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

NCT04400058 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: GAM10-10
• Study Type: interventional
• Target: 207
• Locations: 3 countries
• Sites: 22

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

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (6)

• Length of Hospital Stay (Time to Discharge)

  33 days

• Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14

  14 days

• Cumulative Duration of Invasive Mechanical Venitlation (IMV)

  33 days

• Number of Subjects With Severe Disease Progression

  33 days

• ICU Stay Length

  33 days

Study Arms (2)

Octagam 10%

EXPERIMENTAL

Octagam 10%

Biological: Octagam 10%

Saline Solution

PLACEBO COMPARATOR

Placebo

Other: Saline Solution

Interventions

Octagam 10% BIOLOGICAL

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

Octagam 10%

Saline Solution OTHER

Placebo

Saline Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged ≥18years old
• Provide voluntary, fully informed written and signed consent before any study-related procedures are conducted
• Able to understand and comply with the relevant aspects of the study protocol
• Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or lower respiratory tract samples
• 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
• Chest imaging confirming lung involvement

You may not qualify if:

• 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.
• Known history of serious allergic reactions, including anaphylaxis, to IVIG or its preparation components
• 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)
• 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
• Known history of selective IgA deficiency with antibodies against IgA
• 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
• Currently requiring IMV (invasive mechanical ventilation or having received IMV during the last 30 days
• 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
• Body weight \>125 kg
• Women who are pregnant or breast-feeding
• 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

Sponsors & Collaborators

• Octapharma: lead

Study Sites (22)

Octapharma Research Site

Sheffield, Alabama, 35660, United States

Location

Octapharma Research Site

Loma Linda, California, 92354, United States

Location

Octapharma Research Site

Loma Linda, California, 92357, United States

Location

Octapharma Research Site

Newport Beach, California, 92663, United States

Location

Octapharma Research Site

Orange, California, 92868, United States

Location

Octapharma Research Site

San Diego, California, 92123, United States

Location

Octapharma Research Site

Washington D.C., District of Columbia, 20007, United States

Location

Octapharma Research Site

Honolulu, Hawaii, 96813, United States

Location

Octapharma Research Site

Iowa City, Iowa, 52242, United States

Location

Octapharma Research Site

Covington, Louisiana, 70433, United States

Location

Octapharma Research Site

Midland, Michigan, 48670, United States

Location

Octapharma Research Site

Las Vegas, Nevada, 89102, United States

Location

Octapharma Research Site

Minot, North Dakota, 58701, United States

Location

Octapharma Research Site

Charleston, South Carolina, 29401, United States

Location

Octapharma Research Site

Tyler, Texas, 75708, United States

Location

Octapharma Research Site

Ivanovo, 153025, Russia

Location

Octapharma Research Site

Moscow, 111539, Russia

Location

Octapharma Research Site

Moscow, 129301, Russia

Location

Octapharma Research Site

Ryazan, 390000, Russia

Location

Octapharma Research Site

Ivano-Frankivsk, 76007, Ukraine

Location

Octapharma Research Site

Kharkiv, 61096, Ukraine

Location

Octapharma Research Site

Kremenchuk, 39623, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Post-hoc outcomes were recorded for subjects who chose to enter the post-study phone call registry, therefore, the numbers differ from the overall study population.

Results Point of Contact

• Title: Patrick Murphy
• Organization: CRMG

p.murphy@crmg-usa.com

4138210022

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 22, 2020
• Study Start: June 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2024-01

Locations

US (15); RU (4); UA (3)