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

* receiving any other investigational agents which may affect patient's lymphocyte counts. note: there is no evidence that chloroquine or hydroxychloroquine could affect lymphocyte counts. thus, chloroquine or hydroxychloroquine use is not an exclusion criteria for this study. additionally, it is permissible for potential participants to have received investigational or off-label agents for covid-19 prior to or during study participation. * pregnant or breastfeeding women are excluded from this study because nt-i7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with nt-i7. * transferred from icu to the floor. * requiring dialysis. * shortness of breath or known hypoxia (defined as pao2/fio2 ≤ 300 mmhg), or signs of serious lower airway disease. * evidence of ards, sirs/shock, or cardiac failure. * elevated inflammatory markers such as crp \> 2 x uln, ldh \> 2 x uln, d-dimer \> 2 x uln, ferritin \> uln, or il-6 \> uln (when available). * any established diagnosis of autoimmune disease requiring systemic treatment except for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy. * receipt of live attenuated vaccine within 30 days before the study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus calmette-guérin (bcg), zoster, and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. flumist) are live attenuated vaccines and are not allowed.

* receiving any other investigational agents which may affect patient's lymphocyte counts. note: there is no evidence that chloroquine or hydroxychloroquine could affect lymphocyte counts. thus, chloroquine or hydroxychloroquine use is not an exclusion criteria for this study. additionally, it is permissible for potential participants to have received investigational or off-label agents for covid-19 prior to or during study participation. * pregnant or breastfeeding women are excluded from this study because nt-i7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with nt-i7. * transferred from icu to the floor. * requiring dialysis. * shortness of breath or known hypoxia (defined as pao2/fio2 ≤ 300 mmhg), or signs of serious lower airway disease. * evidence of ards, sirs/shock, or cardiac failure. * elevated inflammatory markers such as crp \> 2 x uln, ldh \> 2 x uln, d-dimer \> 2 x uln, ferritin \> uln, or il-6 \> uln (when available). * any established diagnosis of autoimmune disease requiring systemic treatment except for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy. * receipt of live attenuated vaccine within 30 days before the study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus calmette-guérin (bcg), zoster, and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. flumist) are live attenuated vaccines and are not allowed.

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

- receiving any other investigational agents which may affect patient's lymphocyte counts. note: there is no evidence that chloroquine or hydroxychloroquine could affect lymphocyte counts. thus, chloroquine or hydroxychloroquine use is not an exclusion criteria for this study. additionally, it is permissible for potential participants to have received investigational or off-label agents for covid-19 prior to or during study participation. - pregnant or breastfeeding women are excluded from this study because nt-i7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with nt-i7. - transferred from icu to the floor. - requiring dialysis. - shortness of breath or known hypoxia (defined as pao2/fio2 ≤ 300 mmhg), or signs of serious lower airway disease. - evidence of ards, sirs/shock, or cardiac failure. - elevated inflammatory markers such as crp > 2 x uln, ldh > 2 x uln, d-dimer > 2 x uln, ferritin > uln, or il-6 > uln (when available). - any established diagnosis of autoimmune disease requiring systemic treatment except for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy. - receipt of live attenuated vaccine within 30 days before the study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus calmette-guérin (bcg), zoster, and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. flumist) are live attenuated vaccines and are not allowed.

- receiving any other investigational agents which may affect patient's lymphocyte counts. note: there is no evidence that chloroquine or hydroxychloroquine could affect lymphocyte counts. thus, chloroquine or hydroxychloroquine use is not an exclusion criteria for this study. additionally, it is permissible for potential participants to have received investigational or off-label agents for covid-19 prior to or during study participation. - pregnant or breastfeeding women are excluded from this study because nt-i7 has not been evaluated regarding its potential for teratogenic or abortifacients effects. there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug; therefore, breastfeeding should be discontinued if the mother is treated with nt-i7. - transferred from icu to the floor. - requiring dialysis. - shortness of breath or known hypoxia (defined as pao2/fio2 ≤ 300 mmhg), or signs of serious lower airway disease. - evidence of ards, sirs/shock, or cardiac failure. - elevated inflammatory markers such as crp > 2 x uln, ldh > 2 x uln, d-dimer > 2 x uln, ferritin > uln, or il-6 > uln (when available). - any established diagnosis of autoimmune disease requiring systemic treatment except for vitiligo or endocrine disease (such as diabetes, thyroid disease, and adrenal disease) controlled by replacement therapy. - receipt of live attenuated vaccine within 30 days before the study treatment. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacillus calmette-guérin (bcg), zoster, and typhoid vaccine. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. flumist) are live attenuated vaccines and are not allowed.