Azeliragon for COVID-19

Phase 2 & 3

Recruiting

Research Sponsored by Salim S. Hayek

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%)

Must not have

Patients requiring treatment with strong inhibitors of CYP2C8

Chronic liver disease with Child-Pugh class B of (7 to 9) or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days post-treatment

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need treatment with strong inhibitors of CYP2C8.

Select...

My liver disease is severe, with a Child-Pugh score of 7 or higher.

Select...

I am allergic to azeliragon or its ingredients.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Frequency of AEs (Phase 3 only)

Frequency of each AKI Kidney Disease Improving Global Outcomes (KDIGO) scale scores (Phase 3 only)

Frequency of renal function after prior AKI of stage 2 or higher (Phase 3 only)

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