An Investigator Initiated, International Multi-Centre, Multi-Arm, Multi-Stage Randomised Double Blind Placebo Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19

CTC0312

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.

2022-01-07

2022-08-15

2023-01-28

Terminated

Early phase I

49

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

2023-09-15