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, as documented by either of the following: * pcr positive in sample collected \< 72 hours prior to randomization; * pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking \>24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; 2. at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. at least 1 of the following signs at screening or noted in the 24 hours before screening: * pao2/fio2 ≤200 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; * if spo2 ≥97%, must be receiving 10l or more of supplemental oxygen; 4. the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; 5. the patient is ≥ 18 years of age; 6. 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 cm4620-ie; 7. 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 cm4620-ie. a male patient must not donate sperm for 39 months; 8. 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, as documented by either of the following: * pcr positive in sample collected \< 72 hours prior to randomization; * pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking \>24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; 2. at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. at least 1 of the following signs at screening or noted in the 24 hours before screening: * pao2/fio2 ≤200 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; * if spo2 ≥97%, must be receiving 10l or more of supplemental oxygen; 4. the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; 5. the patient is ≥ 18 years of age; 6. 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 cm4620-ie; 7. 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 cm4620-ie. a male patient must not donate sperm for 39 months; 8. 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, as documented by either of the following: pcr positive in sample collected < 72 hours prior to randomization; pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; at least 1 of the following signs at screening or noted in the 24 hours before screening: pao2/fio2 ≤200 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; if spo2 ≥97%, must be receiving 10l or more of supplemental oxygen; the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; the patient is ≥ 18 years of age; 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 cm4620-ie; 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 cm4620-ie. 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, as documented by either of the following: pcr positive in sample collected < 72 hours prior to randomization; pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; at least 1 of the following signs at screening or noted in the 24 hours before screening: pao2/fio2 ≤200 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; if spo2 ≥97%, must be receiving 10l or more of supplemental oxygen; the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; the patient is ≥ 18 years of age; 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 cm4620-ie; 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 cm4620-ie. 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.

Jan. 29, 2021, 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, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; - pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; 2. at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. at least 1 of the following signs at screening or noted in the 24 hours before screening: - pao2/fio2 ≤200 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; - if spo2 ≥97%, must be receiving 10l or more of supplemental oxygen; 4. the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; 5. the patient is ≥ 18 years of age; 6. 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 cm4620-ie; 7. 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 cm4620-ie. a male patient must not donate sperm for 39 months; 8. 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, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; - pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; 2. at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. at least 1 of the following signs at screening or noted in the 24 hours before screening: - pao2/fio2 ≤200 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; - if spo2 ≥97%, must be receiving 10l or more of supplemental oxygen; 4. the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; 5. the patient is ≥ 18 years of age; 6. 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 cm4620-ie; 7. 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 cm4620-ie. a male patient must not donate sperm for 39 months; 8. 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.

Oct. 26, 2020, 11:31 p.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, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; - pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; 2. at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. at least 1 of the following signs at screening or noted in the 24 hours before screening: - spo2 <92% on room air; - pao2/fio2 ≤300 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; - if spo2 ≥97%, must be receiving 7l or more of supplemental oxygen; 4. the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; 5. the patient is ≥ 18 years of age; 6. 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 cm4620-ie; 7. 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 cm4620-ie. a male patient must not donate sperm for 39 months; 8. 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, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; - pcr positive in sample collected ≥ 72 hours prior to randomization, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; 2. at least 1 of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; 3. at least 1 of the following signs at screening or noted in the 24 hours before screening: - spo2 <92% on room air; - pao2/fio2 ≤300 when receiving supplemental oxygen. the pao2/fio2 may be estimated from pulse oximetry (appendix 1) or determined by arterial blood gas; - if spo2 ≥97%, must be receiving 7l or more of supplemental oxygen; 4. the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a chest x-ray or computerized tomography scan of the lungs; 5. the patient is ≥ 18 years of age; 6. 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 cm4620-ie; 7. 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 cm4620-ie. a male patient must not donate sperm for 39 months; 8. 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.