The Phase II trial for a possible treatment for COVID-19 was launched August 4. The Phase II trial, known as ACTIV-2, follows and coincides with the ongoing Phase III trial of a vaccine that also recently began. Researchers sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, are working with clinical sites to identify potential patient volunteers to participate in the tests.
Therapeutics and vaccines
COVID-19 cases now number above 4.7 million nationwide and over 156,000 deaths have been reported in the United States. Within Michigan, as late as last week there were almost 85,000 confirmed infections and over 6,200 deaths. With increases in the number of infections on a local, state and national level being reported, researchers are working as quickly as possible to develop a reliable vaccine and therapeutic. The purpose of a vaccine is to prevent diseases. Therapeutics focus on treatment and cure. Therapeutics are proteins biologically derived from living cells that can treat or cure a disease. A therapeutic equivalent may also be developed and will work to help curtail symptoms or eliminate them altogether.
As referenced in a previous column, the United States Food and Drug Administration and the American Red Cross are engaged in a joint effort that encourages those who have successfully recovered from COVID-19 to donate blood. The goal is to study the antibodies in their blood. Antibodies assist the immune system in fighting disease. Neutralizing antibodies target specific viruses or other pathogens. Researching the antibodies from COVID-19 patients helped scientists pinpoint an antibody that specifically attacks the coronavirus and develop a therapeutic reliable enough to begin Phase II testing, employing strict protocols.
In the current Phase II therapeutic trial, the first test will focus on LY-CoV555, an investigational monoclonal antibody (mAb). This antibody was isolated from a blood sample from a recovered COVID-19 patient. Copies of this antibody were then synthesized in a lab. The term “monoclonal” refers to laboratory-manufactured antibodies. The development of LY-CoV555, an investigational monoclonal antibody made by Eli Lilly and Company, occurred after a collaboration with AbCellera Biologics.
Phase II and Phase III testing
Phase II of therapeutic and vaccine tests begins with a small number of tests. The initial stage of the current therapeutic trial is designed will involve approximately 220 volunteers who have recently experienced symptoms of COVID-19, tested positive but have not been hospitalized. Randomly chosen, 50% of the volunteers will receive an intravenous (IV) infusion of LY-CoV555. The other volunteers will receive a placebo infusion of a saline solution. The infusion takes approximately an hour to deliver, and volunteers will be observed afterwards to note any reactions.
Over a 28-day period, the participants will be monitored in their homes and in clinics for COVID-19 characteristics. Because those infected with COVID-19 typically have low blood oxygen levels, levels will be monitored for any possible improvements.
Phase II will track the safety of the therapeutic, the ability of it to shorten the length of time that symptoms are present, and its effectiveness in reducing the probability of hospitalization or death.
If the investigational therapeutic shows positive results, the study be expanded from a Phase 2 to a Phase 3 trial to gather additional critical data from a larger pool of volunteers without delay. In addition to the initial 220 participants, another 1,780 will be added, effectively testing the therapeutic on a total of 2,000 people.
The trial will be led by the NIAID-funded AIDS Clinical Trials Group and will enroll participants at sites around the world. Other therapeutics may also be tested using the same protocol.
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Dr. Omar P. Haqqani is the chief of Vascular and Endovascular Surgery at Vascular Health Clinics in Midland: www.vascularhealthclinics.org