The study, published Jan. 20 in , found CBD showed a significant negative association with SARS-CoV-2 positive tests in a national sample of medical records of patients taking the FDA-approved drug for treating epilepsy. The researchers now say that clinical trials should be done to determine whether CBD could eventually be used as a preventative or early treatment for COVID-19.

They caution, however, that the COVID-blocking effects of CBD come only from a high purity, specially formulated dose taken in specific situations. The study’s findings do not suggest that consuming commercially available products with CBD additives that vary in potency and quality can prevent COVID-19.

Scientists have been looking for new therapies for people infected by the coronavirus and emerging variants, especially those who lack access to vaccines, as the pandemic continues across the country and world and as breakthrough infections become more common.

“The Commonwealth of Kentucky has a robust hemp agriculture, so we were pleased to find that pharmaceutical grade CBD is worth testing in future human clinical studies,” said Kenneth Palmer, study coauthor who headed the UofL research team. “In response to the COVID-19 pandemic, our team developed expertise in SARS-CoV-2 infection models and we welcomed the opportunity to collaborate with the University of Chicago team to confirm the efficacy of CBD treatment against SARS-CoV-2.”

Palmer is director of the Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases and the Leona M. and Harry B. Helmsley Charitable Trust Endowed Chair in Plant-based Pharmaceutical Research at UofL. The center houses the Regional Biocontainment Laboratory, one of only 12 regional and two national biocontainment labs in the United States and the only one in Kentucky. Established with support from the NIH to conduct research with infectious agents, the lab includes Biosafety Level 3 facilities built to the most exacting federal safety and security standards.

Researchers from the University of Louisville co-authoring the study with Palmer are Divayasha Saxena, Jon D. Gabbard, Jennifer K. Demarco, William E. Severson and Charles D. Anderson. The research was directed by the University of Chicago and other scientists involved are from the National Argonne Laboratory, the University of Illinois at Chicago and the National COVID Cohort Collaborative Consortium.

For more detail on how medical-grade CBD shows promise as a treatment for COVID-19, check out the full story here.��

Between Aug. 25 and Sept. 1, investigators from the tested nearly 3,000 Jefferson County residents for the to detect the presence of the virus in participants’ nasal swabs by the polymerase chain reaction (PCR) method and for the presence of antibodies against the virus in their blood.

The results showed that approximately 1.1% of all the participants tested positive for active coronavirus infections. Among vaccinated participants only 0.7% had an active infection, while nearly 5% of unvaccinated participants were actively infected. This number would roughly correspond to 7,260 active infections in the county, a nearly tenfold increase in infection rates over the rates measured in April, despite a sharp increase in vaccinated residents, as shown in Figure 1.

As in previous testing rounds, the team also tested for antibodies in participants. They found that independent of their vaccination status, in both the sampled and volunteer groups, nearly 16% of the participants had natural infection antibodies against the virus suggesting that they must have been infected by the virus in the recent past. These data indicate that in the last few months, at least 100,000 adults in Jefferson County have had COVID-19.

“These results highlight the steep rise in coronavirus infections in our community and provide a startling snapshot of the current state of the pandemic,” said Aruni Bhatnagar, director of the Envirome Institute. “Our estimates suggest that the number of infected individuals may be twice as high as that indicated in public records.

“Our work shows the vaccine is working as intended. Our population was almost 90% vaccinated, much higher than the 64% of fully vaccinated county residents. In the entire cohort, vaccinated people were over 12 times less likely to be infected compared with unvaccinated people. Though in our volunteer group, 65% of the active infections were in fully vaccinated individuals who had received the vaccine earlier this year. Most reported no or mild allergy-like symptoms and did not recognize that it may be a COVID infection thus did not think they needed to get tested.”

The study also provided estimates of where in Jefferson County the infections are most prevalent. To identify infection rates in different areas, the researchers classified the participants into neighborhood zones, as shown in Figure 2.

The highest rate of active infection was found in Zone 3A, or far southwestern Jefferson County. The highest rate of those recently having had an infection was found in Zone 3B, central southern Jefferson County, as shown in Figure 3.

Participants from Zone 3B also reported lower rates of vaccination, although vaccination rates were lowest in Zone 1B in western Jefferson County, as shown in Figure 4.

