Created at Source Raw Value Validated value
March 27, 2022, 4 p.m. usa

inclusion criteria: subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. admitted to a hospital with symptoms suggestive of severe covid-19. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay (including rapid antigen test) in any specimen, as documented by either of the following: pcr positive in sample collected < 72 hours prior to randomization; or pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) and progressive disease suggestive of ongoing sars-cov-2 infection. illness of any duration, and at least one of the following: shortness of breath, rr≥30 /minute clinical signs indicative of progressive aggravation, lung radiographic infiltrates by imaging (chest x-ray, ct scan, etc.) showing >50% progression within 24-48 hours pao2/fio≤300mmhg 1mmhg=0.133kpa resting state spo2 ≤ 93% on room air all women of childbearing potential defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. highly effective contraception methods include: 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 use of one of the following combinations (a+b or a+c or b+c): use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. placement of an intrauterine device (iud) or intrauterine system (ius); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; 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; 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; 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; 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

inclusion criteria: subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. admitted to a hospital with symptoms suggestive of severe covid-19. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay (including rapid antigen test) in any specimen, as documented by either of the following: pcr positive in sample collected < 72 hours prior to randomization; or pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) and progressive disease suggestive of ongoing sars-cov-2 infection. illness of any duration, and at least one of the following: shortness of breath, rr≥30 /minute clinical signs indicative of progressive aggravation, lung radiographic infiltrates by imaging (chest x-ray, ct scan, etc.) showing >50% progression within 24-48 hours pao2/fio≤300mmhg 1mmhg=0.133kpa resting state spo2 ≤ 93% on room air all women of childbearing potential defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. highly effective contraception methods include: 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 use of one of the following combinations (a+b or a+c or b+c): use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. placement of an intrauterine device (iud) or intrauterine system (ius); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; 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; 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; 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; 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. admitted to a hospital with symptoms suggestive of covid-19. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay in any specimen, as documented by either of the following: pcr positive in sample collected < 72 hours prior to randomization; or pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) and progressive disease suggestive of ongoing sars-cov-2 infection. illness of any duration, and at least one of the following: radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or spo2 ≤ 93% on room air, or requiring supplemental oxygen 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: 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 use of one of the following combinations (a+b or a+c or b+c): use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. placement of an intrauterine device (iud) or intrauterine system (ius); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; 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; 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; 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; 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

inclusion criteria: subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. admitted to a hospital with symptoms suggestive of covid-19. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay in any specimen, as documented by either of the following: pcr positive in sample collected < 72 hours prior to randomization; or pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) and progressive disease suggestive of ongoing sars-cov-2 infection. illness of any duration, and at least one of the following: radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or spo2 ≤ 93% on room air, or requiring supplemental oxygen 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: 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 use of one of the following combinations (a+b or a+c or b+c): use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. placement of an intrauterine device (iud) or intrauterine system (ius); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; 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; 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; 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; 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

Aug. 26, 2021, 7:30 p.m. usa

inclusion criteria: 1. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 2. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. 4. admitted to a hospital with symptoms suggestive of covid-19. 5. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; or - pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) and progressive disease suggestive of ongoing sars-cov-2 infection. 6. illness of any duration, and at least one of the following: - radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or - spo2 ≤ 93% on room air, or - requiring supplemental oxygen 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: - 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 - use of one of the following combinations (a+b or a+c or b+c): 1. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. 2. placement of an intrauterine device (iud) or intrauterine system (ius); 3. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; - 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; - 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; - 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; 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. 9. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

inclusion criteria: 1. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 2. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. 4. admitted to a hospital with symptoms suggestive of covid-19. 5. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; or - pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) and progressive disease suggestive of ongoing sars-cov-2 infection. 6. illness of any duration, and at least one of the following: - radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or - spo2 ≤ 93% on room air, or - requiring supplemental oxygen 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: - 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 - use of one of the following combinations (a+b or a+c or b+c): 1. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. 2. placement of an intrauterine device (iud) or intrauterine system (ius); 3. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; - 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; - 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; - 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; 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 90 days after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. 9. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

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

inclusion criteria: 1. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 2. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. 4. admitted to a hospital with symptoms suggestive of covid-19. 5. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; or - pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.) and progressive disease suggestive of ongoing sars-cov-2 infection. 6. illness of any duration, and at least one of the following: - radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or - spo2 ≤ 93% on room air, or - requiring supplemental oxygen 7. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception throughout the study and for 3 months after stopping gt0918 treatment. 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 3 months after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid 9. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.

inclusion criteria: 1. subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 2. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 3. male and non-pregnant female subjects with age ≥18 years of age at the time of randomization. 4. admitted to a hospital with symptoms suggestive of covid-19. 5. has laboratory-confirmed sars-cov-2 infection as determined by pcr or other commercial or public health assay in any specimen, as documented by either of the following: - pcr positive in sample collected < 72 hours prior to randomization; or - pcr positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.) and progressive disease suggestive of ongoing sars-cov-2 infection. 6. illness of any duration, and at least one of the following: - radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or - spo2 ≤ 93% on room air, or - requiring supplemental oxygen 7. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception throughout the study and for 3 months after stopping gt0918 treatment. 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 of contraception (less than 1% failure rate) or effective method of contraception with nonpregnant women of childbearing potential partners for the duration of the study and until 3 months after the last dose. a condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid 9. agree not to participate in another clinical trial for the treatment of covid-19 through day 60 after first dose.