Aviptadil NEW

Objectives: Respiratory failure is a lethal complication of COVID-19 that has remained resistant to

drug therapy.Vasoactive intestinal peptide (VIP) is shown in nonclinical studies to upregulate

surfactant production, inhibit cytokine synthesis, prevent cytopathy, and block replication of the

severe acute respiratory syndrome coronavirus 2 virus in pulmonary cells. The study aims to

determine whether Aviptadil (syntheticVIP)can improve survival and recovery in patients with

COVID-19 respiratory failure compared with placebo and demonstrate biological effects in such

patients.

Design: A multicenter, placebo-controlled trial.

Setting:Ten U.S. hospitals: six tertiary-care hospitals and four community hospitals.

Patients: A total of 196 patients with COVID-19respiratory failure.

Interventions: Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.

Measurements and main results: The primary end point (alive and free from respiratory failure at

day 60) did not reach statistical significance (odds ratio [OR], 1.6; 95% Cl, 0.86-3.11) for patients

treated with Aviptadil when controlling for baseline ventilation status as prespecified in the protocol.

There was, however, a statistically significant two-fold odds of improved survival (OR,2.0; 95% CI,

1.1-3.9) at 60 days ( p = 0.035). There was significant improvement in respiratory distress ratio and

reduced interleukin 6 cytokine release ( p = 0.02) by day 3.Subgroup analysis identified a statistically

significant likelihood of achieving primary end point among those treated with high-flow nasal

oxygen at baseline ( p = 0.039). Subjects on mechanical ventilation also experienced a 10-fold

increased odds of survival with drug versus placebo ( p= 0.031).

Conclusions: The primary end point did not reach statistical significance, indicating that there was

no difference between Aviptadil versus placebo. However, Aviptadil improves the likelihood of

survival from respiratory failure at day 60 in critical COVID-19 across all sites of care. Given the

absence of drug-related serious adverse events and acceptable safety profile, we believe the benefit

versus risk for the use of Aviptadil is favorable for patient treatment.

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