Intravenous Immunoglobulin Replacement Therapy for Persistent COVID-19 in Patients With B-cell Impairment

NCT06159283 | Recruiting Phase 2

• 1 other identifier: 2023-11-078
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Evaluation of clinical effectiveness

  Clinical recovery

  14day

Secondary Outcomes (1)

• Evaluation of clinical effectiveness

  30day and 60day

Study Arms (2)

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.

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.

Interventions

Immunoglobulins DRUG

Dosage is Immunoglobulin 1,000mg/kg IV. It administer over 2\~3 days.

Also known as: Immunoglobulins in this study uses commercially avilable drug.

IVIG administration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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:

You may not qualify if:

• 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.
• (2) 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.
• \. 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

Sponsors & Collaborators

• Jaehoon Ko: lead

Study Sites (1)

Jaehoon Ko

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jaehoon Ko, Ph,MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaehoon Ko, Ph,MD

CONTACT

+82-10-3592-2631; jaehoon.ko@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 6, 2023
• Study Start: March 18, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

KR (1)