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

1. severe covid-19 patients who meet any of the following: * shortness of breath, respiratory rate ≥ 30 times/min; * in resting state, blood oxygen saturation (spo2) ≤ 93% when inhaling air; * arterial blood oxygen partial pressure pao2/inhaled oxygen concentration (fio2)≤300mmhg (1mmhg=0.133kpa); note: for areas with high altitude (over 1000 meters above sea level), the following formula should be used to correct pao2/fio2: pao2/fio2×\[760/air pressure (mmhg)\]; * the clinical symptoms are progressively worsened, and lung imaging shows that the lesion progresses significantly within 24 to 48 hours by \>50%; 2. critically ill patients with covid-19 who meet any of the following: * respiratory failure occurs and requires mechanical ventilation; * shock occurs; * complicated with other organ failure requires icu monitoring and treatment; 3. those who are known to be allergic to the test drug and its components; 4. hemodynamic instability within 24 hours before treatment allocation requires the use of vasopressors; 5. suspected or confirmed serious, active bacterial, fungal, viral or other infections (except for covid-19) that the investigator believes may pose a risk when taking interventions; 6. any comorbidities requiring surgery within 7 days prior to screening, or comorbidities deemed life-threatening within 29 days prior to screening; 7. any serious concomitant systemic disease, condition or disorder that the investigator believes should be prevented from participating in this study; 8. patients with positive anti-sars-cov-2 immunoglobulin g (igg) and igg\>10; 9. patients with malignant tumors who are undergoing chemotherapy and radiotherapy before and after surgery; 10. those who have received sars-cov-2 specific immunoglobulin (including monoclonal antibody) therapy; 11. those who have completed the vaccination against covid-19 within 1 month; 12. those who have a history of receiving convalescent covid-19 plasma treatment; 13. received any study treatment for covid-19 within 30 days prior to administration, including but not limited to antiviral drugs, corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulin; 14. participated in clinical trials of other drugs within 3 months before screening; 15. those who are dizzy with acupuncture and blood; 16. within 4 months after signing the icf to the end of the trial, those who have a childbearing plan or who do not agree to take effective non-drug contraceptive measures during this period; 17. pregnant and lactating women; 18. other factors considered by the investigator to be inappropriate for entry into this trial.

1. severe covid-19 patients who meet any of the following: * shortness of breath, respiratory rate ≥ 30 times/min; * in resting state, blood oxygen saturation (spo2) ≤ 93% when inhaling air; * arterial blood oxygen partial pressure pao2/inhaled oxygen concentration (fio2)≤300mmhg (1mmhg=0.133kpa); note: for areas with high altitude (over 1000 meters above sea level), the following formula should be used to correct pao2/fio2: pao2/fio2×\[760/air pressure (mmhg)\]; * the clinical symptoms are progressively worsened, and lung imaging shows that the lesion progresses significantly within 24 to 48 hours by \>50%; 2. critically ill patients with covid-19 who meet any of the following: * respiratory failure occurs and requires mechanical ventilation; * shock occurs; * complicated with other organ failure requires icu monitoring and treatment; 3. those who are known to be allergic to the test drug and its components; 4. hemodynamic instability within 24 hours before treatment allocation requires the use of vasopressors; 5. suspected or confirmed serious, active bacterial, fungal, viral or other infections (except for covid-19) that the investigator believes may pose a risk when taking interventions; 6. any comorbidities requiring surgery within 7 days prior to screening, or comorbidities deemed life-threatening within 29 days prior to screening; 7. any serious concomitant systemic disease, condition or disorder that the investigator believes should be prevented from participating in this study; 8. patients with positive anti-sars-cov-2 immunoglobulin g (igg) and igg\>10; 9. patients with malignant tumors who are undergoing chemotherapy and radiotherapy before and after surgery; 10. those who have received sars-cov-2 specific immunoglobulin (including monoclonal antibody) therapy; 11. those who have completed the vaccination against covid-19 within 1 month; 12. those who have a history of receiving convalescent covid-19 plasma treatment; 13. received any study treatment for covid-19 within 30 days prior to administration, including but not limited to antiviral drugs, corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulin; 14. participated in clinical trials of other drugs within 3 months before screening; 15. those who are dizzy with acupuncture and blood; 16. within 4 months after signing the icf to the end of the trial, those who have a childbearing plan or who do not agree to take effective non-drug contraceptive measures during this period; 17. pregnant and lactating women; 18. other factors considered by the investigator to be inappropriate for entry into this trial.

May 20, 2022, 9 a.m. usa

severe covid-19 patients who meet any of the following: shortness of breath, respiratory rate ≥ 30 times/min; in resting state, blood oxygen saturation (spo2) ≤ 93% when inhaling air; arterial blood oxygen partial pressure pao2/inhaled oxygen concentration (fio2)≤300mmhg (1mmhg=0.133kpa); note: for areas with high altitude (over 1000 meters above sea level), the following formula should be used to correct pao2/fio2: pao2/fio2×[760/air pressure (mmhg)]; the clinical symptoms are progressively worsened, and lung imaging shows that the lesion progresses significantly within 24 to 48 hours by >50%; critically ill patients with covid-19 who meet any of the following: respiratory failure occurs and requires mechanical ventilation; shock occurs; complicated with other organ failure requires icu monitoring and treatment; those who are known to be allergic to the test drug and its components; hemodynamic instability within 24 hours before treatment allocation requires the use of vasopressors; suspected or confirmed serious, active bacterial, fungal, viral or other infections (except for covid-19) that the investigator believes may pose a risk when taking interventions; any comorbidities requiring surgery within 7 days prior to screening, or comorbidities deemed life-threatening within 29 days prior to screening; any serious concomitant systemic disease, condition or disorder that the investigator believes should be prevented from participating in this study; patients with positive anti-sars-cov-2 immunoglobulin g (igg) and igg>10; patients with malignant tumors who are undergoing chemotherapy and radiotherapy before and after surgery; those who have received sars-cov-2 specific immunoglobulin (including monoclonal antibody) therapy; those who have completed the vaccination against covid-19 within 1 month; those who have a history of receiving convalescent covid-19 plasma treatment; received any study treatment for covid-19 within 30 days prior to administration, including but not limited to antiviral drugs, corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulin; participated in clinical trials of other drugs within 3 months before screening; those who are dizzy with acupuncture and blood; within 4 months after signing the icf to the end of the trial, those who have a childbearing plan or who do not agree to take effective non-drug contraceptive measures during this period; pregnant and lactating women; other factors considered by the investigator to be inappropriate for entry into this trial.

severe covid-19 patients who meet any of the following: shortness of breath, respiratory rate ≥ 30 times/min; in resting state, blood oxygen saturation (spo2) ≤ 93% when inhaling air; arterial blood oxygen partial pressure pao2/inhaled oxygen concentration (fio2)≤300mmhg (1mmhg=0.133kpa); note: for areas with high altitude (over 1000 meters above sea level), the following formula should be used to correct pao2/fio2: pao2/fio2×[760/air pressure (mmhg)]; the clinical symptoms are progressively worsened, and lung imaging shows that the lesion progresses significantly within 24 to 48 hours by >50%; critically ill patients with covid-19 who meet any of the following: respiratory failure occurs and requires mechanical ventilation; shock occurs; complicated with other organ failure requires icu monitoring and treatment; those who are known to be allergic to the test drug and its components; hemodynamic instability within 24 hours before treatment allocation requires the use of vasopressors; suspected or confirmed serious, active bacterial, fungal, viral or other infections (except for covid-19) that the investigator believes may pose a risk when taking interventions; any comorbidities requiring surgery within 7 days prior to screening, or comorbidities deemed life-threatening within 29 days prior to screening; any serious concomitant systemic disease, condition or disorder that the investigator believes should be prevented from participating in this study; patients with positive anti-sars-cov-2 immunoglobulin g (igg) and igg>10; patients with malignant tumors who are undergoing chemotherapy and radiotherapy before and after surgery; those who have received sars-cov-2 specific immunoglobulin (including monoclonal antibody) therapy; those who have completed the vaccination against covid-19 within 1 month; those who have a history of receiving convalescent covid-19 plasma treatment; received any study treatment for covid-19 within 30 days prior to administration, including but not limited to antiviral drugs, corticosteroids, interleukin-1 inhibitors, interleukin-6 inhibitors, and intravenous immunoglobulin; participated in clinical trials of other drugs within 3 months before screening; those who are dizzy with acupuncture and blood; within 4 months after signing the icf to the end of the trial, those who have a childbearing plan or who do not agree to take effective non-drug contraceptive measures during this period; pregnant and lactating women; other factors considered by the investigator to be inappropriate for entry into this trial.