Status:
UNKNOWN
Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19
Lead Sponsor:
Throne Biotechnologies Inc.
Conditions:
Severe Acute Respiratory Syndrome (SARS) Pneumonia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAR...
Detailed Description
This is a prospective, two-arm, partially masked, single center clinical study to assess the safety, feasibility, and efficacy of SCE therapy for the treatment of patients with SARS-CoV-2 infection. P...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04299152
Start Date
November 10 2021
End Date
June 10 2022
Last Update
June 30 2021
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