Clinical Trials and Research News Weekly Roundup | AdventHealth Ocala ICAM Protocol Takes on COVID

Oct 5, 2020 | Digital NBA, Video, Weekly Roundup

TrialSite News Roundup


Advent Health Ocala’s ICAM Protocol Takes on COVID-19: Clinician Drives Real World Evidence & Breakthrough: Physicians, nurses, and all healthcare workers have served heroically during this pandemic, not only in the U.S. but all over the world. Faced with a novel coronavirus and minimal treatment options, and in the case of remdesivir, severe shortages and high cost—Health systems, hospitals and community clinics seek alternative, safe treatments that can save lives. Recently, a pharmacist serving as a director of pharmacy for AdventHealth Ocala Florida faced a challenging situation as COVID-19 cases spiked while the only provisionally approved medication at the time, remdesivir, was in short supply. What does an innovative health system do in this situation? In the case of AdventHealth Ocala, part of the nation’s largest not-for-profit, Protestant-based health system, they tapped into their knowledge and creativity, medical and scientific intellect, as well as drive and desire to save lives, and developed a protocol called ICAM. It appears to be highly effective, observationally. If ICAM proves to work consistently, AdventHealth and Carlette Norwood-Williams, PharmD, and her colleagues have done the nation, and for that matter, the world, a compelling service. Next comes a study to investigate the efficacy of the combination treatment.
Argentina Study Supports Ivermectin for COVID-19: Argentina’s largest newspaper, Clarin, reported on September 23 about positive results in an ivermectin study, including reduced viral loads, in a study conducted in that nation. Clarin posits that this, “is the first scientific evidence available in the world, which manages to verify the effect of this drug on the coronavirus under in vivo conditions in infected patients.” The results were reported Wednesday from the Ministry of Science and Technology, and followed a four-month effort; the work was conducted by a public-private consortium being led by Alejandro Krolewiecki of the Tropical Diseases Research Institute. Scientists explained that the 0.6 mg/kg dose was three times the amount “usually used.” They said this dose, “produces the fastest and most profound elimination of the virus when treatment is started in the early stages of infection (up to 5 days from the onset of symptoms).”
Avigan (favipiravir) Meets Endpoints in Phase 3 Japanese Clinical Trial: Sponsor will Register as a Therapy for COVID-19: FUJIFILM Toyama Chemical Co., Ltd (FUJIFILM) reports that the primary endpoint has been met for its Phase 3 clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”), conducted in Japan for patients infected with SARS-CoV-2, the virus behind COVID-19. The efficacy primary endpoint is time to negative conversion of detectable SARS-CoV-2 viral RNA in the RT-PCR assays, and time to alleviation of symptoms (body temperature, oxygen saturation and chest images). TrialSite recently reported FUJIFILM would move to commercialize it as a COVID-19 therapy.
While AZD1222 Clinical Trial Resumes in UK & India FDA Keeps the Study on Hold due to ‘Mystery Illnesses’: AstraZeneca’s COVID-19 vaccine candidate, AZD1222—also known as the “Oxford vaccine” or ChAdOx1 nCoV-19—was purportedly under consideration by at least some factions within the U.S. executive branch to contribute to a potential “October Surprise;” in fact, the vaccine was under consideration for an expedited approval process, prior to the forthcoming U.S. presidential election. Why? According to a report from the Financial Times, it is because of what was deemed positive results from a relatively small UK study. TrialSite wrote that the Phase 3 AstraZeneca study was designed for an unprecedentedly fast conclusion when considering estimated start date and estimated primary completion date it equaled to 3.5 months, as compared to an average of about 15 months for every other Phase 3 COVID-19 vaccine trial.


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