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

Covid-19 Clinical Trial

Official title:

Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400058
• Other study ID #: GAM10-10
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2024
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19
• Disease Progression

Intervention

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

Other:
• Saline Solution
Placebo

Locations

Country	Name	City	State
Russian Federation	Octapharma Research Site	Ivanovo
Russian Federation	Octapharma Research Site	Moscow
Russian Federation	Octapharma Research Site	Moscow
Russian Federation	Octapharma Research Site	Ryazan'
Ukraine	Octapharma Research Site	Ivano-Frankivs'k
Ukraine	Octapharma Research Site	Kharkiv
Ukraine	Octapharma Research Site	Kremenchuk
United States	Octapharma Research Site	Charleston	South Carolina
United States	Octapharma Research Site	Covington	Louisiana
United States	Octapharma Research Site	Honolulu	Hawaii
United States	Octapharma Research Site	Iowa City	Iowa
United States	Octapharma Research Site	Las Vegas	Nevada
United States	Octapharma Research Site	Loma Linda	California
United States	Octapharma Research Site	Loma Linda	California
United States	Octapharma Research Site	Midland	Michigan
United States	Octapharma Research Site	Minot	North Dakota
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	Sheffield	Alabama
United States	Octapharma Research Site	Tyler	Texas
United States	Octapharma Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Countries where clinical trial is conducted

United States,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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).; Hospitalization, not requiring supplemental oxygen.; Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).; ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient =150mmHg.; ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.; Death.	7 days
Secondary	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	33 days
Secondary	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: 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).; Hospitalization, not requiring supplemental oxygen.; Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).; ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient = 150 mmHg.; ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.; Death.	14 days
Secondary	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	33 days
Secondary	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.	33 days
Secondary	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.	33 days
Secondary	Cumulative Mortality Rate Through Day 33	Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33	33 days