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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815485
• Other study ID #: HUM00221960
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 4, 2023
• Est. completion date: April 2026

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Pennelope Kunkle
• Phone: 734-936-2813
• Email: penegonz[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Rush University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Salim S. Hayek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events (AEs) (Phase 2 only)	Including overall, treatment-related, Grade 3 or higher in severity, serious AEs (SAEs), fatal, and those resulting in treatment discontinuation	Up to 28 days post-treatment
Primary	Death, need for mechanical ventilation or Acute Kidney Injury (AKI) of stage 2 or higher per Kidney Disease Improving Global Outcomes (KDIGO) scale (Phase 3 only)	The primary outcome is a composite endpoint, which is defined as the need for mechanical ventilation, in-hospital death or AKI of stage 2 or higher per KDIGO scale.; There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure).; KDIGO Scale definitions: Stage 2 - Serum Creatinine 2-2.9 times baseline Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to =4 mg/dL or Initiation of renal replacement therapy	Day 14 of hospitalization
Secondary	Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)	There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure).; Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine = 0.3 mg/dL OR urine output < 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output <0.5mg/kg/hour for = 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy	Day 14 of hospitalization
Secondary	Frequency of sustained renal function (Phase 3 only)	Renal function defined by no increase in serum creatinine of =0.3mg/dL during any 48hr period, AND no increase in serum creatinine of =1.5 times	Day 14 of hospitalization
Secondary	Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)	Serum creatinine levels to < 1.5 times baseline level	Day 14 of hospitalization
Secondary	Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)		Day 14 of hospitalization
Secondary	Number of days in ICU (Phase 3 only)		Day 14 of hospitalization
Secondary	Frequency of AEs (Phase 3 only)	Including: overall, treatment-related, Grade 3 or higher in severity, serious, fatal, and those resulting in treatment discontinuation	Day 14 of hospitalization
Secondary	Length of hospitalization (Phase 3 only)		Up to 14 days