This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05815485
Recruitment Status : Recruiting
First Posted : April 18, 2023
Last Update Posted : October 31, 2023
Sponsor:
Information provided by (Responsible Party):
Salim S. Hayek, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Azeliragon Drug: Placebo Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Primary Purpose: Treatment
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
Actual Study Start Date : May 4, 2023
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Frequency of Adverse Events (AEs) (Phase 2 only) [ Time Frame: Up to 28 days post-treatment ]
    Including overall, treatment-related, Grade 3 or higher in severity, serious AEs (SAEs), fatal, and those resulting in treatment discontinuation

  2. 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) [ Time Frame: Day 14 of hospitalization ]

    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



Secondary Outcome Measures :
  1. Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only) [ Time Frame: Day 14 of hospitalization ]

    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


  2. Frequency of sustained renal function (Phase 3 only) [ Time Frame: Day 14 of hospitalization ]
    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

  3. Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only) [ Time Frame: Day 14 of hospitalization ]
    Serum creatinine levels to < 1.5 times baseline level

  4. Frequency of Intensive Care Unit (ICU) admission (Phase 3 only) [ Time Frame: Day 14 of hospitalization ]
  5. Number of days in ICU (Phase 3 only) [ Time Frame: Day 14 of hospitalization ]
  6. Frequency of AEs (Phase 3 only) [ Time Frame: Day 14 of hospitalization ]
    Including: overall, treatment-related, Grade 3 or higher in severity, serious, fatal, and those resulting in treatment discontinuation

  7. Length of hospitalization (Phase 3 only) [ Time Frame: Up to 14 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05815485


Contacts
Layout table for location contacts
Contact: Pennelope Kunkle 734-936-2813 penegonz@umich.edu

Locations
Layout table for location information
United States, Illinois
Rush University Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Study Coordinator         
Principal Investigator: James Moy, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Salim Hayek         
Sponsors and Collaborators
Salim S. Hayek
Investigators
Layout table for investigator information
Study Chair: Salim Hayek, MD University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Salim S. Hayek, Assistant Professor of Internal Medicine and Medical Director, UMMG, University of Michigan
ClinicalTrials.gov Identifier: NCT05815485    
Other Study ID Numbers: HUM00221960
First Posted: April 18, 2023    Key Record Dates
Last Update Posted: October 31, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salim S. Hayek, University of Michigan:
Azeliragon
Acute Kidney Injury
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases