Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS

What Was Tested

This registered phase 2 trial tested VIP (Vasoactive Intestinal Peptide).

The world is currently experiencing a coronavirus (CoV-2) pandemic.

A new (SARS)-CoV infection epidemic began in Wuhan, Hubei, China, in late 2019; originally called 2019- nCoV the virus is now known as SARSCoV- 2 and the disease it causes COVID-19.

Previous CoV epidemics included severe acute respiratory syndrome (SARS)-CoV, which started in China in 2003 and Middle East respiratory syndrome (MERS)-CoV in the Middle East, which started in 2012.

It had two arms (groups): Aviptadil Treatment (experimental) and Placebo Treatment (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

ARDS is a known lethal complication due to its low blood oxygenation levels and may result in organ failure.

In the US, VIP has been given FDA Orphan Drug Designation for the treatment of ARDS and was admitted to the FDA Corona Virus Technology Accelerator Program.

A phase II clinical trial using intravenous Aviptadil in patients with COVID-19 infection and ARDS has begun.

Further, a phase II/III clinical trial will study the effect of inhaled Aviptadil for the treatment of non-acute lung injury in COVID- 19 and begins in June 2020.

Who Took Part

83 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: COVID-19 infection diagnosed. Risk factors for the development of an ARDS according to an adapted EALI (early acute lung injury score) ≥ 2 Points (with at least one point from the EALI score). Respiratory rate ≥ 30/min: 1 point. Immunosuppression: 1 Point. Arterial hypertension: 1 point.

The full record lists 12 inclusion and 8 exclusion criteria; among the exclusions: known or highly suspected bacterial infection (antibiotic treatment to avoid bacterial superinfection may be allowed); mechanical ventilation; inability to conduct inhalation therapy.

How the Study Was Run

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

The participants were allocated by chance, so the VIP (Vasoactive Intestinal Peptide) group and the comparison group should start out alike.

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 and investigator.

It started in 2021-05-18 with completion listed for 2023-06-14.

It ran at 2 sites in Switzerland (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Frequency of mechanical ventilation, Oxygen supplementation, SaO2, FiO2, C-reactive Protein and Neutrophile.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of VIP (Vasoactive Intestinal Peptide) in 83 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.