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

STATUS

Recruiting
participants needed

208
sponsor

Octapharma

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Updated on 19 February 2024

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pao2

FIO2

pao2/fio2 ratio

covid-19

chest imaging

coronavirus infection

fraction of inspired oxygen (fio2)

throat

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

Details

Condition	Covid 19
Age	18-100 years
Treatment	Placebo, Octagam 10%
Clinical Study Identifier	NCT04400058
Sponsor	Octapharma
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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
	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 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)
	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
	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 enrolment or plan to receive this treatment during the course of the study
	Enrolled in other experimental studies or taking experimental medications (ie, convalescent plasma)

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