Role of commonly used blood pressure medications in treatment of COVID-19 (CLARITY 2.0)

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/10/037468
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-17
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

1.Adults aged = 18 years

2.Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation (Confirmation through appropriate approved laboratory or Point of Care testing method, including Polymerase Chain Reaction (PCR) or other public health assay.)

3.Systolic Blood Pressure (SBP) = 120 mmHg OR SBP = 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased.

4.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.

5.Documented informed consent

Exclusion Criteria

1.Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi

2.Intolerance of ARBs

3.Serum potassium >5.5 mmol/L

4.An estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.732m

5.Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)

6.Pregnancy, lactation, or inadequate contraception.

o Female participants must be either post-menopausal, infertile or use a reliable means of contraception for at least 60 days after the last dose of investigational product or refrain. Where they are of childbearing potential, female participants must also have a negative pregnancy test result within 7 days prior to registration.

o Male participants must have been surgically sterilised or use a (double if required) barrier method of contraception during the treatment period and for at least 60 days after the last dose of investigational product or refrain from donating sperm during this period.

7.Participation in a study of a novel investigational product within 28 days prior to randomisation.

8.Plans to participate in another study of a novel investigational product during this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is a Clinical Health Score, determined within a 7-point ordinal scale of clinical health status which is a modified version of the 9-point score developed by the WHO for Coronavirus Disease 2019 (COVID-19) trials.Timepoint: Day 1-14 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Clinical Health ScoreTimepoint: Day 28 <br/ ><br>Day 60 <br/ ><br>Day 90 <br/ ><br>Day 180 <br/ ><br>;DeathTimepoint: Day 0-28;ICU admissionTimepoint: Day 0-28;Incidence of Acute Kidney InjuryTimepoint: Day 0-28;Incidence of Respiratory FailureTimepoint: Day 0-28;Length of hospitalisationTimepoint: From admission to discharge/death;Length of ICU admissionTimepoint: From ICU admission to discharge to ward/death;Requirement of dialysisTimepoint: Days 0-28;Requirement of ventilatory supportTimepoint: Days 0-28;Time to deathTimepoint: Between hospital admission and death