COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04510662

Maria Jose Pecero-Hidalgo, MD

mariajose.phgo@gmail.com

2020-08-12

Unknown

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - age greater than or equal to 18 years of age. - admitted to the hospital regional de alta especialidad de zumpango. - confirmed sars-cov-2 infection with either: positive laboratory test for sars-cov-2; or positive ct thorax diagnostic for sars-cov-2 infection according to the prevailing criteria. - hypoxic respiratory failure: spo2 ≤94% on room or tachypnea (respiratory rate ≥22 breaths/min). randomization: - within 24 hours of confirmed in-hospital sars-cov-2 infection diagnosis or - within 24 hours of hospital admission in case of pre-hospital confirmed sars-cov-2 infection. - in case there is a lack of laboratory tests for sars-cov-2 in a potentially eligible patient, a positive laboratory test for sars-cov-2 will be no longer required. in that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of sars-cov-2 infection, such as typical abnormalities on pulmonary ct in the setting of high clinical suspicion of sars-cov-2 infection.

- admitted to icu prior to randomization. - currently taking an an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb). - use of other investigational drugs at the time of enrollment - prior reaction or intolerance to an arb; or severe intolerance to an acei, defined as angio-oedema requiring medical intervention. - systolic blood pressure < 105 mmhg or diastolic blood pressure <65mmhg. - potassium greater than 5.5 meq/l within 4 weeks of study enrollment. - estimated glomerular filtration rate (egfr) of < 30ml/min/1.73 m2 within 4 weeks of study initiation. - a known history of renal artery stenosis. - ast and/or alt > 3 times the upper limit of normal within 4 weeks of study enrollment. - severe liver dysfunction (child-pugh score c), biliary cirrhosis or cholestasis. - severe volume depletion or severe acute kidney injury. - inability to obtain informed consent. - pregnancy or breastfeeding.

2

Abraham Edgar Gracia-Ramos

18

100

Mexico

Mild disease at enrollment

1: Mild disease at enrollment

60

Mechanical ventilation;Death

None

Phase 2

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