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

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of or one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Uncontrolled Diabetes Mellitus <br/ >Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ >4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) <br/ >14. Patients who are contemplating sur

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of or one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Uncontrolled Diabetes Mellitus <br/ >Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ >4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) <br/ >14. Patients who are contemplating sur

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

N/A

N/A

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

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of or one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Uncontrolled Diabetes Mellitus <br/ >Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ >4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) <br/ >14. Patients who are contemplating sur

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of or one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Uncontrolled Diabetes Mellitus <br/ >Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ >4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) <br/ >14. Patients who are contemplating sur

Oct. 26, 2020, 8:29 a.m. oms

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Diabetes Mellitus <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD (Glucose-6-Phosphate Dehydrogenase) deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhoea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ >4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir [LPR/r]), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease [Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock], critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >14. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >15. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgement

1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ >2. Patients with history of one or more known comorbidities at baseline: <br/ >a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ >b. Diabetes Mellitus <br/ >c. COPD, Asthma or Interstitial Lung Disease <br/ >d. Malignancy <br/ >e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ >f. G6PD (Glucose-6-Phosphate Dehydrogenase) deficiency <br/ >g. Psoriasis or porphyria <br/ >h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ >i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ >j. Cardiac conduction delay (QTc > 500 msec) <br/ >k. Retinopathy or macular degeneration <br/ >3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhoea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ >4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir [LPR/r]), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ >5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ >6. Patients clinically assigned as having â??severeâ?? COVID-19 disease [Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock], critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ >7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ >8. Inability to take oral medication. <br/ >9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ >10. Current smoker or has quit smoking within last 3 months <br/ >11. Body Weight < 45 kg <br/ >12. Female patients who are pregnant or lactating <br/ >13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ >14. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ >15. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgement