The goal of this clinical study is to evaluate the safety and efficacy of autologous COVID-19 antigen specific T cell (LB-DTK-COV19) treatment in prolonged SARS-CoV-2 infected patients. The main questions it aims to answer are: * What adverse events occur after the infusion of LB-DTK-COV19? * Is there a clinically significant improvement in clinical symptoms within 4 weeks after the infusion? * Is there a clinically significant reduction in SARS-CoV-2 viral load within 4 weeks after the infusion? The patients will: * Receive a single infusion of LB-DTK-COV19 either intravenously or using central venous catheter during the baseline visit at a dose of 1x10\^7/m\^2. * Receive a second infusion of LB-DTK-COV19 either intravenously or using central venous catheter at the same dose 14 days after the first infusion. * Attend follow-up visits at the clinic for 6 months after the first infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
\- LB-DTK-COV19 is an autologous SARS-CoV-2-specific T cell therapy product derived from a patient and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea
Viral load
Nasopharyngeal swab samples were used for PCR testing and ELISA to assess SARS-CoV-2 viral load and immunoglobulin levels.
Time frame: From the screening visit through 24 weeks after treatment initiation.
WHO Ordinal Scale
The time to improvement in the WHO Ordinal Scale, defined as an improvement of at least 1 point from baseline, is assessed. The outcome is summarized by both the time to improvement and the proportion of participants achieving the improvement by four weeks following LB-DTK-COV19 infusion.
Time frame: From the screening visit through 24 weeks after treatment initiation.
NEWS2 Score
The time to achievement of a NEWS2 score of 0 sustained for at least 24 hours is assessed. The outcome is summarized by both the time to achievement and the proportion of participants achieving the endpoint by four weeks following LB-DTK-COV19 infusion.
Time frame: From the screening visit through 24 weeks after treatment initiation.
Chest CT Severity Score
Proportion of patients with improvement in chest CT severity scores at four weeks following LB-DTK-COV19 infusion is measured.
Time frame: From the screening visit through 24 weeks after treatment initiation.
Quantification of SARS-CoV-2-Specific T cells
SARS-CoV-2-specific T cells and their subsets are quantified using flow cytometry.
Time frame: From the baseline visit through 24 weeks after treatment initiation.
SARS-CoV2-Specific T-cell Responses
SARS-CoV2-specific T-cell responses are assessed using IFN-γ ELISPOT assay and spot-forming units.
Time frame: From baseline through 24 weeks after treatment initiation.
Adverse Events
The investigator must confirm the occurrence of adverse events through medical examinations during regular visits throughout the clinical study period. Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit.
Time frame: From the baseline visit through 24 weeks after treatment initiation.
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