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

inclusion criteria age ≥ 18 years old. able to understand and provide a signed informed consent that fulfills the relevant institutional review board (irb) or independent ethics committee (iec) guidelines. has laboratory-confirmed positive novel coronavirus (sars-cov-2) test, as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (pui) for covid-19 (https://emergency.cdc.gov/han/2020/han00428.asp). has a confirmed new score of 0-5. has at least one of the following high-risk factors associated with a higher risk of covid-19 progression: age ≥ 60 years. hypertension currently managed by at least 1 antihypertensive medication. type 1 or 2 diabetes. chronic obstructive pulmonary disease (copd) diagnosed per medical history. adequate respiratory and heart function, evidenced by the following laboratory results: respiratory rate (rr) < 20 breaths per minute (bpm). heart rate (hr) < 90 beats per minute (bpm). arterial oxygen saturation (sao2) > 93% on room air. agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. ability to participate in required study visits and participate in adequate follow-up, as required by this protocol. agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of n-803. non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of n-803. effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (iuds), oral contraceptives, and abstinence.

inclusion criteria age ≥ 18 years old. able to understand and provide a signed informed consent that fulfills the relevant institutional review board (irb) or independent ethics committee (iec) guidelines. has laboratory-confirmed positive novel coronavirus (sars-cov-2) test, as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (pui) for covid-19 (https://emergency.cdc.gov/han/2020/han00428.asp). has a confirmed new score of 0-5. has at least one of the following high-risk factors associated with a higher risk of covid-19 progression: age ≥ 60 years. hypertension currently managed by at least 1 antihypertensive medication. type 1 or 2 diabetes. chronic obstructive pulmonary disease (copd) diagnosed per medical history. adequate respiratory and heart function, evidenced by the following laboratory results: respiratory rate (rr) < 20 breaths per minute (bpm). heart rate (hr) < 90 beats per minute (bpm). arterial oxygen saturation (sao2) > 93% on room air. agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. ability to participate in required study visits and participate in adequate follow-up, as required by this protocol. agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of n-803. non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of n-803. effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (iuds), oral contraceptives, and abstinence.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria 1. age ≥ 18 years old. 2. able to understand and provide a signed informed consent that fulfills the relevant institutional review board (irb) or independent ethics committee (iec) guidelines. 3. has laboratory-confirmed positive novel coronavirus (sars-cov-2) test, as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (pui) for covid-19 (https://emergency.cdc.gov/han/2020/han00428.asp). 4. has a confirmed new score of 0-5. 5. has at least one of the following high-risk factors associated with a higher risk of covid-19 progression: 1. age ≥ 60 years. 2. hypertension currently managed by at least 1 antihypertensive medication. 3. type 1 or 2 diabetes. 4. chronic obstructive pulmonary disease (copd) diagnosed per medical history. 6. adequate respiratory and heart function, evidenced by the following laboratory results: 1. respiratory rate (rr) < 20 breaths per minute (bpm). 2. heart rate (hr) < 90 beats per minute (bpm). 3. arterial oxygen saturation (sao2) > 93% on room air. 7. agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. 8. ability to participate in required study visits and participate in adequate follow-up, as required by this protocol. 9. agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of n-803. non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of n-803. effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (iuds), oral contraceptives, and abstinence.

inclusion criteria 1. age ≥ 18 years old. 2. able to understand and provide a signed informed consent that fulfills the relevant institutional review board (irb) or independent ethics committee (iec) guidelines. 3. has laboratory-confirmed positive novel coronavirus (sars-cov-2) test, as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (pui) for covid-19 (https://emergency.cdc.gov/han/2020/han00428.asp). 4. has a confirmed new score of 0-5. 5. has at least one of the following high-risk factors associated with a higher risk of covid-19 progression: 1. age ≥ 60 years. 2. hypertension currently managed by at least 1 antihypertensive medication. 3. type 1 or 2 diabetes. 4. chronic obstructive pulmonary disease (copd) diagnosed per medical history. 6. adequate respiratory and heart function, evidenced by the following laboratory results: 1. respiratory rate (rr) < 20 breaths per minute (bpm). 2. heart rate (hr) < 90 beats per minute (bpm). 3. arterial oxygen saturation (sao2) > 93% on room air. 7. agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. 8. ability to participate in required study visits and participate in adequate follow-up, as required by this protocol. 9. agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of n-803. non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the last dose of n-803. effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (iuds), oral contraceptives, and abstinence.