Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

clinical signs and symptoms for severe covid-19, such as: need for hospitalization at the time of screening need for supplemental o2 at the time of screening a person with any of the following laboratory values: ast or alt >/= 1000 u/l known serum creatinine > 1.6 mg/dl prior use of any of the following treatments: covid-19 convalescent plasma, monoclonal antibodies against sars-cov-2, ivig (for covid-19), or covid-19 treatments (authorized, approved, or investigational) current usage (within the last 7 days prior to randomization) of any of the following drugs: anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel. systemic corticosteroids or non-steroidal anti-inflammatory medications for any indication drugs that are known to block the functions of ketotifen, such as propranolol. oral anti-diabetic agents diflunisal or other drugs (or drugs at certain doses) that are contraindicated for concurrent use with indomethacin prior vaccination of at least one dose of vaccine for sars-cov-2 has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational drug sars-cov-2 any other clinically significant acute illness within 7 days prior to first study drug administration that would impact outcome assessment. patients with a history of any gastrointestinal bleeding requiring medical care. exposure to any new investigational agent within 30 days prior to the study drug administration. clinically significant abnormal physical examination unrelated to covid-19 infection that would impact outcome assessment. females who are pregnant or breast feeding. current significant medical condition or illness including cardiac arrhythmias, cardiomyopathy or other cardiac disease, advanced renal disease, immunocompromised state including known hiv infection, or any other illness that the investigator considers should exclude the patient, especially those that require continuation of other medications likely to have an interaction with the study drug. patients with a history of allergy will not be excluded unless the allergy may be directed to the study drug, other nsaids, or other tablet ingredient. any condition that would render the informed consent invalid, or limit the ability of the patient to comply with the study requirements. inability to comply with completing the outcome assessment measure(s). any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the patient.

clinical signs and symptoms for severe covid-19, such as: need for hospitalization at the time of screening need for supplemental o2 at the time of screening a person with any of the following laboratory values: ast or alt >/= 1000 u/l known serum creatinine > 1.6 mg/dl prior use of any of the following treatments: covid-19 convalescent plasma, monoclonal antibodies against sars-cov-2, ivig (for covid-19), or covid-19 treatments (authorized, approved, or investigational) current usage (within the last 7 days prior to randomization) of any of the following drugs: anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel. systemic corticosteroids or non-steroidal anti-inflammatory medications for any indication drugs that are known to block the functions of ketotifen, such as propranolol. oral anti-diabetic agents diflunisal or other drugs (or drugs at certain doses) that are contraindicated for concurrent use with indomethacin prior vaccination of at least one dose of vaccine for sars-cov-2 has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational drug sars-cov-2 any other clinically significant acute illness within 7 days prior to first study drug administration that would impact outcome assessment. patients with a history of any gastrointestinal bleeding requiring medical care. exposure to any new investigational agent within 30 days prior to the study drug administration. clinically significant abnormal physical examination unrelated to covid-19 infection that would impact outcome assessment. females who are pregnant or breast feeding. current significant medical condition or illness including cardiac arrhythmias, cardiomyopathy or other cardiac disease, advanced renal disease, immunocompromised state including known hiv infection, or any other illness that the investigator considers should exclude the patient, especially those that require continuation of other medications likely to have an interaction with the study drug. patients with a history of allergy will not be excluded unless the allergy may be directed to the study drug, other nsaids, or other tablet ingredient. any condition that would render the informed consent invalid, or limit the ability of the patient to comply with the study requirements. inability to comply with completing the outcome assessment measure(s). any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the patient.

Aug. 17, 2021, 6 p.m. usa

1. clinical signs and symptoms for severe covid-19, such as: 1. need for hospitalization at the time of screening 2. need for supplemental o2 at the time of screening 2. a person with any of the following laboratory values: 1. ast or alt >/= 1000 u/l 2. known serum creatinine > 1.6 mg/dl 3. prior use of any of the following treatments: covid-19 convalescent plasma, monoclonal antibodies against sars-cov-2, ivig (for covid-19), or covid-19 treatments (authorized, approved, or investigational) 4. current usage (within the last 7 days prior to randomization) of any of the following drugs: 1. anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel. 2. systemic corticosteroids or non-steroidal anti-inflammatory medications for any indication 3. drugs that are known to block the functions of ketotifen, such as propranolol. 4. oral anti-diabetic agents 5. diflunisal or other drugs (or drugs at certain doses) that are contraindicated for concurrent use with indomethacin 5. prior vaccination of at least one dose of vaccine for sars-cov-2 6. has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational drug sars-cov-2 7. any other clinically significant acute illness within 7 days prior to first study drug administration that would impact outcome assessment. 8. patients with a history of any gastrointestinal bleeding requiring medical care. 9. exposure to any new investigational agent within 30 days prior to the study drug administration. 10. clinically significant abnormal physical examination unrelated to covid-19 infection that would impact outcome assessment. 11. females who are pregnant or breast feeding. 12. current significant medical condition or illness including cardiac arrhythmias, cardiomyopathy or other cardiac disease, advanced renal disease, immunocompromised state including known hiv infection, or any other illness that the investigator considers should exclude the patient, especially those that require continuation of other medications likely to have an interaction with the study drug. patients with a history of allergy will not be excluded unless the allergy may be directed to the study drug, other nsaids, or other tablet ingredient. 13. any condition that would render the informed consent invalid, or limit the ability of the patient to comply with the study requirements. 14. inability to comply with completing the outcome assessment measure(s). 15. any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the patient.

1. clinical signs and symptoms for severe covid-19, such as: 1. need for hospitalization at the time of screening 2. need for supplemental o2 at the time of screening 2. a person with any of the following laboratory values: 1. ast or alt >/= 1000 u/l 2. known serum creatinine > 1.6 mg/dl 3. prior use of any of the following treatments: covid-19 convalescent plasma, monoclonal antibodies against sars-cov-2, ivig (for covid-19), or covid-19 treatments (authorized, approved, or investigational) 4. current usage (within the last 7 days prior to randomization) of any of the following drugs: 1. anticoagulant drugs including, but not limited to, aspirin, warfarin, or clopidogrel. 2. systemic corticosteroids or non-steroidal anti-inflammatory medications for any indication 3. drugs that are known to block the functions of ketotifen, such as propranolol. 4. oral anti-diabetic agents 5. diflunisal or other drugs (or drugs at certain doses) that are contraindicated for concurrent use with indomethacin 5. prior vaccination of at least one dose of vaccine for sars-cov-2 6. has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational drug sars-cov-2 7. any other clinically significant acute illness within 7 days prior to first study drug administration that would impact outcome assessment. 8. patients with a history of any gastrointestinal bleeding requiring medical care. 9. exposure to any new investigational agent within 30 days prior to the study drug administration. 10. clinically significant abnormal physical examination unrelated to covid-19 infection that would impact outcome assessment. 11. females who are pregnant or breast feeding. 12. current significant medical condition or illness including cardiac arrhythmias, cardiomyopathy or other cardiac disease, advanced renal disease, immunocompromised state including known hiv infection, or any other illness that the investigator considers should exclude the patient, especially those that require continuation of other medications likely to have an interaction with the study drug. patients with a history of allergy will not be excluded unless the allergy may be directed to the study drug, other nsaids, or other tablet ingredient. 13. any condition that would render the informed consent invalid, or limit the ability of the patient to comply with the study requirements. 14. inability to comply with completing the outcome assessment measure(s). 15. any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the patient.