KCT0009239尚未招募Unknown
Intravenous Immunoglobulin replacement therapy for persistent COVID-19 in patients with B-cell impairment: a multicenter randomized controlled trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Voluntary written consent to participate in the trial
- •2.Age= 19 years
- •3.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).
- •4.The diagnosis of persistent COVID-19 will be made following the criteria below:
- •(1)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).
- •(2)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.
- •(3)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.
- •a.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)
- •b.Persistent cough despite taking appropriate expectorants and cough suppressants
- •c.Dyspnea upon walking on a flat surface (modified Medical Research Council grade >2)
- •?At least one of the following signs of active inflammation must be present.
- •a.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.
- •b.Decreased oxygen saturation (PaO2/FiO2 =300 mmHg, SpO2 =92%, or PaO2 =63%)
- •5.Cases of patients with B-cell impairment:
- •(1)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.
排除标准
- •1.Difficulty controlling the underlying disease or life expectancy of <3 months even after COVID-19 is successfully treated.
- •2.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.
- •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 ? 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
研究者
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