KCT0009239
Not yet recruiting
未知
Intravenous Immunoglobulin replacement therapy for persistent COVID-19 in patients with B-cell impairment: a multicenter randomized controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Certain infectious and parasitic diseases
- Sponsor
- Samsung Medical Center
- Enrollment
- 58
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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]
Outcomes
Primary Outcomes
Not specified
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