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A study assessing COVID-HIG for the treatment for severe hospitalized patients as well as protection for at-risk individuals

Trial Profile

A study assessing COVID-HIG for the treatment for severe hospitalized patients as well as protection for at-risk individuals

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 02 Apr 2020

At a glance

  • Drugs COVID-2019 immune globulins (Human) (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 02 Apr 2020 According to an Emergent BioSolutions media release, company and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have agreed to incorporate the company COVID-HIG product candidate into one of NIAID clinical studies for assessment of treatments for COVID-19 once clinical material is available, and the study begins.
    • 26 Mar 2020 New trial record
    • 11 Mar 2020 According to an Emergent BioSolutions media release, this study is expected to begin as early as the third quarter of 2020.

Trial Overview

Purpose

This study will be evaluating COVID-HIG for the treatment for severe hospitalized patients as well as protection for at-risk individuals.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female
  • Age Group adult

Trial Details

Organisations

  • Affiliations Emergent BioSolutions

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase II
  • Location Unknown
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
COVID-2019 immune globulins (Human)Primary Drug
-
-

COVID-HIG

Trial History

Event Date Event Type Comment
02 Apr 2020 Other trial event According to an Emergent BioSolutions media release, company and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have agreed to incorporate the company COVID-HIG product candidate into one of NIAID clinical studies for assessment of treatments for COVID-19 once clinical material is available, and the study begins. Updated 06 Apr 2020
26 Mar 2020 New trial record New trial record Updated 26 Mar 2020
11 Mar 2020 Other trial event According to an Emergent BioSolutions media release, this study is expected to begin as early as the third quarter of 2020. Updated 26 Mar 2020

References

  1. Emergent BioSolutions. Emergent BioSolutions Initiates Development of Plasma-Derived Product Candidates for the Treatment and Prevention of Coronavirus Disease. Media-Rel 2020;.

    Media Release
  2. Emergent BioSolutions. Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19. Media-Rel 2020;.

    Media Release
  3. Emergent BioSolutions. Emergent BioSolutions Joins U.S. Governments Warp Speed Program in Landmark Public-Private CDMO Partnership for COVID-19 Vaccine Development and Manufacturing. Media-Rel 2020;.

    Media Release
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