Clinical trial NCT04400058: Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
Official title: Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid-19
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
timeFrame: 7 days
Secondary outcomes:
measure: Length of Hospital Stay (Time to Discharge)
timeFrame: 33 days
measure: Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14
timeFrame: 14 days
measure: Cumulative Duration of Invasive Mechanical Venitlation (IMV)
timeFrame: 33 days
measure: Number of Subjects With Severe Disease Progression
timeFrame: 33 days
measure: ICU Stay Length
timeFrame: 33 days
measure: Cumulative Mortality Rate Through Day 33
timeFrame: 33 days
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Octapharma Research Site
state: Alabama
city: Loma Linda
country: United States
facility: Octapharma Research Site
state: California
city: Loma Linda
country: United States
facility: Octapharma Research Site
state: California
city: Newport Beach
country: United States
facility: Octapharma Research Site
state: California
city: Orange
country: United States
facility: Octapharma Research Site
state: California
city: San Diego
country: United States
facility: Octapharma Research Site
state: California
city: Washington
country: United States
facility: Octapharma Research Site
state: District of Columbia
city: Honolulu
country: United States
facility: Octapharma Research Site
state: Hawaii
city: Iowa City
country: United States
facility: Octapharma Research Site
state: Iowa
city: Covington
country: United States
facility: Octapharma Research Site
state: Louisiana
city: Midland
country: United States
facility: Octapharma Research Site
state: Michigan
city: Las Vegas
country: United States
facility: Octapharma Research Site
state: Nevada
city: Minot
country: United States
facility: Octapharma Research Site
state: North Dakota
city: Charleston
country: United States
facility: Octapharma Research Site
state: South Carolina
city: Tyler
country: United States
facility: Octapharma Research Site
state: Texas
city: Ivanovo
country: Russian Federation
facility: Octapharma Research Site
city: Moscow
country: Russian Federation
facility: Octapharma Research Site
city: Moscow
country: Russian Federation
facility: Octapharma Research Site
city: Ryazan'
country: Russian Federation
facility: Octapharma Research Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Octapharma Research Site
city: Kharkiv
country: Ukraine
facility: Octapharma Research Site
city: Kremenchuk
country: Ukraine
facility: Octapharma Research Site
Study officials:
References: