Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-12-29
• Target enrollment: 0
• Participant gender: All

Summary

CLARITY 2.0 is an investigator-initiated trial that will evaluate the safety and efficacy of dual treatment with repagermanium, a CCR2 antagonist, and candesartan, an ARB, in patients hospitalised with COVID-19 disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Collaborator: The George Institute for Global Health, India
• Treatments: Candesartan; Candesartan cilexetil; Proxigermanium

Criteria

Inclusion Criteria:

1. Adults aged ≥ 18 years (maximum 65 years old in India).

2. Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation. (Confirmation must be through Reverse Transcription Polymerase Chain Reaction [RT-PCR] method)

3. Intended for hospital admission for management of COVID-19.

4. Patients with moderate (respiratory rate of ≥ 24/minute or SPO2: 90% to ≤ 93% on room air) or severe (respiratory rate of ≥ 30/minute or SPO2: <90% on room air) COVID-19.

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

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

7. 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.

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.