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

1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- <18 years old, with written consent obtained for their parent/legal guardian) and comply protocol requirements. <br/ >2. Male or female patients aged 12 years of age or older <br/ >3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected â?¤5 days prior to day of randomization) <br/ >4. Patients with â??mildâ?? COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI, , AND having any of the following symptoms and signs prior to randomization: <br/ >Fever, cough, sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, no shortness of breath/breathlessness <br/ >Respiratory rate of less than 24/min, SpO2 â?¥ 94% on room air. <br/ >5. Patients (12 to <18 years) with â??mildâ?? COVID-19 disease severity, as defined by Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization: <br/ >Children presenting with fever, sore throat, diarrhoea, anorexia/nausea/vomiting, loss of sense of smell and/or taste, malaise/weakness, body ache/headache, rhinorrhea, cough with no breathing difficulty (grunting, severe retractions of chest), somnolence, lethargy and seizures <br/ >Respiratory rate <30 /min, SpO2 â?¥ 94% on room air <br/ >6. Patients with SpO2 â?¥ 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. <br/ >7. Is willing and able to take oral medication <br/ >8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. <br/ >9. Patient agrees to completely abstain from sexual activity or to take effective contraception measures (including hormonal contraception or double barrier method) with his/her partner during the study period. <br/ >As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI <br/ >

1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- <18 years old, with written consent obtained for their parent/legal guardian) and comply protocol requirements. <br/ >2. Male or female patients aged 12 years of age or older <br/ >3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected â?¤5 days prior to day of randomization) <br/ >4. Patients with â??mildâ?? COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI, , AND having any of the following symptoms and signs prior to randomization: <br/ >Fever, cough, sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, no shortness of breath/breathlessness <br/ >Respiratory rate of less than 24/min, SpO2 â?¥ 94% on room air. <br/ >5. Patients (12 to <18 years) with â??mildâ?? COVID-19 disease severity, as defined by Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization: <br/ >Children presenting with fever, sore throat, diarrhoea, anorexia/nausea/vomiting, loss of sense of smell and/or taste, malaise/weakness, body ache/headache, rhinorrhea, cough with no breathing difficulty (grunting, severe retractions of chest), somnolence, lethargy and seizures <br/ >Respiratory rate <30 /min, SpO2 â?¥ 94% on room air <br/ >6. Patients with SpO2 â?¥ 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. <br/ >7. Is willing and able to take oral medication <br/ >8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. <br/ >9. Patient agrees to completely abstain from sexual activity or to take effective contraception measures (including hormonal contraception or double barrier method) with his/her partner during the study period. <br/ >As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI <br/ >

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

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

1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- <18 years old, with written consent obtained for their parent/legal guardian) and comply protocol requirements. <br/ >2. Male or female patients aged 12 years of age or older <br/ >3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected â?¤5 days prior to day of randomization) <br/ >4. Patients with â??mildâ?? COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI, , AND having any of the following symptoms and signs prior to randomization: <br/ >Fever, cough, sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, no shortness of breath/breathlessness <br/ >Respiratory rate of less than 24/min, SpO2 â?¥ 94% on room air. <br/ >5. Patients (12 to <18 years) with â??mildâ?? COVID-19 disease severity, as defined by Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization: <br/ >Children presenting with fever, sore throat, diarrhoea, anorexia/nausea/vomiting, loss of sense of smell and/or taste, malaise/weakness, body ache/headache, rhinorrhea, cough with no breathing difficulty (grunting, severe retractions of chest), somnolence, lethargy and seizures <br/ >Respiratory rate <30 /min, SpO2 â?¥ 94% on room air <br/ >6. Patients with SpO2 â?¥ 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. <br/ >7. Is willing and able to take oral medication <br/ >8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. <br/ >9. Patient agrees to completely abstain from sexual activity or to take effective contraception measures (including hormonal contraception or double barrier method) with his/her partner during the study period. <br/ >As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI <br/ >

1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- <18 years old, with written consent obtained for their parent/legal guardian) and comply protocol requirements. <br/ >2. Male or female patients aged 12 years of age or older <br/ >3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected â?¤5 days prior to day of randomization) <br/ >4. Patients with â??mildâ?? COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI, , AND having any of the following symptoms and signs prior to randomization: <br/ >Fever, cough, sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, no shortness of breath/breathlessness <br/ >Respiratory rate of less than 24/min, SpO2 â?¥ 94% on room air. <br/ >5. Patients (12 to <18 years) with â??mildâ?? COVID-19 disease severity, as defined by Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization: <br/ >Children presenting with fever, sore throat, diarrhoea, anorexia/nausea/vomiting, loss of sense of smell and/or taste, malaise/weakness, body ache/headache, rhinorrhea, cough with no breathing difficulty (grunting, severe retractions of chest), somnolence, lethargy and seizures <br/ >Respiratory rate <30 /min, SpO2 â?¥ 94% on room air <br/ >6. Patients with SpO2 â?¥ 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. <br/ >7. Is willing and able to take oral medication <br/ >8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. <br/ >9. Patient agrees to completely abstain from sexual activity or to take effective contraception measures (including hormonal contraception or double barrier method) with his/her partner during the study period. <br/ >As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI <br/ >