Innovation Pharmaceuticals Inc (IPIX)

[CallMeCrazy]

NIH clinical trial testing antiviral remdesivir plus anti-inflammatory

Baricitinib(link is external), a product licensed to Eli Lilly and Company by Incyte and marketed under the brand name Olumiant, is approved in the U.S. and in more than 65 additional countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Some people with COVID-19 experience acute respiratory distress syndrome (ARDS), in which inflammation of the lungs leads to shortness of breath and rapid breathing. Baricitinib, taken orally, inhibits cytokine signaling in the body that play roles in causing inflammatory responses. The putative benefit of baricitinib for COVID-19 has been described in a case series of critically ill patients who recovered from COVID-19. The combination of remdesivir and baricitinib for COVID-19 has not been evaluated in a large, randomized controlled treatment trial.

In accordance with standard clinical research protocols, eligible patients who provide informed consent will participate in ACTT 2. Participants in the trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation. Individuals with confirmed infection who have mild symptoms, or no apparent symptoms, will not be included in the study. Eligible study participants will be randomly assigned 1:1 to a treatment arm:

Arm 1: participants receive baricitinib tablets orally and intravenous (IV) remdesivir
Arm 2: participants receive placebo tablets orally and IV remdesivir
The study is double-blind, meaning neither trial investigators nor participants know who is receiving which treatment regimen. Remdesivir is administered as one 200-milligram (mg) IV dose followed by a 100-mg once-daily IV dose for the duration of hospitalization up to a 10-day total course of treatment. Baricitinib is administered as a 4-mg oral dose (or crushed and given through a nasogastric tube, if necessary) for the duration of hospitalization up to a 14-day total course of treatment. The placebo tablets resemble baricitinib but contain only inactive ingredients.

Investigators will evaluate whether time to recovery is shorter in the combination arm (baricitinib plus remdesivir), relative to remdesivir alone. Recovery is defined as the participant being well enough for hospital discharge, meaning the participant either no longer requires supplemental oxygen or ongoing medical care in the hospital, or is no longer hospitalized (with or without some limitation on activities). Recovery is evaluated up until day 29. A key secondary goal of the study is to compare patient outcomes at day 15 using an ordinal eight-point scale ranging from fully recovered to death. The trial will also compare other secondary outcome variables between treatment groups, including mortality alone.

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-testing-antiviral-remdesivir-plus-anti-inflammatory-drug-baricitinib-covid-19-begins

Just heard a doctor on 'Daily Mail' say this clinical trial is designed to deliver a 1-2 punch. IMO, Brilacidin will deliver a 1-2-3 punch (therapeutic). B will just have to wait on these warm-up acts before taking the main stage.