Covid19Phase 1/2NCT04797975
Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19
A Phase 1/2 study testing KDS-1000 in people with Covid19, run by Kiadis Pharma.
Trial summary
It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- KDS-1000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Apr 2021
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18-70 years of age;
- Patients must have at least one of the following risk factors for developing severe COVID-19 disease:
- Age 50 to 70 years;
- Obesity (body mass index (BMI) of 30 or greater);
- Hypertension;
- Current smoker;
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- Diabetes mellitus (Type 1 or type 2);
- Stable cardiac disease.
- Experiencing symptoms of mild to moderate COVID-19 not requiring supplemental oxygen;
- Having confirmed infection with SARS-CoV-2, defined as detection of SARS-CoV-2 from nasopharyngeal swab or lower respiratory tract specimen;
- Karnofsky Performance Score ≥70%;
- Enrolled within the first 4 days of onset of symptoms;
- Able and willing to comply with the protocol for duration of the study, including 24 hour hospitalization for study drug administration and monitoring, and compliance with follow-up visit schedule;
- Signed IRB approved informed consent.
Who cannot join
- Patient is at high-risk for severe COVID-19 due to co-morbidities defined as:
- Underlying lung disease such as emphysema, chronic lung disease, COPD, asthma, chronic bronchiectasis or respiratory failure requiring baseline oxygen (O2) support;
- Immunocompromised host status due to cancer, transplant, or other causes of immunodeficiency;
- Immunosuppressive therapy, including but not limited to the following:
- Corticosteroids (except topical corticosteroids);
- Interleukin (IL)-6 or Tumor necrosis factor alpha (TNFα) blockade;
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- Other immunotherapies.
- Patient with the following signs of abnormal organ or bone marrow function as defined below:
- AST(SGOT) and/or ALT(SGPT) > 3 x upper limit of normal (ULN);
- Serum (total) bilirubin > 1.5 x ULN;
- Creatinine Clearance ≤ 30 mL/min (by Modification of Diet in Renal Disease (MDRD) formula);
- Hemoglobin < 9 g/dL;
- Thrombocytes ≤ 75.000/uL;
- Absolute neutrophil count (ANC) ≤ 1.500/uL;
- Prothrombin time (PT) or activated partial thromboplastin (aPTT) time >1.5 × ULN;
- Patient has been admitted to the (ICU);
- Patients with QT prolongation, history of "torsades de pointes" or ventricular arrhythmia (if they are scheduled to receive diphenhydramine);
- Patient with a known history of allergic reactions to any constituent of the product, including a known history of allergic reactions to cellular products or DMSO;
- Pregnant (positive pregnancy test) or breast-feeding female patients;
- Women of childbearing potential who are sexually active and men who have sexual contact with a female of childbearing potential: not willing to use reliable methods of contraception (oral contraceptives, intrauterine device, hormone implants, contraceptive injection or abstinence) up to 90 days post injection of study medication;
- Participation in other COVID-19 studies involving experimental treatments or vaccines for COVID-19. Participation in other observational studies could be allowed if they do not interfere with protocol compliance or blood draws;
- Patients with a history or current evidence of alcohol or drug abuse or dependence, or recreational use of illicit drugs including use of medical marijuana;
- Vulnerable populations such as those currently incarcerated or homeless;
- Any other condition which in the opinion of the investigator makes the patient ineligible for participation in the study.
About this study
Official title: A Phase 1/2a Multicenter Randomized Double-blind Placebo-controlled Trial of Off-the-shelf Natural Killer Cells (KDS-1000) as Immunotherapy for Adult Patients With Mild to Moderate COVID-19 Symptoms at Risk for Complications
It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival.
Read the detailed description
Several publications have suggested a potential role of NK cells, an essential part of the early innate response system, in the management of viral infections like COVID-19. Clinical data has shown that COVID-19 disease severity is correlated with a reduction in the number of NK cells, exhaustion of NK cells and the lack of certain mature, potent NK cell phenotypes. The power of NK cells to fight various other viral infections, such as caused by CMV, HBV and hepatitis C virus (HCV), influenza virus and human immunodeficiency virus (HIV) have been well described, with a durable change in the NK cell profile towards those more mature and potent phenotypes in recovered patients. In view of the lack of (functional) NK cells in patients with COVID-19, adoptive NK cell therapy with KDS-1000 cells may improve survival and reduce rates of disease progression from SARS-CoV-2 infection. Adoptive transfer of expanded NK cells (KDS-1000) early in the course of disease may augment innate immunity, thereby limiting disease progression and could confer a survival benefit to patients infected with SARS-CoV-2.
