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Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400058
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Octapharma

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

Condition or disease Intervention/treatment Phase
Covid-19 Biological: Octagam 10% Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Octagam 10%
Octagam 10%
Biological: Octagam 10%
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 Comparator: Placebo
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Stabilization or Improvement in Clinical Status [ Time Frame: 7 days ]

    Proportion of subjects with stabilized or improved clinical status at Day 7 on 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. 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.
    5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
    6. Death.

  2. Descriptive Clinical Status Analysis [ Time Frame: 7 days ]

    Change from Baseline (Day 1) at Day 7 in terms of the 6-point clinical status scale (descriptive analysis).

    Clinical status categories will be defined as:

    1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. 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.
    5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
    6. Death.


Secondary Outcome Measures :
  1. Clinical Status Assessment [ Time Frame: 14 days ]

    Proportion of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. (This endpoint will go into formal hypothesis testing procedure)

    Clinical status categories will be defined as:

    1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. 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.
    5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
    6. Death.

  2. Time to death [ Time Frame: Up to 33 days ]
    Time to death

  3. Mechanical Ventilation Initiation [ Time Frame: Up to 33 days ]
    Proportion of subjects requiring invasive mechanical ventilation by Day 33.

  4. Mechanical Ventilation Duration [ Time Frame: Up to 33 days ]
    Duration of invasive mechanical ventilation

  5. SARS-CoV-2 Test Result [ Time Frame: 7 days ]
    Results of RT-PCR for SARS-CoV-2 from nares/throat swab and/or sputum and/or lower respiratory tract sample on Day 7.

  6. Incidence of all AEs [ Time Frame: Up to 33 days ]
    Incidence of all AEs

  7. Incidence of AEs considered related to the IMP [ Time Frame: Up to 33 days ]
    Incidence of AEs considered related to the IMP

  8. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 33 days ]
    Incidence of serious adverse events (SAEs)

  9. Radiological findings (chest CT/chest X-ray) [ Time Frame: Up to 7 days ]
    Radiological findings (chest CT/chest X-ray)

