Respiratory failure is defined, according to FDA guidance, as the need for intensive care with mechanical ventilation, non-invasive ventilation, or high-flow nasal oxygen in order to sustain adequate levels of blood oxygen. So far, no drug-related Serious Adverse Events have been reported.
There is currently no FDA-approved drug that has shown efficacy in patients who are already in the Intensive Care Unit with Respiratory Failure.
Although NeuroRx and Relief are optimistic that RLF-100 will also be effective in treating early COVID-19, the companies have focused first on those patients who have no available therapy and are at the highest risk of mortality.
An open-label prospective study in patients with Critical COVID-19 has already shown a nine-fold hazard ratio advantage in both survival and recovery from respiratory failure with both statistically significant (P
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