UTHealth Launches Adaptive Clinical Trial for COVID-19 Treatments

UTHealth Launches Adaptive Clinical Trial for COVID-19 Treatments
A 3d render of a Chronavirus or COVID-19

A new study of multiple treatments aimed at preventing mild COVID-19 from advancing to severe illness has begun at The University of Texas Health Science Center at Houston (UTHealth). The first study is of LY-CoV555, an investigational antibody developed from the blood sample of a recovered COVID-19 patient. That trial is enrolling patients at Harris Health System’s Lyndon B. Johnson Hospital.

The pipeline for COVID-19 treatments has gone from empty to brimming in just the few months since the pandemic began. The FDA has already authorized five treatments for emergency use, but none has yet been approved. Coming up fast, there are almost 600 drug development programs in planning stages and just over 300 clinical trials have been reviewed by the FDA.

UTHealth is the Houston site of the nationwide ACTIV-2 trial, a public-private partnership led by the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The study is also coordinated by Operation Warp Speed, a US government led multi-agency effort to develop, manufacture, and distribute COVID-19 vaccines, therapies, and diagnostics.

The Phase II, randomized, blinded, controlled, adaptive platform trial will allow different medications be added and dropped during the course of the study, allowing researchers to effectively test them against a placebo. Adaptive clinical trials observe patient outcomes and side effects during a trial’s set schedule and allow for modification based on those observations.

The first treatment being tested is LY-CoV555, an investigational antibody developed from the blood sample of a recovered COVID-19 patient. LY-CoV555 is delivered via intravenous infusion.

“Being able to provide our patients with an early treatment option that could prevent severe COVID-19 illness and hospitalization is not only key for improving patient outcomes but for protecting communities that have been hardest hit by this virus,” said Roberto C. Arduino, MD, the study’s lead investigator and professor of infectious disease with McGovern Medical School at UTHealth.

Eligible participants are patients who have been diagnosed with symptomatic COVID-19, but do not require hospitalization. They must have tested positive for the illness within seven days of enrollment and experience symptoms within 10 days. At least half of those enrolled will be at risk for developing severe COVID-19. Risk factors include being age 55 or older and having one of the following conditions: chronic lung, kidney, or liver disease; hypertension; cardiovascular disease; diabetes; obesity; or moderate to severe asthma.

The study will last roughly six months. During the first month, participants will have a series of in-person visits to track their symptoms as well as to determine if the virus’ RNA is still detectable in their nose and saliva using a nasopharyngeal swab. Participants will also give blood samples to help researchers better understand how the medications function and the effect they have on viral shedding to determine if the treatment agents can reduce or stop transmission of SARS-CoV-2. Researchers will follow up with participants via phone calls or video chats during the remaining course of the study.

UTHealth aims to enroll between five and 10 patients for each Phase II trial. If the investigative treatments meet the study’s defined criteria for further evaluation, they will advance from Phase II to Phase III.

Phase III will aim to enroll a larger number of participants to evaluate each treatment’s effectiveness in preventing hospitalization and death in non-hospitalized adults with COVID-19.