Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
Condition: Covid-19
MeSH terms: COVID-19; Disease Progression
Intervention: Octagam 10%; Saline Solution
Intervention description: 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
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult aged ≥18years old

          2. Provide voluntary, fully informed written and signed consent before any study-related
             procedures are conducted

          3. Able to understand and comply with the relevant aspects of the study protocol

          4. Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or
             lower respiratory tract samples

          5. Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio <300mmHg.
             Measurement can be taken from documented source records in the 24 hours prior to
             screening

          6. Chest imaging confirming lung involvement

        Exclusion Criteria:

          1. Existence of other evidence that can explain pneumonia including but not limited to:
             Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the
             combined clinical picture, radiological findings and known laboratory results [eg,
             elevated procalcitonin >0.5ng/mL and concomitant neutrophilia]), known fungal
             pneumonia, suspected fungal pneumonia based on compromised immune system with a
             history of past fungal infections, noninfectious causes, etc.

          2. Known history of serious allergic reactions, including anaphylaxis, to IVIG or its
             preparation components

          3. Subjects with a history of thromboembolic event (TEE) within the last 12 months, such
             as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke,
             transient ischemic attack, peripheral artery disease (Fontaine IV)

          4. Subjects with an underlying medical condition that can lead to hypercoagulable states
             and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C
             deficiency, antiphospholipid syndrome and malignancy

          5. Known history of selective IgA deficiency with antibodies against IgA

          6. Subjects with conditions such as human immunodeficiency virus (HIV) infection, known
             acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR
             positive or currently treated with antivirals), pulmonary fibrosis, elevated
             procalcitonin (> 0.5) with concomitant neutrophilia (elevated polys), heparin induced
             thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator
             discretion based on estimated glomerular filtration rate [eGFR] <59 mL/min/1.73 m2, as
             defined by KDIGO Clinical Practice Guideline):

               -  Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2

               -  Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2

               -  Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2

               -  Kidney failure (G5): GFR <15 ml/min/1.73 m2

          7. Currently requiring IMV (invasive mechanical ventilation or having received IMV during
             the last 30 days

          8. Known clinically significant preexisting lung, heart, or neuromuscular disease that,
             in the investigator's opinion, would impact subject's ability to complete study or may
             confound the study results

          9. Body weight >125 kg

         10. Women who are pregnant or breast-feeding

         11. Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin
             agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment
             or plan to receive this treatment during the course of the study

         12. Enrolled in other experimental interventional studies or taking experimental
             medications (ie, convalescent plasma). Diagnostic studies can be allowed if the
             anticipated total blood volume to be drawn across both studies and for therapeutic
             purposes does not exceed 450 mL over any 8-week period.