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OpenTrials
Completed

NCT Number: NCT04555148

COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
  • The subject who has symptoms of COVID-19 within 7 days
  • The subject with pneumonia confirmed by imaging diagnosis related to COVID-19 OR a 70-year-old or older OR 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker)
  • Willing and able to provide written informed consent prior to performing study procedures

Exclusion criteria

  • asymptomatic patient
  • The subject who requiring mechanical ventilation or ECMO
  • The subject who are underlying oxygen therapy before affected by COVID-19
  • The subject who have received antiviral drugs for other disease within 4 weeks
  • History of allergy to IVIG or plasma products
  • The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
  • IgA deficiency
  • Cretinine > 2 X ULN
  • The subject with a history of thrombosis or high risk of thromboembolism
  • The subject with reduced heart function [NYHA (New York Heart Association) Functional Class III or IV]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)

Treatment and study plan

GC5131

Biological

COVID19 Hyper-Immunoglobulin

Placebo

Other

Placebo

Primary outcomes

  1. Ordinal scale outcome

    Time frame: 7, 14, 21, 28 days

    The percent of participants changed by 2 points or more

Secondary outcomes

  1. Viral negative

    Time frame: 1, 3, 5, 7, 10 days

    The percents of negative patients for COVID-19 virus

  2. Change in NEWS2 (National Early Warning Score 2)

    Time frame: 7, 14, 21, 28 days

    The change of National Early Warning Score 2 (NEWS) from baseline

  3. mortality

    Time frame: 28 days

    The percent of participants

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

A Prospective, Open-label, Randomized, Multi-center, Phase 2a Study to Evaluation the Dose Response, Efficacy and Safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients With COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2020
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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