COVID-19 > Investigator Recruitment

Join Our Trial as an Investigator

Are you interested in participating in our trial? We are seeking physicians treating hospitalized COVID-19 patients. Our goal is to evaluate if high-dose intravenous immunoglobulin (IVIg) can stabilize or improve patient clinical status. Read more to learn the details of our trial, eligibility requirements, and how you and your COVID-19 patients may be able to take part in this important research.

  • Study Design

    Our trial is a randomized, double-blind, placebo-controlled, multicenter, phase 3 study to evaluate if high-dose IVIg therapy can stabilize or improve clinical status in patients with severe COVID-19 disease.

  • Indication

    Immunomodulation in patients with severe COVID-19 disease to prevent deterioration of clinical status.

  • Primary Objective

    The primary objective of this study is to determine if high-dose IVIg therapy will stabilize or improve clinical status in patients with severe COVID-19 disease.

  • Secondary Objective

    The secondary objective of this study is to measure the effects of a high-dose of IVIg on slowing or stopping the processes impacted by COVID-19, by improving pulmonary function, quality of life, and correlated impact on metabolic factors.

  • Number of Patients Required

    208

  • Duration of Treatment

    33 days

  • Inclusion Criteria

    • Hospitalized patients 18 years of age or older with a RT-PCR confirmed COVID-19 infection
    • Resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio <300mmHg
    • Chest imaging confirming lung involvement
  • Exclusion Criteria

    • Existence of other evidence that can explain pneumonia
    • Subjects with a history of a thromboembolic event (TEE) within the last 12 months
    • Subjects with an underlying medical condition that can lead to hypercoagulable states and hyperviscosity
    • Subjects with conditions such as HIV infection, known acute or chronic hepatitis B or C, pulmonary fibrosis, and moderate to severe renal dysfunction
    • Subjects currently requiring invasive mechanical ventilation
    • Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin agents (e.g. Tocilizumab), or interferons

Find out more at clinicaltrials.gov.


Let’s Work Together to Combat COVID-19

For more information or to learn how to become a clinical investigator in this trial, please contact:

Snehal Udavat
Clinical Study Manager
snehal.udavat@octapharma.com
Phone: +1 (201) 604-1124
Mobile: +1 (201) 417-1779