Other Clinical Trial - Adoptive Cell Transfer for the Immunotherapy of

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

COVID

Clinical Trial Details

NCT number	NCT04344548
Study type	Interventional
Source	Universidad Nacional de Colombia
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	March 30, 2020
Completion date	October 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04558125` - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism	Phase 4
Recruiting	`NCT04410510` - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19	Phase 2/Phase 3
Active, not recruiting	`NCT04420676` - Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection	N/A
Completed	`NCT04419025` - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease	Phase 2
Completed	`NCT04395911` - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections	N/A
Completed	`NCT04425317` - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients	N/A
Withdrawn	`NCT04456426` - Characteristics of Patients With COVID-19 in Meta State, Colombia
Completed	`NCT04526769` - Detecting SARS-CoV-2 in Tears
Completed	`NCT04425720` - Use of Remote Monitoring for COVID-19 Patient	N/A
Suspended	`NCT04385771` - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation	N/A
Completed	`NCT04419610` - RAS and Coagulopathy in COVID19	Early Phase 1
Completed	`NCT04546581` - Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)	Phase 3
Completed	`NCT04435327` - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Terminated	`NCT04530448` - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization	Phase 4
Not yet recruiting	`NCT04524156` - COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2	N/A
Completed	`NCT04441710` - Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
Completed	`NCT04357834` - WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Not yet recruiting	`NCT04392427` - New Antiviral Drugs for Treatment of COVID-19	Phase 3
Terminated	`NCT04614025` - Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19	Phase 2
Completed	`NCT04402957` - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms