COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000731998.aspx

Jennifer Martin

jen.martin@newcastle.edu.au

2020-07-13

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Confirmed SARS-CoV-2 infection by any method Current admission as inpatient to hospital ward for management of COVID-19

Current use of RAS agent Known contra-indication to any RAS agent Participation in another clinical trial for COVID-19 or SARS-CoV-2 Current or previous admission to ICU for COVID-19 management

2

NSW Health via the Hunter New England Local Health District

18

100

Australia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

36

To determine the incidence of any treatment emergent AE; using using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Targeted toxicities include hypotension; skin rash. These will be coded at all timepoints by both the clinician and the clinical trial manager in terms of causality.[CTCAE v5.0 will be completed and assessed daily until the patient is no longer on trial; that is 7 days or until discharge; whichever is longer. The primary endpoint will be assessed days 1-7; but in this study all time points will be assessed during analysis.];Incidence of Blood Pressure toxicity; defined as systolic BP readings < 100mmHg that do not return to baseline within 24 hours will be measured as per standard local hospital practice (digital or manual sphygmomanometer); and required to be measured at least daily (once in 24 hours).[The incidence will be assessed daily until patient no longer on trial; that is 7 days or until discharge; whichever is longer. The primary endpoint will be assessed days 1-7; but in this study all time points will be assessed during analysis.]

Phase 1

[{"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"}]