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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Azeliragon and placebo will be dispensed and labeled by the unblinded research pharmacist at each site in a blinded manner that will not reveal if the product dispensed is active or placebo.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2 azeliragon
  • Drug: Azeliragon
    30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest).
Placebo Comparator
Phase 2 placebo
  • Drug: Placebo
    Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest).
Experimental
Phase 3 azeliragon
  • Drug: Azeliragon
    30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest).
Placebo Comparator
Phase 3 placebo
  • Drug: Placebo
    Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest).

Recruiting Locations

More Details

NCT ID
NCT05815485
Status
Active, not recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.