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Fase I Clinical Trial on NK Cells for COVID-19

NCT ID: NCT04634370

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2021-03-30

Brief Summary

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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

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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.

Conditions

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Covid19 Sars-cov 2

Keywords

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Natural Killer Cells COVID-19 Sars-CoV2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Natural Killer Cells infusion

Intervention Type BIOLOGICAL

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)

Interventions

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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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucia Silla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Lucia Silla, MD, PhD

Role: CONTACT

Phone: 55 51 33598371

Email: [email protected]

Annelise Pezzi, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Lucia Silla, Md, PhD

Role: primary

Other Identifiers

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20200210

Identifier Type: -

Identifier Source: org_study_id