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COMPLETEDPHASE1/PHASE2

COVID-19 Study of Safety and Tolerability of Alvelestat

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)

NCT04539795•University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or Female
•Age ≥18 years
•Proven SARS-Cov-2 infection (confirmed by PCR from a nasopharyngeal or lower respiratory tract sample)
•A score of Grade 3 to 5 on the WHO 9-point Ordinal Scale
•Male participants must agree to use a highly effective contraception during the treatment period and for at least 4 days after the last dose of study treatment and refrain from donating sperm during this period.
•Female participants are eligible to participate if not pregnant; not breastfeeding; and at least one of the following conditions is met:
•Not a woman of childbearing potential OR A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment phase and for at least 4 days after the last dose of study medication - Capable of giving signed informed consent which includes a commitment to comply with the requirements and restrictions listed in the informed consent form (ICF) and within this protocol.

Exclusion Criteria

•Patients who have previously had a score of 6 or 7 on the WHO 9-point Ordinal Scale
•Patients who require support with invasive mechanical ventilation at the time of inclusion, or expected to be required within 24 hours of randomization
•Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) \>2 × the upper limit of normal (ULN) OR Total Bilirubin \> ULN. In patients with a documented history of Gilbert's Syndrome AND baseline total bilirubin elevation consistent with an exacerbation of Gilbert's Syndrome (i.e. no other cause of total bilirubin elevation), subjects may enroll if total bilirubin is \< 5x ULN.
•Diagnosis of liver cirrhosis, esophageal varices, ascites or hepatic encephalopathy
•Chronic liver diseases such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, haemochromatosis
•Significant renal disease or infection (as determined by the Investigator) including stage 4 chronic kidney disease or estimated glomerular filtration rate \<60mL/min
•Absolute neutrophil count ≤ 1000/µL at screening
•Myocardial infarction, transient ischemic attack or stroke within 3 months prior to the first dose
•Current unstable angina or congestive heart failure (New York Heart Association III/IV)
•Screening 12-lead EKG with a measurable QTc interval according to Fridericia correction (QTcF) \>450 ms
+11 more criteria

Locations (1)

UAB Lung Health Center

Birmingham, Alabama, United States

Key Dates

Start Date

January 25, 2021

Primary Completion Date

October 29, 2021

Completion Date

October 29, 2021

Last Updated

January 19, 2023

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

Alvelestat

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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COVID-19 Study of Safety and Tolerability of Alvelestat

Inclusion Criteria

Exclusion Criteria

The Effect of the Covid-19 Pandemic Among Operated Patients

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

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