Fase I Clinical Trial on NK Cells for COVID-19

November 17, 2020 updated by: Hospital de Clinicas de Porto Alegre

Fase I Clinical Trial on Natural Killer Cells for COVID-19

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035903
        • Hospital de Clinicas de Porto Alegre
        • Contact:
          • Lucia Silla, Md, PhD
          • Phone Number: 555133598850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 30 days
Assessment of Overall survival at 30 days post intervention
30 days
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)
60 days
Hospital stay
Time Frame: 60 days
days of the patients in hospital
60 days
Oxygenation index (PaO2/FiO2)
Time Frame: 60 days
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
60 days
Improvement in Liao's score (2020)
Time Frame: 60 days
Improvement in Liao's score (2020)
60 days
Radiological improvement
Time Frame: 60 days
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Lucia Silla, MD, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 2, 2021

Primary Completion (Anticipated)

March 30, 2021

Study Completion (Anticipated)

March 30, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Natural Killer Cells infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe