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

inclusion criteria: 1. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; 2. moderate ards characterized by the following criteria: * invasive mechanical ventilation with a minimum peep of 5 cm h2o; * pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; * no evidence of volume overload or heart failure; 3. the patient is ≥18 years of age at the time of consent; 4. qtcf interval ≤ 440 milliseconds; 5. a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; 6. a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; 7. the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

inclusion criteria: 1. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; 2. moderate ards characterized by the following criteria: * invasive mechanical ventilation with a minimum peep of 5 cm h2o; * pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; * no evidence of volume overload or heart failure; 3. the patient is ≥18 years of age at the time of consent; 4. qtcf interval ≤ 440 milliseconds; 5. a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; 6. a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; 7. the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

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

inclusion criteria: has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; moderate ards characterized by the following criteria: invasive mechanical ventilation with a minimum peep of 5 cm h2o; pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; no evidence of volume overload or heart failure; the patient is ≥18 years of age at the time of consent; qtcf interval ≤ 440 milliseconds; a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

inclusion criteria: has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; moderate ards characterized by the following criteria: invasive mechanical ventilation with a minimum peep of 5 cm h2o; pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; no evidence of volume overload or heart failure; the patient is ≥18 years of age at the time of consent; qtcf interval ≤ 440 milliseconds; a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Dec. 12, 2020, 12:31 a.m. usa

inclusion criteria: 1. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; 2. moderate ards characterized by the following criteria: - invasive mechanical ventilation with a minimum peep of 5 cm h2o; - pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; - no evidence of volume overload or heart failure; 3. the patient is ≥18 years of age at the time of consent; 4. qtcf interval ≤ 440 milliseconds; 5. a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; 6. a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; 7. the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

inclusion criteria: 1. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; 2. moderate ards characterized by the following criteria: - invasive mechanical ventilation with a minimum peep of 5 cm h2o; - pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; - no evidence of volume overload or heart failure; 3. the patient is ≥18 years of age at the time of consent; 4. qtcf interval ≤ 440 milliseconds; 5. a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; 6. a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; 7. the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.