Covid19Phase 1NCT04634370
Fase I Clinical Trial on NK Cells for COVID-19
A Phase 1 study testing Natural Killer Cells infusion in people with Covid19 and Sars-cov 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Sars-cov 2
- What is being tested?
- Natural Killer Cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2021to 30 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Annelise Pezzi, PhD contact
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Lucia Silla, Md, PhD, 555133598850
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Sars-cov 2
- Being tested
- Natural Killer Cells infusion
- Keywords
- Natural Killer Cells, COVID-19, Sars-CoV2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Killer Cells infusionBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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) Receives: Biological: Natural Killer Cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Assessment of Overall survival at 30 days post intervention
Measured: 30 days
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)
Measured: 60 days
Hospital stay
days of the patients in hospital
Measured: 60 days
Oxygenation index (PaO2/FiO2)
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
Measured: 60 days
Improvement in Liao's score (2020)
Improvement in Liao's score (2020)
Measured: 60 days
Radiological improvement
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start2 Jan 2021 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Silla, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634370
- Sponsor's protocol ID
- 20200210
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fase I Clinical Trial on Natural Killer Cells for COVID-19
- ClinicalTrials.gov ID
- NCT04634370
- Acronym / sponsor ID
- 20200210
- Conditions
- Covid19, Sars-cov 2
- Keywords
- Natural Killer Cells, COVID-19, Sars-CoV2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 2 Jan 2021 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: Natural Killer Cells infusionEach 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Killer Cells infusionEach 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 | Intervention |
Primary outcome
Overall survival
Time frame: 30 days
Assessment of Overall survival at 30 days post intervention
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)
Hospital stay
Time frame: 60 days
days of the patients in hospital
Oxygenation index (PaO2/FiO2)
Time frame: 60 days
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
Improvement in Liao's score (2020)
Time frame: 60 days
Improvement in Liao's score (2020)
Radiological improvement
Time frame: 60 days
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annelise Pezzi, PhD contact
Lucia Silla, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Natural Killer Cells infusion in people with Covid19 and Sars-cov 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Silla, MD, PhD (55 51 33598371, lsilla@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.