“Even though nearly 90% of the participants in the entire study population were vaccinated, we had areas that reported as low as 60% vaccination, and the persistence of infection in some geographical areas seems to be related to lower rates of reported vaccination,” said Rachel Keith, associate professor of environmental medicine at UofL who conducted the study. “Our results show that much work remains to be done and that knowing that rates of infection are high in their community may be an added incentive for some individuals to get vaccinated.

“Additionally, knowing that fully vaccinated individuals may still get an active infection allows those individuals to take additional precautions such as masking or testing which helps keep the community safe, including any young or immunocompromised friends and families who may need extra protection.”

“The vaccine is very effective. Nearly 96% of vaccinated individuals had detectable levels of antibodies against the virus in their blood. However, in a small number of people (less than 0.6%) the levels of antibodies were undetectable in our assay, even though these individuals were fully vaccinated,” Keith said. “The lack of a measurable response in some individuals even after vaccination may be due to their health and immune status. We are analyzing our results to find out more about why some rare individuals do not develop high antibody levels in response to vaccination.”

Using the data from more than 7,000 individuals tested over the past year, the team is trying to identify personal and environmental characteristics that increase the risk for coronavirus infection and how vaccination reduces this risk.

For this round of testing, the team collected samples at 13 locations across Jefferson County. Active coronavirus infections were analyzed by Bluewater Labs and antibodies against the virus were assayed at at the .

To randomly sample people from all parts of the city and to include proportional number of individuals of different age and race/ethnicity, researchers at UofL partnered with Westat to mail approximately 30,000 letters asking people to participate in the study. Nearly 1,000 people who responded to this invitation were tested and an additional 1,886 booked their own appointments after hearing about the study in the news or on social media.

This study was supported in part by a contract with the Centers for Disease Control and Prevention.

Throughout May, Phase I of the tested 1,372 health care workers at hospitals in the system. Samples were collected by ���Ǵڳ�’s and tested at ��at the Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases.

The study found just two participants had an active infection of SARS-CoV-2, the virus that causes COVID-19. An additional 14 workers tested positive for antibodies, suggesting that they have been exposed to the virus. Unfortunately, due to low amounts of blood in some samples, antibody levels could not be tested in 128 workers.

The Co-Immunity Project, launched in April with an announcement by Kentucky Gov. Andy Beshear, is a collaboration between the and the Brown Envirome Institute. The purpose of Phase I of the project was to test health care workers at the , and UofL Health systems to identify those who have been exposed to COVID-19 and to determine how their body produced a response, or antibodies, to such infection. This information will help identify potential donors of high-quality plasma for treatment of patients with severe COVID-19 symptoms.

Interested health care workers collected their own blood and plasma samples and delivered them to researchers with the Brown Envirome Institute. The samples were then tested at the RBL, one of only 12 such NIH-funded laboratories in the nation and the only one in Kentucky. Results from Baptist Health and Norton Healthcare will be provided at a later date, but researchers say the results from workers at UofL Health facilities provide data that can be used to provide information about the pandemic and its effects.

UofL Health consists of five hospitals, four medical centers, nearly 250 physician practice locations, the UofL Health – Frazier Rehab Center and the UofL Health – James Graham Brown Cancer Center.

“The rates of infection and exposure among our health care workers is surprisingly low,” said CPM/RBL Director Kenneth Palmer, a co-investigator of the project. “Even though the number of individuals who tested positive for the antibody is more than those who had the active virus, this is still a low number, especially for those who are working in high-risk environments such as hospitals.”

“This is good news,” said UofL Assistant Professor of Medicine Rachel Keith, who conducted the study, “It shows that the precautionary measures adopted by our hospitals are working, and that patients seeking care in our hospitals are at a low risk of being infected by their health care providers.��

“These results show the need for appropriate precautions, indicating that with proper PPE and social distancing, we can minimize the threat posed by the virus to our health care community.”

Researchers advised, however, that because so little is known about the novel coronavirus SARS-CoV-2 and the disease it causes, COVID-19, much more research is necessary.

“The rates of infection among health care workers nationwide remains unknown. A recent study of health care workers in Germany who had direct contact with COVID-19 patients did find that only 1.6% tested positive for SARS-CoV-2 antibodies. This is within range of the 1% of antibody-positive health care workers our study found in Louisville,” said Brown Envirome Institute Director Aruni Bhatnagar, a co-investigator with the project.

“However, fewer individuals with antibodies against the virus also could mean that few individuals have acquired immunity, and therefore many of our health care workers may be vulnerable to the virus still lingering in our community. They may remain susceptible should infections increase again, either in the fall or some other time.”

Individuals who have recovered from COVID-19 and have antibodies against the virus are being asked by Norton Healthcare to donate plasma to help treat high-risk patients. More information is available on the .

opened earlier this month to the community to sample 2,400 participants who reside in different parts of Jefferson County to determine the existing prevalence of COVID-19 infection and immunity in the general population.

The project also will re-test health care workers across UofL Health in July to see whether the rates of infection and immunity have changed since May. The results from this second survey will be critical in monitoring how an increase in non-critical care activities in UofL hospitals has affected SARS-CoV-2 infections and see what changes occur to the levels of antibodies in those who showed a positive antibody response in Phase I testing.

The California biomedical company Qualigen Therapeutics Inc. has signed a license agreement for the technology, and plans to fund continued development with UofL to ready it for market.

The technology, first announced in April, is based on a piece of synthetic DNA — an “aptamer” — known as AS1411, which targets and binds with a human protein called nucleolin. Early tests show AS1411 may stop viruses, including coronavirus, from “hijacking” nucleolin to replicate inside the body.

UofL researchers Paula Bates and Kenneth Palmer partnered to apply the AS1411 technology to coronavirus. Bates co-discovered the base aptamer technology with researchers John Trent and Don Miller and has applied it a variety of ways, including to .��The cancer application of the technology also is in development with Qualigen.

“This new use of the AS1411 technology, to fight coronavirus, is another example of the relationship we’ve developed with UofL and how we can work together at a high level,” Qualigen CEO Michael Poirier said. “Because of our outstanding partnership in the cancer area, we believe that our combined effort will be up to the enormous challenge with COVID-19. This is a critically important effort that could provide much needed help to COVID-19 patients worldwide. It is imperative that we do everything we can to succeed.”

Palmer, who is director of ���Ǵڳ�’s Center for Predictive Medicine and Regional Biocontainment Laboratory, conducted proof-of-concept experiments showing the aptamer was effective against the virus at doses shown to be safe in humans by previous research.

The lab is one of only 12 regional and two national biocontainment labs in the United States and the only one in Kentucky. Established with support from the NIH to conduct research with infectious agents, the lab includes Biosafety Level 3 facilities built to the most exacting federal safety and security standards. The stringently secure facilities protect researchers and the public from exposure to the pathogens being investigated.

“This has been a true collaborative effort — everyone at UofL has rallied together to take on this big global challenge,” Bates said. “I am fortunate to be at UofL, which is one of the few places in the country where we have the facilities to do this important work.”

Both AS1411 applications — to fight cancer and coronavirus — are licensed to Qualigen through the , which works with startups and industry to commercialize university-born technologies.

The work so far on the technology’s COVID-19 application has been partially supported by a gift from shipping giant UPS, which in early May to fund trials and test materials.

UofL researchers now are processing test results from 12 hospitals, UofL Campus Health and four outpatient clinics in the Greater Louisville area. As of today, the university had processed 1,797 tests, including 1,032 for Norton Healthcare, 288 for UofL Health and 186 for Jewish Hospital. There have been 204 positive tests.

“We now have the capacity to do up to 1,000 cases per day,” said Kevin Gardner, ���Ǵڳ�’s executive vice president for research and innovation. “We have researchers who have temporarily dropped all of their other duties to devote their time to the fight against COVID-19.”

As part of the expanded testing effort, the university also has committed to processing up to 200 cases per day through the drive-up testing being conducted by UofL Health at its site at Brook and Liberty streets in downtown Louisville.

