CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Alvelestat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04539795
NCT04539795Phase 2Completed
CompareCT.gov

A Phase Ib/II, Single Center, Placebo-Controlled, Randomized, Blinded Study in Adult Patients (> 18 Years) With COVID-19 Respiratory Disease, to Evaluate, Safety, Tolerability and Mechanistic Effect of Alvelestat on Top of Standard of Care (COSTA)

University of Alabama at Birmingham·interventional·Posted Sep 7, 2020·Updated Jan 19, 2023

In Brief

A Phase 2 clinical trial evaluating Alvelestat and Placebo for Covid19. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
CollaboratorsMereo BioPharma

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 7, 2020
Enrollment StartJan 25, 2021
Primary CompletionOct 29, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago

Interventions

Alvelestatdrug

oral tablet

Placebodrug

oral tablet