COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04299152

Laura Zhao

connect@ThroneBio.com

2020-03-06

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: adult patients (18 years) must have a clinical diagnosis of sars-cov-2, with at least one of clinical symptoms (e.g., fever ≥38°c, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (rt-pcr) testing patients must not have received any antiviral treatments known to affect sars-cov-2 patients must agree that they are not permitted to use any other treatment to affect sars-cov-2 during a period of 6 months after undergoing sce therapy adequate venous access for apheresis ability to provide informed consent for female patients only, willingness to use fda-recommended birth control (http://www.fda.gov/downloads/forconsumers/byaudience/forwomen/freepublications/ucm356451.pdf) until 6 months post treatment. must agree to comply with all study requirements and be willing to complete all study visits

ast or alt 2 > x upper limit of normal. abnormal bilirubin (total bilirubin > 1.2 mg/dl, direct bilirubin > 0.4 mg/dl) creatinine > 2.0 mg/dl. known coronary artery disease or ekg suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist. known active infection such as hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers use of immunosuppressive medication within one month of enrollment including but not limited to cyclosporine, tacrolimus, sirolimus, and chemotherapy. anticoagulation other than asa. hemoglobin < 10 g/dl or platelets < 100 k/ml is unable or unwilling to provide informed consent presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation

2

Throne Biotechnologies Inc.

18

None

None

Severe disease at enrollment

6: Severe disease at enrollment

20

Determine the number of Covid-19 patients who were unable to complete SCE Therapy

None

Phase 2

[{"arm_notes": "", "treatment_id": 1239, "treatment_name": "Stem cell educator-treated mononuclear cells apheresis", "treatment_type": "Others non pharmacological treatment", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]