COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04797975

Sally Anne Jones

s.jones@kiadis.com

2021-03-15

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

Kiadis Pharma

18

70

None

Mild disease at enrollment

1: Mild disease at enrollment

0

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)

None

Phase 1/Phase 2

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