Covid19Phase 2NCT04555148
COVIDIG (COVID-19 Hyper-ImmunoGlobulin)
A Phase 2 study testing GC5131 in people with Covid19, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- GC5131
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2020to 23 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
- Conditions
- Covid19
- Being tested
- GC5131, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC5131Biological
COVID19 Hyper-Immunoglobulin
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline Receives: Other: Placebo |
| Low dose Treatment | Experimental | Low dose treatment Receives: Biological: GC5131 |
| Medium dose Treatment | Experimental | Medium dose Treatment Receives: Biological: GC5131 |
| High dose Treatment | Experimental | High dose Treatment Receives: Biological: GC5131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal scale outcome
The percent of participants changed by 2 points or more
Measured: 7, 14, 21, 28 days
Secondary outcomes (3)
Viral negative
The percents of negative patients for COVID-19 virus
Measured: 1, 3, 5, 7, 10 days
Change in NEWS2 (National Early Warning Score 2)
The change of National Early Warning Score 2 (NEWS) from baseline
Measured: 7, 14, 21, 28 days
mortality
The percent of participants
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start19 Sep 2020
- Primary completion22 Jan 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555148
- Sponsor's protocol ID
- GC5131A-HIG_P0201
- Status last verified
- Aug 2021
- First submitted
- 16 Sep 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04555148
- Acronym / sponsor ID
- GC5131A-HIG_P0201
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSaline |
| Low dose Treatment | Experimental | Biological: GC5131Low dose treatment |
| Medium dose Treatment | Experimental | Biological: GC5131Medium dose Treatment |
| High dose Treatment | Experimental | Biological: GC5131High dose Treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC5131COVID19 Hyper-Immunoglobulin | Biological | High dose Treatment, Low dose Treatment, Medium dose Treatment |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Ordinal scale outcome
Time frame: 7, 14, 21, 28 days
The percent of participants changed by 2 points or more
3 secondary outcomes
Viral negative
Time frame: 1, 3, 5, 7, 10 days
Change in NEWS2 (National Early Warning Score 2)
Time frame: 7, 14, 21, 28 days
mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC5131 in people with Covid19, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ordinal scale outcome (time frame: 7, 14, 21, 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.