Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °F), plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â?¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}), and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed. <br/ >2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. <br/ >3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening, study drug administration visit). The onset of symptoms is defined as either: <br/ >3a. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F), or <br/ >3b. Time when the subject experiences at least one general or respiratory symptom. <br/ >4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). <br/ >5. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ >6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ >7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation. <br/ >

1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °F), plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â?¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}), and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed. <br/ >2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. <br/ >3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening, study drug administration visit). The onset of symptoms is defined as either: <br/ >3a. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F), or <br/ >3b. Time when the subject experiences at least one general or respiratory symptom. <br/ >4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). <br/ >5. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ >6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ >7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation. <br/ >

Nov. 13, 2021, 5:33 p.m. oms

Sept. 8, 2021, 1:30 a.m. oms

1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °F), plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â?¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}), and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed. <br/ >2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. <br/ >3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening, study drug administration visit). The onset of symptoms is defined as either: <br/ >3a. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F), or <br/ >3b. Time when the subject experiences at least one general or respiratory symptom. <br/ >4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). <br/ >5. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ >6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ >7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation. <br/ >

1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °F), plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â?¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}), and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed. <br/ >2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. <br/ >3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening, study drug administration visit). The onset of symptoms is defined as either: <br/ >3a. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F), or <br/ >3b. Time when the subject experiences at least one general or respiratory symptom. <br/ >4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). <br/ >5. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ >6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ >7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation. <br/ >