EIND HOUSTON - comparable comorbidity the same ICU, treated by the same clinical team, in the same time-frame who received maximal standard of care (SOC).
OHM you may want to actually read = read the trial results
""""" the Rothman index (16.5(SD 23.7) vs. 56.9 (SD 26.1);P<0.001) and SOFA score (10.6 (SD3.7) vs. 4.3 (SD 2.2); P<.001) for aviptadil-treated patients was significantly worse than for control patients """""
VIP in the Treatment of Critical COVID-19 With Respiratory Failure in Patients With Severe Comorbidity: A Prospective Externally-Controlled Trial
""""" Participants: ...patients with Critical COVID-19, treated with intravenous aviptadil (synthetic VIP), compared to all patients with comparable comorbidity .... from the same ICU, treated by the same clinical team, in the same time-frame who received maximal standard of care (SOC). """""
I give you the link again -
""""" Patients and Methods Standard of Care patients were enrolled between May 23 and August 15, 2020 in the Intensive Care Units of the Houston Methodist Hospital System (Houston, TX). Aviptadil-treated patients were enrolled between June 11 and July 30, 2020. Inclusion criteria for both cases and controls are noted in Table 1. The study follows the CONSORT rules for reporting of pragmatic trials (see online checklist and CONSORT diagram)17. The primary endpoint was survival as measured by Kaplan-Meier lifetable, with Recovery from Respiratory Failure, WHO 10 point ordinal scale, and PaO2:FiO2 ratio while on ventilator as secondary endpoints.
A consecutive series of 21 patients with PCR-proven COVID-19 and respiratory failure who did not respond to maximum Standard of Care therapy and who were screened for NCT04311697 but deemed ineligible on the basis of exclusionary comorbidity (Table 1 and clinicaltrials.gov) were offered enrollment into this study.
Control patients comprised a series of all patients who were similarly ineligible for NCT04311697, either admitted by ICU physicians who were not study investigators over the same time frame or admitted by physicians who were study investigators in the two weeks before and after recruitment of the aviptadil-treated patients.
All patients in this study were treated by the same ICU team of intensive care physicians and nurses (regardless of admitting team) and received maximal available therapy, which included steroids, anti-coagulants, remdesivir, and, in some cases convalescent plasma. As required in the CONSORT description, no additional resources were added or removed from the usual care setting other than treatment or non-treatment with VIP.
n order to identify potential referral bias and confounding based on severity, Rothman score and WHO ordinal scale upon admission, together with Sequential Organ Failure Assessment Score (SOFA),18 at time of ICU admission was compared between aviptadil-treated and control patients (Table 2). Rothman index is a continuous predictor of impending mortality that is implemented as part of the electronic medical record system.19 At hospital admission there were no significant differences in age gender, or Rothman index. At ICU admission, however, the Rothman index (16.5(SD 23.7) vs. 56.9 (SD 26.1);P<0.001) and SOFA score (10.6 (SD3.7) vs. 4.3 (SD 2.2); P<.001) for aviptadil-treated patients was significantly worse than for control patients (Table 1 – detailed data reproduced in online Table 1a). """"""
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