A study on the effectiveness of multiple treatments, including laboratory-made antibodies, at preventing mild COVID-19 from advancing to severe illness in the outpatient setting is underway by researchers at The University of Texas Health Science Center at Houston (UTHealth). The clinical trial is enrolling patients at Harris Health System's Lyndon B. Johnson Hospital.
UTHealth is launching 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. Operation Warp Speed, a multi-agency effort led by the U.S. government to develop, manufacture, and distribute COVID-19 vaccines, therapies, and diagnostics, also coordinates the study.
The Phase II, randomized, blinded, controlled, adaptive platform trial will allow different medications be added and dropped during the course of the study as they are developed, allowing researchers to effectively test them against a placebo. Adaptive clinical trials observe patient outcomes and side effects that occur during the trial's set schedule and allow for modification based on those observations.
The first treatment being tested is LY-CoV555, an investigational monoclonal (laboratory-manufactured) antibody developed from the blood sample of a recovered COVID-19 patient. Once isolated, copies of this antibody were synthesized and produced in a lab. Antibodies are proteins produced by immune cells to fight infections. By isolating and reproducing this protein and delivering it via intravenous infusion, investigators hope to develop a treatment that can target SARS-CoV-2, the virus that causes COVID-19, and prevent patients with a minor case from developing severe illness.
"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 must be adults 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 should be considered "high risk" for developing severe COVID-19. High 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 period 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 in their bodies and the effect 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 Phase II. If the investigative treatments meet the study's defined criteria for further evaluation and reveal positive results, they will advance from Phase II to Phase III.
Phase III will aim to enroll a larger population of participants to evaluate the effectiveness of each treatment as preventing hospitalization and death in nonhospitalized adults with COVID-19.
###
Other co-investigators from McGovern Medical School include Karen J. Vigil, MD; Netanya S. Utay, MD; and Sarah Duong, MD.
For more information about the ACTIV-2 trial, please visit the study website or http://www.actgnetwork.org.