COVID-19Phase 2NCT06159283
Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment
A Phase 2 study testing Immunoglobulins in people with COVID-19, run by Jaehoon Ko at 1 site in South Korea.
Trial summary
This is a multicenter, randomized controlled trial aiming to investigate the efficacy of intravenous immunoglobulin (IVIG) replacement therapy under the hypothesis that immunoglobulin replacement would have therapeutic effects on persistent COVID-19 in patients with B-cell impairment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Immunoglobulins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2024to 31 Dec 2025
- 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
- Voluntary written consent to participate in the trial
- Age≥ 19 years
- Diagnosed as COVID-19: the definitive diagnosis of COVID-19 will be made at a healthcare facility based on COVID-19 tests approved in Korea, such as reverse transcription polymerase chain reaction (RT-PCR), Xpert, film array, and rapid antigen test (RAT).
- The diagnosis of persistent COVID-19 will be made following the criteria below:
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- No improvement or worsening of symptoms/signs of active inflammation, such as fever, pneumonia, and dyspnea requiring oxygen, even after 2 weeks of the initial symptom onset or diagnosis of COVID-19 (persisting symptoms/signs at or after the third week of illness).
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- The day count for the disease course is based on the symptom onset or diagnosis date, whichever is earlier, with Day 1 being the date of symptom onset or diagnosis. The third week refers to the period including and following Day 15. For the purpose of day count calculation, self-test results using RAT are accepted.
- Both symptoms and signs indicative of active inflammation must be present. This status corresponds to the Modified WHO clinical progression scale of ≥ 4.
- Symptoms include at least one of the following.
- Fever of 37.8°C or higher lasting for >48 h (determined based on self-measurement and statements from the patient or caregiver, with fevers persisting from Day 13 to Day 15 also accepted)
- Persistent cough despite taking appropriate expectorants and cough suppressants
- Dyspnea upon walking on a flat surface (modified Medical Research Council grade >2) ② At least one of the following signs of active inflammation must be present.
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- Pulmonary infiltration suggestive of COVID-19 observed in chest radiograph or computed tomography scan findings. Findings may vary, from ground-glass opacities to patchy consolidation, and are determined by the clinician or radiologist.
- Decreased oxygen saturation (PaO2/FiO2 ≤300 mmHg, SpO2 ≤92%, or PaO2 ≤63%) 5. Cases of patients with B-cell impairment:
- Patients with B-cell lineage hematologic malignancies, such as B-cell lymphoma or multiple myeloma, who are presumed to have impaired B-cell function owing to B-cell targeting chemotherapy (i.e., those receiving rituximab, CAR-T, Bispecific T-cell engager therapies), or second-line or higher treatments, such as autologous stem cell transplantation (AutoPBSCT) (2) Patients suffering from diseases known to result in B-cell depletion, such as Good's syndrome associated with thymoma (3) Cases of patients with a congenital primary immunodeficiency who have reduced antibody formation and have not undergone IVIG replacement in the past 3 months.
- Among these, those who received B-cell targeting chemotherapy within the past 3 months are eligible for enrollment based on clinical criteria, but other patients must confirm the reduction of peripheral B cells to <1% via flow cytometry to be eligible for enrollment.
Who cannot join
- Difficulty controlling the underlying disease or life expectancy of <3 months even after COVID-19 is successfully treated.
- T-cell impairment.
- (1)T-cell suppressive drugs (e.g., cyclosporine, tacrolimus) cannot be suspended owing to organ transplantation or autoimmune disorder.
- Patients with human immunodeficiency virus (HIV) infection with a CD4 T-cell count <500 cells/μL or persistent detection of HIV viral RNA in the blood.
- 3. IVIG or COVID-19 convalescent plasma therapy within 3 months of screening 4. History of serious reaction or hypersensitivity to blood, blood products, blood-derived products, IVIG, and IgG 5. Immunoglobulin A (IgA) deficiency or IgA antibodies present 6. Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) 7. Hemolytic anemia, hemorrhagic anemia 8. Impaired cardiac function [New York Heart Association Functional Class Ⅲ or IV] 9. High risk for thrombosis/embolism clinically owing to a history of cerebrovascular and cardiovascular disorders, thrombosis, or embolism 10. Cases of pregnant or breastfeeding women 11. Current participation in another clinical trial related to COVID-19 drugs 12. Cases of participants that are inappropriate to participate in the trial based on the investigator's discretion
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jaehoon Ko
Seoul
Jaehoon Ko, +821035922631, jaehoon.ko@samsung.com
About this study
Official title: Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment: a Multicenter Randomized Controlled Trial
This is a multicenter, randomized controlled trial aiming to investigate the efficacy of intravenous immunoglobulin (IVIG) replacement therapy under the hypothesis that immunoglobulin replacement would have therapeutic effects on persistent COVID-19 in patients with B-cell impairment.
Read the detailed description
This project aims to provide passive immunization to patients with persistent COVID-19 who experience inflammation owing to continuous replication of SARS-CoV-2, as a consequence of B-cell impairment that hinders normal antibody formation. As opposed to relying on the non-specific immune mechanism of IVIG in other studies, this trial focuses on the antiviral effect and antibody-dependent cytotoxicity induced by SARS-CoV-2-specific antibodies from plasma donors who have formed high antibody titers through vaccination and breakthrough infections. Thus, in contrast to previous studies, the therapy may demonstrate clinical efficacy. In this work, we aim to elucidate the role of IVIG in treating persistent COVID-19 in patients with B-cell depletion who cannot produce antibodies, and to establish grounds for clinical application of the therapy.
Once the participants voluntarily provide written consent to participate in the trial, they will undergo screening tests, and eligible participants will be randomly assigned to the treatment or control (standard of care) group in a 1:1 ratio.
- Conditions
- COVID-19
- Being tested
- Immunoglobulins
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoglobulinsDrug
Also called Immunoglobulins in this study uses commercially avilable drug.
Dosage is Immunoglobulin 1,000mg/kg IV. It administer over 2~3 days.
| Study group | Role | What they receive |
|---|---|---|
| IVIG administration | Experimental | The patients who will meet the inclusion criteria will be administered IVIG at a dose of 1,000 mg/kg, divided over 2-3 days. After administration, the patient's condition will be thoroughly observed. In case of adverse effects from an increased administration rate, the rate will be reduced immediately or suspended until symptom improvement. Other standards of care can be continued. Receives: Drug: Immunoglobulins |
| Standard Of Care | No intervention | The same anti-viral, anti-inflammatory, and anti-coagulation treatment criteria are applied to the treatment group. If the primary endpoint will be not reached by day 14 of randomization, IVIG can be given at a dose of 1,000 mg/kg based on clinicians' discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical effectiveness
Clinical recovery
Measured: 14day
Secondary outcomes (1)
Evaluation of clinical effectiveness
Clinical recovery
Measured: 30day and 60day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start18 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaehoon Ko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaehoon Ko, Samsung Medical Center
- Investigators
- Jaehoon Ko, Ph,MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159283
- Sponsor's protocol ID
- 2023-11-078
- Status last verified
- May 2024
- First submitted
- 4 Dec 2023
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06159283
- Acronym / sponsor ID
- 2023-11-078
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Jaehoon KoUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
This is a multicenter, randomized controlled trial aiming to investigate the efficacy of intravenous immunoglobulin (IVIG) replacement therapy under the hypothesis that immunoglobulin replacement would have therapeutic effects on persistent COVID-19 in patients with B-cell impairment.
Detailed description
This project aims to provide passive immunization to patients with persistent COVID-19 who experience inflammation owing to continuous replication of SARS-CoV-2, as a consequence of B-cell impairment that hinders normal antibody formation. As opposed to relying on the non-specific immune mechanism of IVIG in other studies, this trial focuses on the antiviral effect and antibody-dependent cytotoxicity induced by SARS-CoV-2-specific antibodies from plasma donors who have formed high antibody titers through vaccination and breakthrough infections. Thus, in contrast to previous studies, the therapy may demonstrate clinical efficacy. In this work, we aim to elucidate the role of IVIG in treating persistent COVID-19 in patients with B-cell depletion who cannot produce antibodies, and to establish grounds for clinical application of the therapy.
Once the participants voluntarily provide written consent to participate in the trial, they will undergo screening tests, and eligible participants will be randomly assigned to the treatment or control (standard of care) group in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG administration | Experimental | Drug: ImmunoglobulinsThe patients who will meet the inclusion criteria will be administered IVIG at a dose of 1,000 mg/kg, divided over 2-3 days. After administration, the patient's condition will be thoroughly observed. In case of adverse effects from an increased administration rate, the rate will be reduced immediately or suspended until symptom improvement. Other standards of care can be continued. |
| Standard Of Care | No intervention | –The same anti-viral, anti-inflammatory, and anti-coagulation treatment criteria are applied to the treatment group. If the primary endpoint will be not reached by day 14 of randomization, IVIG can be given at a dose of 1,000 mg/kg based on clinicians' discretion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntary written consent to participate in the trial
- Age≥ 19 years
- Diagnosed as COVID-19: the definitive diagnosis of COVID-19 will be made at a healthcare facility based on COVID-19 tests approved in Korea, such as reverse transcription polymerase chain reaction (RT-PCR), Xpert, film array, and rapid antigen test (RAT).
- The diagnosis of persistent COVID-19 will be made following the criteria below:
- <!-- -->
Key exclusion criteria (5 listed)
- Difficulty controlling the underlying disease or life expectancy of <3 months even after COVID-19 is successfully treated.
- T-cell impairment.
- (1)T-cell suppressive drugs (e.g., cyclosporine, tacrolimus) cannot be suspended owing to organ transplantation or autoimmune disorder.
- Patients with human immunodeficiency virus (HIV) infection with a CD4 T-cell count <500 cells/μL or persistent detection of HIV viral RNA in the blood.
- 3. IVIG or COVID-19 convalescent plasma therapy within 3 months of screening 4. History of serious reaction or hypersensitivity to blood, blood products, blood-derived products, IVIG, and IgG 5. Immunoglobulin A (IgA) deficiency or IgA antibodies present 6. Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) 7. Hemolytic anemia, hemorrhagic anemia 8. Impaired cardiac function [New York Heart Association Functional Class Ⅲ or IV] 9. High risk for thrombosis/embolism clinically owing to a history of cerebrovascular and cardiovascular disorders, thrombosis, or embolism 10. Cases of pregnant or breastfeeding women 11. Current participation in another clinical trial related to COVID-19 drugs 12. Cases of participants that are inappropriate to participate in the trial based on the investigator's discretion
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 |
|---|---|---|
| ImmunoglobulinsAlso: Immunoglobulins in this study uses commercially avilable drug.Dosage is Immunoglobulin 1,000mg/kg IV. It administer over 2~3 days. | Drug | IVIG administration |
Primary outcome
Evaluation of clinical effectiveness
Time frame: 14day
Clinical recovery
1 secondary outcome
Evaluation of clinical effectiveness
Time frame: 30day and 60day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Jaehoon Ko, Ph,MD principal investigator
Samsung Medical Center
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 Immunoglobulins in people with COVID-19, run by Jaehoon Ko 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 17 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaehoon Ko, Ph,MD (+82-10-3592-2631, jaehoon.ko@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical effectiveness (time frame: 14day). 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 16 May 2024.