“NP said two things in the latest Proactive: the
Post# of 153822
(Total Views: 535)
Posted On: 05/05/2020 8:11:54 AM
“NP said two things in the latest Proactive: there is the possibility that the enrollment is finalized before end of May and the results available end of May.”
Great post TechGuru. Another board member pointed out a detail that is missed on clinicaltrials.gov that clearly shows the primary and secondary endpoints are measured at 3, 7, and 14 days, not 6 weeks like a few of us had mentioned. This means that if the final patient is enrolled by the end of May, we could have results by mid-June. I’ve pasted the information from the website below, which is updated as of May 1st, 2020. This increases my hope dramatically that we will see data soon as long as the trials can be enrolled. There are enough primary and secondary outcomes in this trial, along with the placebo arm, to clearly demonstrate leronlimab’s efficacy if it continues to work as it has in the 50+ EINDs.
Primary Outcome Measures:
1. Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
2. Secondary Outcome Measures :
1.Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]
2. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
3. Change from baseline in pulse oxygen saturation (SpO2) [ Time Frame: Days 3, 7, and 14 ]
4. Change from baseline in the patient's health status on a 7-category ordinal scale [ Time Frame: Days 3, 7, and 14 ].
5. Incidence of hospitalization [ Time Frame: Day 14 ]
6. Duration (days) of hospitalization [ Time Frame: Day 14 ]
7. Incidence of mechanical ventilation supply [ Time Frame: Day 14 ]
8. Duration (days) of mechanical ventilation supply [ Time Frame: Day 14
9. Incidence of oxygen use [ Time Frame: Day 14 ]
10. Duration (days) of oxygen use [ Time Frame: Day 14 ]
11. Mortality rate [ Time Frame: Day 14 ]
12. Time to return to normal activity [ Time Frame: Day 14 ]
https://clinicaltrials.gov/ct2/show/NCT043436...amp;rank=2
Great post TechGuru. Another board member pointed out a detail that is missed on clinicaltrials.gov that clearly shows the primary and secondary endpoints are measured at 3, 7, and 14 days, not 6 weeks like a few of us had mentioned. This means that if the final patient is enrolled by the end of May, we could have results by mid-June. I’ve pasted the information from the website below, which is updated as of May 1st, 2020. This increases my hope dramatically that we will see data soon as long as the trials can be enrolled. There are enough primary and secondary outcomes in this trial, along with the placebo arm, to clearly demonstrate leronlimab’s efficacy if it continues to work as it has in the 50+ EINDs.
Primary Outcome Measures:
1. Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
2. Secondary Outcome Measures :
1.Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]
2. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
3. Change from baseline in pulse oxygen saturation (SpO2) [ Time Frame: Days 3, 7, and 14 ]
4. Change from baseline in the patient's health status on a 7-category ordinal scale [ Time Frame: Days 3, 7, and 14 ].
5. Incidence of hospitalization [ Time Frame: Day 14 ]
6. Duration (days) of hospitalization [ Time Frame: Day 14 ]
7. Incidence of mechanical ventilation supply [ Time Frame: Day 14 ]
8. Duration (days) of mechanical ventilation supply [ Time Frame: Day 14
9. Incidence of oxygen use [ Time Frame: Day 14 ]
10. Duration (days) of oxygen use [ Time Frame: Day 14 ]
11. Mortality rate [ Time Frame: Day 14 ]
12. Time to return to normal activity [ Time Frame: Day 14 ]
https://clinicaltrials.gov/ct2/show/NCT043436...amp;rank=2
(7)
(0)