Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04360551
Eligibility Criteria:
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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04360551
Study Brief:
Protocol Section:
NCT04360551