Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19 (CLARITY 2)
COVID-19, SARS-CoV2 Infection
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV2, Angiotensin Receptor Blocker (ARB), C-C chemokine receptor type 2 (CCR2) antagonist
Eligibility Criteria
Inclusion Criteria:
- Adults aged ≥ 18 years (maximum 65 years old in India).
- 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)
- Intended for hospital admission for management of COVID-19.
- 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.
- Systolic Blood Pressure (SBP) ≥ 120 mmHg OR SBP ≥ 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Documented informed consent.
Exclusion Criteria:
- Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi
- Intolerance of ARBs
- Serum potassium >5.5 mmol/L
- An estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.732m
- Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)
- Pregnancy, lactation, or inadequate contraception.
- Participation in a study of a novel investigational product within 28 days prior to randomisation.
- Plans to participate in another study of a novel investigational product during this study.
Sites / Locations
- Jawaharlal Nehru Medical College and Hospital
- Government Medical College and Hospital
- Samishta Hospital and Research Institute
- Maharaja Agrasen Hospital
- Amrita Institute of Medical Science
- Kasturba Medical College
- DM Wayanad Institute of Medical Sciences
- Sterling Hospital
- Jivanrekha Multi-Speciality Hospital
- All India Institute of Medical Sciences, Raipur
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Placebo Comparator
Interventional Arm
Control Arm #1
Control Arm #2
Titratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + fixed dose repagermanium one x 120mg immediate release capsule twice daily (total daily dose 240mg). Treatment will continue for 28 days.
Titratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
Titratable matched placebo candesartan one tablet twice daily + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.