COVID-19Phase 2/3NCT04370236

INB03 for the Treatment of Pulmonary Complications From COVID-19

A Phase 2/3 study testing INB03 in people with COVID-19, run by Inmune Bio, Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients. 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?: INB03
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 9 sitesUnited States
Study dates: 21 Oct 2020to 18 Nov 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Have one or more of the following comorbidities:
Age ≥ 65 years;
Obesity (BMI ≥ 30);
Hypertension (on one or more drugs for treatment of hypertension);
Diabetes (on one or more drugs for Type I or Type II diabetes);
Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin);

Show all 13Show fewer

History of congestive heart failure (CHF) or myocardial infarction (MI);
Black or African-American race (at least one parent identifies as Black or African-American);
Hispanic or Latino ethnicity.
Have a positive COVID-19 test in the last 28 days;
Have room air SaO2 < 96%, or SpO2 < 96% on room air at sea level, or PaO2/FiO2 < 300;
Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
Provide written informed consent prior to any study related procedures being performed.

Who cannot join

Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:
Age < 18 years;
Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);
Require immediate admission to an Intensive Care Unit (ICU) for any reason;
On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;
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;

Show all 17Show fewer

Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months;
Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months;
Known to be pregnant;
Has known HIV, HCV or HBV infection;
Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray;
Significant hepatic disease (ALT/AST> 4 times the ULN);
On therapy for cancer in the last 6 months;
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;
Known hypersensitivity to investigational product or its excipients;
Participating in an investigational drug or device trial;
Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Memorial Hermann
Houston, Texas, 77030
Memorial Hermann Southeast
Houston, Texas, 77089
NEA Baptist
Jonesboro, Arkansas, 72401
St. Bernard's
Jonesboro, Arkansas, 72401
Mississippi Baptist
Kosciusko, Mississippi, 39090
Jewish Hospital
Louisville, Kentucky, 40202
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
Baptist Memorial Hospital-DeSoto
Southard, Missouri, 38671
Richmond University Medical Center
Staten Island, New York, 10312

Other trials in United States

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

Read the detailed description

The trial is a Phase 2, double-blind, randomized, placebo-controlled clinical trial of INB03 in participants with pulmonary complications due to COVID-19 infection.

Patients with COVID-19 infection and low blood oxygen levels with at least one high risk factor (see below) are eligible to participate in a 40-day study to determine whether INB03 can prevent the progression of pulmonary complications.

Eligible participants will be randomized (1:1) to receive either INB03 + standard of care (SOC) or Placebo + SOC. Participants randomized to INB03 + SOC will receive a 1mg/kg injection of INB03 after randomization. Patients that remain in the hospital 7 days after the first dose will receive a second dose. A final safety visit will occur on Day 70.

Conditions: COVID-19
Being tested: INB03, Placebo
Keywords: TNF, XPro1595, DN-TNF, cytokine storm, Quellor, Anti-TNF, Anti-TNF therapy, TNF inhibitor, INB03
Medical subject headings: COVID-19, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INB03Drug
Also called DN-TNF, XPro1595, XENP345, Quellor
Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03
PlaceboDrug
Also called Saline
Patients will receive up to two once per week subcutaneous injections of Placebo

Study groups in NCT04370236
Study group	Role	What they receive
Placebo + Standard of Care	Placebo comparator	Patients will receive placebo + standard medical care Receives: Drug: Placebo
INB03 + Standard of Care	Experimental	Patients will receive INB03 + standard medical care Receives: Drug: INB03

What is being measured

The primary outcome is the main question the study is designed to answer.

Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression
Primary Endpoint: Cochran-Mantel-Haenszel Analysis of Proportion of Patients with Disease Progression (mITT Population)
Measured: 28 days

Secondary outcomes (13)

Proportion of Patients With All-cause Mortality
Assessing the effect of INB03 on all-cause mortality in participants with pulmonary complications from COVID-19 infection (mITT Population)
Measured: Through study completion which could be up to Day 70
Proportion Transferred to ICU Level Care by Day 28
Proportion of participants who transferred to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is < 4) - mITT population
Measured: Randomization to Day 28
Proportion With New Onset of Neurologic Disease by Day 28
Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28 (mITT population)
Measured: Randomization to Day 28
Proportion With Evidence of New CHF or New MI Requiring Medical Intervention by Day 28
Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28 - mITT population
Measured: Randomization to Day 28
Proportion With New Onset Embolus or Thrombus by Day 28
Proportion of participants with a new onset embolus or thrombus by Day 28 - mITT population
Measured: Randomization to Day 28
Proportion Developing a Need for Renal Replacement Therapy by Day 28
Proportion of participants who develop a need for renal replacement therapy (defined as need for any type of dialysis including intermittent or continuous peritoneal or hemodialysis) by Day 28 - mITT population
Measured: Randomization to Day 28
Proportion With an Increase in the WHO Ordinal Scale of Clinical Improvement Score at Any Time During the Study
Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study - mITT population
Measured: Through study completion, which could be up to Day 70
Length of Hospital Stay
Length of hospital stay defined as the number of days in hospital from time of randomization to time of discharge or death, whichever occurs first, mITT population
Measured: Randomization to time of discharge or death, whichever occurs firts
Change From Baseline in Inflammation Markers Over Time - Troponin I
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Troponin I
Measured: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - Glomerular Filtration Rate
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Glomerular Filtration Rate
Measured: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - Ferritin
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Ferritin
Measured: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - D-Dimer
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - D-Dimer
Measured: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - CRP
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - C-Reactive Protein
Measured: Baseline to Day 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202018 Nov 2021

