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

inclusion criteria: 1. has provided informed consent and any authorizations required by local law; 2. is a male or female patient ≥18 and \<65 years of age; 3. has a laboratory-documented positive test for sars cov 2 infection as determined by local laboratory using a standard, food and drug administration (fda)-approved viral rna or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; 4. has at least 2 symptoms associated with covid-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following: * mild covid-19 * positive testing by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent test; * symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and * no clinical signs indicative of moderate, severe, or critical severity; * moderate covid-19 * positive testing by standard rt-pcr assay or equivalent testing; * symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion; * clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (spo2) \>93% on room air at sea level, heart rate ≥90 beats per minute; and * no clinical signs indicative of severe or critical severity; 5. has adequate hepatic function during screening, defined as the following: * serum alanine aminotransferase ≤3 × upper limit of normal (uln); * serum aspartate aminotransferase ≤3 × uln; and * serum bilirubin (total) ≤1.5 × uln (unless due to gilbert's syndrome or hemolysis); 6. has adequate bone marrow function during screening, defined as the following: * absolute neutrophil count ≥1.0 × 10 9/l; * platelet count ≥75 × 109/l; and * hemoglobin ≥90 g/l (9.0 g/dl or 5.6 mmol/l); 7. has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 ml/min, calculated by the cockcroft-gault formula using actual body weight; 8. female patients of childbearing potential must meet all of the following criteria: * is not pregnant (confirmed via a negative urine pregnancy test); * is not breastfeeding; and * is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months). 9. male patients who can father a child must meet all of the following criteria: * is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and * is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 10. is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and note: psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered. 11. in the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.

inclusion criteria: 1. has provided informed consent and any authorizations required by local law; 2. is a male or female patient ≥18 and \<65 years of age; 3. has a laboratory-documented positive test for sars cov 2 infection as determined by local laboratory using a standard, food and drug administration (fda)-approved viral rna or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; 4. has at least 2 symptoms associated with covid-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following: * mild covid-19 * positive testing by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent test; * symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and * no clinical signs indicative of moderate, severe, or critical severity; * moderate covid-19 * positive testing by standard rt-pcr assay or equivalent testing; * symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion; * clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (spo2) \>93% on room air at sea level, heart rate ≥90 beats per minute; and * no clinical signs indicative of severe or critical severity; 5. has adequate hepatic function during screening, defined as the following: * serum alanine aminotransferase ≤3 × upper limit of normal (uln); * serum aspartate aminotransferase ≤3 × uln; and * serum bilirubin (total) ≤1.5 × uln (unless due to gilbert's syndrome or hemolysis); 6. has adequate bone marrow function during screening, defined as the following: * absolute neutrophil count ≥1.0 × 10 9/l; * platelet count ≥75 × 109/l; and * hemoglobin ≥90 g/l (9.0 g/dl or 5.6 mmol/l); 7. has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 ml/min, calculated by the cockcroft-gault formula using actual body weight; 8. female patients of childbearing potential must meet all of the following criteria: * is not pregnant (confirmed via a negative urine pregnancy test); * is not breastfeeding; and * is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months). 9. male patients who can father a child must meet all of the following criteria: * is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and * is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 10. is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and note: psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered. 11. in the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.

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

inclusion criteria: has provided informed consent and any authorizations required by local law; is a male or female patient ≥18 and <65 years of age; has a laboratory-documented positive test for sars cov 2 infection as determined by local laboratory using a standard, food and drug administration (fda)-approved viral rna or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; has at least 2 symptoms associated with covid-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following: mild covid-19 positive testing by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent test; symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and no clinical signs indicative of moderate, severe, or critical severity; moderate covid-19 positive testing by standard rt-pcr assay or equivalent testing; symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion; clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (spo2) >93% on room air at sea level, heart rate ≥90 beats per minute; and no clinical signs indicative of severe or critical severity; has adequate hepatic function during screening, defined as the following: serum alanine aminotransferase ≤3 × upper limit of normal (uln); serum aspartate aminotransferase ≤3 × uln; and serum bilirubin (total) ≤1.5 × uln (unless due to gilbert's syndrome or hemolysis); has adequate bone marrow function during screening, defined as the following: absolute neutrophil count ≥1.0 × 10 9/l; platelet count ≥75 × 109/l; and hemoglobin ≥90 g/l (9.0 g/dl or 5.6 mmol/l); has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 ml/min, calculated by the cockcroft-gault formula using actual body weight; female patients of childbearing potential must meet all of the following criteria: is not pregnant (confirmed via a negative urine pregnancy test); is not breastfeeding; and is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months). male patients who can father a child must meet all of the following criteria: is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and note: psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered. in the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.

