COVID-19Phase 2/3NCT05815485
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
A Phase 2/3 study testing Azeliragon in people with COVID-19, run by The University of Texas Medical Branch, Galveston at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Azeliragon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2023to Apr 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Rush University
Chicago, Illinois, 60612
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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.
- Conditions
- COVID-19
- Being tested
- Azeliragon, Placebo
- Keywords
- Azeliragon, Acute Kidney Injury
- Medical subject headings
- COVID-19, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzeliragonDrug
30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest).
PlaceboDrug
Twice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest).
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 azeliragon | Experimental | Not described Receives: Drug: Azeliragon |
| Phase 2 placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Phase 3 azeliragon | Experimental | Not described Receives: Drug: Azeliragon |
| Phase 3 placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 28 days post-treatment
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
Measured: Day 14 of hospitalization
Secondary outcomes (7)
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
Measured: Day 14 of hospitalization
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
Measured: Day 14 of hospitalization
Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)
Serum creatinine levels to < 1.5 times baseline level
Measured: Day 14 of hospitalization
Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)
Measured: Day 14 of hospitalization
Number of days in ICU (Phase 3 only)
Measured: Day 14 of hospitalization
Frequency of AEs (Phase 3 only)
Including: overall, treatment-related, Grade 3 or higher in severity, serious, fatal, and those resulting in treatment discontinuation
Measured: Day 14 of hospitalization
Length of hospitalization (Phase 3 only)
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start4 May 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucas S. Blanton, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815485
- Sponsor's protocol ID
- 24-0103
- Other IDs
- HUM00221960
- Status last verified
- Feb 2025
- First submitted
- 13 Apr 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05815485
- Acronym / sponsor ID
- 24-0103
- Conditions
- COVID-19
- Keywords
- Azeliragon, Acute Kidney Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 2 azeliragon | Experimental | Drug: Azeliragon |
| Phase 2 placebo | Placebo comparator | Drug: Placebo |
| Phase 3 azeliragon | Experimental | Drug: Azeliragon |
| Phase 3 placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azeliragon30 mg twice daily for 5 days followed by 20 mg once daily for 5 days or until discharge (whichever is earliest). | Drug | Phase 2 azeliragon, Phase 3 azeliragon |
| PlaceboTwice daily for 5 days then 1 time daily for 5 days or until discharge (whichever is earliest). | Drug | Phase 2 placebo, Phase 3 placebo |
Primary outcome
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
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
7 secondary outcomes
Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)
Time frame: Day 14 of hospitalization
Frequency of sustained renal function (Phase 3 only)
Time frame: Day 14 of hospitalization
Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)
Time frame: Day 14 of hospitalization
Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)
Time frame: Day 14 of hospitalization
Number of days in ICU (Phase 3 only)
Time frame: Day 14 of hospitalization
Frequency of AEs (Phase 3 only)
Time frame: Day 14 of hospitalization
Length of hospitalization (Phase 3 only)
Time frame: Up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for COVID-19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas S. Blanton, MD principal investigator
University of Texas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azeliragon in people with COVID-19, run by The University of Texas Medical Branch, Galveston at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (AEs) (Phase 2 only) (time frame: Up to 28 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.