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Withdrawal of funding support from the trial funder.
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| Name | Class |
|---|---|
| The George Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | 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. |
|
| Control Arm #1 | Placebo Comparator | 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. |
|
| Control Arm #2 | Placebo Comparator | Titratable matched placebo candesartan one tablet twice daily + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan Cilexetil | Drug | Angiotensin Receptor Blocker (ARB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Incidence of Hyperkalemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meg Jardine | NHMRC Clinical Trials Centre, The University of Sydney | Study Chair |
| Vivekanand Jha | The George Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Nehru Medical College and Hospital | Aligarh | India | ||||
| Government Medical College and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39438096 | Derived | O'Hara DV, Bassi A, Wilcox A, Jha V, Rathore V, D'Cruz S, Snelling TL, Jones M, Totterdell J, Bangi A, Jain MK, Pollock C, Burrell L, Fox G, Jones C, Kotwal S, Faridah Syed Omar S, Jardine M; CLARITY 2.0 trial investigators. Combination of the chemokine receptor type 2 (CCR2) antagonist DMX-200 and candesartan for COVID-19: a randomised controlled trial. BMJ Open. 2024 Oct 22;14(10):e081790. doi: 10.1136/bmjopen-2023-081790. |
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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.
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Data will be available after publication for an indefinite time / for a finite time (specify dates) All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement that the requester must agree to before access is granted.
Access can be requested via the Health Data Australia catalogue
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| Repagermanium | Drug | C-C chemokine receptor type 2 (CCR2) antagonist |
|
|
| Candesartan Placebo | Drug | Angiotensin Receptor Blocker (ARB) placebo |
|
| Repagermanium Placebo | Drug | C-C chemokine receptor type 2 (CCR2) antagonist placebo |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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:
| 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:
| 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:
| 180 days |
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. |
| 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. | 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. | 28 days |
| Incidence of hospital readmission | Admission for overnight stay up to day 90 following initial hospital discharge. | 90 days |
| Chandigarh |
| India |
| Samishta Hospital and Research Institute | Guntur | India |
| Maharaja Agrasen Hospital | Jaipur | India |
| 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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| C066750 | propagermanium |
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