Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

What Was Tested

This registered phase 3 trial tested VIP (Vasoactive Intestinal Peptide).

Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.

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

The registry classes the interventions as biological and drug.

More on the Plan

This protocol will be adaptive, randomized, blinded and initially placebo-controlled.

The protocol is for a Phase 3 study.

Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints.

Selected secondary endpoints will be measured at 180 days.

Who Took Part

471 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.

The full record lists 0 inclusion and 5 exclusion criteria; among the exclusions: refractory hypotension; severe diarrhea; current c. difficile infection.

How the Study Was Run

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

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, care provider and investigator.

It started in 2021-04-20 with completion listed for 2022-08-22.

It ran at 40 sites in United States (40).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 (time frame: Status on Day 90).

It also tracked 4 secondary outcomes, for example Number of Participants With a Safety Outcome Through Day 5 and Number of Participants With a Safety Outcome Through Day 28.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of VIP (Vasoactive Intestinal Peptide) in 471 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.