Clinical Trials and Research News Weekly Roundup | MedinCell’s ‘Mass Roll-out’ of Ivermectin for COVID-19: Study Data Show Promise

MedinCell’s Mission for ‘Mass Roll-out’ of Ivermectin for COVID-19: Early Study Data Points Reveal Promise:
TrialSite News first introduced Montpellier, France-based MedinCell, and their efforts to commercialize an ivermectin-based treatment for COVID-19 back in April. The French biotech company now reports positive first results from a clinical trial aiming at the validating the safety of continuous administration of ivermectin. Presented at an international “Collaborative Workshop—Ivermectin against COVID-19,” MedinCell reports no side effects observed with the first two doses in the study, which totals three doses. And so, they announced via press release that a first long-acting injectable formulation is ready to enter regulatory development. Embracing a prophylactic strategy, the company seeks to mimic the approach taken against HIV: “preexposure prophylaxis” (PrEP) evidencing efficacy as well as the need for long-acting injectable treatments, as the are the only ones that guarantee the continuity of protection. This French company also explores a “postexposure prophylaxis” (PEP) effort for established close contact with COVID-19.

Real-World Retrospective Exposure-Crossover Study of 70K+ Patients Reveals Most Frequent Complications Associated with COVID-19:
A sizable retrospective study involving the University of Buffalo, Aetion, Inc., HealthVerity, Inc. and the University of Toronto confirms a significant number of complications associated with COVID-19. Published in the Canadian Medical Association Journal (CMAJ), the team used de-identified outpatient and inpatient medical claims from American health databases to identify 70,288 patients who were infected with SARS-CoV-2, the virus behind COVID-19. Covering a duration from March 1 to April 30, 2020 over half of the health visits involved hospitalization, with about 5% of the total admitted into intensive care. With a median age of 65 and 55.8% female the authors studied a plethora of medical codes targeting those that increased in number post pandemic onset. Sure enough this real world evidence (RWE)-based study found that the most frequent complications associated with COVID-19 included pneumonia, respiratory failure, kidney failure and sepsis or systemic inflammation. These findings aligned with other observations. Overall, the risk associated with a patient with COVID-19 succumbing to these more serious ailments equaled 27.6% for pneumonia, 22.6% for respiratory failure, 11.8% kidney failure and 10.4% associated with sepsis or systemic inflammation.
Additionally these researchers found other real world evidence, although rare in association with COVID-19, such as a range of other conditions associated with COVID-19 such as collapsed lung, blood clotting disorders and heart inflammation. COVID-19 isn’t associated with a higher risk of stroke according to this study.