Experimental drug INB03 tested to stop COVID-19 lung decline – trial halted early
NCT ID NCT04370236
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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79 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Nov 2021
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Baptist Clinical Research Institute
Memphis, Tennessee, 38120, United States
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Baptist Memorial Hospital-DeSoto
Southard, Missouri, 38671, United States
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Jewish Hospital
Louisville, Kentucky, 40202, United States
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Memorial Hermann
Houston, Texas, 77030, United States
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Memorial Hermann Southeast
Houston, Texas, 77089, United States
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Mississippi Baptist
Kosciusko, Mississippi, 39090, United States
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NEA Baptist
Jonesboro, Arkansas, 72401, United States
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Richmond University Medical Center
Staten Island, New York, 10312, United States
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St. Bernard's
Jonesboro, Arkansas, 72401, United States
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Other studies related to the condition(s) this trial covers.
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- Can an oral drug stop COVID-19 from turning deadly?
- Can COVID-19 rapid tests slip into HIV and TB clinics without disrupting care?