inb03 for the treatment of pulmonary complications from covid-19

Conditions: COVID-19

Summary: the purpose of this study is to determine whether xpro1595 can prevent the progression of respiratory complications in covid19 patients.

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.

Eligibility criteria:
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.

Keywords: tnf xpro1595 dn-tnf cytokine storm quellor anti-tnf anti-tnf therapy tnf inhibitor inb03