None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Dose: 1x10e7 cells/m2/dose (low dose) or 2x10e7 cells/m2/dose (high dose)
Number of doses: Maximum of two doses, two week interval
Administration period: Total o
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 19 years old or older 2) Those diagnosed with COVID-19 and have had a positive COVID-19 RT-PCR result from the date of first symptom onset or the date of first confirmation 21 days or oler 3) Among patients who meet the criteria of #2, those with severe immunosuppression 4) Among patients who satisfy the criteria of #2, patients who are refractory to standard of care (steroids, immunosuppresants, etc. depending on the severity of the disease) 5) Those who are expected to survive for more than three months 6) Patients who have voluntarily signed an informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients with the following severe symptoms (WHO ordinal scale of 7 or higher: -Those who needs invasive mechanical ventilation or extracorporeal membrane oxygen therapy (ECMO) - Acute respiratory distress syndrome (ARDS), shock, multiple organ failure 2) Uncontrolled lung disease other than COVID-19 pneumonia (e.g. chronic obstructive pulmonary disease, asthma, cystic lung disease, tuberculosis, etc.) 3) Pregnant women, lactating women or women of childbearing potential who have not taken appropriate contraceptive measures. 4) Patients with active infection or fever (=38?) of unknown etiology or those with ongoing bacterial or fungal infection 5) Patients under the age of 19 6) Previously proven HIV infection, uncontrolled hypertension (diastolic blood pressure > 115 mmHg), unstable angina, congestive heart failure (NY class II or higher), poorly controlled severe diabetes mellitus, coronary angioplasty within 6 months, patients with non-malignant disease including acute myocardial infarction or uncontrolled atrial or ventricular arrhythmias within the past 6 months 7) Patients with mental disorders, drug addiction, etc. who are judged to have an impact on the results of this study 8) Patients participating in other clinical studies (however, it may be subject to the clinical judgment of the researcher) 9) Patients who are judged to be inappropriate for the clinical research by the prinicipal investigator 10) Other serious medical conditions that may reduce complicance to the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of autologous COVID-19 specific T cell therapy;Clinical improvement rate of at least 1 point of WHO ordinal scale on week 4 following autologous COVID-19 specific T cell therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| SARs-CoV-2 viral load and seronegativity at week 4 from autologous COVID-19 specific T cell infusion;Time to clinical improvement and rate of clinical improvement at week 4 from autologous COVID-19 specific T cell infusion;Deterioration rate of clinical symptoms and signs at 4 weeks from COVID-19 specific T cell infusion | — |
Countries
Korea, Republic of
Contacts
Public ContactNayoun Kim
LucasBio
Outcome results
None listed