A Laredo, Texas, area physician, Dr. Asuncion Ramos Soriano, was recently profiled in local media discussing a novel clinical trial in that part of deep southern Texas. After training back east at NYU and Johns Hopkins, Dr. Soriano has been caring for people along the border here for 25 years. Laredo’s population has grown to 261,000 with a metropolitan area size of 300,000 on the U.S. side and another 640,000 in Nuevo Laredo on the Mexican side of the border. As this part of Texas gets exposed to various parasite pathogens, Dr. Soriano was familiar with a treatment called Nitazoxanide as it worked better than some more traditional antiparasitic medications. The drug has been found to inhibit a broad range of respiratory pathogens in cell cultures, including SARS-CoV-2. Dr. Soriano has used this drug off label to treat COVID-19, successfully! Now Dr. Ramos Soriano, in conjunction with local trial site organization Envision Clinical Research, LLC, will lead a study of Nitazoxanide, a drug used for over four decades against parasites and other conditions, against SARS-CoV-2, the virus behind COVID-19. The clinical trial sponsor is Romark Laboratories. TrialSite showcased another study with the same drug targeting COVID-19 in Alabama.
The Study Drug
Produced by Romark Laboratories, this antiparasitic drug has been found to inhibit a broad range of respiratory pathogens in cell cultures, and this includes SARS-CoV-2, the virus behind COVID-19. Nitazoxanide was approved by the U.S. Food and Drug Administration (FDA) by 2002 as a treatment for diarrhea caused by the water-borne parasitic infection Cryptosporidium under the trade name Alinia.®
By April, Romark Laboratories announced the intention to test its new drug candidate, NT-300, based on the FDA approved drug nitazoxanide, against COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
The company uncovered that in cell cultures, the active ingredient in NT-300 (nitazoxanide) inhibits the replication of a broad range of respiratory viruses, including SARS-CoV-2. Interestingly, this is similar to another FDA approved antiparasitic drug, ivermectin.
Nitazoxanide has been shown to inhibit the replication of SARS, MERS, and other coronaviruses as well as influenza viruses, rhinoviruses, parainfluenza viruses, RSV, and others in cell culture studies. This substance’s broad-spectrum antiviral activity is based on its ability to interfere with human cellular pathways that viruses are known to exploit for replication, rather than to a virus-targeted mechanism
The Principal Investigator
Dr. Asuncion Ramos Soriano with Laredo Medical has been practicing in this border region for 25 years. Originally trained in medical school at the University of the Philippines Manila, she went on to achieve her Residency at New York University Medical Center and then her Fellowship at Johns Hopkins University School of Medicine. Dr. Soriano moved to the South Texas region where she became exposed to developing world -like conditions with some of the parasitic pathogens—often seen in the tropical world. It was there that she learned about the current study drug and in addition to its powerful anti-parasitic attributes but also its ability to inhibit viral pathogens.
Real World Evidence
Dr. Soriano shares in a recent Facebook Live session her story and how she has started treating COVID-19 patients off label with the FDA approved drug nitazoxanide. Thus far, she has an incredible track record of success but she of course understands the importance of evidence hence the clinical trial.
Sponsored by Romark Laboratories, the study seeks participants but with a special emphasis on healthcare providers. All participants must be 18 or up.
This study could possibly be related to another Romark Laboratories study, targeting 800 COVID-19 patients. This study (NCT04359680) seeks to evaluate the efficacy and safety of Nitazoxanide for Pre-and Post-Exposure Prophylaxis of COVID-19 and other viral respiratory illnesses in healthcare workers and others at increased risk of SARS-CoV-2 infection. This latter study started in May and runs through the end of the year.
The Trial Site in Laredo
The clinical trial will be conducted with the support of Envision Clinical Research, LLC, of Laredo, Texas. This trial site is led by Monica Gonzalez, Clinical Project Manager operating in Laredo since 2007. Gonzalez and her research site often collaborate with Dr. Soriano.
For an extensive interview of Dr. Soriano and Ms. Gonzalez, see a Facebook Live from 8 KGNS TV.
Call to Action: If you are based in the Laredo area and work in healthcare or other at-risk jobs, consider connecting with Envision Clinical Research. Sponsors and CROs interested in a solid research site and PI team (Dr. Soriano and Ms. Gonzalez) consider contacting them as well. The trial site can be reached at (956) 290-0166