Aways easy to slam big pharma, but this is a good first trial with additional data coming. Details of the trial:
Two, randomized multi-center Phase 3 trials in countries with high COVID prevalence
397 patients received 200mg on the first day, followed by 100mg until day 5 or day 10 in addition to standard of care
Patients had severe COVID manifestations: pneumonia but not under mechanical ventilation
An additional expansion phase of the study will enroll and additional 5,600 patients including those on mechanical ventilation, conducted at 180 trial sites (US, China, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Singapore, Spain, Sweden Switzerland, Taiwan, UK)
A second trial will read out in May, comparing safety and efficacy of 5 and 10-day durations compared to standard of care. The first data from 600 patients will be available at the end of May.
Data from the trial:
Study sought to see if 5-day was as effective as the shorter 5-day course (10-day is currently being used world-wide)
10-day treatment course as effected in achieving clinical status as 5-day
No new safety signals seen
Benefit as measured by improvement in clinical score as determined by a seven point scale including hospital discharge, increasing levels of oxygen support, and death
Patients achieved clinical recovery if they no longer required oxygen support and medical care or were discharged from the hospital.
Time for clinical improvement for 50% of patients was 10 days in the 5-day treatment, and 11 days in the 10-day treatment
Clinical outcomes varied by geography - Outside of Italy, the overall morality rate at day 14 was 7% across both groups
61-64% of patients were discharged from the hospital on the 5 and 10 day regimens, respectively
Patients who received the drug within 10 days of symptom onset had improved outcomes compare to those treated after 10 days
Worst tox I see is Grade 3 ALT in 7% of patients, with 3% discontinuing due to liver tox.