Created at Source Raw Value Validated value
Dec. 14, 2021, 9 a.m. eu

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction testing (qRT-PCR positive with ≥10^5 viral copies from a throat swashb on Day -1), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction testing (qRT-PCR positive with ≥10^5 viral copies from a throat swashb on Day -1), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg

July 9, 2021, 3 p.m. eu

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed. Subject has given written consent to participation in the trial and has delivered the signed Informed Consent Form to the site/Investigator prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction testing (qRT-PCR positive with ≥10^5 viral copies from a throat swashb on Day -1), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. As vomiting or diarrhoea may reduce the efficacy of oral contraceptives, women of childbearing potential should use other methods or avoid heterosexual intercourse during the timeframe of potentially reduced efficacy. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed. Subject has given written consent to participation in the trial and has delivered the signed Informed Consent Form to the site/Investigator prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction testing (qRT-PCR positive with ≥10^5 viral copies from a throat swashb on Day -1), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. As vomiting or diarrhoea may reduce the efficacy of oral contraceptives, women of childbearing potential should use other methods or avoid heterosexual intercourse during the timeframe of potentially reduced efficacy. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg

July 7, 2021, 12:30 p.m. eu

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction testing (qRT-PCR positive with ≥10^5 viral copies from a throat swashb on Day -1), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg

Subjects meeting the following criteria will be considered for inclusion into the trial: 1. Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure. Consent for sampling for epigenetic analysis will be obtained separately and is not mandatory for trial participation. 2. Male and female subjects of any ethnic origin aged between 18 and 55 years (inclusive). Assessed as otherwise healthy based on a pre-trial examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results. 3. SARS-CoV-2 positive by quantitative polymerase chain reaction testing (qRT-PCR positive with ≥10^5 viral copies from a throat swashb on Day -1), but no relevant with at most mild COVID-19 symptoms (excluding: see exclusion criterion 10) 4. First dosing as soon as possible and within 4 days of first positive SARS-CoV-2 (q)RT-PCR or antigen test 5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting treatment) or postmenopausal (defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at start of treatment based on the laboratory’s ranges). Female subjects of childbearing potential must use an adequate method of contraception (see definition below). Lesbian subjects who are refraining from heterosexual intercourse for at least 3 months prior to screening may be included without a contraceptive method if they agree to further refrain from heterosexual intercourse until the end of trial examination, and for at least one full month thereafter. An adequate method of contraception is defined as a highly effective method of contraception plus use of a condom during participation in this trial and for at least 1 complete month after the final dose of trial medication. A highly effective method of contraception is defined as: a. copper intrauterine device, b. the levonorgestrel-releasing intrauterine system, c. the progestogen implant, d. combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, e. progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation. 6. In women of childbearing potential, a negative serum ß-HCG (beta human chorionic gonadotropin) test at screening 7. A Body Mass Index (BMI) between ≥18.0 and ≤30.0 kg/m², and a body weight >50.0 kg