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Experimental drug INB03 tested to stop COVID-19 lung decline – trial halted early

NCT ID NCT04370236

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called INB03 in 79 high-risk COVID-19 patients to see if it could prevent their breathing from getting worse. Participants received two weekly injections of either INB03 or a placebo. The trial was terminated early, so we do not have clear results on whether the drug helped.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INB03 (also called XPro1595 or Quellor)
What this could lead to
If it worked, this could point toward a treatment to prevent severe breathing problems in high-risk COVID-19 patients.
What could go wrong
The trial was terminated early with only 79 participants, so results are limited. It is unclear if INB03 is safe or effective for COVID-19.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

79 people

The number who actually took part.

Started

Oct 2020

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have one or more of the following comorbidities: 1. Age ≥ 65 years; 2. Obesity (BMI ≥ 30); 3. Hypertension (on one or more drugs for treatment of hypertension); 4. Diabetes (on one or more drugs for Type I or Type II diabetes); 5. Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin); 6. History of congestive heart failure (CHF) or myocardial infarction (MI); 7. Black or African-American race (at least one parent identifies as Black or African-American); 8. Hispanic or Latino ethnicity. 2. Have a positive COVID-19 test in the last 28 days; 3. Have room air SaO2 \< 96%, or SpO2 \< 96% on room air at sea level, or PaO2/FiO2 \< 300; 4. Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19; 5. Provide written informed consent prior to any study related procedures being performed. Exclusion Criteria: Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening: 1. Age \< 18 years; 2. Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP); 3. Require immediate admission to an Intensive Care Unit (ICU) for any reason; 4. On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months; 5. Being treated with dexamethasone (IV or PO) at a dose of \>15mg per day or solumedrol or equivalent corticosteroid at a dose of \>75mg per day; 6. Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months; 7. Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months; 8. Known to be pregnant; 9. Has known HIV, HCV or HBV infection; 10. Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray; 11. Significant hepatic disease (ALT/AST\> 4 times the ULN); 12. On therapy for cancer in the last 6 months; 13. On therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason; 14. Known hypersensitivity to investigational product or its excipients; 15. Participating in an investigational drug or device trial; 16. Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120, United States

  • Baptist Memorial Hospital-DeSoto

    Southard, Missouri, 38671, United States

  • Jewish Hospital

    Louisville, Kentucky, 40202, United States

  • Memorial Hermann

    Houston, Texas, 77030, United States

  • Memorial Hermann Southeast

    Houston, Texas, 77089, United States

  • Mississippi Baptist

    Kosciusko, Mississippi, 39090, United States

  • NEA Baptist

    Jonesboro, Arkansas, 72401, United States

  • Richmond University Medical Center

    Staten Island, New York, 10312, United States

  • St. Bernard's

    Jonesboro, Arkansas, 72401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.