Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial

‘This is, to the best of our knowledge, the first large, randomised controlled trial to test the efficacy of fluvoxamine for acute treatment of COVID-19. We found a clinically important absolute risk reduction of 5·0%, and 32% RR reduction, on the primary outcome of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19, consequent on the administration of fluvoxamine for 10 days. This study is only the second study to show an important treatment benefit for a repurposed drug in the early treatment population.13 Our findings represent the complete analysis of the trial after the DSMC recommended stopping the active fluvoxamine group and all 28-day follow-up of randomly assigned patients. Given fluvoxamine's safety, tolerability, ease of use, low cost, and widespread availability, these findings might influence national and international guidelines on the clinical management of COVID-19.’

Read here (The Lancet, Oct 27, 2021)

Effect of ivermectin on time to resolution of symptoms among adults with mild Covid-19: A randomised clinical trial

‘In this randomized clinical trial that included 476 patients, the duration of symptoms was not significantly different for patients who received a 5-day course of ivermectin compared with placebo (median time to resolution of symptoms, 10 vs 12 days; hazard ratio for resolution of symptoms, 1.07).

‘The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand effects on other clinically relevant outcomes.’

Read here (JamaNetwork, Mar 4, 2021)

FLCCC Alliance issues open letter to UK researchers planning a new trial to test ivermectin for use in Covid-19

‘The Front Line COVID-19 Critical Care Alliance (FLCCC) has issued an open letter to researchers  in England at the University of Oxford who are planning to conduct a double-blind, Randomized Controlled Trial (RCT) of ivermectin for use in COVID-19.  The letter states, “Our manuscript, which reviewed both epidemiologic data and the existing clinical trials evidence base, concluded that ivermectin should be the standard of care in COVID-19.”

• ‘A meta-analysis of existing data of ivermectin as a therapeutic finds large, statistically significant reductions in time to clinical recovery, length of hospitalization, and death.
• ‘The Declaration of Helsinki – Ethical Principles for Medical Research involving Human Subjects” states that “when combining medical research with medical care, patients can only be studied...if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.”

Read here (Newswire, Jan 25, 2021)

Download FLCCC Aliiance PDF here

Oxford’s PRINCIPLE trial: Bringing ivermectin directly into the developed world in the battle against Covid-19

‘The University of Oxford soon kicks “the PRINCIPLE Trial” into a higher gear now, in what they consider a pathbreaking “high-quality trial” of Ivermectin, a generic drug already evidencing significant efficacy in over two dozen clinical trials around the world, according to some researchers. The UK government also backs this pivotal study via the Department of Health and Social Care. 

‘Searching for early-onset, home-based ambulatory treatments for COVID-19, the PRINCIPLE Trial seeks to meet a gap in research in the world’s richest nations to date. Nearly all of the taxpayer-financed research-based expenditures of governments in the US, UK and Europe, for example, have gone into vaccines, novel monoclonal antibodies, and novel therapeutics, with an emphasis on treating severely ill patients. 

‘Ivermectin, hailed as the “wonder drug” or “the People’s medicine” for COVID-19, gains growing attention worldwide made more widely available, frankly, partly due to TrialSite’s consistent chronicling of these trials around the world since the original University of Monash breakthrough.’

Read here (TrialSite News, Jan 23, 2021)