Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: male or non-pregnant female adult ≥ 18 years of age diagnosed with covid-19 by standard rt-pcr assay or equivalent testing outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. adequate hematopoietic capacity, as defined by the following: hemoglobin ≥ 9.0 g/dl and not transfusion dependent platelets ≥ 100,000/mm3 absolute neutrophil count ≥ 1500 cells/mm3 adequate hepatic function, as defined by the following: ast and alt ≤ 2.5 times upper limit of normal (uln) total bilirubin ≤ 1.5 x uln albumin ≥ 3.0 g/dl adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

inclusion criteria: male or non-pregnant female adult ≥ 18 years of age diagnosed with covid-19 by standard rt-pcr assay or equivalent testing outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. adequate hematopoietic capacity, as defined by the following: hemoglobin ≥ 9.0 g/dl and not transfusion dependent platelets ≥ 100,000/mm3 absolute neutrophil count ≥ 1500 cells/mm3 adequate hepatic function, as defined by the following: ast and alt ≤ 2.5 times upper limit of normal (uln) total bilirubin ≤ 1.5 x uln albumin ≥ 3.0 g/dl adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

Aug. 17, 2021, 6 p.m. usa

inclusion criteria: 1. male or non-pregnant female adult ≥ 18 years of age 2. diagnosed with covid-19 by standard rt-pcr assay or equivalent testing 3. outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, - symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and - clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and - no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) 4. patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. adequate hematopoietic capacity, as defined by the following: 1. hemoglobin ≥ 9.0 g/dl and not transfusion dependent 2. platelets ≥ 100,000/mm3 3. absolute neutrophil count ≥ 1500 cells/mm3 6. adequate hepatic function, as defined by the following: 1. ast and alt ≤ 2.5 times upper limit of normal (uln) 2. total bilirubin ≤ 1.5 x uln 3. albumin ≥ 3.0 g/dl 7. adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). 8. ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

inclusion criteria: 1. male or non-pregnant female adult ≥ 18 years of age 2. diagnosed with covid-19 by standard rt-pcr assay or equivalent testing 3. outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, - symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and - clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and - no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) 4. patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. adequate hematopoietic capacity, as defined by the following: 1. hemoglobin ≥ 9.0 g/dl and not transfusion dependent 2. platelets ≥ 100,000/mm3 3. absolute neutrophil count ≥ 1500 cells/mm3 6. adequate hepatic function, as defined by the following: 1. ast and alt ≤ 2.5 times upper limit of normal (uln) 2. total bilirubin ≤ 1.5 x uln 3. albumin ≥ 3.0 g/dl 7. adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). 8. ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

July 21, 2021, 4 p.m. usa

inclusion criteria: male or non-pregnant female adult ≥ 18 years of age diagnosed with covid-19 by standard rt-pcr assay or equivalent testing outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. adequate hematopoietic capacity, as defined by the following: hemoglobin ≥ 9.0 g/dl and not transfusion dependent platelets ≥ 100,000/mm3 absolute neutrophil count ≥ 1500 cells/mm3 adequate hepatic function, as defined by the following: ast and alt ≤ 2.5 times upper limit of normal (uln) total bilirubin ≤ 1.5 x uln albumin ≥ 3.0 g/dl adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

inclusion criteria: male or non-pregnant female adult ≥ 18 years of age diagnosed with covid-19 by standard rt-pcr assay or equivalent testing outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. adequate hematopoietic capacity, as defined by the following: hemoglobin ≥ 9.0 g/dl and not transfusion dependent platelets ≥ 100,000/mm3 absolute neutrophil count ≥ 1500 cells/mm3 adequate hepatic function, as defined by the following: ast and alt ≤ 2.5 times upper limit of normal (uln) total bilirubin ≤ 1.5 x uln albumin ≥ 3.0 g/dl adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

Dec. 13, 2020, 12:31 a.m. usa

inclusion criteria: 1. male or non-pregnant female adult ≥ 18 years of age 2. diagnosed with covid-19 by standard rt-pcr assay or equivalent testing 3. outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, - symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and - clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and - no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) 4. patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. adequate hematopoietic capacity, as defined by the following: 1. hemoglobin ≥ 9.0 g/dl and not transfusion dependent 2. platelets ≥ 100,000/mm3 3. absolute neutrophil count ≥ 1500 cells/mm3 6. adequate hepatic function, as defined by the following: 1. ast and alt ≤ 2.5 times upper limit of normal (uln) 2. total bilirubin ≤ 1.5 x uln 3. albumin ≥ 3.0 g/dl 7. adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). 8. ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.

inclusion criteria: 1. male or non-pregnant female adult ≥ 18 years of age 2. diagnosed with covid-19 by standard rt-pcr assay or equivalent testing 3. outpatient subjects with moderate illness caused by sars-cov-2 infection as defined below, - symptoms of moderate systemic illness/infection with covid-19: at least two of the key covid-19-related symptoms with score 2 or higher (0=none, 1=mild, 2=moderate, and 3=severe): cough, sore throat, malaise, headache, muscle pain, fever, neurological symptoms such as brain fog/concentration challenges, gastrointestinal symptoms or shortness of breath with exertion and - clinical signs indicative of moderate systemic illness/infection with covid-19 at least 1 of the following: respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute and - no clinical signs indicative of severe or critical illness severity required hospitalization (see exclusion criterion #1) 4. patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. adequate hematopoietic capacity, as defined by the following: 1. hemoglobin ≥ 9.0 g/dl and not transfusion dependent 2. platelets ≥ 100,000/mm3 3. absolute neutrophil count ≥ 1500 cells/mm3 6. adequate hepatic function, as defined by the following: 1. ast and alt ≤ 2.5 times upper limit of normal (uln) 2. total bilirubin ≤ 1.5 x uln 3. albumin ≥ 3.0 g/dl 7. adequate renal function, as defined by the following: a. renal: calculated creatinine clearance >45 ml/min for patients with abnormal, increased creatinine levels (cockcroft-gault formula). 8. ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see section 6.3) throughout study duration.