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

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever or chills 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) or body aches 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath or difficulty breathing 9. nasal congestion or runny nose 10. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: * chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis * obesity with bmi ≥ 30 kg/m2 * cardiovascular disease * sickle cell disease or thalassemia * diabetes mellitus being managed with concomitant medications * hypertension being managed with concomitant medications * chronic kidney disease 4. oxygen saturation by pulse oximeter \> 93% on room air. note: at altitudes of \>4000 feet above sea level, oxygen saturation by pulse oximeter \> 91% on room air is permitted 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient (or legally authorized decision maker) must give informed consent

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever or chills 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) or body aches 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath or difficulty breathing 9. nasal congestion or runny nose 10. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: * chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis * obesity with bmi ≥ 30 kg/m2 * cardiovascular disease * sickle cell disease or thalassemia * diabetes mellitus being managed with concomitant medications * hypertension being managed with concomitant medications * chronic kidney disease 4. oxygen saturation by pulse oximeter \> 93% on room air. note: at altitudes of \>4000 feet above sea level, oxygen saturation by pulse oximeter \> 91% on room air is permitted 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient (or legally authorized decision maker) must give informed consent

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

inclusion criteria: patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: fever or chills new onset or worsening cough sore throat malaise or fatigue headache muscle pain (myalgias) or body aches gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) new onset or worsening shortness of breath or difficulty breathing nasal congestion or runny nose new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. at higher risk for progression to more severe covid-19 age ≥ 60 years age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis obesity with bmi ≥ 30 kg/m2 cardiovascular disease sickle cell disease or thalassemia diabetes mellitus being managed with concomitant medications hypertension being managed with concomitant medications chronic kidney disease oxygen saturation by pulse oximeter > 93% on room air. note: at altitudes of >4000 feet above sea level, oxygen saturation by pulse oximeter > 91% on room air is permitted negative pregnancy test (if woman of childbearing potential) females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 the patient (or legally authorized decision maker) must give informed consent

inclusion criteria: patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: fever or chills new onset or worsening cough sore throat malaise or fatigue headache muscle pain (myalgias) or body aches gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) new onset or worsening shortness of breath or difficulty breathing nasal congestion or runny nose new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. at higher risk for progression to more severe covid-19 age ≥ 60 years age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis obesity with bmi ≥ 30 kg/m2 cardiovascular disease sickle cell disease or thalassemia diabetes mellitus being managed with concomitant medications hypertension being managed with concomitant medications chronic kidney disease oxygen saturation by pulse oximeter > 93% on room air. note: at altitudes of >4000 feet above sea level, oxygen saturation by pulse oximeter > 91% on room air is permitted negative pregnancy test (if woman of childbearing potential) females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 the patient (or legally authorized decision maker) must give informed consent

Oct. 25, 2021, 10:30 a.m. usa

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever or chills 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) or body aches 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath or difficulty breathing 9. nasal congestion or runny nose 10. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease or thalassemia - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications - chronic kidney disease 4. oxygen saturation by pulse oximeter > 93% on room air. note: at altitudes of >4000 feet above sea level, oxygen saturation by pulse oximeter > 91% on room air is permitted 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient (or legally authorized decision maker) must give informed consent

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever or chills 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) or body aches 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath or difficulty breathing 9. nasal congestion or runny nose 10. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease or thalassemia - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications - chronic kidney disease 4. oxygen saturation by pulse oximeter > 93% on room air. note: at altitudes of >4000 feet above sea level, oxygen saturation by pulse oximeter > 91% on room air is permitted 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient (or legally authorized decision maker) must give informed consent

June 27, 2021, 2:30 a.m. usa

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever or chills 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) or body aches 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath or difficulty breathing 9. nasal congestion or runny nose 10. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease or thalassemia - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications - chronic kidney disease 4. oxygen saturation by pulse oximeter > 93% on room air 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient (or legally authorized decision maker) must give informed consent

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever or chills 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) or body aches 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath or difficulty breathing 9. nasal congestion or runny nose 10. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease or thalassemia - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications - chronic kidney disease 4. oxygen saturation by pulse oximeter > 93% on room air 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient (or legally authorized decision maker) must give informed consent

March 4, 2021, 12:31 a.m. usa

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath (dyspnea) 9. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease or thalassemia - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications - chronic kidney disease 4. oxygen saturation by pulse oximeter > 93% on room air 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient must give informed consent

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath (dyspnea) 9. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years with a clinically stable medical history of at least 1 or more of the following conditions that could lead to severe covid-19: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease or thalassemia - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications - chronic kidney disease 4. oxygen saturation by pulse oximeter > 93% on room air 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods from screening to day 28 7. the patient must give informed consent

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

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath (dyspnea) 9. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years and having one or more of the following co-morbid conditions which are clinically stable in the opinion of the investigator: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications 4. oxygen saturation by pulse oximeter > 93% on room air 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods for the duration of the study (screening to day 28) 7. the patient must give informed consent

inclusion criteria: 1. patients with a positive laboratory diagnosis of sars-cov-2 infection by an antigen or a molecular test ≤5 days prior to randomization. the test should have been authorized by the relevant regulatory authority. 2. have one or more of the following mild or moderate covid-19 symptoms for ≤5 days prior to randomization: 1. fever 2. new onset or worsening cough 3. sore throat 4. malaise or fatigue 5. headache 6. muscle pain (myalgias) 7. gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) 8. new onset or worsening shortness of breath (dyspnea) 9. new loss of taste (ageusia) and/or smell (anosmia). note: any of these symptoms (ageusia, anosmia) alone or in combination cannot be used as the sole qualifying symptoms for enrollment. 3. at higher risk for progression to more severe covid-19 1. age ≥ 60 years 2. age 18-59 years and having one or more of the following co-morbid conditions which are clinically stable in the opinion of the investigator: - chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis - obesity with bmi ≥ 30 kg/m2 - cardiovascular disease - sickle cell disease - diabetes mellitus being managed with concomitant medications - hypertension being managed with concomitant medications 4. oxygen saturation by pulse oximeter > 93% on room air 5. negative pregnancy test (if woman of childbearing potential) 6. females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods for the duration of the study (screening to day 28) 7. the patient must give informed consent