inclusion criteria: has provided informed consent and any authorizations required by local law; is a male or female patient ≥18 and <65 years of age; has a laboratory-documented positive test for sars cov 2 infection as determined by local laboratory using a standard, food and drug administration (fda)-approved viral rna or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; has at least 2 symptoms associated with covid-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following: mild covid-19 positive testing by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent test; symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and no clinical signs indicative of moderate, severe, or critical severity; moderate covid-19 positive testing by standard rt-pcr assay or equivalent testing; symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion; clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (spo2) >93% on room air at sea level, heart rate ≥90 beats per minute; and no clinical signs indicative of severe or critical severity; has adequate hepatic function during screening, defined as the following: serum alanine aminotransferase ≤3 × upper limit of normal (uln); serum aspartate aminotransferase ≤3 × uln; and serum bilirubin (total) ≤1.5 × uln (unless due to gilbert's syndrome or hemolysis); has adequate bone marrow function during screening, defined as the following: absolute neutrophil count ≥1.0 × 10 9/l; platelet count ≥75 × 109/l; and hemoglobin ≥90 g/l (9.0 g/dl or 5.6 mmol/l); has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 ml/min, calculated by the cockcroft-gault formula using actual body weight; female patients of childbearing potential must meet all of the following criteria: is not pregnant (confirmed via a negative urine pregnancy test); is not breastfeeding; and is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months). male patients who can father a child must meet all of the following criteria: is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and note: psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered. in the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.

Nov. 19, 2020, 12:31 a.m. usa

inclusion criteria: 1. has provided informed consent and any authorizations required by local law; 2. is a male or female patient ≥18 and <65 years of age; 3. has a laboratory-documented positive test for sars cov 2 infection as determined by local laboratory using a standard, food and drug administration (fda)-approved viral rna or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; 4. has at least 2 symptoms associated with covid-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following: - mild covid-19 - positive testing by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent test; - symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and - no clinical signs indicative of moderate, severe, or critical severity; - moderate covid-19 - positive testing by standard rt-pcr assay or equivalent testing; - symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion; - clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (spo2) >93% on room air at sea level, heart rate ≥90 beats per minute; and - no clinical signs indicative of severe or critical severity; 5. has adequate hepatic function during screening, defined as the following: - serum alanine aminotransferase ≤3 × upper limit of normal (uln); - serum aspartate aminotransferase ≤3 × uln; and - serum bilirubin (total) ≤1.5 × uln (unless due to gilbert's syndrome or hemolysis); 6. has adequate bone marrow function during screening, defined as the following: - absolute neutrophil count ≥1.0 × 10 9/l; - platelet count ≥75 × 109/l; and - hemoglobin ≥90 g/l (9.0 g/dl or 5.6 mmol/l); 7. has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 ml/min, calculated by the cockcroft-gault formula using actual body weight; 8. female patients of childbearing potential must meet all of the following criteria: - is not pregnant (confirmed via a negative urine pregnancy test); - is not breastfeeding; and - is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months). 9. male patients who can father a child must meet all of the following criteria: - is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and - is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 10. is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and note: psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered. 11. in the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.

inclusion criteria: 1. has provided informed consent and any authorizations required by local law; 2. is a male or female patient ≥18 and <65 years of age; 3. has a laboratory-documented positive test for sars cov 2 infection as determined by local laboratory using a standard, food and drug administration (fda)-approved viral rna or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; 4. has at least 2 symptoms associated with covid-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following: - mild covid-19 - positive testing by standard reverse transcriptase polymerase chain reaction (rt-pcr) assay or equivalent test; - symptoms of mild illness with covid-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and - no clinical signs indicative of moderate, severe, or critical severity; - moderate covid-19 - positive testing by standard rt-pcr assay or equivalent testing; - symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion; - clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (spo2) >93% on room air at sea level, heart rate ≥90 beats per minute; and - no clinical signs indicative of severe or critical severity; 5. has adequate hepatic function during screening, defined as the following: - serum alanine aminotransferase ≤3 × upper limit of normal (uln); - serum aspartate aminotransferase ≤3 × uln; and - serum bilirubin (total) ≤1.5 × uln (unless due to gilbert's syndrome or hemolysis); 6. has adequate bone marrow function during screening, defined as the following: - absolute neutrophil count ≥1.0 × 10 9/l; - platelet count ≥75 × 109/l; and - hemoglobin ≥90 g/l (9.0 g/dl or 5.6 mmol/l); 7. has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 ml/min, calculated by the cockcroft-gault formula using actual body weight; 8. female patients of childbearing potential must meet all of the following criteria: - is not pregnant (confirmed via a negative urine pregnancy test); - is not breastfeeding; and - is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months). 9. male patients who can father a child must meet all of the following criteria: - is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and - is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; note: a male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. 10. is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and note: psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered. 11. in the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.