The "trial" was expanded access not a phase 1, 2 o
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Posted On: 10/21/2020 6:54:04 AM
The "trial" was expanded access not a phase 1, 2 or 3. The EUA submission was based on 51 patients. only 21 of which were treated with RLF-100. No blinding at all. The MOA they attribute to a vasodilator including directly antiviral and an EUA submission based on so little seems more hype than anything else.
Their actual trial is 288 patients, randomized - placebo controlled, moderate or severe with the primary outcome progression to ARDS. Exclusions are respiratory failure or impending ventilation or high flow oxygen and no extensive comorbidities. Which would assuredly mean most of the patients would be moderate. Since the vast majority of moderate patients don't progress to ARDS there's a very high likelihood of trial failure.
Their actual trial is 288 patients, randomized - placebo controlled, moderate or severe with the primary outcome progression to ARDS. Exclusions are respiratory failure or impending ventilation or high flow oxygen and no extensive comorbidities. Which would assuredly mean most of the patients would be moderate. Since the vast majority of moderate patients don't progress to ARDS there's a very high likelihood of trial failure.
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