���Ǵڳ�’s efforts are producing all test results within 24 hours, according to Gardner, who is reporting the results directly to the Kentucky Cabinet for Health and Family Services, which relays the reports to Gov. Andy Beshear’s office on a daily basis. Rapid turnaround allows hospitals to isolate patients and health care providers with COVID-19 and move others out of isolation, saving supplies of personal protective equipment that are critically low in the state and protecting the health care workforce.

By processing the tests and studying the SARS-CoV-2 virus, UofL researchers and the university’s Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases are hoping to answer urgent questions about how it is spread, who becomes sick and how the illness progresses. That information is needed to help prevent transmission of COVID-19.

UofL is supporting this research with $500,000 in funding, but additional funds are needed to continue the work over time. Donations specifically for the research can be made at��.

UofL also continues to work on long-term approaches to the virus.

Kenneth Palmer, director of ���Ǵڳ�’s Center for Predictive Medicine, is testing potential treatments, including one developed at UofL in partnership with the National Cancer Institute and the University of Pittsburgh.

Over the past decade, the laboratory has responded to national emergencies, studying highly infectious diseases such as SARS and others. Today it is being called upon in research efforts focusing on the novel coronavirus, SARS-CoV-2, and the disease it causes, COVID-19. And in that lab, researchers are exploring compounds that hold promise as therapeutic agents against the disease and could be grown quickly in host tobacco plants.

That’s right, tobacco. A strain of the reviled plant that has caused fatal diseases for centuries could be the key to quickly mass-producing a preventive agent, treatment or vaccine for COVID-19.

“A protein in the university’s own proprietary portfolio and other compounds from industry sources may be useful against SARS-CoV-2,” said Kenneth Palmer, PhD, director of ���Ǵڳ�’s (CPM).�� “We are currently conducting laboratory research with these compounds that could eventually lead to a therapeutic agent against COVID-19.”

���Ǵڳ�’s (RBL) is housed in the CPM and is part of a network of 12 regional and two national labs that were established with support from the NIH to conduct research with infectious agents. The national labs are located at Boston University and at the University of Texas Medical Branch at Galveston. Regional labs are located at the University of Chicago, Duke University, Boston University and other universities throughout the U.S. The RBL network stands ready in response to public health emergencies and emerging diseases such as the novel coronavirus.

The UofL RBL includes Biosafety Level 3 facilities built to the most exacting federal safety and security standards. The stringently secure facilities protect researchers and the public from exposure to the pathogens being investigated. As part of the RBL network, the UofL RBL is able to respond to needs of researchers, federal agencies and pharmaceutical companies nationwide to conduct research with infectious agents.

Palmer and his research team received samples of SARS-CoV-2 last month and are researching it only in the highly secure confines of the RBL. Covered head to toe in personal protective equipment to prevent self-infection, the researchers now are testing the therapeutic candidates against the disease in cell cultures.

The UofL compound is known as and is co-owned by the university with the National Cancer Institute and the University of Pittsburgh. It is a potent anti-viral protein that possesses microbicidal capabilities. The other compounds are proprietary to their respective companies.

The research goal is to identify the best potential treatment option that could eventually be tested in humans, first at UofL to gauge its safety and efficacy and then later at the University of Pittsburgh and other clinical trial sites to continue to test its effectiveness. Although there are no guarantees, “we believe we could move into human clinical trials by the end of the year,” Palmer said.

That’s where the tobacco plants come in. A large amount of the ultimate therapeutic will be needed for human trials. Kentucky’s historical cash crop is a perfect host to produce the quantities needed.

“The unique quality about studying these compounds in Kentucky is that we can rapidly scale up production of tobacco plants to produce the large amounts of the agent we will need for human testing,” Palmer said. “As people already know, tobacco grows very well in Kentucky.”

Some of the compounds are already showing promise in the laboratory. While the end of the year seems far off in the current coronavirus climate, it is realistic because “SARS-CoV-2 may be with us for a couple of winter seasons. We’d like to have a product that could be tested if the infection comes back in the cold season like influenza does,” Palmer said.

If it does, Palmer and his team will be ready. “We think we will be able to deliver the drug as a nasal spray and hope we can use it as a preventive, pre-exposure treatment before a vaccine could be developed. This will be important for the public and especially for those who are at risk because of their age or pre-existing health conditions or because they work in health care.”

.��