Covid19 Clinical Trial
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
Verified date | March 2021 |
Source | Kiadis Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Patients are 18-70 years of age; 2. Patients must have at least one of the following risk factors for developing severe COVID-19 disease: 1. Age 50 to 70 years; 2. Obesity (body mass index (BMI) of 30 or greater); 3. Hypertension; 4. Current smoker; 5. Diabetes mellitus (Type 1 or type 2); 6. Stable cardiac disease. 3. Experiencing symptoms of mild to moderate COVID-19 not requiring supplemental oxygen; 4. Having confirmed infection with SARS-CoV-2, defined as detection of SARS-CoV-2 from nasopharyngeal swab or lower respiratory tract specimen; 5. Karnofsky Performance Score =70%; 6. Enrolled within the first 4 days of onset of symptoms; 7. 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; 8. Signed IRB approved informed consent. Exclusion Criteria: 1. Patient is at high-risk for severe COVID-19 due to co-morbidities defined as: 1. Underlying lung disease such as emphysema, chronic lung disease, COPD, asthma, chronic bronchiectasis or respiratory failure requiring baseline oxygen (O2) support; 2. Immunocompromised host status due to cancer, transplant, or other causes of immunodeficiency; 3. Immunosuppressive therapy, including but not limited to the following: - Corticosteroids (except topical corticosteroids); - Interleukin (IL)-6 or Tumor necrosis factor alpha (TNFa) blockade; - Other immunotherapies. 2. 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; 3. Patient has been admitted to the (ICU); 4. Patients with QT prolongation, history of "torsades de pointes" or ventricular arrhythmia (if they are scheduled to receive diphenhydramine); 5. 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; 6. Pregnant (positive pregnancy test) or breast-feeding female patients; 7. 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; 8. 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; 9. 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; 10. Vulnerable populations such as those currently incarcerated or homeless; 11. Any other condition which in the opinion of the investigator makes the patient ineligible for participation in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kiadis Pharma |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 28 Days | |
Secondary | 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. | 90 Days | |
Secondary | 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). | 28 days | |
Secondary | 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. | 90 Days |
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