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

inclusion criteria: 1. men and women 18 years of age or older. 2. able and willing to provide informed consent. 3. able and willing to sufficiently operate smart phones and study-provided monitoring devices per the investigator. 4. early covid-19 diagnosis with mild severity defined as meeting all of the below: 1. confirmation of covid-19 by a pcr-based diagnostic within 4 days of randomization. * covid-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. * clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. note: the total score per patient ranges from 0 to 27 points. each symptom is rated from 0 to 3. \[0 = none, 1 = mild, 2 = moderate, and 3 = severe\] 2. no signs of a more serious lower airway disease per clinical exam, chest x-ray or chest ct. 3. resting rr ≤ 20, hr ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. 5. for women of childbearing potential (women who are not permanently sterile \[documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy\] or postmenopausal \[12 months with no menses without an alternative medical cause\]): 1. negative urine pregnancy test at screening. 2. willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. 6. ability and willingness to comply with all aspects of the study through the entire study period.

inclusion criteria: 1. men and women 18 years of age or older. 2. able and willing to provide informed consent. 3. able and willing to sufficiently operate smart phones and study-provided monitoring devices per the investigator. 4. early covid-19 diagnosis with mild severity defined as meeting all of the below: 1. confirmation of covid-19 by a pcr-based diagnostic within 4 days of randomization. * covid-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. * clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. note: the total score per patient ranges from 0 to 27 points. each symptom is rated from 0 to 3. \[0 = none, 1 = mild, 2 = moderate, and 3 = severe\] 2. no signs of a more serious lower airway disease per clinical exam, chest x-ray or chest ct. 3. resting rr ≤ 20, hr ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. 5. for women of childbearing potential (women who are not permanently sterile \[documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy\] or postmenopausal \[12 months with no menses without an alternative medical cause\]): 1. negative urine pregnancy test at screening. 2. willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. 6. ability and willingness to comply with all aspects of the study through the entire study period.

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

inclusion criteria: men and women 18 years of age or older. able and willing to provide informed consent. able and willing to sufficiently operate smart phones and study-provided monitoring devices per the investigator. early covid-19 diagnosis with mild severity defined as meeting all of the below: confirmation of covid-19 by a pcr-based diagnostic within 4 days of randomization. covid-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. note: the total score per patient ranges from 0 to 27 points. each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe] no signs of a more serious lower airway disease per clinical exam, chest x-ray or chest ct. resting rr ≤ 20, hr ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. for women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]): negative urine pregnancy test at screening. willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. ability and willingness to comply with all aspects of the study through the entire study period.

inclusion criteria: men and women 18 years of age or older. able and willing to provide informed consent. able and willing to sufficiently operate smart phones and study-provided monitoring devices per the investigator. early covid-19 diagnosis with mild severity defined as meeting all of the below: confirmation of covid-19 by a pcr-based diagnostic within 4 days of randomization. covid-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. note: the total score per patient ranges from 0 to 27 points. each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe] no signs of a more serious lower airway disease per clinical exam, chest x-ray or chest ct. resting rr ≤ 20, hr ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. for women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]): negative urine pregnancy test at screening. willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. ability and willingness to comply with all aspects of the study through the entire study period.

June 5, 2021, 12:32 a.m. usa

inclusion criteria: 1. men and women 18 years of age or older. 2. able and willing to provide informed consent. 3. able and willing to sufficiently operate smart phones and study-provided monitoring devices per the investigator. 4. early covid-19 diagnosis with mild severity defined as meeting all of the below: 1. confirmation of covid-19 by a pcr-based diagnostic within 4 days of randomization. - covid-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. - clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. note: the total score per patient ranges from 0 to 27 points. each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe] 2. no signs of a more serious lower airway disease per clinical exam, chest x-ray or chest ct. 3. resting rr ≤ 20, hr ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. 5. for women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]): 1. negative urine pregnancy test at screening. 2. willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. 6. ability and willingness to comply with all aspects of the study through the entire study period.

inclusion criteria: 1. men and women 18 years of age or older. 2. able and willing to provide informed consent. 3. able and willing to sufficiently operate smart phones and study-provided monitoring devices per the investigator. 4. early covid-19 diagnosis with mild severity defined as meeting all of the below: 1. confirmation of covid-19 by a pcr-based diagnostic within 4 days of randomization. - covid-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. - clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. note: the total score per patient ranges from 0 to 27 points. each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe] 2. no signs of a more serious lower airway disease per clinical exam, chest x-ray or chest ct. 3. resting rr ≤ 20, hr ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. 5. for women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]): 1. negative urine pregnancy test at screening. 2. willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. 6. ability and willingness to comply with all aspects of the study through the entire study period.