A Phase 2 interventional study of Candesartan Cilexetil and Repagermanium in COVID-19 and SARS-CoV2 Infection, sponsored by University of Sydney. Terminated at 10 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by University of Sydney · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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.
Drug: Candesartan Cilexetil · Drug: Repagermanium
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.
Drug: Candesartan Cilexetil · Drug: Repagermanium Placebo
Titratable matched placebo candesartan one tablet twice daily + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
Drug: Candesartan Placebo · Drug: Repagermanium Placebo
Angiotensin Receptor Blocker (ARB)
C-C chemokine receptor type 2 (CCR2) antagonist
Also known as: DMX-200
Angiotensin Receptor Blocker (ARB) placebo
C-C chemokine receptor type 2 (CCR2) antagonist placebo
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.
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
Incidence of Hypotension
The specific safety objectives are to evaluate the safety of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of hypotension in days 0-28.
Time frame: 28 days
Incidence of Hyperkalemia
The specific safety objectives are to evaluate the safety of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of hyperkalemia in days 0-28.
Time frame: 28 days
Incidence of Deranged Liver Function Tests
The specific safety objectives are to evaluate the safety of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by incidence of deranged liver function tests in days 0-28.
Time frame: 28 days
Total Serious Adverse Events (SAEs)
The specific safety objectives are to evaluate the safety of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by total number of SAEs in days 0-28.
Time frame: 28 days
Incidence of hospital readmission
Admission for overnight stay up to day 90 following initial hospital discharge.
Time frame: 90 days
Plan to share: Yes — Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University of Sydney