UCLA Health needs volunteers for large trial investigating ways to reduce coronavirus hospitalizations and speed recovery.
As COVID-19 cases spike across the country, hundreds of research studies are underway to identify potential treatments for the virus.
One of the largest studies – sponsored by the National Institutes of Health and involving UCLA Health – is actively recruiting people who have tested positive for the coronavirus. Joining the ACTIV-2 study is a chance to contribute to science and possibly receive experimental medication.
Unprecedented in scope, scale and speed, ACTIV-2 — Accelerating COVID-19 Therapeutic Interventions and Vaccines – 2 (Outpatient Monoclonal Antibodies and Other Therapies) is designed to reduce hospitalization and speed recovery for COVID-19 patients. There are more than 80 active domestic study sites, with plans to expand internationally soon.
“We’re looking for treatments that will help people get better faster and keep them out of the hospital and prevent death,” says Kara Chew, MD, an infectious disease specialist and a co-chair of the study.
ACTIV-2 is a “platform trial,” she says, meaning multiple medications and treatment interventions can be studied simultaneously.
“Our goal is to rapidly get them through the phase two and three evaluation process to find safe and effective treatment that can then move forward to FDA approval and widespread use,” she says.
To achieve full FDA approval, proposed treatments must undergo three phases of study involving progressively larger populations, followed by comprehensive analysis of potential risks and benefits. Emergency use authorization (EUA) allows therapies to be offered to patients before full approval is issued, a process that can take years. The FDA has granted EUAs for two monoclonal antibody therapies, one from drug maker Eli Lilly and the other from Regeneron, for the treatment of select non-hospitalized patients with COVID-19.
Monoclonal antibodies are lab-created antibodies similar to those the body naturally produces in response to disease. These antibodies bind to the spikes of the coronavirus and prevent the virus from infecting or entering cells and further replicating. The treatment is currently available at UCLA Health for patients at high risk of developing severe disease.
As the number of therapeutic agents being studied is ever increasing, ACTIV-2 is continually seeking volunteer participants who have tested positive for COVID-19 but have not become sick enough to be hospitalized.
Adults of all ages are eligible to participate. Of particular interest to researchers, however, are individuals at high risk of disease progression, such as those who are older, those with comorbidities such as diabetes or heart disease, people who are immunosuppressed and people who smoke.
“Because COVID can cause a wide spectrum of symptoms — and, for some people, long-term symptoms that can be debilitating — we are interested in therapies that can not only prevent hospitalization and death, but also shorten symptom duration and improve symptoms more quickly and avoid these long-term effects,” Dr. Chew says.
Study of a new medication — a combination of two monoclonal antibodies — is about to begin. While the existing monoclonal antibody treatments are intravenous infusions, ACTIV-2 researchers also want to evaluate potential treatments that can be injected, inhaled or taken as pills that could one day be available at drug stores.
The ACTIV-2 studies are placebo-controlled trials, meaning study volunteers receive either the test medication or an inert substance. By comparing participants who get the medication with those who receive the placebo, researchers can determine the efficacy of the intervention. Participants will be tracked for at least six months.
Many more potential treatments are to be studied in the trial, Dr. Chew says. Some of the therapies are existing medications being examined in the context of COVID-19; others are new formulations scientists are creating in response to the pandemic.
“The study will go on until there are sufficient effective and safe therapies for outpatient COVID-19,” Dr. Chew says, so volunteers will be needed for months to come.
“What’s interesting about COVID is we’re reaching out to a community that has largely not been engaged in research,” she says. “The vast majority of people with COVID-19 are your average person who has never considered being in a clinical trial, so we want people to know that investigational therapies are an option.”
To find out more about ACTIV-2 and how to get involved, visit riseabovecovid.org.