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

1.Male or female patients between 18 and 60 years of age (both inclusive). <br/ >2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ >3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. <br/ >Respiratory rate â?¥24/min, breathlessness <br/ >SpO2: 90% to â?¤93% on room air <br/ >4.Patients who are able to consume oral medications. <br/ >5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >6.Refrain from donating sperm, and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or must agree to use contraception <br/ >7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP), or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention, a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention <br/ >8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. <br/ >9.For female subjects: evidence of post-menopause, or for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ >10.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ >11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his <br/ >/her partner during the study period and for at least 28 days following the last study treatment. <br/ >12.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures

1.Male or female patients between 18 and 60 years of age (both inclusive). <br/ >2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ >3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. <br/ >Respiratory rate â?¥24/min, breathlessness <br/ >SpO2: 90% to â?¤93% on room air <br/ >4.Patients who are able to consume oral medications. <br/ >5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >6.Refrain from donating sperm, and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or must agree to use contraception <br/ >7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP), or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention, a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention <br/ >8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. <br/ >9.For female subjects: evidence of post-menopause, or for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ >10.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ >11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his <br/ >/her partner during the study period and for at least 28 days following the last study treatment. <br/ >12.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures

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

Sept. 8, 2021, 1:30 a.m. oms

1.Male or female patients between 18 and 60 years of age (both inclusive). <br/ >2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ >3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. <br/ >Respiratory rate â?¥24/min, breathlessness <br/ >SpO2: 90% to â?¤93% on room air <br/ >4.Patients who are able to consume oral medications. <br/ >5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >6.Refrain from donating sperm, and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or must agree to use contraception <br/ >7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP), or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention, a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention <br/ >8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. <br/ >9.For female subjects: evidence of post-menopause, or for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ >10.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ >11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his <br/ >/her partner during the study period and for at least 28 days following the last study treatment. <br/ >12.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures

1.Male or female patients between 18 and 60 years of age (both inclusive). <br/ >2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ >3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. <br/ >Respiratory rate â?¥24/min, breathlessness <br/ >SpO2: 90% to â?¤93% on room air <br/ >4.Patients who are able to consume oral medications. <br/ >5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >6.Refrain from donating sperm, and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or must agree to use contraception <br/ >7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP), or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention, a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention <br/ >8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. <br/ >9.For female subjects: evidence of post-menopause, or for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ >10.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ >11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his <br/ >/her partner during the study period and for at least 28 days following the last study treatment. <br/ >12.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures