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

1. Patients with â??moderateâ?? or â??severeâ?? COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI and Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI at the time of randomization. This includes any one or more of the following: <br/ >A) Peripheral Blood oxygen saturation < 94% <br/ >B) Respiratory Rate â?¥ 24 breaths per minute for adults and â?¥ 30 breaths per minute for patients aged 12 to <18 years. <br/ >C) Presence of shortness of breath (dyspnea) at rest, as a symptom <br/ >D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to <18 years <br/ >2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization <br/ >3. Patients who are currently hospitalized/ need hospitalization OR are expected to deteriorate to need hospitalization for COVID-19 management within 48 hours after randomization, in the opinion of the Investigator <br/ >4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). <br/ >5. Patients with : <br/ >A) Presence of Uncontrolled diabetes mellitus <br/ >B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment <br/ >C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution <br/ >D) Presence or history of any other disease or condition which, in the opinion of the Investigator, could prevent, limit or confound protocol-specified assessments or could jeopardize the safety of patient if (s)he were to participate in the study <br/ >6. Pregnant and Lactating patients. <br/ >7. Patients not expected to survive longer than 48 hours (due to any reason) at the time of randomization, in the opinion of the Investigator <br/ >8. Patients who are receiving drugs that are known to prolong QT interval of the heart (including hydroxychloroquine) or are expected to require treatment with the same during the study period <br/ >9. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer). <br/ >10. Patients with body weight <35 or > 105 kg. <br/ >Categorization of COVID-19 disease severity as â??mildâ??, â??moderateâ??, â??severeâ?? is as per the â??Comprehensive Guidelines for Management of COVID-19 patientsâ?? (In Adults) Directorate General of Health Services, MoHFW, GOI and <br/ >COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI <br/ >

1. Patients with â??moderateâ?? or â??severeâ?? COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI and Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI at the time of randomization. This includes any one or more of the following: <br/ >A) Peripheral Blood oxygen saturation < 94% <br/ >B) Respiratory Rate â?¥ 24 breaths per minute for adults and â?¥ 30 breaths per minute for patients aged 12 to <18 years. <br/ >C) Presence of shortness of breath (dyspnea) at rest, as a symptom <br/ >D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to <18 years <br/ >2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization <br/ >3. Patients who are currently hospitalized/ need hospitalization OR are expected to deteriorate to need hospitalization for COVID-19 management within 48 hours after randomization, in the opinion of the Investigator <br/ >4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). <br/ >5. Patients with : <br/ >A) Presence of Uncontrolled diabetes mellitus <br/ >B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment <br/ >C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution <br/ >D) Presence or history of any other disease or condition which, in the opinion of the Investigator, could prevent, limit or confound protocol-specified assessments or could jeopardize the safety of patient if (s)he were to participate in the study <br/ >6. Pregnant and Lactating patients. <br/ >7. Patients not expected to survive longer than 48 hours (due to any reason) at the time of randomization, in the opinion of the Investigator <br/ >8. Patients who are receiving drugs that are known to prolong QT interval of the heart (including hydroxychloroquine) or are expected to require treatment with the same during the study period <br/ >9. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer). <br/ >10. Patients with body weight <35 or > 105 kg. <br/ >Categorization of COVID-19 disease severity as â??mildâ??, â??moderateâ??, â??severeâ?? is as per the â??Comprehensive Guidelines for Management of COVID-19 patientsâ?? (In Adults) Directorate General of Health Services, MoHFW, GOI and <br/ >COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI <br/ >

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

N/A

N/A

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

1. Patients with â??moderateâ?? or â??severeâ?? COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI and Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI at the time of randomization. This includes any one or more of the following: <br/ >A) Peripheral Blood oxygen saturation < 94% <br/ >B) Respiratory Rate â?¥ 24 breaths per minute for adults and â?¥ 30 breaths per minute for patients aged 12 to <18 years. <br/ >C) Presence of shortness of breath (dyspnea) at rest, as a symptom <br/ >D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to <18 years <br/ >2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization <br/ >3. Patients who are currently hospitalized/ need hospitalization OR are expected to deteriorate to need hospitalization for COVID-19 management within 48 hours after randomization, in the opinion of the Investigator <br/ >4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). <br/ >5. Patients with : <br/ >A) Presence of Uncontrolled diabetes mellitus <br/ >B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment <br/ >C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution <br/ >D) Presence or history of any other disease or condition which, in the opinion of the Investigator, could prevent, limit or confound protocol-specified assessments or could jeopardize the safety of patient if (s)he were to participate in the study <br/ >6. Pregnant and Lactating patients. <br/ >7. Patients not expected to survive longer than 48 hours (due to any reason) at the time of randomization, in the opinion of the Investigator <br/ >8. Patients who are receiving drugs that are known to prolong QT interval of the heart (including hydroxychloroquine) or are expected to require treatment with the same during the study period <br/ >9. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer). <br/ >10. Patients with body weight <35 or > 105 kg. <br/ >Categorization of COVID-19 disease severity as â??mildâ??, â??moderateâ??, â??severeâ?? is as per the â??Comprehensive Guidelines for Management of COVID-19 patientsâ?? (In Adults) Directorate General of Health Services, MoHFW, GOI and <br/ >COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI <br/ >

1. Patients with â??moderateâ?? or â??severeâ?? COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI and Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI at the time of randomization. This includes any one or more of the following: <br/ >A) Peripheral Blood oxygen saturation < 94% <br/ >B) Respiratory Rate â?¥ 24 breaths per minute for adults and â?¥ 30 breaths per minute for patients aged 12 to <18 years. <br/ >C) Presence of shortness of breath (dyspnea) at rest, as a symptom <br/ >D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to <18 years <br/ >2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization <br/ >3. Patients who are currently hospitalized/ need hospitalization OR are expected to deteriorate to need hospitalization for COVID-19 management within 48 hours after randomization, in the opinion of the Investigator <br/ >4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). <br/ >5. Patients with : <br/ >A) Presence of Uncontrolled diabetes mellitus <br/ >B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment <br/ >C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution <br/ >D) Presence or history of any other disease or condition which, in the opinion of the Investigator, could prevent, limit or confound protocol-specified assessments or could jeopardize the safety of patient if (s)he were to participate in the study <br/ >6. Pregnant and Lactating patients. <br/ >7. Patients not expected to survive longer than 48 hours (due to any reason) at the time of randomization, in the opinion of the Investigator <br/ >8. Patients who are receiving drugs that are known to prolong QT interval of the heart (including hydroxychloroquine) or are expected to require treatment with the same during the study period <br/ >9. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer). <br/ >10. Patients with body weight <35 or > 105 kg. <br/ >Categorization of COVID-19 disease severity as â??mildâ??, â??moderateâ??, â??severeâ?? is as per the â??Comprehensive Guidelines for Management of COVID-19 patientsâ?? (In Adults) Directorate General of Health Services, MoHFW, GOI and <br/ >COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI <br/ >