- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797975
Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19
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
Study Overview
Detailed Description
Study Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: KDS-1000
NK cells expanded ex vivo using PM21 membrane particles:
|
Non-randomized part of study:
Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts):
|
PLACEBO_COMPARATOR: Control
0.9% Normal Saline
|
0.9% Normal Saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the efficacy KDS-1000 given at low and high doses compared to placebo by COVID-19 specific questionnaire.
Time Frame: 90 Days
|
Improvement in COVID-19 disease symptoms/progression of disease.
|
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
|
Determined by real time reverse transcription polymerase chain reaction (rRT-PCR).
|
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
|
Rate and severity of AE.
|
90 Days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNK-COV-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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