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

inclusion criteria: 1. age \>18 at the time of informed consent 2. able to understand and provide informed consent in either english or spanish 3. at high risk for covid-19 disease progression by fulfilling at least one of the following criteria at screening: 1. age ≥65 years 2. has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. copd, chronic persistent asthma, cystic fibrosis, chronic bronchitis) 3. has a diagnosis of chronic heart disease 4. has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy 5. has hypertension requiring at least one oral medication for treatment 6. has a body mass index (bmi) of ≥33 kg/m2 7. has an immunocompromising disease (e.g. hiv infection with cd4 count \< 200 cells/mm3) 8. is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent 9. has received a solid organ transplant 10. has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of covid-19 4. documentation of positive diagnostic test for sars-cov-2 (confirmed by pcr assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the screening visit. 5. is symptomatic for covid-19 for no more than 7 days prior to the screening visit 6. has a who clinical progression scale (whob 2020) score of either '2' or '3' at screening and randomization 7. has at least one of the following symptoms at the screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to screening: · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia 8. if female of child-bearing potential, must agree to use of 2 forms of contraception from screening to end of the study. males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. acceptable methods of birth control which must be used together are: 1. oral or injectable contraceptive and condom, or 2. iud and condom, or 3. diaphragm with spermicide and condom. 9. agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.

inclusion criteria: 1. age \>18 at the time of informed consent 2. able to understand and provide informed consent in either english or spanish 3. at high risk for covid-19 disease progression by fulfilling at least one of the following criteria at screening: 1. age ≥65 years 2. has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. copd, chronic persistent asthma, cystic fibrosis, chronic bronchitis) 3. has a diagnosis of chronic heart disease 4. has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy 5. has hypertension requiring at least one oral medication for treatment 6. has a body mass index (bmi) of ≥33 kg/m2 7. has an immunocompromising disease (e.g. hiv infection with cd4 count \< 200 cells/mm3) 8. is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent 9. has received a solid organ transplant 10. has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of covid-19 4. documentation of positive diagnostic test for sars-cov-2 (confirmed by pcr assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the screening visit. 5. is symptomatic for covid-19 for no more than 7 days prior to the screening visit 6. has a who clinical progression scale (whob 2020) score of either '2' or '3' at screening and randomization 7. has at least one of the following symptoms at the screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to screening: · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia 8. if female of child-bearing potential, must agree to use of 2 forms of contraception from screening to end of the study. males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. acceptable methods of birth control which must be used together are: 1. oral or injectable contraceptive and condom, or 2. iud and condom, or 3. diaphragm with spermicide and condom. 9. agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.

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

inclusion criteria: age >18 at the time of informed consent able to understand and provide informed consent in either english or spanish at high risk for covid-19 disease progression by fulfilling at least one of the following criteria at screening: age ≥65 years has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. copd, chronic persistent asthma, cystic fibrosis, chronic bronchitis) has a diagnosis of chronic heart disease has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy has hypertension requiring at least one oral medication for treatment has a body mass index (bmi) of ≥33 kg/m2 has an immunocompromising disease (e.g. hiv infection with cd4 count < 200 cells/mm3) is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent has received a solid organ transplant has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of covid-19 documentation of positive diagnostic test for sars-cov-2 (confirmed by pcr assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the screening visit. is symptomatic for covid-19 for no more than 7 days prior to the screening visit has a who clinical progression scale (whob 2020) score of either '2' or '3' at screening and randomization has at least one of the following symptoms at the screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to screening: · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia if female of child-bearing potential, must agree to use of 2 forms of contraception from screening to end of the study. males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. acceptable methods of birth control which must be used together are: oral or injectable contraceptive and condom, or iud and condom, or diaphragm with spermicide and condom. agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.

