Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF), willingness and capability to complete all the study procedures. <br/ >Age 18-75 years (inclusive) at the time of signing ICF. <br/ >Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ >For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test. <br/ >Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ >Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >Additional Inclusion criteria for mild cases only: <br/ >Time interval between symptoms onset and randomization to no more than 7 days. <br/ >Pyrexia (temperature < 102.2oF), respiratory rate 12 to �20/min. <br/ >No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention, moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention, severe is defined as symptoms resulting in marked impairment of function): <br/ >Cough <br/ >Sore throat <br/ >Headache <br/ >Nasal congestion <br/ >Body aches and pains <br/ >Fatigue <br/ >Additional Inclusion criteria for moderate cases: <br/ >Patients with the interval between symptoms onset and randomization is no more than 10 days <br/ >Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia <br/ >Patients with pyrexia (axillary � 98.6°F or oral � 99.5°F), respiratory rate > 20 to < 30/min. <br/ > <br/ >

Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF), willingness and capability to complete all the study procedures. <br/ >Age 18-75 years (inclusive) at the time of signing ICF. <br/ >Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ >For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test. <br/ >Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ >Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >Additional Inclusion criteria for mild cases only: <br/ >Time interval between symptoms onset and randomization to no more than 7 days. <br/ >Pyrexia (temperature < 102.2oF), respiratory rate 12 to �20/min. <br/ >No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention, moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention, severe is defined as symptoms resulting in marked impairment of function): <br/ >Cough <br/ >Sore throat <br/ >Headache <br/ >Nasal congestion <br/ >Body aches and pains <br/ >Fatigue <br/ >Additional Inclusion criteria for moderate cases: <br/ >Patients with the interval between symptoms onset and randomization is no more than 10 days <br/ >Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia <br/ >Patients with pyrexia (axillary � 98.6°F or oral � 99.5°F), respiratory rate > 20 to < 30/min. <br/ > <br/ >

Nov. 13, 2021, 5:33 p.m. oms

Oct. 26, 2020, 8:29 a.m. oms

Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF), willingness and capability to complete all the study procedures. <br/ >Age 18-75 years (inclusive) at the time of signing ICF. <br/ >Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ >For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test. <br/ >Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ >Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >Additional Inclusion criteria for mild cases only: <br/ >Time interval between symptoms onset and randomization to no more than 7 days. <br/ >Pyrexia (temperature < 102.2oF), respiratory rate 12 to �20/min. <br/ >No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention, moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention, severe is defined as symptoms resulting in marked impairment of function): <br/ >Cough <br/ >Sore throat <br/ >Headache <br/ >Nasal congestion <br/ >Body aches and pains <br/ >Fatigue <br/ >Additional Inclusion criteria for moderate cases: <br/ >Patients with the interval between symptoms onset and randomization is no more than 10 days <br/ >Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia <br/ >Patients with pyrexia (axillary � 98.6°F or oral � 99.5°F), respiratory rate > 20 to < 30/min. <br/ > <br/ >

Voluntarily participating in the clinical study, fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF), willingness and capability to complete all the study procedures. <br/ >Age 18-75 years (inclusive) at the time of signing ICF. <br/ >Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ >For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test. <br/ >Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ >Not participating in any other interventional drug clinical studies before completion of the present study. <br/ >Additional Inclusion criteria for mild cases only: <br/ >Time interval between symptoms onset and randomization to no more than 7 days. <br/ >Pyrexia (temperature < 102.2oF), respiratory rate 12 to �20/min. <br/ >No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention, moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention, severe is defined as symptoms resulting in marked impairment of function): <br/ >Cough <br/ >Sore throat <br/ >Headache <br/ >Nasal congestion <br/ >Body aches and pains <br/ >Fatigue <br/ >Additional Inclusion criteria for moderate cases: <br/ >Patients with the interval between symptoms onset and randomization is no more than 10 days <br/ >Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia <br/ >Patients with pyrexia (axillary � 98.6°F or oral � 99.5°F), respiratory rate > 20 to < 30/min. <br/ > <br/ >