Clinical Trials and Research News Weekly Roundup | S2 E27 | WHO and Ivermectin

TrialSite News Weekly Roundup

WHO & Pan American Health Organization Position on Ivermectin Use & COVID-19: Produce Evidence via RCT

  • In recent episodes, we’ve covered a plethora of stories about Ivermectin from around the globe. Recently, the Pan American Health Organization (PAHO) and the WHO (World Health Organization) came together to respond to the growing use of Ivermectin (especially in South America) to treat COVID-19. Although the “Monash” study demonstrated successfully that Ivermectin could be used to treat SARS-CoV-2 in experimentally infected cells and two preprint publications, based on observational studies reporting the apparent utility of Ivermectin to treat patients with COVID-19 needing mechanical ventilation, none of these sources represent sufficient evidence justifying use of the drug off label. The observational studies were not accepted in any peer reviewed journals and one of them was associated with the suspect “Surgisphere” group. Which we discussed at length in our Watchlist Episode titled: Hydroxychloroquine and the Mysteries Surgisphere Database. Consequently, PAHO and WHO recommend the only Ivermectin use occur in randomized controlled trials. Now… we here at TrialSite News would only add that there are a growing number of well-respected physicians around the world that have set up careful Ivermectin off label case studies with successful results according to their reports and associated interviews. Moreover at least 30 clinical trials involving Ivermectin have already commenced and in fact two are now completed. So we must ask the question, could there be an institutional bias against Ivermectin?
  • Could Unrelated Live Attenuated Vaccine Help Reduce Deadly Septic Inflammation Associated with SARS-CoV-2?: Two Louisiana researchers recently proposed that administering MMR (measles, mumps, rubella) vaccine could possibly represent a preventive measure to reduce septic inflammation observed with SARS-CoV-2 infection. The basis for this hypothesis stems from research in the labs of both Dr. Paul Fidel, Jr., Department Chair, Oral and Craniofacial Biology, and Associate Dean for Research, Louisiana State University Health School of Dentistry and Dr. Mairi Noverr, Professor of Microbiology & Immunology at Tulane University School of Medicine. The pair, who have collaborated in the past, hypothesize that an MMR vaccine in healthy individuals has few risks (no contraindications) and could be an effective approach to better protect individuals exposed to high-risk exposure scenarios, such as health care workers.
  • A Global Village of Volunteers as the Oxford COVID-19 Study Heads to Odisha: Meanwhile, in other COVID-19 related news: Ankan Nayak, an IT sales manager based in Odisha’s Sambalpur district, is a long way from Oxford University but that won’t stop him from stepping up and giving back to society by volunteering for the forthcoming Oxford University ChAdOx1 nCoV-19 vaccine. One of the leading candidates, Oxford teamed with AstraZeneca to progress the vaccine to the next phase. Already, they have immunized 1,000 healthy adults by May.
  • AstraZeneca Presents Positive Data from Phase III ETHOS Trial of Triple-Combination Therapy Breztri Aerosphere in Moderate to Severe COPD: For our final story of the day, we’re going to shift away from Covid-19 to talk about COPD. AstraZeneca announced positive results from the phase 3 ETHOS trial which compared triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) with two dual combination therapies: Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (single inhaler, fixed-dose budesonide and formoterol fumarate), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Treatment with Breztri Aerosphere resulted in a statistically significant reduction in the rate of moderate or severe exacerbations versus the dual combination treatments, thus reaching the primary endpoint