Status:
WITHDRAWN
Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19
Lead Sponsor:
Kiadis Pharma
Conditions:
Covid19
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 i...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04797975
Start Date
December 1 2020
End Date
April 1 2021
Last Update
August 30 2021
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