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

inclusion criteria hospitalized patient age >= 18 years able to ingest oral medication or be administered medication via gastric tube or equivalent laboratory confirmation of sars-cov-2 infection within 1 week prior to randomization randomization within 72 hr of hospital admission negative pregnancy test for reproductive age women patient or lar able to provide informed consent exclusion criteria allergy or intolerance to losartan or other arbs already taking ace or arb (within 1 month) hypotension at time of enrollment (sbp < 100 mm hg) hyperkalemia (k >/= 5.0 at time of screening or history of hyperkalemia) severe renal dysfunction (estimated gfr < 30 ml/min at time of screening or history advanced renal disease) severe volume depletion or acute kidney injury (aki) at time of enrollment known cirrhotic ascites known severe aortic or mitral valve stenosis known unstented renal artery stenosis co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr severe hepatic insufficiency (lfts > 5 times the upper limit of normal or known esld or cirrhosis) nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube pregnancy or breast feeding absence of dependable contraception in reproductive age women inability to obtain or declined informed consent

inclusion criteria hospitalized patient age >= 18 years able to ingest oral medication or be administered medication via gastric tube or equivalent laboratory confirmation of sars-cov-2 infection within 1 week prior to randomization randomization within 72 hr of hospital admission negative pregnancy test for reproductive age women patient or lar able to provide informed consent exclusion criteria allergy or intolerance to losartan or other arbs already taking ace or arb (within 1 month) hypotension at time of enrollment (sbp < 100 mm hg) hyperkalemia (k >/= 5.0 at time of screening or history of hyperkalemia) severe renal dysfunction (estimated gfr < 30 ml/min at time of screening or history advanced renal disease) severe volume depletion or acute kidney injury (aki) at time of enrollment known cirrhotic ascites known severe aortic or mitral valve stenosis known unstented renal artery stenosis co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr severe hepatic insufficiency (lfts > 5 times the upper limit of normal or known esld or cirrhosis) nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube pregnancy or breast feeding absence of dependable contraception in reproductive age women inability to obtain or declined informed consent

Feb. 18, 2021, 12:31 a.m. usa

inclusion criteria 1. hospitalized patient 2. age >= 18 years 3. able to ingest oral medication or be administered medication via gastric tube or equivalent 4. laboratory confirmation of sars-cov-2 infection within 1 week prior to randomization 5. randomization within 72 hr of hospital admission 6. negative pregnancy test for reproductive age women 7. patient or lar able to provide informed consent exclusion criteria 1. allergy or intolerance to losartan or other arbs 2. already taking ace or arb (within 1 month) 3. hypotension at time of enrollment (sbp < 100 mm hg) 4. hyperkalemia (k >/= 5.0 at time of screening or history of hyperkalemia) 5. severe renal dysfunction (estimated gfr < 30 ml/min at time of screening or history advanced renal disease) 6. severe volume depletion or acute kidney injury (aki) at time of enrollment 7. known cirrhotic ascites 8. known severe aortic or mitral valve stenosis 9. known unstented renal artery stenosis 10. co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr 11. severe hepatic insufficiency (lfts > 5 times the upper limit of normal or known esld or cirrhosis) 12. nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube 13. pregnancy or breast feeding 14. absence of dependable contraception in reproductive age women 15. inability to obtain or declined informed consent

inclusion criteria 1. hospitalized patient 2. age >= 18 years 3. able to ingest oral medication or be administered medication via gastric tube or equivalent 4. laboratory confirmation of sars-cov-2 infection within 1 week prior to randomization 5. randomization within 72 hr of hospital admission 6. negative pregnancy test for reproductive age women 7. patient or lar able to provide informed consent exclusion criteria 1. allergy or intolerance to losartan or other arbs 2. already taking ace or arb (within 1 month) 3. hypotension at time of enrollment (sbp < 100 mm hg) 4. hyperkalemia (k >/= 5.0 at time of screening or history of hyperkalemia) 5. severe renal dysfunction (estimated gfr < 30 ml/min at time of screening or history advanced renal disease) 6. severe volume depletion or acute kidney injury (aki) at time of enrollment 7. known cirrhotic ascites 8. known severe aortic or mitral valve stenosis 9. known unstented renal artery stenosis 10. co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr 11. severe hepatic insufficiency (lfts > 5 times the upper limit of normal or known esld or cirrhosis) 12. nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube 13. pregnancy or breast feeding 14. absence of dependable contraception in reproductive age women 15. inability to obtain or declined informed consent

