COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

August 17, 2021 updated by: Green Cross Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Saline
Other: Placebo
Placebo
EXPERIMENTAL: Low dose Treatment
Low dose treatment
Biological: GC5131
COVID19 Hyper-Immunoglobulin
EXPERIMENTAL: Medium dose Treatment
Biological: GC5131
COVID19 Hyper-Immunoglobulin
EXPERIMENTAL: High dose Treatment
Biological: GC5131
COVID19 Hyper-Immunoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordinal scale outcome
Time Frame: 7, 14, 21, 28 days
The percent of participants changed by 2 points or more
7, 14, 21, 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral negative
Time Frame: 1, 3, 5, 7, 10 days
The percents of negative patients for COVID-19 virus
1, 3, 5, 7, 10 days
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
7, 14, 21, 28 days
mortality
Time Frame: 28 days
The percent of participants
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2020

Primary Completion (ACTUAL)

January 22, 2021

Study Completion (ACTUAL)

April 23, 2021

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (ACTUAL)

September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC5131A-HIG_P0201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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