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

* (1) severe patients with sars-cov-2 meet any of the following criteria 1. shortness of breath, breathing rate ≥ 30 times /min 2. at rest, oxygen saturation (spo2) ≤ 93% during air intake 3. progressive exacerbation of clinical symptoms, lung imaging showed obvious progression of lesions within 24 \~ 48 hours \>50% (2) critically ill patients with sars-cov-2 meet any of the following criteria 1. respiratory failure occurs and requires mechanical ventilation 2. shock occurs 3. combined with other organ failure requires icu care (3) allergic constitution, known allergic to the test drug and its components (4) suspected or confirmed severe, active bacterial, fungal, viral, or other infections (other than covid-19) that researchers believe may pose a risk when implementing interventions (5) patients who underwent surgery or chemotherapy or radiotherapy within 28days prior to screening (6) the investigator considers that participation in the study should be prevented from any serious concomitant systemic disease, condition, or disorder (7) any of the following drugs or treatments were used before screening: <!-- --> 1. antiviral therapy (e.g., paxlovid (nematavir/ritonavir packaged in combination), azvudine tablets, monogravir capsules, ambavirumab/romissuvir injection, or for the duration of the study) is planned to be used within 3 half-life periods before the first dose. covid-19 human immunoglobulin or convalescent plasma), glucocorticoids, il-6 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), antineoplastic drugs, anti-transplant rejection drugs, or immunomodulatory biologics 2. those who plan to receive vaccines (including but not limited to covid-19 vaccine) within 28 days prior to screening or during the study period 3. he is on dialysis (8) when screening, any of the laboratory test indicators meet the following standards <!-- --> 1. alt or ast \>3uln 2. total bilirubin ≥2 uln 3. white blood cell count \> uln 4. neutrophil absolute value \< 0.5×109/l 5. platelet count \< 100×109/l 6. egfr \<60ml /min/ 1.73m2 (calculated by ckd-epi formula) (9) weight ≤40 kg (10) dizzy needle dizzy blood (11) participated in other drug clinical trials within 3 months prior to screening (12) pregnant or lactating women or pregnancy-positive women (13) hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, and human immunodeficiency virus (hiv) antibody were positive for any one of the results (14) patients inappropriate for participation for any other reasons at the investigator's discretion. note:the investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening.if the conditions of a subject are changed (including laboratory test results)and meet any exclusion criterion at any time from the screening to the first administration,the subject shall beexcluded from the study.

* (1) severe patients with sars-cov-2 meet any of the following criteria 1. shortness of breath, breathing rate ≥ 30 times /min 2. at rest, oxygen saturation (spo2) ≤ 93% during air intake 3. progressive exacerbation of clinical symptoms, lung imaging showed obvious progression of lesions within 24 \~ 48 hours \>50% (2) critically ill patients with sars-cov-2 meet any of the following criteria 1. respiratory failure occurs and requires mechanical ventilation 2. shock occurs 3. combined with other organ failure requires icu care (3) allergic constitution, known allergic to the test drug and its components (4) suspected or confirmed severe, active bacterial, fungal, viral, or other infections (other than covid-19) that researchers believe may pose a risk when implementing interventions (5) patients who underwent surgery or chemotherapy or radiotherapy within 28days prior to screening (6) the investigator considers that participation in the study should be prevented from any serious concomitant systemic disease, condition, or disorder (7) any of the following drugs or treatments were used before screening: <!-- --> 1. antiviral therapy (e.g., paxlovid (nematavir/ritonavir packaged in combination), azvudine tablets, monogravir capsules, ambavirumab/romissuvir injection, or for the duration of the study) is planned to be used within 3 half-life periods before the first dose. covid-19 human immunoglobulin or convalescent plasma), glucocorticoids, il-6 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), antineoplastic drugs, anti-transplant rejection drugs, or immunomodulatory biologics 2. those who plan to receive vaccines (including but not limited to covid-19 vaccine) within 28 days prior to screening or during the study period 3. he is on dialysis (8) when screening, any of the laboratory test indicators meet the following standards <!-- --> 1. alt or ast \>3uln 2. total bilirubin ≥2 uln 3. white blood cell count \> uln 4. neutrophil absolute value \< 0.5×109/l 5. platelet count \< 100×109/l 6. egfr \<60ml /min/ 1.73m2 (calculated by ckd-epi formula) (9) weight ≤40 kg (10) dizzy needle dizzy blood (11) participated in other drug clinical trials within 3 months prior to screening (12) pregnant or lactating women or pregnancy-positive women (13) hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, and human immunodeficiency virus (hiv) antibody were positive for any one of the results (14) patients inappropriate for participation for any other reasons at the investigator's discretion. note:the investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening.if the conditions of a subject are changed (including laboratory test results)and meet any exclusion criterion at any time from the screening to the first administration,the subject shall beexcluded from the study.

Jan. 12, 2023, noon usa

(1) severe patients with sars-cov-2 meet any of the following criteria shortness of breath, breathing rate ≥ 30 times /min at rest, oxygen saturation (spo2) ≤ 93% during air intake progressive exacerbation of clinical symptoms, lung imaging showed obvious progression of lesions within 24 ~ 48 hours >50% (2) critically ill patients with sars-cov-2 meet any of the following criteria respiratory failure occurs and requires mechanical ventilation shock occurs combined with other organ failure requires icu care (3) allergic constitution, known allergic to the test drug and its components (4) suspected or confirmed severe, active bacterial, fungal, viral, or other infections (other than covid-19) that researchers believe may pose a risk when implementing interventions (5) patients who underwent surgery or chemotherapy or radiotherapy within 28days prior to screening (6) the investigator considers that participation in the study should be prevented from any serious concomitant systemic disease, condition, or disorder (7) any of the following drugs or treatments were used before screening: antiviral therapy (e.g., paxlovid (nematavir/ritonavir packaged in combination), azvudine tablets, monogravir capsules, ambavirumab/romissuvir injection, or for the duration of the study) is planned to be used within 3 half-life periods before the first dose. covid-19 human immunoglobulin or convalescent plasma), glucocorticoids, il-6 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), antineoplastic drugs, anti-transplant rejection drugs, or immunomodulatory biologics those who plan to receive vaccines (including but not limited to covid-19 vaccine) within 28 days prior to screening or during the study period he is on dialysis (8) when screening, any of the laboratory test indicators meet the following standards alt or ast >3uln total bilirubin ≥2 uln white blood cell count > uln neutrophil absolute value < 0.5×109/l platelet count < 100×109/l egfr <60ml /min/ 1.73m2 (calculated by ckd-epi formula) (9) weight ≤40 kg (10) dizzy needle dizzy blood (11) participated in other drug clinical trials within 3 months prior to screening (12) pregnant or lactating women or pregnancy-positive women (13) hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, and human immunodeficiency virus (hiv) antibody were positive for any one of the results (14) patients inappropriate for participation for any other reasons at the investigator's discretion. note:the investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening. if the conditions of a subject are changed (including laboratory test results) and meet any exclusion criterion at any time from the screening to the first administration, the subject shall be excluded from the study.

(1) severe patients with sars-cov-2 meet any of the following criteria shortness of breath, breathing rate ≥ 30 times /min at rest, oxygen saturation (spo2) ≤ 93% during air intake progressive exacerbation of clinical symptoms, lung imaging showed obvious progression of lesions within 24 ~ 48 hours >50% (2) critically ill patients with sars-cov-2 meet any of the following criteria respiratory failure occurs and requires mechanical ventilation shock occurs combined with other organ failure requires icu care (3) allergic constitution, known allergic to the test drug and its components (4) suspected or confirmed severe, active bacterial, fungal, viral, or other infections (other than covid-19) that researchers believe may pose a risk when implementing interventions (5) patients who underwent surgery or chemotherapy or radiotherapy within 28days prior to screening (6) the investigator considers that participation in the study should be prevented from any serious concomitant systemic disease, condition, or disorder (7) any of the following drugs or treatments were used before screening: antiviral therapy (e.g., paxlovid (nematavir/ritonavir packaged in combination), azvudine tablets, monogravir capsules, ambavirumab/romissuvir injection, or for the duration of the study) is planned to be used within 3 half-life periods before the first dose. covid-19 human immunoglobulin or convalescent plasma), glucocorticoids, il-6 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), antineoplastic drugs, anti-transplant rejection drugs, or immunomodulatory biologics those who plan to receive vaccines (including but not limited to covid-19 vaccine) within 28 days prior to screening or during the study period he is on dialysis (8) when screening, any of the laboratory test indicators meet the following standards alt or ast >3uln total bilirubin ≥2 uln white blood cell count > uln neutrophil absolute value < 0.5×109/l platelet count < 100×109/l egfr <60ml /min/ 1.73m2 (calculated by ckd-epi formula) (9) weight ≤40 kg (10) dizzy needle dizzy blood (11) participated in other drug clinical trials within 3 months prior to screening (12) pregnant or lactating women or pregnancy-positive women (13) hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, and human immunodeficiency virus (hiv) antibody were positive for any one of the results (14) patients inappropriate for participation for any other reasons at the investigator's discretion. note:the investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening. if the conditions of a subject are changed (including laboratory test results) and meet any exclusion criterion at any time from the screening to the first administration, the subject shall be excluded from the study.