COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04328012

Daniel Freilich

Not reported

2020-03-31

Terminated

RCT

Randomized

Adaptive

Blind label

single-center

Treatment

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

None

2

Bassett Healthcare

18

None

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

15

National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS)

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 744, "treatment_name": "Losartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]