Ongoing clinical trials search for coronavirus cure
One year after the first patient with COVID-19 was diagnosed in the U.S., the world is still searching for safe and effective drugs to treat the coronavirus. UC Davis School of Medicine researchers have partnered with many drug developers to test potential therapies and vaccines. Currently, they are recruiting for more than 12 clinical trials to find potent COVID-19 treatments.
"Fighting the COVID-19 pandemic has fostered collaboration among drug developers, academic medical and research centers as well as supportive funding agencies," said Allison Brashear, the dean of the UC Davis School of Medicine. “UC Davis School of Medicine, renowned for its research expertise, is a trusted partner on many COVID-19 clinical trials at the forefront of efforts to cure this terrible disease.”
Treating COVID-19 with stem cells
- Christian Sandrock, director of critical care and professor of internal medicine, is leading a phase 2 study to evaluate injections of stromal cells (called PLX-PAD) in the muscle for the treatment of severe COVID-19 patients. The trial, sponsored by Pluristem Therapeutics, will test if PLX-PAD can help patients intubated and on ventilators due to COVID-19 to recover faster with fewer complications. PLX-PAD cells, extracted from the human placenta, have regenerative potential that might help reduce tissue damage caused by hyperimmune reaction to coronavirus.
- Stuart Cohen, chief of infectious diseases, is testing how well a treatment with natural killer cells (CYNK-001) works in people with COVID-19. The study is sponsored by Celularity Incorporated. Natural killer cells from the human placenta are immune cells known to kill some types of cancers without hurting normal healthy tissues.
- A study led by the chair of internal medicine, Timothy Albertson, evaluates the intravenous (IV) infusion of CAP-1002 as a treatment for patients with COVID-19. CAP-1002, produced by Capricor Therapeutics, consists of stem cells extracted from the cardiac tissue.
- Albertson is also co-managing a stem-cell trial with Rachael Callcut,associate professor of surgery and vice chair of clinical sciences. The trial, sponsored by the Department of Defense, aims to see how effective mesenchymal stromal cells are in reducing inflammation associated with acute respiratory distress syndrome (ARDS) and in helping damaged lungs to repair themselves. ARDS is one of the severe complications of COVID-19 infection.
Treating COVID-19 with monoclonal antibodies
Antibodies are proteins made by the body’s immune cells to fight infections. Monoclonal antibodies are laboratory-produced molecules that act as substitute antibodies. Their role is to restore, enhance or mimic the immune system's attack on cells.
- Albertson is testing Regeneron’s combined monoclonal antibodies as a treatment of hospitalized and non-hospitalized patients with COVID-19. The experimental drug targets the virus that causes COVID-19, making it harder for the virus to infect people. These monoclonal antibodies are also being tested for household members of patients with COVID-19.
- UC Davis Health is testing VIR-7831, a monoclonal antibody by Vir Biotechnology and GlaxoSmithKline. George Thompson, associate professor of medicine, is studying the safety and effectiveness of VIR-7831 as an early treatment of COVID-19 in non-hospitalized patients.
Other antiviral clinical trials
- Albertson is leading a phase 1b trial to evaluate the safety and efficacy of a Pfizer antiviral protease inhibitor (C4611001). This study is available to hospitalized patients and administered via a 5-day continuous IV infusion.
- Thompson is also leading a trial of Remdesivir, an antiviral drug given intravenously, as a treatment of COVID-19 in an outpatient setting. Remdesivir was initially developed by Gilead Sciences to combat Ebola.
- Another phase 2/3 clinical study led by Thompson evaluates the efficacy and safety of molnupiravir (MK-4482) in hospitalized and non-hospitalized adults with COVID-19. Molnupiravir, by Ridgeback Biotherapeutics and Merck & Co, is taken orally, making it easier to use and distribute.
- Thompson is also testing the orally administered AT-527 for moderate COVID-19 infection in hospitalized patients. AT-527, an experimental antiviral drug by Atea Pharmaceuticals in collaboration with Roche, is designed to prevent viral replication.
The adaptive I-SPY and ACTIV-3 COVID-19 trials
- On Jan. 22, UC Davis Health was approved for patient recruitment to the I-SPY COVID trial (An Adaptive Platform Trial for Critically Ill Patients). The trial, part of the Quantum Leap Healthcare Collaborative, is co-led by Albertson and Angela Haczku, professor of pulmonology and associate dean for translational research. It is an adaptive platform trial that aims to rapidly screen promising drugs for the treatment of critically ill COVID-19 patients.
- Similar to the I-SPY trial, the ACTIV-3 study is an adaptive study testing a host of monoclonal antibodies that target various virus functions. The study, also led by Albertson and funded by the National Institutes of Health, is enrolling hospitalized patients who are not mechanically ventilated.
“We take this opportunity to thank all the participants who volunteer in our clinical trials,” Albertson said. “Their contribution helps to save lives and push science forward.”
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