  10. Blood glucose [ Time Frame: Up to 33 daya ]
    Change from baseline in blood glucose

  11. Blood calcium [ Time Frame: Up to 33 days ]
    Change from baseline in blood calcium

  12. Sodium [ Time Frame: Up to 33 days ]
    Change from baseline in sodium

  13. Potassium [ Time Frame: Up to 33 days ]
    Change from baseline in potassium

  14. Carbon dioxide [ Time Frame: Up to 33 days ]
    Change from baseline in carbon dioxide

  15. Chloride [ Time Frame: Up to 33 days ]
    Change from baseline in chloride

  16. Albumin [ Time Frame: Up to 33 days ]
    Change from baseline in albumin

  17. Total protein [ Time Frame: Up to 33 days ]
    Change from baseline in total protein

  18. Alkaline phosphatase [ Time Frame: Up to 33 days ]
    Change from baseline in alkaline phosphatase

  19. Alanine transaminase [ Time Frame: Up to 33 days ]
    Change from baseline in alanine transaminase

  20. Aspartate aminotransferase [ Time Frame: Up to 33 days ]
    Change from baseline in aspartate aminotransferase

  21. Bilirubin [ Time Frame: Up to 33 days ]
    Change from baseline in bilirubin

  22. Blood urea nitrogen [ Time Frame: Up to 33 days ]
    Change from baseline in blood urea nitrogen

  23. D-dimer [ Time Frame: Up to 33 days ]
    Change from baseline in D-dimer

  24. Fibrinogen [ Time Frame: Up to 33 days ]
    Change from baseline in fibrinogen

  25. PT [ Time Frame: Up to 33 days ]
    Change from baseline in PT

  26. PTT [ Time Frame: Up to 33 days ]
    Change from baseline in PTT

  27. INR [ Time Frame: Up to 33 days ]
    Change from baseline in INR

  28. hsCRP [ Time Frame: Up to 33 days ]
    Change from baseline in hsCRP

  29. Ferritin [ Time Frame: Up to 33 days ]
    Change from baseline in ferritin

  30. LDH [ Time Frame: Up to 33 days ]
    Change from baseline in LDH

  31. IgG [ Time Frame: Up to 33 days ]
    Change from baseline in IgG

  32. IgM [ Time Frame: Up to 33 days ]
    Change from baseline in IgM

  33. IgA [ Time Frame: Up to 33 days ]
    Change from baseline in IgA

  34. IFE [ Time Frame: Up to 33 days ]
    Change from baseline in IFE

  35. Troponin [ Time Frame: Up to 33 days ]
    Change from baseline in troponin

  36. Red blood cell count [ Time Frame: Up to 33 days ]
    Change from baseline in red blood cell count

  37. Hemoglobin [ Time Frame: Up to 33 days ]
    Change from baseline in hemoglobjn

  38. Hematocrit [ Time Frame: Up to 33 days ]
    Change from baseline in hematocrit

  39. Mean corpuscular volume [ Time Frame: Up to 33 days ]
    Change from baseline in mean corpuscular volume

  40. Mean corpuscular hemoglobin [ Time Frame: Up to 33 days ]
    Change from baseline in mean corpuscular hemoglobin

  41. Mean corpuscular hemoglobin concentration [ Time Frame: Up to 33 days ]
    Change from baseline in mean corpuscular hemoglobin concentration

  42. Red cell distribution width [ Time Frame: Up to 33 days ]
    Change from baseline in red cell distribution width

  43. White blood cell count [ Time Frame: Up to 33 days ]
    Change from baseline in white blood cell count

  44. White blood cell differential [ Time Frame: Up to 33 days ]
    Change from baseline in white blood cell differential

  45. Platelet count [ Time Frame: Up to 33 days ]
    Change from baseline in platelet count

  46. Mean platelet volume [ Time Frame: Up to 33 days ]
    Change from baseline in mean platelet volume

  47. Platelet distribution width [ Time Frame: Up to 33 days ]
    Change from baseline in platelet distribution width

  48. SpO2 [ Time Frame: Up to 33 days ]
    Change from baseline in SpO2

  49. A-a gradient [ Time Frame: Up to 33 days ]
    Change from baseline in A-a gradient

  50. Blood Pressure [ Time Frame: Up to 33 days ]
    Change from baseline in blood pressure

  51. Pulse [ Time Frame: Up to 33 days ]
    Change from baseline in pulse

  52. Respiration Rate [ Time Frame: Up to 33 days ]
    Change from baseline in respiration rate

  53. Body Temperature [ Time Frame: Up to 33 days ]
    Change from baseline in body temperature



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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 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 glomerular filtration rate [GFR] <15 mL/min/1.73 m2 to 59 mL/ min/1.73 m2, as defined by KDIGO Clinical Practice Guideline)<15mL/min/1.73 m2 to 59mL/min/1.73 m2, as defined by KDIGO Clinical Practice Guideline)
  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. Women who are pregnant or breast-feeding
  10. Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin agents (eg Tocilizumab), or interferons for their COVID-19 disease before enrolment or plan to receive this treatment during the course of the study
  11. Enrolled in other experimental studies or taking experimental medications (ie, convalescent plasma)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400058


Contacts
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Contact: Mikaela Raymond 8663371868 ctgov@clinicalresearchmgt.com

Locations
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United States, California
Octapharma Research Site Recruiting
Loma Linda, California, United States, 92354
Octapharma Research Site Recruiting
Loma Linda, California, United States, 92357
Octapharma Research Site Recruiting
Orange, California, United States, 92868
Octapharma Research Site Recruiting
San Diego, California, United States, 92123
United States, District of Columbia
Octapharma Research Site Recruiting
Washington, District of Columbia, United States, 20007
United States, Hawaii
Octapharma Research Site Recruiting
Honolulu, Hawaii, United States, 96813
United States, Iowa
Octapharma Research Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Louisiana
Octapharma Research Site Recruiting
Covington, Louisiana, United States, 70433
United States, South Carolina
Octapharma Research Site Recruiting
Charleston, South Carolina, United States, 29401
United States, Texas
Octapharma Research Site Recruiting
Tyler, Texas, United States, 75708
Sponsors and Collaborators
Octapharma
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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT04400058    
Other Study ID Numbers: GAM10-10
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs