Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

What Was Tested

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

Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification.

Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI (aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care.

It had two arms (groups): one (experimental) and Placebo + standard of care (experimental).

Patients will first be treated with placebo infusion + maximal intensive care.

The registry classes the interventions as drug.

More on the Plan

Acute Lung Injury, which triggers Critical COVID-19 is a known lethal complication of Corona Virus (SARS-CoV-2) infection.

Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) has been awarded FDA Orphan Drug Designation for the treatment of ARDS and admitted to the FDA CoronaVirus Technology Accelerator Program.

VIP binds to VPAC1 receptors on the pulmonary Alveolar Type II (ATII) cell.

The Type II cell is also the cell selectively attacked by the SARS-CoV-2 virus via the ACE2 surface receptor.

Who Took Part

Enrollment: 203 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: Critical COVID-19 with respiratory failure. Physician determination that patient is on maximal conventional medical therapy.

The full record lists 2 inclusion and 17 exclusion criteria; among the exclusions: pregnancy (pregnant women may apply for open label treatment under compassionate care ind; age \<18 years; mechanical ventilation for more than 7 days in primary cohort. mechanical ventilation\>21 days in the exploratory cohort.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this VIP (Vasoactive Intestinal Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The VIP (Vasoactive Intestinal Peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on VIP (Vasoactive Intestinal Peptide), so expectations could not easily colour the readings.

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

It started in 2020-05-15 with completion listed for 2021-02-22.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Resolution of Respiratory Failure (Alive and Free of Respiratory Failure) (time frame: Day 28).

It also tracked 3 secondary outcomes, for example Number of Participants Alive at Day 60, Number of Participants Achieving a Score of 6-8 on NIAID Ordinal Score Through Day 60 and Oxygenation Index as Measured by PaO2:FiO2 Ratio.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of VIP (Vasoactive Intestinal Peptide) in 203 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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