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

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study * hospitalized subjects with a positive severe acute respiratory syndrome (sars)-corona virus (cov)-2 virologic test (nucleic acid amplification test) performed within 2 weeks prior to screening. for subjects with a positive covid test result within 2 weeks of screening, a confirmatory polymerase chain reaction (pcr) test will be done before randomization. * symptoms of moderate illness with covid-19, which could include any one of the following: fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste or smell, shortness of breath with exertion, or respiratory distress. * clinical signs suggestive of moderate to severe illness with covid-19, which could include any one of the following symptoms: respiratory rate ≥ 20 breaths per minutes, heart rate ≥ 90 beats per minute, abnormal saturation of peripheral oxygen (spo2) defined by pulse oximeter \<95% room air at sea level, or lung infiltration on chest x-ray imaging. * willingness to provide informed consent and being able to comply with the protocol therapy required monitoring and follow-up. * age ≥18 years old. * females of childbearing potential (fcbp) must have a negative serum pregnancy test at screening. fcbp and males of reproductive potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate) from the time of signing the informed consent and for the duration of study and at least 2 months following the last dose of study drug.

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study * hospitalized subjects with a positive severe acute respiratory syndrome (sars)-corona virus (cov)-2 virologic test (nucleic acid amplification test) performed within 2 weeks prior to screening. for subjects with a positive covid test result within 2 weeks of screening, a confirmatory polymerase chain reaction (pcr) test will be done before randomization. * symptoms of moderate illness with covid-19, which could include any one of the following: fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste or smell, shortness of breath with exertion, or respiratory distress. * clinical signs suggestive of moderate to severe illness with covid-19, which could include any one of the following symptoms: respiratory rate ≥ 20 breaths per minutes, heart rate ≥ 90 beats per minute, abnormal saturation of peripheral oxygen (spo2) defined by pulse oximeter \<95% room air at sea level, or lung infiltration on chest x-ray imaging. * willingness to provide informed consent and being able to comply with the protocol therapy required monitoring and follow-up. * age ≥18 years old. * females of childbearing potential (fcbp) must have a negative serum pregnancy test at screening. fcbp and males of reproductive potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate) from the time of signing the informed consent and for the duration of study and at least 2 months following the last dose of study drug.

Jan. 26, 2022, 10:48 a.m. usa

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study hospitalized subjects with a positive severe acute respiratory syndrome (sars)-corona virus (cov)-2 virologic test (nucleic acid amplification test) performed within 2 weeks prior to screening. for subjects with a positive covid test result within 2 weeks of screening, a confirmatory polymerase chain reaction (pcr) test will be done before randomization. symptoms of moderate illness with covid-19, which could include any one of the following: fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste or smell, shortness of breath with exertion, or respiratory distress. clinical signs suggestive of moderate to severe illness with covid-19, which could include any one of the following symptoms: respiratory rate ≥ 20 breaths per minutes, heart rate ≥ 90 beats per minute, abnormal saturation of peripheral oxygen (spo2) defined by pulse oximeter <95% room air at sea level, or lung infiltration on chest x-ray imaging. willingness to provide informed consent and being able to comply with the protocol therapy required monitoring and follow-up. age ≥18 years old. females of childbearing potential (fcbp) must have a negative serum pregnancy test at screening. fcbp and males of reproductive potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate) from the time of signing the informed consent and for the duration of study and at least 2 months following the last dose of study drug.

inclusion criteria: subjects who meet all of the following criteria will be eligible to participate in the study hospitalized subjects with a positive severe acute respiratory syndrome (sars)-corona virus (cov)-2 virologic test (nucleic acid amplification test) performed within 2 weeks prior to screening. for subjects with a positive covid test result within 2 weeks of screening, a confirmatory polymerase chain reaction (pcr) test will be done before randomization. symptoms of moderate illness with covid-19, which could include any one of the following: fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste or smell, shortness of breath with exertion, or respiratory distress. clinical signs suggestive of moderate to severe illness with covid-19, which could include any one of the following symptoms: respiratory rate ≥ 20 breaths per minutes, heart rate ≥ 90 beats per minute, abnormal saturation of peripheral oxygen (spo2) defined by pulse oximeter <95% room air at sea level, or lung infiltration on chest x-ray imaging. willingness to provide informed consent and being able to comply with the protocol therapy required monitoring and follow-up. age ≥18 years old. females of childbearing potential (fcbp) must have a negative serum pregnancy test at screening. fcbp and males of reproductive potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate) from the time of signing the informed consent and for the duration of study and at least 2 months following the last dose of study drug.