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria 1. hospitalized patient 2. laboratory confirmation of sars-cov-2 infection </= 72 hr prior to randomization 3. randomization within 72 hr of hospital admission 4. negative pregnancy test for reproductive age women 5. patient or lar able to provide informed consent exclusion criteria, general (all groups) 1. end stage renal disease (esrd) not undergoing renal replacement therapy 2. severe hepatic insufficiency (lfts > 5 times the upper limit of normal or known esld or cirrhosis) 3. nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube 4. use of another sars-cov-2 directed medication empirically or within another clinical trial within the prior week 5. pregnancy or breast feeding 6. absence of dependable contraception in reproductive age women 7. inability to obtain or declined informed consent exclusion criteria, group specific group 1 (lopinavir/ritonavir) 1. allergy or intolerance to lopinavir/ritonavir 2. already taking lopinavir/ritonavir (within 1 month) 3. known hiv infection and/or taking antiretroviral therapy for another indication 4. co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr group 2 (losartan) 1. allergy or intolerance to losartan (or ace inhibitors or other arbs) 2. already taking ace or arb (within 1 month) 3. hypotension 4. hyperkalemia (k >/= 5.0 at time of screening or history of hyperkalemia) 5. blood pressure < 110/70 mm hg or history of hypotension or recent (within 1 month) or recurrent syncope 6. severe renal dysfunction (estimated gfr < 30 ml/min at time of screening or history advanced renal disease) 7. severe volume depletion or acute kidney injury (aki) 8. known cirrhotic ascites 9. known severe aortic or mitral valve stenosis 10. known unstented renal artery stenosis 11. co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr group 3 (standard care [placebo]) 1. none

inclusion criteria 1. hospitalized patient 2. laboratory confirmation of sars-cov-2 infection </= 72 hr prior to randomization 3. randomization within 72 hr of hospital admission 4. negative pregnancy test for reproductive age women 5. patient or lar able to provide informed consent exclusion criteria, general (all groups) 1. end stage renal disease (esrd) not undergoing renal replacement therapy 2. severe hepatic insufficiency (lfts > 5 times the upper limit of normal or known esld or cirrhosis) 3. nausea/vomiting or aspiration risk precluding oral medications unless can be given by gastric tube 4. use of another sars-cov-2 directed medication empirically or within another clinical trial within the prior week 5. pregnancy or breast feeding 6. absence of dependable contraception in reproductive age women 7. inability to obtain or declined informed consent exclusion criteria, group specific group 1 (lopinavir/ritonavir) 1. allergy or intolerance to lopinavir/ritonavir 2. already taking lopinavir/ritonavir (within 1 month) 3. known hiv infection and/or taking antiretroviral therapy for another indication 4. co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr group 2 (losartan) 1. allergy or intolerance to losartan (or ace inhibitors or other arbs) 2. already taking ace or arb (within 1 month) 3. hypotension 4. hyperkalemia (k >/= 5.0 at time of screening or history of hyperkalemia) 5. blood pressure < 110/70 mm hg or history of hypotension or recent (within 1 month) or recurrent syncope 6. severe renal dysfunction (estimated gfr < 30 ml/min at time of screening or history advanced renal disease) 7. severe volume depletion or acute kidney injury (aki) 8. known cirrhotic ascites 9. known severe aortic or mitral valve stenosis 10. known unstented renal artery stenosis 11. co-administration with certain drugs due to cyp3a interactions if taken in < 24 hr group 3 (standard care [placebo]) 1. none