Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. severe type patients who comply with any of the following: * shortness of breath, rr ≥ 30 times/min; * in the resting state, the oxygen saturation is less than or equal to 93%; * arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × \[760/atmospheric pressure (mmhg)\]; * pulmonary imaging shows that patients with obvious lesion progression \> 50% within 24-48 hours. 2. critical type patients who comply with any of the following: * respiratory failure occurs and mechanical ventilation is required; * shock; * icu monitoring and treatment are required for other organ failure. 3. people who are known to be allergic to the test drug and its components; 4. people with inflammatory bowel disease, chronic diarrhea, malabsorption; 5. people with previous neuromuscular disease; 6. people with severe renal insufficiency (glomerular filtration rate \<30 ml/min/1.73m2); 7. people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; 8. patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); 9. people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; 10. people who test positive for anti-sars-cov-2 immunoglobulin g (igg); 11. people who have been vaccinated against covid-19; 12. any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; 13. suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); 14. suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; 15. pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; 16. people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; 17. participated in other clinical studies within 30 days before screening; 18. people who have other factors that the researcher believes are not suitable for inclusion.

1. severe type patients who comply with any of the following: * shortness of breath, rr ≥ 30 times/min; * in the resting state, the oxygen saturation is less than or equal to 93%; * arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × \[760/atmospheric pressure (mmhg)\]; * pulmonary imaging shows that patients with obvious lesion progression \> 50% within 24-48 hours. 2. critical type patients who comply with any of the following: * respiratory failure occurs and mechanical ventilation is required; * shock; * icu monitoring and treatment are required for other organ failure. 3. people who are known to be allergic to the test drug and its components; 4. people with inflammatory bowel disease, chronic diarrhea, malabsorption; 5. people with previous neuromuscular disease; 6. people with severe renal insufficiency (glomerular filtration rate \<30 ml/min/1.73m2); 7. people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; 8. patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); 9. people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; 10. people who test positive for anti-sars-cov-2 immunoglobulin g (igg); 11. people who have been vaccinated against covid-19; 12. any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; 13. suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); 14. suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; 15. pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; 16. people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; 17. participated in other clinical studies within 30 days before screening; 18. people who have other factors that the researcher believes are not suitable for inclusion.

Nov. 16, 2021, 6:30 p.m. usa

severe type patients who comply with any of the following: shortness of breath, rr ≥ 30 times/min; in the resting state, the oxygen saturation is less than or equal to 93%; arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × [760/atmospheric pressure (mmhg)]; pulmonary imaging shows that patients with obvious lesion progression > 50% within 24-48 hours. critical type patients who comply with any of the following: respiratory failure occurs and mechanical ventilation is required; shock; icu monitoring and treatment are required for other organ failure. people who are known to be allergic to the test drug and its components; people with inflammatory bowel disease, chronic diarrhea, malabsorption; people with previous neuromuscular disease; people with severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2); people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; people who test positive for anti-sars-cov-2 immunoglobulin g (igg); people who have been vaccinated against covid-19; any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; participated in other clinical studies within 30 days before screening; people who have other factors that the researcher believes are not suitable for inclusion.

severe type patients who comply with any of the following: shortness of breath, rr ≥ 30 times/min; in the resting state, the oxygen saturation is less than or equal to 93%; arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × [760/atmospheric pressure (mmhg)]; pulmonary imaging shows that patients with obvious lesion progression > 50% within 24-48 hours. critical type patients who comply with any of the following: respiratory failure occurs and mechanical ventilation is required; shock; icu monitoring and treatment are required for other organ failure. people who are known to be allergic to the test drug and its components; people with inflammatory bowel disease, chronic diarrhea, malabsorption; people with previous neuromuscular disease; people with severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2); people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; people who test positive for anti-sars-cov-2 immunoglobulin g (igg); people who have been vaccinated against covid-19; any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; participated in other clinical studies within 30 days before screening; people who have other factors that the researcher believes are not suitable for inclusion.

Sept. 11, 2021, 4 a.m. usa

1. severe type patients who comply with any of the following: - shortness of breath, rr ≥ 30 times/min; - in the resting state, the oxygen saturation is less than or equal to 93%; - arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × [760/atmospheric pressure (mmhg)]; - pulmonary imaging shows that patients with obvious lesion progression > 50% within 24-48 hours. 2. critical type patients who comply with any of the following: - respiratory failure occurs and mechanical ventilation is required; - shock; - icu monitoring and treatment are required for other organ failure. 3. people who are known to be allergic to the test drug and its components; 4. people with inflammatory bowel disease, chronic diarrhea, malabsorption; 5. people with previous neuromuscular disease; 6. people with severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2); 7. people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; 8. patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); 9. people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; 10. people who test positive for anti-sars-cov-2 immunoglobulin g (igg); 11. people who have been vaccinated against covid-19; 12. any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; 13. suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); 14. suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; 15. pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; 16. people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; 17. participated in other clinical studies within 30 days before screening; 18. people who have other factors that the researcher believes are not suitable for inclusion.

1. severe type patients who comply with any of the following: - shortness of breath, rr ≥ 30 times/min; - in the resting state, the oxygen saturation is less than or equal to 93%; - arterial oxygen partial pressure (pao2)/oxygen inhalation concentration (fio2) ≤ 300 mmhg (1mmhg=0.133kpa). note: at high altitudes (above 1000 m), pao2/fio2 shall be corrected according to the following formula: pao2/fio2 × [760/atmospheric pressure (mmhg)]; - pulmonary imaging shows that patients with obvious lesion progression > 50% within 24-48 hours. 2. critical type patients who comply with any of the following: - respiratory failure occurs and mechanical ventilation is required; - shock; - icu monitoring and treatment are required for other organ failure. 3. people who are known to be allergic to the test drug and its components; 4. people with inflammatory bowel disease, chronic diarrhea, malabsorption; 5. people with previous neuromuscular disease; 6. people with severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2); 7. people with medical history of liver cirrhosis, active chronic hepatitis, or severe liver disease with serum got or gpt 3 times higher than the normal upper limit; 8. patients who are taking colchicine or have a history of colchicine treatment (mainly chronic prescriptions for familial mediterranean fever or gout); 9. people who have used immunosuppressants, corticosteroids, interleukin-1 inhibitors, or interleukin-6 inhibitors within 30 days before screening; 10. people who test positive for anti-sars-cov-2 immunoglobulin g (igg); 11. people who have been vaccinated against covid-19; 12. any comorbidities that require surgery within 7 days before screening, or life-threatening comorbidities within 30 days before screening; 13. suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected); 14. suffering from any serious concomitant systemic disease, condition or disorder that the researcher believes should be prevented from participating in this study; 15. pregnant or lactating women who have a positive human chorionic gonadotropin (hcg) test; 16. people who have a fertility plan or do not consent to effective non-drug contraception during the signing of the icf to 6 months after the end of the trial; 17. participated in other clinical studies within 30 days before screening; 18. people who have other factors that the researcher believes are not suitable for inclusion.