Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS

Exclusion Criteria

• •1. Patients with a history of transplantation of cells or organ(s).
• •2. Patients with a history of malignancy or pathology indicating severe atypical hyperplasia.
• •3. Patients without life expectancy of 48 hours.
• •4. Patients with moderate to severe liver failure (Childs Pugh scores \> 12).
• •5. Patients with cardiogenic pulmonary edema.
• •6. Patients with a history of deep vein thrombosis or pulmonary embolism within 3 months before the screening.
• •7. Patients with severe chronic pulmonary diseases, including but not restricted to the patients with WHO grade III or IV pulmonary hypertension or those with chronic pulmonary diseases requiring long-term oxygen therapy.
• •8. Patients with unstable ventricular tachycardia or ventricular fibrillation.
• •9. Patients with poor coagulation, severe bleeding tendency or active bleeding at present.
• •10. Patients with serious dysfunction involved in the major organs or systems (liver, kidney, gastrointestinal, cardiovascular, blood coagulation, central system, etc.) besides the respiratory system are not suitable to participate in the present study.
• •11. Patients with a history of severe conditions in any organs or systems.
• •12. Patients who are unable to accept other invasive rescue except cardiopulmonary resuscitation.
• •13. Patients who are allergic to the main active ingredients or excipients of the investigational drug.
• •14. Women who are pregnant, breastfeeding or planning to become pregnant during the study period. Woman of childbearing age who is not willing to use appropriate contraceptive methods through the completion of the clinical study.
• •15. Patients whose participation is considered to bring significant risks to the present clinical study, cause confusion in analysis, or significantly interfere with the clinical research results.