- Conditions
- Covid19
- Being tested
- KDS-1000, Placebo
- Keywords
- Cell Therapy, COVID-19, Natural Killer Cells, NK Cells, Off-the-shelf
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDS-1000Biological
Non-randomized part of study:
- At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals.
Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts):
- Cohort 1: Low Dose, 2x10E8 cells/dose
- Cohort 2: High Dose, 1x10E9 cells/dose
PlaceboOther
0.9% Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| KDS-1000 | Experimental | NK cells expanded ex vivo using PM21 membrane particles: Receives: Biological: KDS-1000 |
| Control | Placebo comparator | 0.9% Normal Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of adverse events (AE)
Rate and severity of AE.
Measured: 28 Days
Secondary outcomes (3)
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by COVID-19 specific questionnaire.
Improvement in COVID-19 disease symptoms/progression of disease.
Measured: 90 Days
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by measurement of SARS-CoV-2 clearance.
Determined by real time reverse transcription polymerase chain reaction (rRT-PCR).
Measured: 28 days
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of AE.
Rate and severity of AE.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study startDec 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: The sponsor decided to withdraw this study
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiadis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797975
- Sponsor's protocol ID
- KNK-COV-001
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Multicenter Randomized Double-blind Placebo-controlled Trial of Off-the-shelf Natural Killer Cells (KDS-1000) as Immunotherapy for Adult Patients With Mild to Moderate COVID-19 Symptoms at Risk for Complications
- ClinicalTrials.gov ID
- NCT04797975
- Acronym / sponsor ID
- KNK-COV-001
- Conditions
- Covid19
- Keywords
- Cell Therapy, COVID-19, Natural Killer Cells, NK Cells, Off-the-shelf
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor decided to withdraw this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kiadis PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 15 Mar 2021 (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.
It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival.
Detailed description
Several publications have suggested a potential role of NK cells, an essential part of the early innate response system, in the management of viral infections like COVID-19. Clinical data has shown that COVID-19 disease severity is correlated with a reduction in the number of NK cells, exhaustion of NK cells and the lack of certain mature, potent NK cell phenotypes. The power of NK cells to fight various other viral infections, such as caused by CMV, HBV and hepatitis C virus (HCV), influenza virus and human immunodeficiency virus (HIV) have been well described, with a durable change in the NK cell profile towards those more mature and potent phenotypes in recovered patients. In view of the lack of (functional) NK cells in patients with COVID-19, adoptive NK cell therapy with KDS-1000 cells may improve survival and reduce rates of disease progression from SARS-CoV-2 infection. Adoptive transfer of expanded NK cells (KDS-1000) early in the course of disease may augment innate immunity, thereby limiting disease progression and could confer a survival benefit to patients infected with SARS-CoV-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KDS-1000 | Experimental | Biological: KDS-1000NK cells expanded ex vivo using PM21 membrane particles: |
| Control | Placebo comparator | Other: Placebo0.9% Normal Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients are 18-70 years of age;
- Patients must have at least one of the following risk factors for developing severe COVID-19 disease:
- Experiencing symptoms of mild to moderate COVID-19 not requiring supplemental oxygen;
- Having confirmed infection with SARS-CoV-2, defined as detection of SARS-CoV-2 from nasopharyngeal swab or lower respiratory tract specimen;
- Karnofsky Performance Score ≥70%;
Key exclusion criteria (24 listed)
- Patient is at high-risk for severe COVID-19 due to co-morbidities defined as:
- Patient with the following signs of abnormal organ or bone marrow function as defined below:
- Patient has been admitted to the (ICU);
- Patients with QT prolongation, history of "torsades de pointes" or ventricular arrhythmia (if they are scheduled to receive diphenhydramine);
- Patient with a known history of allergic reactions to any constituent of the product, including a known history of allergic reactions to cellular products or DMSO;
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 |
|---|---|---|
| KDS-1000Non-randomized part of study: * At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals. Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts): * Cohort 1: Low Dose, 2x10E8 cells/dose * Cohort 2: High Dose, 1x10E9 cells/dose | Biological | KDS-1000 |
| Placebo0.9% Normal Saline | Other | Control |
Primary outcome
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of adverse events (AE)
Time frame: 28 Days
Rate and severity of AE.
3 secondary outcomes
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by COVID-19 specific questionnaire.
Time frame: 90 Days
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by measurement of SARS-CoV-2 clearance.
Time frame: 28 days
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of AE.
Time frame: 90 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KDS-1000 in people with Covid19, run by Kiadis Pharma.
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 14 inclusion and 24 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: withdrawn, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of adverse events (AE) (time frame: 28 Days). 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 30 Aug 2021.