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

1 <br/ >Participant and/or legally acceptable representative must sign an ICF to participate in the study indicating that the participant understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol. <br/ >2 <br/ >Participant must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent. <br/ >3 <br/ >Participants must have documented laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) in any specimen, within less than 72 hours prior to randomization, <br/ >4 <br/ >Participants with moderate or severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as <br/ >a. Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ >b. SpO2 of less than 94 % on room air AND <br/ >c. Respiratory rate of greater than or equal to 24 per minute <br/ >5 <br/ >A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ >a. Is not a woman of childbearing potential (WOCBP) <br/ >OR <br/ >b. Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 30 days until after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. <br/ >c. A WOCBP must have a negative highly sensitive pregnancy test [serum] within 4 days before the first dose of study intervention. <br/ >d. Additional requirements for pregnancy testing during and after study intervention are in Appendix 10.2 <br/ >e. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ >6 <br/ >Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >a. Must agree not to donate sperm for the purpose of reproduction <br/ >PLUS <br/ >b. Must agree to use contraception /barrier as detailed below <br/ >i. a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person <br/ >ii. Should also be advised of the benefit for a female partner to use a highly effective method of contraception described in Appendix 10.4 as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant

1 <br/ >Participant and/or legally acceptable representative must sign an ICF to participate in the study indicating that the participant understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol. <br/ >2 <br/ >Participant must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent. <br/ >3 <br/ >Participants must have documented laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) in any specimen, within less than 72 hours prior to randomization, <br/ >4 <br/ >Participants with moderate or severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as <br/ >a. Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ >b. SpO2 of less than 94 % on room air AND <br/ >c. Respiratory rate of greater than or equal to 24 per minute <br/ >5 <br/ >A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ >a. Is not a woman of childbearing potential (WOCBP) <br/ >OR <br/ >b. Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 30 days until after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. <br/ >c. A WOCBP must have a negative highly sensitive pregnancy test [serum] within 4 days before the first dose of study intervention. <br/ >d. Additional requirements for pregnancy testing during and after study intervention are in Appendix 10.2 <br/ >e. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ >6 <br/ >Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >a. Must agree not to donate sperm for the purpose of reproduction <br/ >PLUS <br/ >b. Must agree to use contraception /barrier as detailed below <br/ >i. a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person <br/ >ii. Should also be advised of the benefit for a female partner to use a highly effective method of contraception described in Appendix 10.4 as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant

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

Nov. 6, 2020, 11:45 p.m. oms

1 <br/ >Participant and/or legally acceptable representative must sign an ICF to participate in the study indicating that the participant understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol. <br/ >2 <br/ >Participant must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent. <br/ >3 <br/ >Participants must have documented laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) in any specimen, within less than 72 hours prior to randomization, <br/ >4 <br/ >Participants with moderate or severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as <br/ >a. Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ >b. SpO2 of less than 94 % on room air AND <br/ >c. Respiratory rate of greater than or equal to 24 per minute <br/ >5 <br/ >A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ >a. Is not a woman of childbearing potential (WOCBP) <br/ >OR <br/ >b. Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 30 days until after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. <br/ >c. A WOCBP must have a negative highly sensitive pregnancy test [serum] within 4 days before the first dose of study intervention. <br/ >d. Additional requirements for pregnancy testing during and after study intervention are in Appendix 10.2 <br/ >e. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ >6 <br/ >Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >a. Must agree not to donate sperm for the purpose of reproduction <br/ >PLUS <br/ >b. Must agree to use contraception /barrier as detailed below <br/ >i. a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person <br/ >ii. Should also be advised of the benefit for a female partner to use a highly effective method of contraception described in Appendix 10.4 as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant

1 <br/ >Participant and/or legally acceptable representative must sign an ICF to participate in the study indicating that the participant understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol. <br/ >2 <br/ >Participant must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent. <br/ >3 <br/ >Participants must have documented laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) in any specimen, within less than 72 hours prior to randomization, <br/ >4 <br/ >Participants with moderate or severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as <br/ >a. Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ >b. SpO2 of less than 94 % on room air AND <br/ >c. Respiratory rate of greater than or equal to 24 per minute <br/ >5 <br/ >A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ >a. Is not a woman of childbearing potential (WOCBP) <br/ >OR <br/ >b. Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 30 days until after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. <br/ >c. A WOCBP must have a negative highly sensitive pregnancy test [serum] within 4 days before the first dose of study intervention. <br/ >d. Additional requirements for pregnancy testing during and after study intervention are in Appendix 10.2 <br/ >e. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ >6 <br/ >Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ >a. Must agree not to donate sperm for the purpose of reproduction <br/ >PLUS <br/ >b. Must agree to use contraception /barrier as detailed below <br/ >i. a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person <br/ >ii. Should also be advised of the benefit for a female partner to use a highly effective method of contraception described in Appendix 10.4 as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant