Created at Source Raw Value Validated value
March 6, 2021, 1:30 a.m. eu

1. Clinical signs of critical status: a) SpO2  90%, while oxygen supply with FiO2 > 100% b) PaO2/FiO2  200 mmHg c) Respiratory failure which requiring mechanical ventilation d) Shock e) Combined with organ failure other than lung, need to be admitted to ICU 2. Known sensitivity/allergy to azacitidine or other class effect pyrimidine nucleoside analogues, or hypersensitivity to any of the excipients listed. 3. Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) /alkaline phosphatase (ALP) ≥ 3x upper limit of normal (ULN) and Total Bilirubin (TBILI) ≥2x ULN, or Creatinine clearance <30 mL/min. 4. Neutrophil count (ANC) below 1500/mcl, 5. Haemoglobin (Hgb)<7.0 mmol/L 6. Platelet count below 100,000/mcl 7. Advanced malignant hepatic tumors / patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. 8. Cardial disorders by Echocardiography or by medical history (arrhythmia, atrialfibrillation or fluttern, sick sinus syndrome (SSS) ventricular arrhythmia, coronary disorders, AMI, EF 50% or valve disorders (excl. mitralis prolapsus). Severe heart failure/ with a history of severe congestive heart failure, (NYHA III-IV, or NYHA IV) 9. Severe chronic renal disorder, or renal impairment requiring dialysis (eGFR<30) 10. Ongoing/suspected sever bacterial infection 11. Acute cerebrovascular disease within 3 months prior to enrolment 12. Pregnancy or breast-feeding (latter can be stopped) 13. Has received other immunomodulatory drug in the past for the treatment of other medical conditions 14. Previously diagnosed with HIV (HIV-Ab test positive) or anti-HCV antibodies positive 15. Obesity of 35 BMI or above 16. Uncontrolled hypertension (RR >170/100 Hgmm) or above. 17. Dementia, or inability to give informed consent 18. Any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participates in the study. 19. Use of concomitant medication: - Drugs with reported antiviral activity against SARS-CoV-2 included hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, etc. at baseline or within 7 days prior randomization unless a part of standard of care. With the exception of prior or ongoing treatment with antivirals of favipiravir, remdesivir (or generics of these products) are allowed. - Concurrent immunomodulating biologics or use of Palifermin, Dipyrone, Deferiprone, interferon-alpha. 20. Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision 21. Any medical condition, per opinion of PI that would affect subject safety and/or compliance

1. Clinical signs of critical status: a) SpO2  90%, while oxygen supply with FiO2 > 100% b) PaO2/FiO2  200 mmHg c) Respiratory failure which requiring mechanical ventilation d) Shock e) Combined with organ failure other than lung, need to be admitted to ICU 2. Known sensitivity/allergy to azacitidine or other class effect pyrimidine nucleoside analogues, or hypersensitivity to any of the excipients listed. 3. Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) /alkaline phosphatase (ALP) ≥ 3x upper limit of normal (ULN) and Total Bilirubin (TBILI) ≥2x ULN, or Creatinine clearance <30 mL/min. 4. Neutrophil count (ANC) below 1500/mcl, 5. Haemoglobin (Hgb)<7.0 mmol/L 6. Platelet count below 100,000/mcl 7. Advanced malignant hepatic tumors / patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. 8. Cardial disorders by Echocardiography or by medical history (arrhythmia, atrialfibrillation or fluttern, sick sinus syndrome (SSS) ventricular arrhythmia, coronary disorders, AMI, EF 50% or valve disorders (excl. mitralis prolapsus). Severe heart failure/ with a history of severe congestive heart failure, (NYHA III-IV, or NYHA IV) 9. Severe chronic renal disorder, or renal impairment requiring dialysis (eGFR<30) 10. Ongoing/suspected sever bacterial infection 11. Acute cerebrovascular disease within 3 months prior to enrolment 12. Pregnancy or breast-feeding (latter can be stopped) 13. Has received other immunomodulatory drug in the past for the treatment of other medical conditions 14. Previously diagnosed with HIV (HIV-Ab test positive) or anti-HCV antibodies positive 15. Obesity of 35 BMI or above 16. Uncontrolled hypertension (RR >170/100 Hgmm) or above. 17. Dementia, or inability to give informed consent 18. Any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participates in the study. 19. Use of concomitant medication: - Drugs with reported antiviral activity against SARS-CoV-2 included hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, etc. at baseline or within 7 days prior randomization unless a part of standard of care. With the exception of prior or ongoing treatment with antivirals of favipiravir, remdesivir (or generics of these products) are allowed. - Concurrent immunomodulating biologics or use of Palifermin, Dipyrone, Deferiprone, interferon-alpha. 20. Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision 21. Any medical condition, per opinion of PI that would affect subject safety and/or compliance