Clinical Investigators:

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