Created at Source Raw Value Validated value
May 12, 2022, 6 p.m. eu

1.Adult male or female patient, aged 18 to 75 years, both inclusive. 2.Patient is diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test. 3.Patient with conditions meeting all of the following criteria: a.Oxygen saturation > 94% on room air. b.Not requiring supplemental oxygen. 4.Patient whose onset of symptom is no more than 7 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one SARS-CoV-2 infection associated symptom. 5.Patient has one or more of the following (but not limiting to) SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration: Feeling feverish Cough Shortness of breath or difficulty breathing Sore throat Body pain or muscle pain Fatigue Headache Chills Nasal obstruction or congestion Loss of taste or smell Nausea or vomiting Diarrhea 6.Patient has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 hours prior to the study drug administration: Feeling feverish Cough Shortness of breath or difficulty breathing Sore throat Body pain or muscle pain Fatigue Headache 7.Patient with a body weight of ≤99.9 kg 8.Patient (or legal guardian, if applicable) who is informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the ICF prior to participation in the study. 9.For both male and female patients, the patient and his or her partner of childbearing potential who agree to use a highly effective or medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug as specified below: Combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation Intrauterine devices True 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), declaration of abstinence of the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception. Condom in addition to use spermicide, hormonal contraceptive or barrier method in female, for male patient with his female partner of childbearing potential only. Spermicide condom (condoms coated with spermicide) use alone is not allowed. Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any highly effective or medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.

1.Adult male or female patient, aged 18 to 75 years, both inclusive. 2.Patient is diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test. 3.Patient with conditions meeting all of the following criteria: a.Oxygen saturation > 94% on room air. b.Not requiring supplemental oxygen. 4.Patient whose onset of symptom is no more than 7 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one SARS-CoV-2 infection associated symptom. 5.Patient has one or more of the following (but not limiting to) SARS-CoV-2 infection associated symptoms within 7 days prior to the study drug administration: Feeling feverish Cough Shortness of breath or difficulty breathing Sore throat Body pain or muscle pain Fatigue Headache Chills Nasal obstruction or congestion Loss of taste or smell Nausea or vomiting Diarrhea 6.Patient has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 hours prior to the study drug administration: Feeling feverish Cough Shortness of breath or difficulty breathing Sore throat Body pain or muscle pain Fatigue Headache 7.Patient with a body weight of ≤99.9 kg 8.Patient (or legal guardian, if applicable) who is informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the ICF prior to participation in the study. 9.For both male and female patients, the patient and his or her partner of childbearing potential who agree to use a highly effective or medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug as specified below: Combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation Intrauterine devices True 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), declaration of abstinence of the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception. Condom in addition to use spermicide, hormonal contraceptive or barrier method in female, for male patient with his female partner of childbearing potential only. Spermicide condom (condoms coated with spermicide) use alone is not allowed. Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any highly effective or medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.