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

1 Subject voluntarily agrees to participate in this study and is able to provide written informed consent or has a legal representative who can provide informed consent or is enrolled under International Conference on Harmonization (ICH) E6 (R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (where permitted according to local law and approved nationally and by the relevant IRB) prior to performing any of the Screening Visit procedures. <br/ > 2 Males and females over 18 years of age, inclusive, at the time of signing the ICF. <br/ > 3 Hospitalized, with COVID-19 symptoms of respiratory illness caused by SARS-CoV-2 <br/ > infection (defined as Scale 5 â?? 7 on the WHO 8-point ordinal scale for clinical improvement. <br/ > 4 Laboratory confirmation SARS-CoV-2 by real time polymerase chain reaction in the respiratory tract (NP swab, oropharyngeal swab, tracheal aspirate, BAL) lesser or equal to 14 days prior to randomization. <br/ > 5 Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection <br/ > 6 Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period from the screening visit until the end of study visit. In the context of this study, an effective method is defined as those which result in low failure rate <br/ > (i.e. less than 1 percent per year) when used consistently and correctly such as: <br/ > -Combined (estrogen and progestogen containing) hormonal contraception combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, or transdermal) <br/ > -Progestogen only hormonal contraception associated with inhibition of Ovulation (oral, injectable, implantable) <br/ > -Intrauterine device (IUD) <br/ > -Intrauterine hormone releasing system <br/ > -Vasectomized partner <br/ > -Bilateral tubal occlusion <br/ > -True abstinence. When this is in line with the preferred and usual lifestyle of the subject. <br/ > Periodic abstinence, such as calendar, ovulation, symptothermal, post ovulation methods, and withdrawal are not acceptable methods of contraception. <br/ > 7 Men must be willing to use a double barrier contraception from enrollment until at 5 months <br/ > after the last dose of study drug, if not abstinent.

1 Subject voluntarily agrees to participate in this study and is able to provide written informed consent or has a legal representative who can provide informed consent or is enrolled under International Conference on Harmonization (ICH) E6 (R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (where permitted according to local law and approved nationally and by the relevant IRB) prior to performing any of the Screening Visit procedures. <br/ > 2 Males and females over 18 years of age, inclusive, at the time of signing the ICF. <br/ > 3 Hospitalized, with COVID-19 symptoms of respiratory illness caused by SARS-CoV-2 <br/ > infection (defined as Scale 5 â?? 7 on the WHO 8-point ordinal scale for clinical improvement. <br/ > 4 Laboratory confirmation SARS-CoV-2 by real time polymerase chain reaction in the respiratory tract (NP swab, oropharyngeal swab, tracheal aspirate, BAL) lesser or equal to 14 days prior to randomization. <br/ > 5 Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection <br/ > 6 Women of childbearing potential must be willing and able to use at least one highly effective contraceptive method for a period from the screening visit until the end of study visit. In the context of this study, an effective method is defined as those which result in low failure rate <br/ > (i.e. less than 1 percent per year) when used consistently and correctly such as: <br/ > -Combined (estrogen and progestogen containing) hormonal contraception combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, or transdermal) <br/ > -Progestogen only hormonal contraception associated with inhibition of Ovulation (oral, injectable, implantable) <br/ > -Intrauterine device (IUD) <br/ > -Intrauterine hormone releasing system <br/ > -Vasectomized partner <br/ > -Bilateral tubal occlusion <br/ > -True abstinence. When this is in line with the preferred and usual lifestyle of the subject. <br/ > Periodic abstinence, such as calendar, ovulation, symptothermal, post ovulation methods, and withdrawal are not acceptable methods of contraception. <br/ > 7 Men must be willing to use a double barrier contraception from enrollment until at 5 months <br/ > after the last dose of study drug, if not abstinent.