JAVITT'S BIG SPIN = PART 1 DATA MINING
Here is What Javitt Wrote on February 28, 2021
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Methods: Randomized prospective double-blind placebo-controlled trial with 28 day and 60 day endpoints .
Setting: Ten US-based acute care hospitals, which included 4 tertiary care teaching hospitals and 6 regional hospitals.
Participants: 196 patients with PCR+ Critical COVID-19 treated with High Flow Nasal Cannula (HFNC: n=127) Non-Invasive Ventilation (NIV: n=32) or Mechanical Ventilation (MV: n=36).
Intervention: Participants were randomly allocated to intravenous aviptadil (synthetic VIP) or placebo at a 2:1 ratio, in addition to maximal standard of care (SOC). Participants received 3 successive 12-hour intravenous infusions of Aviptadil at 50/100/150 pmol/kg/hr or normal saline placebo, each day for 3 consecutive days.
The main outcome measure was cumulative probability of time to recovery from respiratory failure without relapse and with survival through day 28 and through day 60. Secondary endpoints included time to ICU discharge, time to hospital discharge, NIAID ordinal scale, and survival lifetable. Analysis was by intent to treat.
Results: Overall, 91 of 131 Aviptadil-treated participants survived to day 28 compared to 47 of 65 placebo-treated patients (70.6% vs 71.7%; P=NS).
Among those treated with HFNC (n=127), the main outcome measure demonstrated a trend in favor of the drug treated group (Hazard Ratio 1.53; P=.08).
Participants treated in tertiary care hospitals demonstrated a greater effect (HR 1.84; P=.058).
A 10 day median difference in hospital length of stay was seen in all HFNC patients (P=.006) and a thirteen day difference was seen in those treated in tertiary care centers (P=.004), with both differences favoring treatment with aviptadil.
No drug-related serious adverse events were seen in either group. The only adverse event reported more frequently in drug- vs. placebo-treated participants was mild to moderate diarrhea (30% vs 1.5% P<.001), which was expected.
At 28 days, a smaller percentage of Aviptadil-treated vs. placebo-treated participants remained hospitalized for respiratory failure (37% vs 51%).
The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
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The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
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Effectiveness of ZYESAMI™ (Aviptadil) in accelerating recovery and shortening hospitalization in critically-ill patients with COVID-19 Respiratory Failure: interim report from a phase 2b/3 multicenter trial
10 Pages Posted:
Jihad G. Youssef
Houston Methodist Research Institute
Richard Lee
University of California, Irvine
Jonathan Javitt
Johns Hopkins School of Medicine; Potomac Institute for Policy Studies; NeuroRx
Philip Lavin
Boston Biostatistical Research Foundation
Dushyantha Jayaweera
affiliation not provided to SSRN
Date Written: February 28, 2021
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THIS SSRN PAPER WAS POSTED THEN RETRACTED BY JAVITT OR OTHER FOR REASONS UNKNOWN - I DOWNLOADED IT ==========================
