I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Suggests No Clinical Benefit with Addition of Nebulized ZYESAMI® (aviptadil) When Given by Mouth Inhalation in Critically Ill Patients with COVID-19

Gibbs et al., NCT04488081, I-SPY, NCT04488081, Mar 2022

https://c19early.org/gibbs.html

RCT 118 patients showing significantly worse recovery with aviptadil treatment.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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risk of no recovery, 78.6% higher, HR 1.79, p = 0.02, treatment 51, control 67, inverted to make HR<1 favor treatment.

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1. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Gibbs et al., 31 Mar 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, trial NCT04488081 (history) (I-SPY).

This Paper Aviptadil All

Late treatment
is less effective

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