I am somehow still not completely clear about the trial timelines. I would be very grateful for some definitive clarification.
Phase 2
Mild to Moderate Trial: 75 Patients
Latest Trial Revision: May 12, 2020
Link: https://clinicaltrials.gov/ct2/show/NCT043436...amp;rank=2
Recruiting:
University of California, Los Angeles – Recruiting
Montefiore Medical Center -- Recruiting
Novant Health -- Recruiting
Not Yet Recruiting:
Palmtree Clinical Research, Inc. -- Not yet recruiting
Eisenhower Health -- Not yet recruiting
Yale -- Not yet recruiting
Atlantic Health System Hospital -- Not yet recruiting
Ohio Health -- Not yet recruiting
Oregon Health and Science University -- Not yet recruiting
Background:
As of yesterday, we were told that ~45 patients have been enrolled - but not necessarily injected (I had hoped for more)
There are 17 days left in May, if we recruit 2 per day, we will have a total of 79 patients (4 more than required)
With significant number of locations “Not yet recruiting”, I suppose it is possible it could happen earlier
All of the Primary and Secondary Outcome Measures have a maximum of 14 Days
Questions:
1. If the 75th patient is enrolled on May 31, 2020, what would be the typical time interval before they were injected?
2. Based on that last patient’s FIRST injection, is it reasonable to assume that 14 days later all trial data will have been collected?
3. Is it reasonable to assume that all trial data can be scrubbed and formatted for the FDA submission in one week – or would it take longer?
Phase 2b/3
Severe or Critical Trial: 390 Patients
Latest Trial Revision: May 12, 2020
Link: https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=3
Recruiting:
University of California, Los Angeles – Recruiting
Montefiore Medical Center -- Recruiting
Novant Health -- Recruiting
Not Yet Recruiting:
Eisenhower Health -- Not yet recruiting
Yale -- Not yet recruiting
Beth Israel, Harvard -- Not yet recruiting
St. Barnabas -- Not yet recruiting
Atlantic Health System Hospital -- Not yet recruiting
Ohio Health -- Not yet recruiting
Oregon Health and Science University -- Not yet recruiting
University of Texas -- Not yet recruiting
Background:
As of yesterday, we were told that ~25 patients have been enrolled -- but not necessarily injected (I was surprised at the increase from 1 or 2)
With significant number of locations “Not yet recruiting”, I suppose it is possible this number could grow quickly
On the other hand, if a Compassionate Use is approved, I could see it and the EIND ‘cannibalizing’ potential patients in this trial
All of the Primary and Secondary Outcome Measures have a maximum of 28 Days
Questions:
1. Using the link above, can anyone show me where the reference is to the “peek look” at 50 patients is located?
2. Relatedly, can anyone show me where the “peek look” is identified as being possible after a 2-week (14-day) interval?
3. Have we gained any clarity as to whether the 50 patients is: 34-Leronlimab / 17-Placebo –or– 100-Leronlimab / 50-Placebo?
4. I am assuming the answers to Questions 1, 2, and 3 in the Mild to Moderate section also apply to the Severe or Critical – correct?
Phase 2
Mild to Moderate Trial: 75 Patients
Latest Trial Revision: May 12, 2020
Link: https://clinicaltrials.gov/ct2/show/NCT043436...amp;rank=2
Recruiting:
University of California, Los Angeles – Recruiting
Montefiore Medical Center -- Recruiting
Novant Health -- Recruiting
Not Yet Recruiting:
Palmtree Clinical Research, Inc. -- Not yet recruiting
Eisenhower Health -- Not yet recruiting
Yale -- Not yet recruiting
Atlantic Health System Hospital -- Not yet recruiting
Ohio Health -- Not yet recruiting
Oregon Health and Science University -- Not yet recruiting
Background:
As of yesterday, we were told that ~45 patients have been enrolled - but not necessarily injected (I had hoped for more)
There are 17 days left in May, if we recruit 2 per day, we will have a total of 79 patients (4 more than required)
With significant number of locations “Not yet recruiting”, I suppose it is possible it could happen earlier
All of the Primary and Secondary Outcome Measures have a maximum of 14 Days
Questions:
1. If the 75th patient is enrolled on May 31, 2020, what would be the typical time interval before they were injected?
2. Based on that last patient’s FIRST injection, is it reasonable to assume that 14 days later all trial data will have been collected?
3. Is it reasonable to assume that all trial data can be scrubbed and formatted for the FDA submission in one week – or would it take longer?
Phase 2b/3
Severe or Critical Trial: 390 Patients
Latest Trial Revision: May 12, 2020
Link: https://clinicaltrials.gov/ct2/show/NCT043472...amp;rank=3
Recruiting:
University of California, Los Angeles – Recruiting
Montefiore Medical Center -- Recruiting
Novant Health -- Recruiting
Not Yet Recruiting:
Eisenhower Health -- Not yet recruiting
Yale -- Not yet recruiting
Beth Israel, Harvard -- Not yet recruiting
St. Barnabas -- Not yet recruiting
Atlantic Health System Hospital -- Not yet recruiting
Ohio Health -- Not yet recruiting
Oregon Health and Science University -- Not yet recruiting
University of Texas -- Not yet recruiting
Background:
As of yesterday, we were told that ~25 patients have been enrolled -- but not necessarily injected (I was surprised at the increase from 1 or 2)
With significant number of locations “Not yet recruiting”, I suppose it is possible this number could grow quickly
On the other hand, if a Compassionate Use is approved, I could see it and the EIND ‘cannibalizing’ potential patients in this trial
All of the Primary and Secondary Outcome Measures have a maximum of 28 Days
Questions:
1. Using the link above, can anyone show me where the reference is to the “peek look” at 50 patients is located?
2. Relatedly, can anyone show me where the “peek look” is identified as being possible after a 2-week (14-day) interval?
3. Have we gained any clarity as to whether the 50 patients is: 34-Leronlimab / 17-Placebo –or– 100-Leronlimab / 50-Placebo?
4. I am assuming the answers to Questions 1, 2, and 3 in the Mild to Moderate section also apply to the Severe or Critical – correct?
