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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of pneumonia or COVID-19 during the first 48 hours of hospitalization
Patients with at least two of the following signs or symptoms: cough, chest pain, shortness of breath, hypoxia (oxygen saturation <90%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days post-treatment
Awards & highlights
Study Summary
This trial is testing a drug, azeliragon, to see if it helps COVID-19 patients recover faster. Researchers don't know if it'll work.
Who is the study for?
This trial is for hospitalized patients with COVID-19 or pneumonia showing symptoms like cough, chest pain, or low oxygen levels. They must have been admitted within the last 48 hours and be able to consent. It's not for those with severe liver issues, likely need for intubation soon after admission, certain heart conditions, pregnant or breastfeeding women without effective contraception, or allergies to azeliragon.Check my eligibility
What is being tested?
Researchers are testing a new drug called Azeliragon against a placebo in people hospitalized with COVID-19 or pneumonia. The study is randomized and double-blind, meaning neither the doctors nor the patients know who gets the real drug versus a dummy pill.See study design
What are the potential side effects?
While specific side effects of Azeliragon aren't listed here, common medication-related side effects could include allergic reactions to ingredients in the capsule, potential liver enzyme elevations if there's pre-existing liver disease risk noted in exclusion criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with pneumonia or COVID-19 within the first 2 days of my hospital stay.
Select...
I have at least two symptoms: cough, chest pain, shortness of breath, or low oxygen levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Frequency of Adverse Events (AEs) (Phase 2 only)
Secondary outcome measures
Frequency of AEs (Phase 3 only)
Frequency of Intensive Care Unit (ICU) admission (Phase 3 only)
Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 3 azeliragonExperimental Treatment1 Intervention
Group II: Phase 2 azeliragonExperimental Treatment1 Intervention
Group III: Phase 2 placeboPlacebo Group1 Intervention
Group IV: Phase 3 placeboPlacebo Group1 Intervention
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Who is running the clinical trial?
Salim S. HayekLead Sponsor
Salim Hayek, MDStudy ChairUniversity of Michigan
3 Previous Clinical Trials
3,458 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity, as measured by an ECG, shows a prolonged QT interval.I was diagnosed with pneumonia or COVID-19 within the first 2 days of my hospital stay.I am not pregnant, breastfeeding, and I use effective birth control.I have at least two symptoms: cough, chest pain, shortness of breath, or low oxygen levels.I was on dialysis when I was admitted.I need treatment with strong inhibitors of CYP2C8.Your liver enzyme levels (ALT or AST) are more than 3 times the normal limit, or your total bilirubin level is more than 2 times the normal limit.My liver disease is severe, with a Child-Pugh score of 7 or higher.It is likely that you will need a breathing tube within 24 hours of being admitted.I am allergic to azeliragon or its ingredients.I was admitted to the hospital less than 48 hours ago.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 placebo
- Group 2: Phase 2 azeliragon
- Group 3: Phase 3 azeliragon
- Group 4: Phase 3 placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the estimated enrollment capacity for this trial?
"Correct. Evidence from clinicaltrials.gov confirms that this medical research, which was launched on April 1st 2023, is actively calling for volunteers. A total of 144 participants need to be enrolled across two medical facilities."
Answered by AI
Are researchers currently recruiting participants for this clinical experimentation?
"Absolutely, the information provided on clinicaltrials.gov verify that this trial is now recruiting patients. This experiment was first advertised on April 1st 2023 and its data recently updated on April 13th of the same year. The team need to enlist 144 people from 2 medical centres across the country."
Answered by AI
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