Clinical Trials & Research News Weekly Roundup | FDA: Expanded Access Protocol to RLF-100 for Respiratory Failure for COVID-19

TrialSite News Weekly Roundup
FDA Grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19 Patients: The U.S. Food and Drug Administration (FDA) has granted RELIEF THERAPEUTICS Holding AG and its U.S. partner NeuroRX, Inc. Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (Aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP). This action makes the treatment available to patients who have exhausted standard therapies and are not eligible for the current Phase 2/3 clinical trial of RLF-100 due to confounding medical conditions and specifically makes the treatment available to pregnant women.
Beloit Memorial Hospital Case Series The Combo of Famotidine & COX-2 Antagonist Cures all 14 COVID-19 Patients: Two highly respected physicians from Beloit Memorial Hospital in Wisconsin recently uploaded the results of their research for the world to review. These physicians articulate that Famotidine, a histamine H2 receptor antagonist/inverse agonist commonly used to treat mast cell activation syndrome (symptoms include anaphylaxis) reduced COVID-19 mortality in one hospital-based retrospective study.
More on the Recent Impressive Leronlimab Results: Why Doesn’t Leronlimab Attract more Attention? TrialSite News recently reported that Baylor University Medical Center recently announced its initiative to study leronlimab, an investigational drug for HIV infections that is under evaluation due to its apparent ability to inhibit lung inflammation associated with COVID-19. The largest not-for-profit health system in Texas was selected by sponsor CytoDyn to participate in an ongoing Phase 3 study.
NC-Based Velocity Clinical Research Selected for All Five Major Vaccine Research Programs Nationwide: Durham-based Velocity Clinical Research (Velocity Clinical) continues executing on its goal of expanding the company’s national base of research sites while transforming the research sector from one of many fragmented small sites and at times non-responsive networks to a more scalable model: one that looks like a clinical research organization.
Lure Children’s Hospital Chicago Research Breakthrough: Young Children May have 100X More COVID-19 Virus than Older Children & Adults: Researchers from the Ann & Robert H. Lurie Children’s Hospital have uncovered that children younger than five years of age with mild to moderate COVID-19 appear to have far greater levels of genetic material for the virus in the nasal passages as do older children and adults. These findings contradict other findings that show children are infected at lower rates than elder children or adults. But the new findings out of Chicago raise serious concern about the role children may have in spreading this pathogen.
Politicization Continues as Ohio Board of Pharmacy Bans Drug & Then Rescinds: Only in the age of COVID-19 have drugs become so politicized. For example, the story of Hydroxychloroquine: drug that was promoted early on across the board as considered at least one early-stage option to attempt to treat the novel coronavirus. Some of the world’s largest studies, such as University of Oxford’s COPCOV, embraced the anti-malarial drug. But with the controversial Trump promotion as well as intense scrutiny on the data thereafter, came the emergence of medicinal “camps” and, of course, such polarization tends to produce the data that fits into the convenient paradigm or world view.
At-Home Decentralized COLCORONA Trial Investigates if Colchicine Keeps COVID-19 Symptoms from Progressing to Reduce Hospitalization & Death: There is presently no available, FDA-approved medicine that can be administered at a patient’s home that can prevent the negative progression of SARS-CoV-2 symptoms leading to hospitalization and potentially death. Can a widely available, generic drug used for gout change this? Based on preclinical animal research, the Montreal Heart Institute thinks potentially it can.