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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Angiotensin Receptor Blocker (ARB)
C-C chemokine receptor type 2 (CCR2) antagonist
Angiotensin Receptor Blocker (ARB) placebo
Jawaharlal Nehru Medical College and Hospital
Aligarh, India
Government Medical College and Hospital
Chandigarh, India
Samishta Hospital and Research Institute
Guntur, India
Maharaja Agrasen Hospital
Jaipur, India
Clinical Health Score at day 14
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 14, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
Time frame: 14 days
Clinical Health Score at day 28
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 28, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
Time frame: 28 days
ICU admission
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of ICU admission in days 0-28.
Time frame: 28 days
Death
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of deaths in days 0-28.
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C-C chemokine receptor type 2 (CCR2) antagonist placebo
Amrita Institute of Medical Science
Kochi, India
Kasturba Medical College
Mangaluru, India
DM Wayanad Institute of Medical Sciences
Meppādi, India
Sterling Hospital
Nigdi, India
Jivanrekha Multi-Speciality Hospital
Pune, India
All India Institute of Medical Sciences, Raipur
Raipur, India
Time frame: 28 days
Time to death
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed from hospital admission to death.
Time frame: 28 days
Acute Kidney Injury
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of acute kidney injury in days 0-28.
Time frame: 28 days
Respiratory Failure
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of respiratory failure in days 0-28.
Time frame: 28 days
Length of hospital admission
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by days of inpatient stay from admission to discharge or death.
Time frame: 28 days
Length of ICU Admission
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by days in ICU from admission to transfer to ward or death.
Time frame: 28 days
Requirement of ventilatory support
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by count of days with ventilation in days 0-28.
Time frame: 28 days
Requirement of dialysis
The secondary objectives are to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by count of days with dialysis in days 0-28.
Time frame: 28 days
Clinical Health Score at day 60
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 60, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
Time frame: 60 days
Clinical Health Score at day 90
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 90, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
Time frame: 90 days
Clinical Health Score at day 180
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 180, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
Time frame: 180 days