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

1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline <br/ >2. Patients with previous history of hypersensitivity or a contra-indication to the IMP 2-deoxy-D-glucose or the imaging marker Fludeoxyglucose (FDG) <br/ >3. Patients with history of one or more known comorbidities at baseline: <br/ >a. Cardiac Failure <br/ >b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetalâ??s angina <br/ >c. Cardiac conduction delay (QTc > 500 msec) or taking any prescription medications known to prolong QT interval <br/ >d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ >e. Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ >f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ >g. Asthma or Interstitial Lung Disease <br/ >h. Malignancy <br/ >i. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >j. Presence of any contra-indication to the chosen Standard of Care treatment <br/ >4. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment). <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit). <br/ >6. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19. <br/ >7. Inability to take oral medication. <br/ >8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >9. Body Weight < 45 kg or >130 kg <br/ >10. Female patients who are pregnant or lactating <br/ >11. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >12. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >13. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgeme

1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline <br/ >2. Patients with previous history of hypersensitivity or a contra-indication to the IMP 2-deoxy-D-glucose or the imaging marker Fludeoxyglucose (FDG) <br/ >3. Patients with history of one or more known comorbidities at baseline: <br/ >a. Cardiac Failure <br/ >b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetalâ??s angina <br/ >c. Cardiac conduction delay (QTc > 500 msec) or taking any prescription medications known to prolong QT interval <br/ >d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ >e. Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ >f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ >g. Asthma or Interstitial Lung Disease <br/ >h. Malignancy <br/ >i. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >j. Presence of any contra-indication to the chosen Standard of Care treatment <br/ >4. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment). <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit). <br/ >6. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19. <br/ >7. Inability to take oral medication. <br/ >8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >9. Body Weight < 45 kg or >130 kg <br/ >10. Female patients who are pregnant or lactating <br/ >11. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >12. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >13. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgeme

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

N/A

N/A

Dec. 16, 2020, 10:47 a.m. oms

1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline <br/ >2. Patients with previous history of hypersensitivity or a contra-indication to the IMP 2-deoxy-D-glucose or the imaging marker Fludeoxyglucose (FDG) <br/ >3. Patients with history of one or more known comorbidities at baseline: <br/ >a. Cardiac Failure <br/ >b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetalâ??s angina <br/ >c. Cardiac conduction delay (QTc > 500 msec) or taking any prescription medications known to prolong QT interval <br/ >d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ >e. Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ >f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ >g. Asthma or Interstitial Lung Disease <br/ >h. Malignancy <br/ >i. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >j. Presence of any contra-indication to the chosen Standard of Care treatment <br/ >4. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment). <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit). <br/ >6. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19. <br/ >7. Inability to take oral medication. <br/ >8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >9. Body Weight < 45 kg or >130 kg <br/ >10. Female patients who are pregnant or lactating <br/ >11. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >12. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >13. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgeme

1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline <br/ >2. Patients with previous history of hypersensitivity or a contra-indication to the IMP 2-deoxy-D-glucose or the imaging marker Fludeoxyglucose (FDG) <br/ >3. Patients with history of one or more known comorbidities at baseline: <br/ >a. Cardiac Failure <br/ >b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetalâ??s angina <br/ >c. Cardiac conduction delay (QTc > 500 msec) or taking any prescription medications known to prolong QT interval <br/ >d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ >e. Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ >f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ >g. Asthma or Interstitial Lung Disease <br/ >h. Malignancy <br/ >i. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >j. Presence of any contra-indication to the chosen Standard of Care treatment <br/ >4. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment). <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit). <br/ >6. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19. <br/ >7. Inability to take oral medication. <br/ >8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >9. Body Weight < 45 kg or >130 kg <br/ >10. Female patients who are pregnant or lactating <br/ >11. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >12. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >13. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgeme