Fase I Clinical Trial on NK Cells for COVID-19
- Conditions
- Sars-cov 2Covid19
- Interventions
- Biological: Natural Killer Cells infusion
- Registration Number
- NCT04634370
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention 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)
- Primary Outcome Measures
Name Time Method Improvement in Liao's score (2020) 60 days Improvement in Liao's score (2020)
Hospital stay 60 days days of the patients in hospital
Changes on inflammatory C-reactive protein 60 days To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)
Oxygenation index (PaO2/FiO2) 60 days Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
Overall survival 30 days Assessment of Overall survival at 30 days post intervention
Radiological improvement 60 days Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil