Clinical Trials and Research News Weekly Roundup | India State’s Health Authority Approve Ivermectin

Weekly ROundup


Goa Game Changer: Indian State’s Health Authority Approves & Distributes Ivermectin & Doxycycline to Treat COVID-19 as Prophylaxis: Goa’s Chief Minister Pramod Sawant alongside State Health Minister Vishwajit Rane launched the ‘Home Isolation Kit’ to combat COVID-19. Apparently, the Indian state was influenced by Australia’s Dr. Thomas Borody and his combination treatment involving Ivermectin and Doxycycline (and zinc) targeting SARS-CoV-2, the virus behind COVID. Dr. Tarek Alam at the Bangladesh Medical College has also demonstrated the efficacy of the treatment in a hospital-approved case series study and is now conducting a randomized controlled study in that country. Back to beautiful southwestern India in Goa, calling it a “game-changer,” the Health Minister of this small Indian state is targeting the complete eradication of the virus in a people-centric home-based program. COVID-19 in Goa
Regeneron Submits Request for FDA EUA for REGN-COV2 in Head to Head Competition with Eli Lilly: Regeneron reported that subsequent to the New York-based company’s discussions with regulatory authorities, they have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for their investigational REGN-COV2 investigational antibody combination for COVID-19. This was one of the experimental therapies administered to POTUS at Walter Reed Medical Center. Under their agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and the company expects to have doses available for 300,000 patients in total within the next few months. The company received $450m from the U.S. federal government for advanced purchases and secured ongoing support from NIAID. Eli Lilly just submitted a request for an EUA for their monotherapy monoclonal antibody called LY-CoV555.
Nitazoxanide Used Off Label in Laredo, TX, to Successfully Treat COVID-19: Now Clinical Trials! 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. 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 vir us behind COVID-19. The clinical trial sponsor is Romark Laboratories. TrialSite showcased another study with the same drug targeting COVID-19 in Alabama.
FDA Clinical Trial Oversight “Lax, Slow, and Secretive”: In a time when we need agile and open research regulation, the “FDA’s own documents reveal agency’s lax, slow, and secretive oversight of clinical research,” according to an October 1 article from Science. One case is that of osteopath Michael Harris, who was cited by the FDA for almost ten years for “egregious errors” in trials he oversaw. His firm Aspen Clinical Research out of Orem, Utah, had contracts “to evaluate many drugs, including ones aiming to treat postoperative pain, pediatric schizophrenia, and migraines.” Citations included informed-consent violations, medical assessments by nonqualified staff, and failure to report abnormal test results. Further, he effectively hid subjects’ use of opioids, SSRIs, and antipsychotics, skewing results and raising safety concerns. Aspen’s, “records were disorganized, contradictory, and sometimes backdated in a way that ‘begs the question of the authenticity and veracity of data collected.” All together, the errors might be scientific misconduct, fraud, and substantial violations of the rights of human study subjects.