Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

Subjects will be considered eligible for the study based on the following criteria: <br/ > <br/ > 1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. <br/ > 2. Understand and agree to comply with planned study procedures. <br/ > 3. Male and non-pregnant female subjects with age greater than or equal to 18 years of age at the time of randomization <br/ > 4. Are currently not hospitalized. <br/ > 5. Have one or more COVID-19-related symptoms within 5 days of onset of symptoms onset (FDA COVID-19-Related symptom guidance, See Appendix 2, available at: https://www.fda.gov/media/142143/download) <br/ > 6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) less than or equal to 3 days prior to start of the first dose. <br/ > 7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment. Highly effective contraception methods include: <br/ > Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or <br/ > Use of one of the following combinations (a+b or a+c or b+c): <br/ > a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1%), for example hormone vaginal ring or transdermal hormone contraception. <br/ > b. Placement of an intrauterine device or intrauterine system, <br/ > c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or vaginal suppository, <br/ > Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, <br/ > Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject, <br/ > In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of childbearing potential, <br/ > 8. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method

Subjects will be considered eligible for the study based on the following criteria: <br/ > <br/ > 1. The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. <br/ > 2. Understand and agree to comply with planned study procedures. <br/ > 3. Male and non-pregnant female subjects with age greater than or equal to 18 years of age at the time of randomization <br/ > 4. Are currently not hospitalized. <br/ > 5. Have one or more COVID-19-related symptoms within 5 days of onset of symptoms onset (FDA COVID-19-Related symptom guidance, See Appendix 2, available at: https://www.fda.gov/media/142143/download) <br/ > 6. Must have first positive SARS-CoV-2 viral infection determination (has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen) less than or equal to 3 days prior to start of the first dose. <br/ > 7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment. Highly effective contraception methods include: <br/ > Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or <br/ > Use of one of the following combinations (a+b or a+c or b+c): <br/ > a. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1%), for example hormone vaginal ring or transdermal hormone contraception. <br/ > b. Placement of an intrauterine device or intrauterine system, <br/ > c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical or vault caps) with spermicidal foam or gel or film or cream or vaginal suppository, <br/ > Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, <br/ > Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject, <br/ > In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of childbearing potential, <br/ > 8. Regardless of their fertility status, male subjects must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms as well as one additional highly effective method