COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04360551

Cecilia M Shikuma

Not reported

2020-04-24

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - able to provide written informed consent prior to initiation of any study procedures. - understands and agrees to comply with planned study procedures including self testing of blood pressure daily - male or non-pregnant female adult ≥18 years of age at time of enrolment. - has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (sars-cov-2) infection as determined by fda-approved commercial or public health assay in any specimen collected ideally < 72 hours prior to randomization. exceptions to the <72 hr inclusion criteria may be made at the discretion of the investigator. - positive for covid-19 symptoms: fever defined as a temperature of >100.4 on study screening or self-report of daily fever at home or shortness of breath of any degree or fatigue causing greater than minimal interference with usual social & functional activities - women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study - able to easily swallow pills

- immediate need for hospitalization on screening - systolic blood pressure less than 100 mmhg - self-reported presence of chronic kidney disease or requiring dialysis - self-reported history of liver failure or untreated hepatitis b or c - pregnancy or breast feeding - allergy to the study medication - current use of angiotensin receptor blocker (arb) or angiotensin converting enzyme (ace) inhibitor medications. other blood pressure medications will be permitted in the systolic bp is higher than 90 mmhg - prior reaction or intolerance to arb or ace inhibitor - use of aliskiren in patients with diabetes - current use of and on-going need for lithium, digoxin, potassium sparing diuretics such as spironolactone - current use of and need for potassium supplements - current or past participation in a research study within 12 weeks prior to the screening visit unless cleared by study team - inability to drive safely for study visits - subjects, who, in the opinion of the investigator, are unable to comply with the protocol evaluation, or for whom study participation may not be advisable

2

University of Hawaii

18

None

United States

No restriction on type of patients

0: No restriction on type of patients

24

Maximum Clinical Severity of Disease Since Entry

None

Phase 2

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