First posted30 Apr 2020
Study start21 Oct 2020
Primary completion13 Oct 2021
Study completion18 Nov 2021

Why it stopped: Futility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Parallel groups
Model description: Placebo + Standard of Care vs. INB03 + Standard of Care
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04370236
Sponsor's protocol ID: INB03-COVID-19_01
Status last verified: Mar 2026
First submitted: 29 Apr 2020
Last updated: 19 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)
ClinicalTrials.gov ID: NCT04370236
Acronym / sponsor ID: INB03-COVID-19_01
Conditions: COVID-19
Keywords: TNF, XPro1595, DN-TNF, cytokine storm, Quellor, Anti-TNF, Anti-TNF therapy, TNF inhibitor
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Futility
Enrolment: 79 participants (actual)
Lead sponsor: Inmune Bio, Inc.Industry (pharma, biotech, devices)
Study start: 21 Oct 2020 (actual)
Primary completion: 13 Oct 2021 (actual)
Study completion: 18 Nov 2021 (actual)
First posted: 30 Apr 2020 (actual)
Results: Posted 19 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

Detailed description

The trial is a Phase 2, double-blind, randomized, placebo-controlled clinical trial of INB03 in participants with pulmonary complications due to COVID-19 infection.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Placebo + Standard of Care vs. INB03 + Standard of Care

Arm	Type	Receives
Placebo + Standard of Care	Placebo comparator	Drug: PlaceboPatients will receive placebo + standard medical care
INB03 + Standard of Care	Experimental	Drug: INB03Patients will receive INB03 + standard medical care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Have one or more of the following comorbidities:
Have a positive COVID-19 test in the last 28 days;
Have room air SaO2 < 96%, or SpO2 < 96% on room air at sea level, or PaO2/FiO2 < 300;
Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
Provide written informed consent prior to any study related procedures being performed.

Key exclusion criteria (17 listed)

Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:
Age < 18 years;
Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);
Require immediate admission to an Intensive Care Unit (ICU) for any reason;
On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;

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
INB03Also: DN-TNF, XPro1595, XENP345, QuellorPatients will receive up to two once per week subcutaneous injections of 1mg/kg INB03	Drug	INB03 + Standard of Care
PlaceboAlso: SalinePatients will receive up to two once per week subcutaneous injections of Placebo	Drug	Placebo + Standard of Care

Primary outcome

Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression
Time frame: 28 days
Primary Endpoint: Cochran-Mantel-Haenszel Analysis of Proportion of Patients with Disease Progression (mITT Population)

13 secondary outcomes

Proportion of Patients With All-cause Mortality
Time frame: Through study completion which could be up to Day 70
Proportion Transferred to ICU Level Care by Day 28
Time frame: Randomization to Day 28
Proportion With New Onset of Neurologic Disease by Day 28
Time frame: Randomization to Day 28
Proportion With Evidence of New CHF or New MI Requiring Medical Intervention by Day 28
Time frame: Randomization to Day 28
Proportion With New Onset Embolus or Thrombus by Day 28
Time frame: Randomization to Day 28
Proportion Developing a Need for Renal Replacement Therapy by Day 28
Time frame: Randomization to Day 28
Proportion With an Increase in the WHO Ordinal Scale of Clinical Improvement Score at Any Time During the Study
Time frame: Through study completion, which could be up to Day 70
Length of Hospital Stay
Time frame: Randomization to time of discharge or death, whichever occurs firts
Change From Baseline in Inflammation Markers Over Time - Troponin I
Time frame: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - Glomerular Filtration Rate
Time frame: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - Ferritin
Time frame: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - D-Dimer
Time frame: Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - CRP
Time frame: Baseline to Day 40

Results and safety

Results posted to the registry on 19 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INB03+SOC	40	23
Placebo+SOC	39	28

Primary outcome: Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression

Time frame: 28 days. Count of participants. Unit: Participants

Measure	INB03 + Standard of Care n = 39	Placebo + Standard of Care n = 38
Value	10	6

Population analysed: mITT population

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INB03+SOC	8 of 39 (20.5%)	4 of 39 (10.3%)	4 of 39
Placebo+SOC	5 of 38 (13.2%)	10 of 38 (26.3%)	1 of 38

Limitations and caveats (from the sponsor): An interim analysis was planned to be performed when approximately 70 participants in the mITT population had completed the Study Day 28 assessment or had an intercurrent event within 28 days on study (withdrawal or lost to follow-up). Imputation of missing data was performed. Efficacy data, including the primary endpoint and cumulative safety data, were reviewed at the time of the interim analysis by the DMC. A non-binding one-way futility analysis was performed as described in the SAP.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Company WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Raymond Tesi, MD study chair

Inmune Bio, Inc.

9 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 INB03 in people with COVID-19, run by Inmune Bio, Inc. at 9 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 13 inclusion and 17 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: stopped early, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04370236.

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 19 May 2026.