” says Beigel.

Adaptive COVID-19 Treatment Trials (ACTT) 1-4 Citations: Beigel shared a video prepared by Anthony Fauci, MD, director of NIAID, congratulating and thanking the ACTT study team for their tireless dedication to advance understanding of optimal treatments for hospitalized patients with COVID-19 through the NIAID-sponsored trials.
Beigel thanked the study team on behalf of NIAID for making ACTT successful, and noted
that on a personal level, “working on ACTT was one of the highlights of my career. This is one of
the most successful groups that I have seen in this pandemic for therapeutics when it comes to
quality and quantity of the research.”

This program is an example of dedication to science and patients, and what a collaborative network of government, academia and industry all united with a common goal can accomplish.
About Infectious Disease Clinical Research Consortium (IDCRC)
The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group (under award number UM1AI148684), was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, other affiliated sites and NIAID.