Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04765449|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : July 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Cytotoxic T Lymphocytes||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Third-Party COVID-19-Specific Cytotoxic T Lymphocytes for the Treatment of Elderly and High-Risk Patients With COVID-19 Infection|
|Estimated Study Start Date :||July 19, 2021|
|Estimated Primary Completion Date :||July 29, 2022|
|Estimated Study Completion Date :||July 29, 2022|
Experimental: ARM A: Covid-19 Patients Receiving CTLs
Patients who have an HLA antigen in common with COVID-19 fighting T cells will be admitted to the hospital and receive the COVID-19 T cells. They will be premedicated with diphenhydramine and acetaminophen before the cells are infused intravenously. The patients will be monitored for side effects for at least 4 days prior to discharge. Close monitoring will continue in the patients' homes for 14 days. Three to six patients will receive a specific dose of T cells, and then if there are no serious side effects, the dose will be increased for the next group of patients. There are 4 doses of T cells to be tested, and each patient will complete a 14 day monitoring period before the next patient can be treated.
Drug: Cytotoxic T Lymphocytes
Given IV. Cytotoxic T Lymphocytes collected from healthy volunteer donors who have recovered from COVID-19. The T cells are collected, manufactured to be COVID-specific, and stored frozen at Thomas Jefferson University.
Other Name: CTLs
No Intervention: ARM B: Covid-19 Patients Not Receiving CTLs
Patients in the observation arm will not have inherited an HLA antigen in common with the COVID-19 T cells and so cannot receive the T cells. They will be monitored by the study staff for the 14 day monitoring period in their homes. They will be taught to record their own blood pressure, temperature, and oxygen level (pulse oximetry) at home and report this information, as well as their progress in getting over the COVID-19 infection, to the study staff every day by phone. The outcomes of patients on arm B will be compared to the outcomes of patients treated on Arm A to see if the T cells made a difference in how patients recovered from COVID-19. Patients in Arm B are not prevented from being treated with any available COVID-19 therapy.
- Safety of COVID-19-specific CTLs: Infusion Reactions [ Time Frame: Within 48 Hours of CTL Infusion ]Safety will be measured by the absence of: Grade ≥ 3 acute infusion reactions
- Safety of COVID-19-specific CTLs: Grade 4 AEs [ Time Frame: Within 14 days of CTL infusion ]Safety will be measured by the absence of: Any grade 4 or higher adverse event thought to be related to the CTL therapy and outside the spectrum of identified COVID related events.
- Safety of COVID-19-specific CTLs: GVHD [ Time Frame: Within 14 days of CTL infusion ]Safety will be measured by the absence of: Any manifestation of acute GVHD (for acute grades 2-4 GVHD-Glucksberg criteria) 53 resistant to 2 mg/kg of solumedrol or equivalent
- Safety of COVID-19-specific CTLs: Marrow Aplasia [ Time Frame: Within 14 days of CTL infusion ]Safety will be measured by the absence of: Marrow aplasia due to 3rd party engraftment
- Safety of COVID-19-specific CTLs: Neurotoxicty [ Time Frame: Within 14 days of CTL infusion ]Safety will be measured by the absence of: Grade ≥ 2+ Neurotoxicity as measured by the ASTCT/ICANS consensus grading system
- Safety of COVID-19-specific CTLs: CRS [ Time Frame: Within 14 days of CTL infusion ]Safety will be measured by the absence of: Grade ≥ 2+ CRS as measured by the ASTCT Consensus Grading Criteria for CRS
- Measurement of COVID-19 viral load [ Time Frame: Up to 14 Days ]Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
- Studies to detect the persistence of the COVID-19-specific T cells after COVID-19 T cell infusion [ Time Frame: Up to 6 months ]Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
- Studies to examine the development of endogenous COVID-19 specific T cells [ Time Frame: Up to 6 months ]Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
- Studies to examine the development of anti-COVID-19 antibodies [ Time Frame: Up to 6 months ]Patients will have blood drawn, nasal (not nasopharyngeal) specimens collected
- Review of medical history including the need for supplemental oxygen, the ability to return to work, performance status, grade of dyspnea, grade of fatigue, survival, the need for blood pressure support [ Time Frame: Up to 6 months ]Patients will have their medical course followed by the study team
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765449
|Contact: Dolores Grosso, DNP||215-955-8874||Dolores.Grosso@jefferson.edu|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|