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NCT04539795 · ClinicalTrials.gov registry record · Phase 1

COVID-19 Study of Safety and Tolerability of Alvelestat

A Phase 1 study of Covid19, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT04539795 is a Phase 1 study of Covid19 that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 15 participants, below the 2,702-participant average among 94 other Covid19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04539795, a Phase 1 study of Covid19, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK), and explore the mechanistic and clinical effect of alvelestat (an oral neutrophil elastase inhibitor) orally twice per day for 10 days added to standard of care in adult patients (≥18 years) with COVID-19 respiratory disease.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Alvelestat

Study Locations (1)

Alabama

  • UAB Lung Health Center - Birmingham

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-01-25
Est. Completion 2021-10-29
Phase Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT04539795

The ClinicalTrials.gov registry entry for NCT04539795 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,702-participant average among 94 other Covid19 trials with a reported enrollment target (99% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Covid19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04539795 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT04539795 about?

NCT04539795 is a clinical study titled "COVID-19 Study of Safety and Tolerability of Alvelestat". The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK), and explore the mechanistic and clinical effect of alvelestat (an oral neutrophil elastase inhibitor) orally twice per day for 10 days added to standard of care in adult patients (≥18 years) with COVID-19 r...

What is the current status of trial NCT04539795?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2021-01-25. Estimated completion is 2021-10-29.

What conditions does trial NCT04539795 study?

This clinical trial studies the following conditions: Covid19.

What interventions are being tested in trial NCT04539795?

The interventions under investigation include: Placebo (DRUG), Alvelestat (DRUG).

Who is sponsoring clinical trial NCT04539795?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04539795 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.