Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection
- Conditions
- Covid19Pneumonia, Viral
- Interventions
- Drug: Antiviral Agents
- Registration Number
- NCT04675086
- Lead Sponsor
- Blessing Corporate Services, Inc
- Brief Summary
This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.
- Detailed Description
Approximately 20 subjects in total will be randomized with 1:1 ratio to the high dose of Aralast NP infusion therapy plus antiviral and standard of care versus antiviral therapy and standard of care.
Each subject will participate in the study for 24 days and have one safety follow-up phone call at 30 days. Active treatment will last 17 days, subject will be dosed on Days 1, 3, 5, 7, 9 and have a final booster infusion on Day 17. If the subject is discharged from hospital, any remaining infusions and assessments will be conducted via outpatient clinic visit or home health visit. Subjects will have an in-person visit (hospital or clinic) on Day 24 for a CT scan and follow-up assessment.
Efficacy will be evaluated by measuring the duration of new non-invasive ventilation or high flow oxygen used. Additional endpoints include clinical status, cytokine levels, oxygen requirements, SOFA scores, risk of coagulopathy, need for Vasopressors, mortality during the treatment period, PK samples, average days spent in the hospital/ICU, and number of days without a fever.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antiviral Treatment + Standard of Care Antiviral Agents The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices. Aralast NP + Antiviral Treatment + Standard of Care Antiviral Agents The investigational product is alpha1-proteinase inhibitor, administered as a loading dose of 120mg/kg/body weight intravenous infusion on the first day, and then 60mg/kg/BW intravenous infusion on Days 3, 5, 7 and 9. Booster infusion of 120 mg/kg/BWon Day 17. The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices. Aralast NP + Antiviral Treatment + Standard of Care alpha1-proteinase inhibitor The investigational product is alpha1-proteinase inhibitor, administered as a loading dose of 120mg/kg/body weight intravenous infusion on the first day, and then 60mg/kg/BW intravenous infusion on Days 3, 5, 7 and 9. Booster infusion of 120 mg/kg/BWon Day 17. The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices.
- Primary Outcome Measures
Name Time Method Duration of new non-invasive ventilation or high flow oxygen use (measured by days) 365 Days
- Secondary Outcome Measures
Name Time Method Clinical status on a 7-point ordinal scale (from 1=death to 7=not hospitalized 1 Year To evaluate the number of days with a PO2/FiO2 <300 or other parameters decided on with oxygen 1 Year The percentage change in oxygen requirements including PEEP and FiO2 from screening through day 10. 10 Days To evaluate the average number of days in the ICU 1 Year To evaluate the average number of days in the hospital 1 Year The risk of coagulopathy by measuring D-Dimer 1 Year The percentage change in cytokine levels from screening through day 10, Day 17 and Day 24 10 Days, 17 Days, & 24 Days Number of Days fever free (defined by temperature of <100°F (oral) for 24 hours) 1 Year The percentage of subjects that required mechanical ventilation during the treatment period. 1 Year The percent of patients with a SOFA score between 0-6 during treatment period. 1 Year The percent of mortality during the treatment period. 1 Year Evaluate the need, dosage and duration of vasopressors (number of days and average daily dose). 1 Year The risk of coagulopathy by measuring Prothrombin time & Partial Thromboplastin time 1 Year The risk of coagulopathy by measuring Platelet Counts 1 Year
Trial Locations
- Locations (1)
Blessing Corporate Services, Inc
🇺🇸Hannibal, Missouri, United States