Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Determine the Safety and Effectiveness of Azeliragon in the Treatment of Patients Hospitalized for Coronavirus Disease 2019 (COVID-19) or Pneumonia
Brief Summary

A new drug called azeliragon could be used to treat patients with COVID-19 or otherpneumonia infections but the researchers don't know. In this study, they are learning theeffects of azeliragon patients hospitalized for COVID-19 or pneumonia.

Detailed Description

Not Provided

Recruiting
COVID-19

Drug: Azeliragon

30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge
(whichever is earliest).

Drug: Placebo

Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is
earliest).

Eligibility Criteria

Inclusion Criteria:

- Patients with at least two of the following signs or symptoms: cough, chest pain,
shortness of breath, hypoxia (oxygen saturation <90%)

- Clinical diagnosis of pneumonia or COVID-19 during the first 48 hours of
hospitalization.

- Patients admitted to the hospital within the previous 48 hours (from time of
admission to initial treatment dose.)

- Provide informed consent to participate in the study (by participant or
legally-acceptable representative).

Exclusion Criteria:

- Patients for whom intubation within 24 hours of admission is considered likely.

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit
of normal (ULN), OR total serum bilirubin >2x ULN.

- Patients who were receiving dialysis as a regular treatment at the time of
admission. (Participants are not excluded for historic need for dialysis.)

- Chronic liver disease with Child-Pugh class B of (7 to 9) or higher.

- Patients with an electrocardiogram (ECG) corrected QT interval (QTc) > 500 ms.

- Patients requiring treatment with strong inhibitors of CYP2C8

- Females of childbearing potential who are pregnant, breastfeeding, and/or not using
a highly-effective method of contraception (consistent with local regulations
regarding the methods of contraception for those participating in clinical studies,
including willingness to use 2 acceptable forms of contraception from screening
until after the end of drug treatment. Acceptable forms include tubal ligation, male
latex condom with or without spermicide, partner's vasectomy, diaphragm with
spermicide, intrauterine device, cervical cap/sponge with spermicide, contraceptive
sponge, female condom, hormonal contraceptive including oral, transdermal, vaginal
ring, subcutaneous injection, or implanted rod.)

- Allergy to azeliragon or formulation excipients in the azeliragon or placebo
capsule.

- Concurrent participation in another device or drug trial for treatment purposes.
Trials with devices intended for diagnostic purposes only are allowable..

- Any other condition, including abnormal laboratory values that, in the judgment of
the investigator, could put the participant at increased risk, or would interfere
with the conduct or planned analysis of the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Rush University
Chicago, Illinois, United States

University of Michigan
Ann Arbor, Michigan, United States

Contacts

Pennelope Kunkle
734-936-2813
penegonz@umich.edu

Salim Hayek, MD, Study Chair
University of Michigan

Salim S. Hayek
NCT Number
Keywords
Azeliragon
Acute Kidney Injury
MeSH Terms
COVID-19
Pneumonia