Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19

What Was Tested

The trial (phase 2, phase 3) is built around VIP (Vasoactive Intestinal Peptide).

Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation.

It had two arms (groups): Severe COVID-19 ZYESAMI™ (experimental) and Severe COVID-19 Placebo (experimental).

Patients with Severe COVID-19 to be treated with inhaled placebo 3x daily.

The registry classes the interventions as device and drug.

More on the Plan

Detailed Description: Attack of the Alveolar Type II (ATII) cell via its ACE2 surface receptor by the SARS-CoV-2 virus leads to respiratory failure, morbidity, and frequently mortality in COVID-19.

There is no approved treatment that specifically targets the pulmonary injury.

Vasoactive Intestinal Peptide (VIP) is known to target the VPAC1 receptor of the ATII cell and to protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents.

Aviptadil acetate, a synthetic form of Vasoactive Intestinal Polypeptide (VIP) has been awarded FDA Orphan Drug Designation for the treatment of ARDS and Pulmonary Hypertension and EMEA Orphan Drug Designation for the treatment of ARDS and Sarcoid.

Who Took Part

The registry lists 144 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting. Positive test by standard RT-PCR assay or equivalent within last 7 days. Physician determination that patient is on SOC therapy, and will receive standard of care if patient progresses to Critical COVID-19, patient must be full CODE.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: evidence of critical covid-19; inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications; age \<12 years;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got VIP (Vasoactive Intestinal Peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received VIP (Vasoactive Intestinal Peptide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-02-15 with completion listed for 2021-12-15.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression to Respiratory Failure (time frame: 28 days).

It also tracked 3 secondary outcomes, for example Blood oxygenation, RPD Dyspnea Scale and Distance walked in six minutes.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of VIP (Vasoactive Intestinal Peptide) in 144 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the VIP (Vasoactive Intestinal Peptide) compound page, all human trials.