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Fase I Clinical Trial on NK Cells for COVID-19

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ClinicalTrials.gov Identifier: NCT04634370
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Covid19 Sars-cov 2 Biological: Natural Killer Cells infusion Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fase I Clinical Trial on Natural Killer Cells for COVID-19
Estimated Study Start Date : January 2, 2021
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Arm Intervention/treatment
Experimental: Intervention

Each patient will receive on dose of intravenous natural killer cell in following levels:

Level 1 : 1x106 cells/kg body weight (patients 1 to 3) Level 2: 5x106 cells/kg body weight (patients 4 to 6) Level 3: 1x107 cells/kg body weight (patients 7 to 24)

Biological: Natural Killer Cells infusion

Each patient will receive on dose of intravenous natural killer cell in following levels:

Level 1 : 1x106 cells/kg body weight (patients 1 to 3) Level 2: 5x106 cells/kg body weight (patients 4 to 6) Level 3: 1x107 cells/kg body weight (patients 7 to 24)





Primary Outcome Measures :
  1. Overall survival [ Time Frame: 30 days ]
    Assessment of Overall survival at 30 days post intervention

  2. 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)

  3. Hospital stay [ Time Frame: 60 days ]
    days of the patients in hospital

  4. Oxygenation index (PaO2/FiO2) [ Time Frame: 60 days ]
    Evaluation of functional respiratory changes: PaO2 / FiO2 ratio

  5. Improvement in Liao's score (2020) [ Time Frame: 60 days ]
    Improvement in Liao's score (2020)

  6. Radiological improvement [ Time Frame: 60 days ]
    Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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): NCT04634370


Contacts
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Contact: Lucia Silla, MD, PhD 55 51 33598371 lsilla@hcpa.edu.br
Contact: Annelise Pezzi, PhD annepezzi@gmail.com

Locations
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Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035903
Contact: Lucia Silla, Md, PhD    555133598850      
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Lucia Silla, MD, PhD Hospital de Clinicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04634370    
Other Study ID Numbers: 20200210
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Natural Killer Cells
COVID-19
Sars-CoV2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases