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.
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.
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)
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).
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil
Investigator: Lucia Silla, Md, PhD
Contact: 555133598850
Lucia Silla, MD, PhD
55 51 33598371
lsilla@hcpa.edu.br
Annelise Pezzi, PhD
annepezzi@gmail.com
Lucia Silla, MD, PhD, Principal Investigator
Hospital de Clinicas de Porto Alegre