An Open-Label Phase Followed by a Randomized, Double-Blind, Placebo-Controlled Phase in a Study Designed to Evaluate Intravenous 2-O, 3-O Desulfated Heparin (ODSH) in Hospitalized Subjects with Exacerbations of Chronic Obstructive Pulmonary Disease

INTERVENTION: Product Name: ODSH Product Code: 2‐O, 3‐O Desulfated Heparin, PGX‐100 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: ODSH Other descriptive name: 2‐O, 3‐O Desulfated Heparin, HM 0506394, ODS, ODS heparin, ODS‐HEP, and 2‐O, 3‐ODSH. Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous bolus use (Noncurrent) CONDITION: Acute exacerbations of chronic obstructive pulmonary disease (COPD) ; MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease PRIMARY OUTCOME: Main Objective: The primary outcome of the study is “treatment failure”, meaning either that the patient failed to improve in the hoped for manner (in which case the hospitalization might be prolonged beyond some reasonable expectation) or having improved to the point where he/she was discharged, a relapse requiring some discrete medical treatment or health care utilization event occurred before the end of 21 days. Primary end point(s): Incidence of treatment failure Secondary Objective: • Changes of pulmonary function test measures; • C‐reactive protein (CRP);; • Improvement of dyspnea using the Borg CR10 Scale®;; • Exercise capacity measured by the 6‐minute walk test;; • Change in the BODE; • The need for intubation and mechanical ventilation 24 hours or later after starting study drug;; • The amount of rescue beta‐agonist use during Days 1, 2 and 3; • The oxygen requirements needed to maintain a pulse oximetry of 90‐92% during Days 1‐4; • Length of hospitalization and any ICU stay.; • Time to new exacerbation if < 90 days from initiation of ODSH or placebo infusion; • Incidence of exacerbations within 90 days of initiating ODSH or placebo infusion.; • Incidence of re‐hospitalization for COPD exacerbation within 60 days of initiating ODSH or placebo infusion.; • Incidence of re‐hospitalization for COPD exacerbation within 90 days of initiating ODSH or placebo infusion.; • Subject deaths within 30 days, 60 days, and 90 days of initiation of ODSH infusion. INCLUSION CRITERIA: 1. Male and female patients requiring hospitalization for treatment of an exacerbation of COPD; 2. Established diagnosis of COPD based upon medical history 3. Age of 40 years or more; 4. History of 20 pack years of cigarette smoking; 5. Anticipated need for four or more days of hospitalization, in the investigator’s judgment; 6. Normal prothrombin time (PT = 15 seconds or = the upper limit of normal value for the study site or corresponding INR); 7. Normal activated partial thromboplastin time (aPTT = 38 seconds or = the upper limit of normal value for the study site); 8. Platelet count > 80,000 per mm3, hemoglobin > 9.5 g/dL but < 18 g/dL, and hematocrit > 30% but < 60% at screening; 9. Able and willing to provide informed consent and to comply with the study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range