Fase I Clinical Trial on NK Cells for COVID-19
Primary Purpose
Covid19, Sars-cov 2
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Natural Killer Cells infusion
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Natural Killer Cells, COVID-19, Sars-CoV2
Eligibility 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).
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
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)
Outcomes
Primary Outcome Measures
Overall survival
Assessment of Overall survival at 30 days post intervention
Changes on inflammatory C-reactive protein
To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)
Hospital stay
days of the patients in hospital
Oxygenation index (PaO2/FiO2)
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
Improvement in Liao's score (2020)
Improvement in Liao's score (2020)
Radiological improvement
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
Secondary Outcome Measures
Full Information
NCT ID
NCT04634370
First Posted
November 16, 2020
Last Updated
November 17, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT04634370
Brief Title
Fase I Clinical Trial on NK Cells for COVID-19
Official Title
Fase I Clinical Trial on Natural Killer Cells for COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2021 (Anticipated)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Sars-cov 2
Keywords
Natural Killer Cells, COVID-19, Sars-CoV2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
Natural Killer Cells infusion
Intervention Description
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 Measure Information:
Title
Overall survival
Description
Assessment of Overall survival at 30 days post intervention
Time Frame
30 days
Title
Changes on inflammatory C-reactive protein
Description
To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)
Time Frame
60 days
Title
Hospital stay
Description
days of the patients in hospital
Time Frame
60 days
Title
Oxygenation index (PaO2/FiO2)
Description
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
Time Frame
60 days
Title
Improvement in Liao's score (2020)
Description
Improvement in Liao's score (2020)
Time Frame
60 days
Title
Radiological improvement
Description
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Silla, MD, PhD
Phone
55 51 33598371
Email
lsilla@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Annelise Pezzi, PhD
Email
annepezzi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Silla, MD, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Silla, Md, PhD
Phone
555133598850
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fase I Clinical Trial on NK Cells for COVID-19
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