Fase I Clinical Trial on NK Cells for COVID-19

Overview

Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. This study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with COVID-19.

Full Title of Study: “Fase I Clinical Trial on Natural Killer Cells for COVID-19”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2021

Detailed Description

In March 2020, the World Health Organization secreted COVID-19 as a pandemic. Although most infected individuals can develop effective immunity, the population at risk (elderly, obese and individual with comorbidities) develop a rapid and frequently fatal disease, with severe acute respiratory syndrome, cytokine storm and coagulopathies; for those who recover, severe pulmonary sequels are frequently observed. We propose a phase I clinical trial to test safety and feasibility of NK cells adoptive immunotherapy for COVID-19. Natural Killer cells are innate granular lymphocytes able to rapidly recognize and kill, without previous exposition, altered cells; it is widely recognized as immune effectors specialized in lysing virus infected cells releasing antigens and activating cytokines to antigen presenting cells and, by doing so, stimulating effective adaptive immunity. We hypothesize that the early infusion of highly activated NK cells will activate adaptive immune effectors preventing the severe clinical evolution of COVID-19 infection. Adoptive NK cell immunotherapy for severe virus infections is innovative. Our proposition is in line with the Brazilian Public Health system purposes, which is to offer secure and effective therapies for all COVID-19 infected individuals. Upon proving NK cell immunotherapy effectiveness for serious virus infections, we can evolve to test this strategy for common viruses that cause epidemics and endemics such as the ones caused by Dengue, Zika, Chikungunya, C and B hepatitis and HIV.

Interventions

  • Biological: Natural Killer Cells infusion
    • Each patient will receive on dose of intravenous natural killer cell in following levels: Level 1 : 1×106 cells/kg body weight (patients 1 to 3) Level 2: 5×106 cells/kg body weight (patients 4 to 6) Level 3: 1×107 cells/kg body weight (patients 7 to 24)

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Each patient will receive on dose of intravenous natural killer cell in following levels: Level 1 : 1×106 cells/kg body weight (patients 1 to 3) Level 2: 5×106 cells/kg body weight (patients 4 to 6) Level 3: 1×107 cells/kg body weight (patients 7 to 24)

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival
    • Time Frame: 30 days
    • Assessment of Overall survival at 30 days post intervention
  • Changes on inflammatory C-reactive protein
    • Time Frame: 60 days
    • To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)
  • Hospital stay
    • Time Frame: 60 days
    • days of the patients in hospital
  • Oxygenation index (PaO2/FiO2)
    • Time Frame: 60 days
    • Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
  • Improvement in Liao’s score (2020)
    • Time Frame: 60 days
    • Improvement in Liao’s score (2020)
  • Radiological improvement
    • Time Frame: 60 days
    • Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19

Participating in This Clinical Trial

Inclusion Criteria

  • Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR); – The patient or legal donor agrees to participate in the study and signs the informed consent; – Patients with white or yellow criteria according to the score proposed by Liao et al (2020). Exclusion Criteria:

  • Patient with pregnancy, are planning to become pregnant or breastfeeding; – Patients with malignant blood-borne diseases such as HIV or syphilis; – Not consenting for clinical trial; – Patients with other than white or yellow criteria according to the score proposed by Liao et al (2020).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Clinicas de Porto Alegre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lucia Silla, MD, PhD, Principal Investigator, Hospital de Clinicas de Porto Alegre
  • Overall Contact(s)
    • Lucia Silla, MD, PhD, 55 51 33598371, lsilla@hcpa.edu.br

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