A Clinical Study Evaluating Inhaled Aviptadil on COVID-19

What Was Tested

In this phase 2 trial, researchers set out to test VIP (Vasoactive Intestinal Peptide).

This study is a multicenter, prospective, placebo-controlled, comparative, randomized, double-blind local phase II clinical trial.

Duration of study is 18 months.

In the study, patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy + placebo versus standard medical therapy + inhaled Aviptadil arms.

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

The registry classes the interventions as drug.

Who Took Part

80 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Years and older women or men, under 70 years old. Patients with positive SARS-CoV-2 real time PCR result and an appearance in line with COVID-19 pneumonia on thorax CT.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: intensive care admission; the need for mechanical ventilation; patients with previously known organ (kidney, heart and liver) failure.

How the Study Was Run

The set-up was randomized, parallel-group and double-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 and investigator.

It started in 2021-03-10 with completion listed for 2022-06-07.

It ran at 9 sites in Turkey (Türkiye) (9).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 17 secondary outcomes, for example Time to discharge of patients, The rate of patients entering intensive care, Patients' rate of needing mechanical ventilation, Change in SpO2 (measured by pulse oximetry), Normalization in body temperature and Dyspnea Scale (Modified Borg Dyspnea Scale (MBS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of VIP (Vasoactive Intestinal Peptide) in 80 people.

The trial is marked completed; 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.