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Trial - NCT04340557


Column Value
Trial registration number NCT04340557
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

George Sakoulas

Contact
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Katie Miller, kathryn.miller@sharp.com (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-09

Recruitment status
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - confirmed covid-19 positive test result - mild to moderate respiratory symptoms of covid-19. - systolic blood pressure ≥ 105 mmhg. - screen within 3 days of a positive covid-19 test. - age ≥18 years old. - access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls. - able to read/write/speak english or spanish fluently. - subjects must have the capacity to provide consent or an appropriate lar to provide informed consent. - negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- severe allergy to any arb or ace-inhibitor, including angioedema - in the intensive care unit at screening. - home meds include any kind of ace inhibitor or arb - acute kidney injury (50% reduction in gfr from baseline at admission to any time during treatment in the study treatment arm) - hyperkalemia >5.0 mmol/l at baseline or any time during treatment in the study treatment arm - creatinine clearance < 30 ml/min at baseline or any time during treatment in the study treatment arm

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Sharp HealthCare

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

31

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mechanical ventilation

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 744, "treatment_name": "Losartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]