COVID-positive patients who aren’t hospitalized can play a crucial role in the development of medications for COVID
NASHVILLE – Vanderbilt University Medical Center is actively enrolling volunteers in an ongoing clinical treatment study for adults with COVID-19. While there is very little good that can come from contracting COVID, helping us identify safe and effective medications could be a huge positive for anyone who qualifies for the study.
According to Dr. Judith Currier at UCLA, one of the leaders in the nationwide trial, this study is designed to rapidly identify treatments with the potential to “…radically alter the current pandemic landscape and make a profound difference in the lives of people with and at risk for the disease.”
Vanderbilt is one of over 100 sites nationwide conducting this “ACTIV-2” research, which includes multiple phases and evaluations of promising investigational drugs for treating early COVID-19.
Led locally by David Haas, M.D., professor of medicine and principal investigator for the study at Vanderbilt, the ACTIV-2 trial is studying the safety and efficacy of medications to treat adults with COVID-19 and who are not hospitalized.
Researchers are also studying how quickly treatment changes the amount of virus in the upper airway, which may be important in reducing or halting transmission of the virus that causes COVID-19 illness.
ACTIV-2 is a randomized, blinded, placebo-controlled adaptive study that allows promising investigational drugs to be added and removed over the course of the study. The study is designed to efficiently test various new drugs, alone or in combination, within the same clinical trial.
“We are excited about this effort to help find a safe and effective treatment for COVID-19,” Haas said. “We hope that treatment keeps people alive, feeling better, and out of the hospital. People infected with COVID-19 may feel pretty well at first but can become very sick very fast. People newly diagnosed with COVID-19 in the Nashville area who are not hospitalized can make a big difference by volunteering for this study.”
To qualify for ACTIV-2, volunteers must still have at least one symptom of COVID-19 (fever, cough, shortness of breath or other symptoms), have first tested positive for COVID-19 as an outpatient within 7 days and had symptoms start no more than 7 days ago. Vanderbilt is committed to enrolling individuals in under-represented communities that have been most impacted by COVID-19.
Qualified volunteers will be compensated for their participation in ACTIV-2 and will also be a part of a wonderful effort to make a medical breakthrough helping everyone rise above COVID.
For more information about the ACTIV-2 clinical trial, please visit the study website, the local Vanderbilt study website, www.actgnetwork.org, or ClinicalTrials.gov using study identifier NCT04518410. To enroll in the trial at Vanderbilt, please call (615) 936-8594 or click here.
About Vanderbilt Therapeutics Clinical Research Site
The Vanderbilt Therapeutics Clinical Research Site was established in 2000 and is led by David Haas, M.D., professor of Medicine in the Division of Infectious Diseases at Vanderbilt. Beverly Woodward, MSN, RN is the site coordinator as well as a research nurse. Vanderbilt contributes to the research at the national level with research nurse, Joan Gottesman, BSN, RN serving as one of two field representatives for the ACTIV-2 protocol. The study is led by the nationwide AIDS Clinical Trials Group (ACTG), which includes Vanderbilt’s Therapeutics Clinical Research Site, and is funded by the NIH. ACTIV-2 will mostly enroll people living without HIV, but people living with HIV may also enroll.
About ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial
ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private research partnership to speed development of the most promising treatments and vaccines. It is also receiving support from Operation Warp Speed, the U.S. government’s effort to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.