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NCT04389671 · ClinicalTrials.gov registry record · Phase 2

The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)

A Phase 2 study, sponsored by Windtree Therapeutics.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT04389671: Completed Phase 2 study, sponsored by Windtree Therapeutics.

NCT04389671 is a Phase 2 study that has completed, run by Windtree Therapeutics. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04389671, a Phase 2 study, has completed, sponsored by Windtree Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.

Primary Outcome

Change from baseline in OI. OI is an index value, calculated as (Mean Airway Pressure \[Paw\]) x (Fraction of Inspired Oxygen \[FiO2\]) x (100) / (Partial Pressure of Oxygen \[PaO2\]) measured using mean and standard deviation. It is a calculation that measures the fraction of inspired oxygen and its usage within the body, and a lower value is better. Values can range from 0 to 1000; values under 25 are correspond with a good outcome.

Interventions

  • DRUG Lucinactant

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-01-05
Est. Completion 2022-02-20
Phase Phase 2
Windtree Therapeutics

11 total trials

What the finished NCT04389671 record still lists

NCT04389671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which Lucinactant is the first listed.

NCT04389671 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04389671 about?

NCT04389671 is a clinical study titled "The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)". This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19 associated acute lung injury who are being cared for in a critical care environment.

What is the current status of trial NCT04389671?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-01-05. Estimated completion is 2022-02-20.

What interventions are being tested in trial NCT04389671?

The interventions under investigation include: Lucinactant (DRUG).

Who is sponsoring clinical trial NCT04389671?

This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04389671's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04389671, the US trial registry maintained by the National Library of Medicine. NCT04389671 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.