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Adoptive Cell Transfer for the Immunotherapy of COVID-19 in Colombia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344548
Recruitment Status : Withdrawn (The study did not get financed. Never get started.)
First Posted : April 14, 2020
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Fundación Salud de los Andes
Information provided by (Responsible Party):
Carlos Alberto Parra Lopez, Universidad Nacional de Colombia

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE March 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Adverse effects and Safety [ Time Frame: 3 months ]
Adverse effects monitoring during and after vaccination
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
NK transfer Immunogenicity [ Time Frame: 6 months ]
Measure of NK response against SARS-Cov2 virus
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adoptive Cell Transfer for the Immunotherapy of COVID-19 in Colombia
Official Title  ICMJE Phase I / II Clinical Study of Immunotherapy Based on Adoptive Cell Transfer as a Therapeutic Alternative for Patients With COVID-19 in Colombia
Brief Summary

Immunotherapy based on Adoptive Cellular Transfer (ACT) uses several types of immune cells, including dendritic cells, cytotoxic T lymphocytes, lymphokine-activated killer cells, and NK cells. NK cell-based immunotherapies are an attractive approach for treating diseases because of their characteristic recognition and killing mechanisms; they are involved in the early defense against infectious pathogens and against MHC class-I-negative or -low-expressing targets without the requirement for prior immune sensitization of the host and are able to lyse target through the release of perforin and granzymes and using antibody-dependent cellular cytotoxicity pathways mediated by Fc receptor for IgG (CD16).

The aim of this project is to evaluate the safety and immunogenicity of allogeneic NK cells from peripheral blood mononuclear cells (PBMCs) of healthy donors in patients infected with COVID-19 collected by apheresis. This allows us to collect cGMP PBMCs and immunomagnetic remove several types of undesirable cells including B, T and CD33+ cells with enrichment of NK cells that will be expanded in bioreactors with GMP culture media (AIM-V) supplemented with human AB serum and GMP grade IL-2, and IL-15. After quality control verification the final NK cell product will be resuspended in 300 mL saline solution for intravenous infusion. Initially, we will enroll in this study ten COVID-19 infected adult patients with moderate symptoms (NEWS 2 scale score>4). Consent forms will be signed by the patient before the therapy. Patients will be treated with three different infusions of NK cells 48 h apart with 1, 10, and 20 million cells/kg body weight. We will follow the patients for any adverse effect, clinical response and immune effects by flow cytometry including markers for NK cells expressing different markers (CD158b, NKG2A, and IFN-y). We anticipated that the release of IFN-y by exogenous NK cells could attract other immune cell populations to boost the immune response against COVID-19.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Phase I/II immunotherapy with NK cells for mild infected COVID-19 patients
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE Biological: Allogeneic NK transfer
Three doses of allogeneic NK cell transfer
Study Arms  ICMJE Experimental: Treatment group
Adult patients with COVID-19 infection with NEWS 2 score >4
Intervention: Biological: Allogeneic NK transfer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 29, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
10
Actual Study Completion Date  ICMJE October 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years at the time of the evaluation
  • Able and willing to understand the study, follow all study procedures, and provide written informed consent.
  • Initial diagnosis of COVID-19 disease as defined by a molecular diagnostic test approved by the National Institute of Health positive for SARS-CoV-2
  • Clinical presentation of moderate or severe (identified at the time of admission to the room by the National Early Warning Score NEWS-2; moderate >4)

Exclusion Criteria:

  • Patients who are hospitalized for inpatient treatment or are currently being evaluated for possible hospitalization at the time of informed consent initiation.
  • Oxygen saturation in ambient air of <92%
  • History of Chronic Obstructive Pulmonary Disease (COPD)
  • Participation in a clinical trial with or use of any investigational agent within 30 days prior to detection, or treatment with interferons (IFN) or immunomodulators within 12 months prior to detection
  • Pregnant or lactating female patients.
  • Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
  • Co-infected with the human immunodeficiency virus (HIV) or the hepatitis C virus (HCV)
  • Significant abnormal laboratory test results on screening.
  • Significant concurrent diseases and other comorbidities that may require intervention during the study.
  • Concurrent use of any of the following medications: Therapy with an immunomodulatory agent. Current use of heparin o Coumadin. Received blood products within 30 days prior to study randomization. Use of hematological growth factors within 30 days prior to the randomization of the study. Any recipe or herbal product that is not approved by the researcher. Long-term treatment (> 2 weeks) with agents that have a high risk of nephrotoxicity or hepatotoxicity unless approved by the medical monitor. Receiving systemic immunosuppressive therapy within 3 months prior to detection.
  • Considered by researchers to be unfit to participate in this clinical trial
  • Chronic heart failure with ejection fraction less than 30%.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04344548
Other Study ID Numbers  ICMJE UNAL FSA COVID
Estudio Clinico ( Other Identifier: Fundación Salud de los Andes-Universidad Nacional )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Carlos Alberto Parra Lopez, Universidad Nacional de Colombia
Original Responsible Party Carlos Alberto Parra Lopez, Universidad Nacional de Colombia, CARLOS A PARRA-LOPEZ
Current Study Sponsor  ICMJE Universidad Nacional de Colombia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fundación Salud de los Andes
Investigators  ICMJE Not Provided
PRS Account Universidad Nacional de Colombia
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP