Coocoo, This should be forwarded to NP. Might s
Post# of 153886
(Total Views: 851)
Posted On: 08/05/2020 12:29:23 AM
Coocoo,
This should be forwarded to NP. Might stir some conversations w/ the FDA.
"rlftf phase 2/3 PR. From July.
Their DMSC recommended continuation but changed their primary endpoint.
Thoughts?
With resurgent COVID-19, enrollment has accelerated in Miami, Houston, and Irvine
Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping. The study is to continue until the next interim analysis.
The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.
This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks. "
This should be forwarded to NP. Might stir some conversations w/ the FDA.
"rlftf phase 2/3 PR. From July.
Their DMSC recommended continuation but changed their primary endpoint.
Thoughts?
With resurgent COVID-19, enrollment has accelerated in Miami, Houston, and Irvine
Data Monitoring Committee determined that so far RLF-100 has generated no drug-related Serious Adverse Events or other safety concerns that would mandate stopping. The study is to continue until the next interim analysis.
The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.
This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks. "
(3)
(0)