Fase I Clinical Trial on NK Cells for COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Overall survival [30 days]
Assessment of Overall survival at 30 days post intervention
- 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)
- Hospital stay [60 days]
days of the patients in hospital
- Oxygenation index (PaO2/FiO2) [60 days]
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
- Improvement in Liao's score (2020) [60 days]
Improvement in Liao's score (2020)
- Radiological improvement [60 days]
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
Eligibility Criteria
Criteria
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;
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Patients with white or yellow criteria according to the score proposed by Liao et al (2020).
Exclusion Criteria:
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Patient with pregnancy, are planning to become pregnant or breastfeeding;
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Patients with malignant blood-borne diseases such as HIV or syphilis;
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Not consenting for clinical trial;
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Patients with other than white or yellow criteria according to the score proposed by Liao et al (2020).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Clinicas de Porto Alegre | Porto Alegre | RS | Brazil | 90035903 |
Sponsors and Collaborators
- Hospital de Clinicas de Porto Alegre
Investigators
- Principal Investigator: Lucia Silla, MD, PhD, Hospital de Clinicas de Porto Alegre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20200210