Status:
WITHDRAWN
Adoptive Cell Transfer for the Immunotherapy of COVID-19 in Colombia
Lead Sponsor:
Universidad Nacional de Colombia
Collaborating Sponsors:
Fundación Salud de los Andes
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04344548
Start Date
March 30 2020
End Date
October 30 2020
Last Update
May 5 2021
Active Locations (2)
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1
Fundacion Salud De Los Andes
Bogotá, Bogotá Distrito Capital, Colombia, 111321
2
Universidad Nacional de Colombia
Bogota, Cundinamarca, Colombia, 111321