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

inclusion criteria: 1. signed and approved informed consent before initiation of protocol-specified procedures; 2. male or female subjects, ≥18 to ≤80 years of age with covid-19 3. sars-2-cov-2 infection confirmed by pcr in the last 8 days 4. hospitalized 5. symptoms of severe covid-19 as demonstrated by one of the following: * respiratory frequency \>30 breaths per minute * spo2 \<94% on room air at sea level * ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) \<300 mmhg * lung infiltrates \>50% 6. for a female subject; either: * subject is of non-childbearing potential, defined as: menopause with amenorrhea \>1 years, hysterectomy, or bilateral oopherectomy or * agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (\<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; 7. in the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

inclusion criteria: 1. signed and approved informed consent before initiation of protocol-specified procedures; 2. male or female subjects, ≥18 to ≤80 years of age with covid-19 3. sars-2-cov-2 infection confirmed by pcr in the last 8 days 4. hospitalized 5. symptoms of severe covid-19 as demonstrated by one of the following: * respiratory frequency \>30 breaths per minute * spo2 \<94% on room air at sea level * ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) \<300 mmhg * lung infiltrates \>50% 6. for a female subject; either: * subject is of non-childbearing potential, defined as: menopause with amenorrhea \>1 years, hysterectomy, or bilateral oopherectomy or * agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (\<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; 7. in the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

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

inclusion criteria: signed and approved informed consent before initiation of protocol-specified procedures; male or female subjects, ≥18 to ≤80 years of age with covid-19 sars-2-cov-2 infection confirmed by pcr in the last 8 days hospitalized symptoms of severe covid-19 as demonstrated by one of the following: respiratory frequency >30 breaths per minute spo2 <94% on room air at sea level ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mmhg lung infiltrates >50% for a female subject; either: subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; in the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

inclusion criteria: signed and approved informed consent before initiation of protocol-specified procedures; male or female subjects, ≥18 to ≤80 years of age with covid-19 sars-2-cov-2 infection confirmed by pcr in the last 8 days hospitalized symptoms of severe covid-19 as demonstrated by one of the following: respiratory frequency >30 breaths per minute spo2 <94% on room air at sea level ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mmhg lung infiltrates >50% for a female subject; either: subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; in the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

Feb. 4, 2021, 12:31 a.m. usa

inclusion criteria: 1. signed and approved informed consent before initiation of protocol-specified procedures; 2. male or female subjects, ≥18 to ≤80 years of age with covid-19 3. sars-2-cov-2 infection confirmed by pcr in the last 8 days 4. hospitalized 5. symptoms of severe covid-19 as demonstrated by one of the following: - respiratory frequency >30 breaths per minute - spo2 <94% on room air at sea level - ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mmhg - lung infiltrates >50% 6. for a female subject; either: - subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or - agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; 7. in the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

inclusion criteria: 1. signed and approved informed consent before initiation of protocol-specified procedures; 2. male or female subjects, ≥18 to ≤80 years of age with covid-19 3. sars-2-cov-2 infection confirmed by pcr in the last 8 days 4. hospitalized 5. symptoms of severe covid-19 as demonstrated by one of the following: - respiratory frequency >30 breaths per minute - spo2 <94% on room air at sea level - ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) <300 mmhg - lung infiltrates >50% 6. for a female subject; either: - subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or - agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; 7. in the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.