Fase I Clinical Trial on NK Cells for COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04634370
• Other study ID #: 20200210
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Lucia Silla, MD, PhD
• Phone: 55 51 33598371
• Email: lsilla[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Covid19
• Sars-cov 2

Intervention

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)

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

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