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

Octapharma

Status and phase: Completed; Phase 3

Conditions: Covid-19

Treatments: Biological: Octagam 10%; Other: Saline Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04400058

GAM10-10

Details and patient eligibility

About

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

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Octagam 10%

Experimental group

Description:

Octagam 10%

Treatment:

Biological: Octagam 10%

Saline Solution

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Saline Solution