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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    208
  • sponsor
    Octapharma
Updated on 31 July 2020
FIO2
pao2
covid-19
pao2/fio2 ratio
coronavirus infection

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
Treatment Placebo, Octagam 10%
Clinical Study IdentifierNCT04400058
SponsorOctapharma
Last Modified on31 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Covid-19 or *COVID-19?
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 HIV infection, known acute or chronic active hepatitis B or C (HBsAG positive or HCV RNA PCR positive or currently treated with antivirals), pulmonary fibrosis, and moderate to severe renal dysfunction (per investigator discretion based on glomerular filtration rate (GFR) <15mL/min/1.73 m2 to 59mL/min/1.73 m2, as defined by KDIGO Clinical Practice Guideline)
Currently requiring invasive mechanical ventilation
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 (e.g. 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 (i.e., convalescent plasma)
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