COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04370236

Christopher Barnum, PhD

trials@inmunebio.com

2020-04-30

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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); 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.

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; 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.

2

Inmune Bio, Inc.

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

79

Proportion of participants with disease progression from randomization to 28 days post-randomization

None

Phase 2/Phase 3

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