UC San Diego Kicks Off Testing In First Of Kind Outpatient Worldwide COVID-19 Trial
UC San Diego began to recruit patients this month for a worldwide trial of treatments for coronavirus patients who are in the early stage of their infection, and local San Diego scientists are spearheading the effort.
Patients who participate in this trial, called ACTIV-2, are those are have tested positive for coronavirus, but are still feeling well enough not to be hospitalized. The goal of the trial, which is happening under the National Institutes Of Health's Operation Warp Speed program, aims to try multiple coronavirus-specific therapies at once, quickly and efficiently. These are all intended to treat patients outside of the hospital to stop them from getting any sicker.
Virologist Dr. David Smith of UC San Diego is the principal investigator on the study.
"The first studies that happened were very much about keeping people from dying once they get into the hospital. This one is about keeping people out of the hospital. So in that setting we have to find people who are early in their infection," Smith said.
One of the therapies being tested is a unique and highly potent synthetic antibody created specifically to attack the coronavirus, Smith said. At the UC San Diego Health campus in Hillcrest outside the Antiviral Research Center, there's a large white tent, where patients will receive any one of these treatments or a placebo.
"[The antibody] is going to be infused in them so we have to have some space so they can get infused and its gonna take a bit of time because we are also monitoring," Smith said.
The first stage of the trial will try to recruit around 200 patients, and each patient will get 1 type of therapy, Smith said. The idea is that by testing out a number of Phase 2 drugs, which have already gone through some trials, this study can be efficient with resources. For example, scientists can just use the same placebo.
UCSD physician Dr. Constance Benson, who’s also heading the study, has already spearheaded a global HIV research network.
"How do you find patients? That requires that we have staff that are available for outreach, we specifically hire people who can go to doctors' offices and testing sites," she said.
Steve Hendrickx, the nurse on the ACTIV-2 trial, says scientists are hoping to get a diverse group of patients.
"We have the ability to enroll patients that are native Spanish speakers," said Hendrickx. "If you look at the map of San Diego, the worst impacted people are of South Bay and East County ... we are focusing on the areas of San Diego that are worst impacted."
Benson said worldwide efforts are always challenging, especially in a global pandemic.
"There’s a lot of pressure on all of the investigators and all of the sites to enroll people as quickly as we can so we can have answers for these things fast," Benson said.
Both Smith and Benson say this type of trial is necessary to find therapies for patients that are in the beginning stages of infection.