The National Institutes of Health (NIH)-backed ACTIV-2 clinical program has been billed by one of leading participating investigators as having 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.” Recently, a participating trial site organization, Vanderbilt University Medical Center (VUMC), issued a press release to showcase the study in an effort to attract more volunteers. The ongoing clinical treatment study for adults with COVID-19, located at the prestigious Nashville academic medical center, reminds that contributing to helping them to identify safe and effective treatments represents a big contribution to society. One of 100 sites nationwide, ACTIV-2 includes multiple phases and evaluations of promising investigational drugs currently undergoing testing to treat early COVID-19. Treatment for this phase or lifecycle of the disease remains a critical and elusive goal as no treatment today has been authorized, even on an emergency basis. The study at VUMC is led by David Haas, MD, professor of medicine. TrialSite notes that Vanderbuilt researchers actually developed one of the investigational therapies involved in this study—AZD7442, now under sponsorship by AstraZeneca.
What is ACTIV-2?
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.
ACTIV-2 (NCT4518410) includes a range of therapies identified in the NIH’s ACTIV protocols. This Phase 2 clinical trial can seamlessly expand to a Phase 3 if the study drug produces positive evidence. And there are multiple drugs under investigation for adults with COVID-19 who are not hospitalized with an aim to evaluate the safety and efficacy of multiple treatments including monoclonal antibodies and therapeutics. TrialSite shares a table showing the different treatments:
|LY-CoV555 An investigational antibody developed by Eli Lilly in partnership with AbCellera Biologics. This is a monoclonal antibody originally identified with NIAID’s Vaccine Research Center.||The therapy was given emergency use authorization (EUA) by the FDA in November 2020, They issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19.|
Bamlanivimab is authorized for people with positive results of direct SARS-CoV-2 viral testing who are twelve years of age and older
|BRII-196 & BRII-198 developed by a Chinese biotech firm called Brii Biosciences. The company was founded by a prominent pharmaceutical executive and maintains a U.S. headquarters in Research Triangle Park in NC.||Under investigation|
|SNG-001—inhalable beta interferon delivered via nebulizer and developed by a biotech called Synairgen||Under investigation|
|AZD7442—combination of two monoclonal antibodies (AZD8895 and AZD1061) profiled by TrialSite. Note one is undergoing testing as a prophylaxis (AstraZeneca). Vanderbilt researchers first discovered.||Under investigation|
|Camostat Mesilate—orally administered serine protease inhibitor developed by Sagent Pharmaceuticals that can possibly block the coronavirus from entering the human cells||Under investigation|
VUMC’s Dr. Haas Point of View
Principal Investigator Dr. Haas shared recently in the VUMC press release about this randomized, double-blinded, placebo-controlled adaptive study: “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 as VUMC positions will also be a part of a wonderful effort to make a medical breakthrough helping everyone rise above COVID.
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.
David Haas, MD, professor of medicine.
Call to Action: For more information about the ACTIV-2 clinical trial, please visit the study website, the local Vanderbilt study website, or check out the listing here. To enroll in the trial here call 615-936-8594 or follow the link to the trial site’s website.