Novel Coronavirus PneumoniaPhase 1NCT04280224
NK Cells Treatment for COVID-19
A Phase 1 study testing NK Cells in people with Novel Coronavirus Pneumonia, run by Henan Medical University at 1 site in China.
Trial summary
Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Novel Coronavirus Pneumonia
- What is being tested?
- NK Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2020to 31 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female, aged at 18 years-65 years old
- 2. Pneumonia that is judged by chest radiograph or computed tomography
- 3. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source
Who cannot join
- 1. Pregnancy or breastfeeding
- 2. Known HIV, HBV or HCV infection
- 3. Patients with malignant tumor, other serious systemic diseases and psychosis
- 4. Patients who are participating in other clinical trials
- 5. Inability to provide informed consent or to comply with test requirements
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453000
About this study
Official title: Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
- Conditions
- Novel Coronavirus Pneumonia
- Being tested
- NK Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK CellsBiological
twice a week of NK cells (0.1-2*10E7 cells/kg body weight)
| Study group | Role | What they receive |
|---|---|---|
| NK Cells Treatment Group | Experimental | Conventional treatment plus NK cells. Participants will receive conventional treatment plus twice a week of NK cells (0.1-2*10E7 NK cells/kg body weight). Receives: Biological: NK Cells |
| Conventional Control Group | No intervention | Participants will only receive conventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical symptoms including duration of fever
Evaluation of pneumonia improvement
Measured: Measured from day 0 through day 28
Improvement of clinical symptoms including respiratory frequency
Evaluation of pneumonia improvement
Measured: Measured from day 0 through day 28
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
Safety evaluation
Measured: Measured from day 0 through day 28
Secondary outcomes (4)
Time of virus nucleic acid test negative
Marker for 2019-nCoV
Measured: Measured from day 0 through day 28
CD4+ and CD8+ T cell count
Marker of immunological function
Measured: Measured from day 0 through day 28
Rate of mortality within 28-days
Marker for efficacy of treatment
Measured: Day 28
Size of lesion area by thoracic imaging
Recovery of lung injury
Measured: Measured from day 0 through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start15 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel Coronavirus PneumoniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280224
- Sponsor's protocol ID
- NK-COVID19
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus
- ClinicalTrials.gov ID
- NCT04280224
- Acronym / sponsor ID
- NK-COVID19
- Conditions
- Novel Coronavirus Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Henan Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Feb 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.
Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NK Cells Treatment Group | Experimental | Biological: NK CellsConventional treatment plus NK cells. Participants will receive conventional treatment plus twice a week of NK cells (0.1-2*10E7 NK cells/kg body weight). |
| Conventional Control Group | No intervention | –Participants will only receive conventional treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Male or female, aged at 18 years-65 years old
- 2. Pneumonia that is judged by chest radiograph or computed tomography
- 3. Laboratory confirmation of NCP infection by reverse-transcription polymerase chain reaction(RT-PCR) from any diagnostic sampling source
Key exclusion criteria (5 listed)
- 1. Pregnancy or breastfeeding
- 2. Known HIV, HBV or HCV infection
- 3. Patients with malignant tumor, other serious systemic diseases and psychosis
- 4. Patients who are participating in other clinical trials
- 5. Inability to provide informed consent or to comply with test requirements
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 |
|---|---|---|
| NK Cellstwice a week of NK cells (0.1-2*10E7 cells/kg body weight) | Biological | NK Cells Treatment Group |
Primary outcome
Improvement of clinical symptoms including duration of fever
Time frame: Measured from day 0 through day 28
Evaluation of pneumonia improvement
Improvement of clinical symptoms including respiratory frequency
Time frame: Measured from day 0 through day 28
Evaluation of pneumonia improvement
Number of participants with treatment-related adverse events evaluated with CTCAE,version 4.0
Time frame: Measured from day 0 through day 28
Safety evaluation
4 secondary outcomes
Time of virus nucleic acid test negative
Time frame: Measured from day 0 through day 28
CD4+ and CD8+ T cell count
Time frame: Measured from day 0 through day 28
Rate of mortality within 28-days
Time frame: Day 28
Size of lesion area by thoracic imaging
Time frame: Measured from day 0 through day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NK Cells in people with Novel Coronavirus Pneumonia, run by Henan Medical University at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 8 Feb 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of clinical symptoms including duration of fever (time frame: Measured from day 0 through day 28). The study lists 3 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 8 Feb 2024.