This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
207
Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
Placebo
Octapharma Research Site
Sheffield, Alabama, United States
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
Time frame: 7 days
Length of Hospital Stay (Time to Discharge)
Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33
Time frame: 33 days
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14
Number of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. Clinical status categories will be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥ 150 mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
Time frame: 14 days
Cumulative Duration of Invasive Mechanical Venitlation (IMV)
Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33
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Octapharma Research Site
Loma Linda, California, United States
Octapharma Research Site
Loma Linda, California, United States
Octapharma Research Site
Newport Beach, California, United States
Octapharma Research Site
Orange, California, United States
Octapharma Research Site
San Diego, California, United States
Octapharma Research Site
Washington D.C., District of Columbia, United States
Octapharma Research Site
Honolulu, Hawaii, United States
Octapharma Research Site
Iowa City, Iowa, United States
Octapharma Research Site
Covington, Louisiana, United States
...and 12 more locations
Time frame: 33 days
Number of Subjects With Severe Disease Progression
Number of subjects who experienced severe disease progression while treated with Octagam 10% compared to those that received placebo at Day 33. Severe disease progression is defined as subjects requiring extracorporeal membrane oxygenation, mechanical ventilation and/or died through day 33.
Time frame: 33 days
ICU Stay Length
Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.
Time frame: 33 days
Cumulative Mortality Rate Through Day 33
Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33
Time frame: 33 days