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

inclusion criteria: adult male or female ≥18 to ≤80 years of age proven covid-19 infection per rt-pcr assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) and pneumonia defined as radiographic opacities on chest x-ray the patient requires supplemental oxygen at baseline the patient, guardian or legal representative has signed a written irb-approved informed consent. 5) male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug: abstinence from penile-vaginal intercourse and agree to remain abstinent. male condom, with female partner using a highly effective contraceptive method. (for further details regarding highly effective contraceptive methods please see section 9.3.) in addition, male participants must refrain from donating sperm for the duration of the study and for 1 months after last dose of study drug. male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 months after the last dose of study drug female participants: a female participant is eligible to participate if she is: not pregnant not breastfeeding not a woman of child-bearing potential (wocbp, as defined in section 9.3) a wocbp who agrees to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 1 months after the last dose of study drug (please see further details on section 9.3).

inclusion criteria: adult male or female ≥18 to ≤80 years of age proven covid-19 infection per rt-pcr assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) and pneumonia defined as radiographic opacities on chest x-ray the patient requires supplemental oxygen at baseline the patient, guardian or legal representative has signed a written irb-approved informed consent. 5) male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug: abstinence from penile-vaginal intercourse and agree to remain abstinent. male condom, with female partner using a highly effective contraceptive method. (for further details regarding highly effective contraceptive methods please see section 9.3.) in addition, male participants must refrain from donating sperm for the duration of the study and for 1 months after last dose of study drug. male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 months after the last dose of study drug female participants: a female participant is eligible to participate if she is: not pregnant not breastfeeding not a woman of child-bearing potential (wocbp, as defined in section 9.3) a wocbp who agrees to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 1 months after the last dose of study drug (please see further details on section 9.3).

Dec. 21, 2020, 12:31 a.m. usa

inclusion criteria: 1. adult male or female ≥18 to ≤80 years of age 2. proven covid-19 infection per rt-pcr assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) and pneumonia defined as radiographic opacities on chest x-ray 3. the patient requires supplemental oxygen at baseline 4. the patient, guardian or legal representative has signed a written irb-approved informed consent. 5) male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug: - abstinence from penile-vaginal intercourse and agree to remain abstinent. - male condom, with female partner using a highly effective contraceptive method. (for further details regarding highly effective contraceptive methods please see section 9.3.) in addition, male participants must refrain from donating sperm for the duration of the study and for 1 months after last dose of study drug. male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 months after the last dose of study drug female participants: a female participant is eligible to participate if she is: 1. not pregnant 2. not breastfeeding 3. not a woman of child-bearing potential (wocbp, as defined in section 9.3) 4. a wocbp who agrees to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 1 months after the last dose of study drug (please see further details on section 9.3).

inclusion criteria: 1. adult male or female ≥18 to ≤80 years of age 2. proven covid-19 infection per rt-pcr assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) and pneumonia defined as radiographic opacities on chest x-ray 3. the patient requires supplemental oxygen at baseline 4. the patient, guardian or legal representative has signed a written irb-approved informed consent. 5) male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug: - abstinence from penile-vaginal intercourse and agree to remain abstinent. - male condom, with female partner using a highly effective contraceptive method. (for further details regarding highly effective contraceptive methods please see section 9.3.) in addition, male participants must refrain from donating sperm for the duration of the study and for 1 months after last dose of study drug. male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 months after the last dose of study drug female participants: a female participant is eligible to participate if she is: 1. not pregnant 2. not breastfeeding 3. not a woman of child-bearing potential (wocbp, as defined in section 9.3) 4. a wocbp who agrees to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 1 months after the last dose of study drug (please see further details on section 9.3).

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

inclusion criteria: 1. adult male or female ≥18 to ≤80 years of age 2. proven covid-19 infection per rt-pcr assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) and pneumonia defined as radiographic opacities on chest x-ray 3. the patient requires supplemental oxygen at baseline 4. the patient, guardian or legal representative has signed a written irb-approved informed consent

inclusion criteria: 1. adult male or female ≥18 to ≤80 years of age 2. proven covid-19 infection per rt-pcr assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) and pneumonia defined as radiographic opacities on chest x-ray 3. the patient requires supplemental oxygen at baseline 4. the patient, guardian or legal representative has signed a written irb-approved informed consent