A brief summary of the White Board Doctor statements on the intravenous Aviptadil study and some other issues:
This is a very well designed (randomized, double blind, placebo, controlled) multi center study, “a high quality setup, the epitome of trial design.”
It is done with tremendously sick patients who have severe or critical COVID19 and respiratory failure.
The report is a news release and we don’t have the specific data and definitions, especially of recovery.
Still, all P values given were well under 0.05. The P values for recovery from respiratory failure (28 days 0.014 and 60 days 0.013) and overall survival with adjustments for site and vent status (<0.001).
HFNC recovery P values were also very impressive (28 days 0.017, 60 days 0.036 and at tertiary centers [large hospitals with multiple sub-specialists (0.007)]. Javitt had previously said “hospitalization data further suggest that patients treated at an earlier stage of illness (i.e., those who can be managed with HFNC) may have a better response to treatment.” That explains at least part of the purpose for this focus.
Javitt also said: “In reviewing our results you will notice a striking difference in the likelihood of survival and recovery seen at tertiary care hospitals, compared to that seen in regional hospitals that participated in our study. In no way should this be interpreted to imply that the quality of care that is frequently achieved in regional hospitals seen across the US, is in any way inferior to those seen in tertiary care medical centers. However, our study entered the regional hospitals just as the December and January surge hit, with 200% ICU over capacity, bays in the parking lot, and staffing shortages that were exacerbated by staff members contracting covid. There is ample evidence to show that as ICU capacity nears 100%, covid survival is reduced because of the enormous attention that must be paid to patients with covid19, from minute to minute in order to maximize survival and recovery.“
We do need the specific data and more precision about definition of some terms. Javitt also did say: “We have achieved all of the key endpoints we set out to achieve when we embarked on this study. We still have a great deal of work to do. We have not yet received or analyzed the thousands of laboratory values related to VIP levels, cytokines and other markers of covid pathology. We still have not analyzed the effect of ZyeSami of clearing of radiographic or x-ray findings in covid19, even though we have seen some very encouraging results in open label studies. There is much to learn from this study about critical covid19 and its treatment, and you can expect to hear more from us.”
Like clambottler, I can make some guesses. Though we don’t have the specific data the P values we have in this very well designed study are so good it is hard to imagine what would wipe them out as clambottler seems to think will happen. When everything is in it may make an even better story based on more specific data and evidence. I, myself, am especially looking forward to the “Improvement in chest radiographic and x-ray” results.
