Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT05764993
Eligibility Criteria:
Inclusion criteria:
1. Patients \> 18 years and ≤ 82 years old.
2. Patient that meet three (3) or more of the five (5) following criteria.
1. Dyspnea ≥ 5 on a visual analog scale
2. Respiratory rate ≥ 24 breaths per minute
3. Heart rate ≥ 95 beats per minute
4. Resting SaO2 \< 92% breathing ambient air of the patient's usual oxygen prescription and/or change in saturation \> 3% from baseline
5. CRP ≥ 10 mg/L
3. Established diagnosis of COPD with PFTs showing FEV1/FVC \< 70% or FEV1/VC ratio below the 5th percentile of the predicted value.\[14\]
4. Subjects must have adherence with triple therapy \[Inhaled Corticosteroid (ICS), Long-acting beta2-adrenergic agonist (LABA), Long-acting muscarinic antagonist (LAMA)\] for greater than 90 Days prior to consideration of participation in this study.
5. With triple therapy onboard, the subject must have ≥ 2 steroid-requiring exacerbations (defined by increased respiratory symptoms of increased cough, dyspnea, sputum, sputum purulence, wheeze, chest tightness) requiring treatment with systemic steroids within the past 12 months OR one exacerbation requiring inpatient hospitalization
6. Medically stable with no acute hospitalizations for non-COPD related events within the last 3 months
7. Expected life expectancy \> 1 year
8. Stable Cardiovascular Disease, with no planned intervention
9. No history of pulmonary embolism or embolic event
10. Hepatic function \< Class B Child-Pugh criteria
11. Renal insufficiency with eGFR \> 60 mL/min/1.73m2
12. No history of DVT or thrombotic events
13. No history of prior organ transplant
14. Female subjects of childbearing potential will need to have a negative pregnancy test performed within 14 days prior to study procedure (if applicable) and be adherent to an accepted method of contraception.
15. Male subject will need to adhere to barrier contraception during the course of the trial and for 1 month after completion of the final injection of Cuvitru.
16. Ability to sign informed consent
Exclusion criteria:
1. Known history of humoral dysfunction/immunodeficiency
2. Known hereditary/genetic/congenital defects, and autoimmune disease including hereditary spherocytosis, hereditary elliptocytosis, paroxysmal nocturnal hemoglobinuria, and sickle cell disease
3. Ongoing or recent therapy with immunoglobulin replacement therapy within the past 6 months
4. Chronic oral steroid use of prednisone treatment of ≥20 mg daily (or equivalent) will be excluded to ensure subject is medically stable.
5. Alpha-1 antitrypsin deficiency
6. Obesity with a BMI \> 40
7. Unstable hypertension systolic blood pressure (SBP) \>160 mmHg upon repeated measure
8. Diabetes mellitus Type I
9. Known history of acquired or inherited thrombophilia disorders
10. Known risk factors of hemolysis, including G6PD deficiency, mitral valve replacement, aortic valve replacement.
11. Known prolonged periods of immobilization
12. Known severe hypovolemia noted by SBP ≤ 85 and/or heart rate (HR) \>130
13. Known hypercoagulable conditions
14. Use of estrogens
15. Indwelling central vascular catheters
16. Currently actively smoking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT05764993
Study Brief:
Protocol Section:
NCT05764993