inclusion criteria: age >18 at the time of informed consent able to understand and provide informed consent in either english or spanish at high risk for covid-19 disease progression by fulfilling at least one of the following criteria at screening: age ≥65 years has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. copd, chronic persistent asthma, cystic fibrosis, chronic bronchitis) has a diagnosis of chronic heart disease has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy has hypertension requiring at least one oral medication for treatment has a body mass index (bmi) of ≥33 kg/m2 has an immunocompromising disease (e.g. hiv infection with cd4 count < 200 cells/mm3) is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent has received a solid organ transplant has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of covid-19 documentation of positive diagnostic test for sars-cov-2 (confirmed by pcr assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the screening visit. is symptomatic for covid-19 for no more than 7 days prior to the screening visit has a who clinical progression scale (whob 2020) score of either '2' or '3' at screening and randomization has at least one of the following symptoms at the screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to screening: · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia if female of child-bearing potential, must agree to use of 2 forms of contraception from screening to end of the study. males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. acceptable methods of birth control which must be used together are: oral or injectable contraceptive and condom, or iud and condom, or diaphragm with spermicide and condom. agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.

Jan. 15, 2021, 12:31 a.m. usa

inclusion criteria: 1. age >18 at the time of informed consent 2. able to understand and provide informed consent in either english or spanish 3. at high risk for covid-19 disease progression by fulfilling at least one of the following criteria at screening: 1. age ≥65 years 2. has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. copd, chronic persistent asthma, cystic fibrosis, chronic bronchitis) 3. has a diagnosis of chronic heart disease 4. has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy 5. has hypertension requiring at least one oral medication for treatment 6. has a body mass index (bmi) of ≥33 kg/m2 7. has an immunocompromising disease (e.g. hiv infection with cd4 count < 200 cells/mm3) 8. is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent 9. has received a solid organ transplant 10. has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of covid-19 4. documentation of positive diagnostic test for sars-cov-2 (confirmed by pcr assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the screening visit. 5. is symptomatic for covid-19 for no more than 7 days prior to the screening visit 6. has a who clinical progression scale (whob 2020) score of either '2' or '3' at screening and randomization 7. has at least one of the following symptoms at the screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to screening: · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia 8. if female of child-bearing potential, must agree to use of 2 forms of contraception from screening to end of the study. males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. acceptable methods of birth control which must be used together are: 1. oral or injectable contraceptive and condom, or 2. iud and condom, or 3. diaphragm with spermicide and condom. 9. agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.

inclusion criteria: 1. age >18 at the time of informed consent 2. able to understand and provide informed consent in either english or spanish 3. at high risk for covid-19 disease progression by fulfilling at least one of the following criteria at screening: 1. age ≥65 years 2. has a diagnosis of chronic pulmonary disease requiring daily treatment (e.g. copd, chronic persistent asthma, cystic fibrosis, chronic bronchitis) 3. has a diagnosis of chronic heart disease 4. has a diagnosis of diabetes (type 1 or type 2) requiring oral therapy and/or insulin therapy 5. has hypertension requiring at least one oral medication for treatment 6. has a body mass index (bmi) of ≥33 kg/m2 7. has an immunocompromising disease (e.g. hiv infection with cd4 count < 200 cells/mm3) 8. is immunocompromised due to daily treatment with ≥20 mg of prednisone or equivalent 9. has received a solid organ transplant 10. has any chronic condition that, in the opinion of the investigator, places the patient at increased risk for progression of covid-19 4. documentation of positive diagnostic test for sars-cov-2 (confirmed by pcr assay or other approved diagnostic test) performed with a sample from nares or saliva, collected within 7 days of the screening visit. 5. is symptomatic for covid-19 for no more than 7 days prior to the screening visit 6. has a who clinical progression scale (whob 2020) score of either '2' or '3' at screening and randomization 7. has at least one of the following symptoms at the screening visit that are new in onset, or if present by history, has worsened during the 7 days prior to screening: · fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion, nausea, vomiting, diarrhea, anosmia or dysosmia, ageusia or dysgeusia 8. if female of child-bearing potential, must agree to use of 2 forms of contraception from screening to end of the study. males must agree to use 2 forms of contraception from screening to the end of the study if their partners are of childbearing potential. acceptable methods of birth control which must be used together are: 1. oral or injectable contraceptive and condom, or 2. iud and condom, or 3. diaphragm with spermicide and condom. 9. agrees to participate in all in-person visits and remote or home visits as required by the protocol and to provide updated contact information, as necessary.