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| Name | Class |
|---|---|
| Ontario Ministry of Colleges and Universities | UNKNOWN |
| London Health Sciences Foundation | UNKNOWN |
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Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days |
|
| Low dose | Experimental | 50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days |
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| High dose | Experimental | 100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human annexin A5 | Drug | recombinant human annexin A5, manufactured as SY-005 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment | Participants enrolled per site per month with success defined as enrollment >= 50% of screened eligible patients | 12 months |
| Protocol adherence | Delivery of investigational product within 1 hour of scheduled dose; success defined as >= 90% | 7 days |
| Data completeness | Case Report Forms completed with <10% missing data after verification and monitoring | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Organ failure | Sequential Organ Failure Assessment (SOFA) at 30 days; range 0 (normal) to 24 | 30 days |
| Organ function at end of treatment measured with SOFA | SOFA at end of treatment (EOT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Martin, MD, MSc | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38269269 | Derived | Tschirhart BJ, Lu X, Mokale Kognou AL, Martin CM, Slessarev M, Fraser DD, Leligdowicz A, Urquhart B, Feng Q. Pharmacokinetics of recombinant human annexin A5 (SY-005) in patients with severe COVID-19. Front Pharmacol. 2024 Jan 10;14:1299613. doi: 10.3389/fphar.2023.1299613. eCollection 2023. |
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Information and data sharing will be considered on individual basis at conclusion of the study.
To be evaluated on individual basis
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Placebo | Drug | Normal saline 50 ml |
|
| 7 days |
| Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS) | MODS at end of treatment (EOT); range 0 (normal) to 24 | 7 days |
| Individual organ function scores at EOT measured with SOFA | SOFA for individual organ systems | 30 days |
| Individual organ function scores at 30 days measured with SOFA | SOFA for individual organ systems | 30 days |
| Individual organ function scores at EOT measured with MODS | MODS for individual organ systems | 30 days |
| Individual organ function scores at 30 days measured with MODS | MODS for individual organ systems | 30 days |
| Plasma annexin A5 levels daily days 1-8 (treatment period) and on day 14 | Annexin A5 will be measured daily during treatment and on day 14 | 14 days |
| Mortality at 60 days | All cause mortality | 60 days |
| Hospital mortality | Hospital mortality censored at 60 days | 60 days |
| Ventilator-free days | Days alive and off ventilator at 30 days | 30 days |
| ICU-free days | Days alive and not in ICU at 30 days | 30 days |
| Number of participants with persistent organ dysfunction | MODS score greater or equal to 2 in any organ system at day 30 | 30 days |
| Number of serious adverse events (SAE) | SAE | 60 days |
| Maximum plasma concentration (Cmax) of annexin A5 (SY-005) | Pharmacokinetic profile on day 1 | 1 day |
| Elimination half-life of annexin A5 (SY-005) | Pharmacokinetic profile on day 1 | 1 day |
| Number of participants with anti-annexin A5 antibodies | Anti-annexin A5 antibodies | 21 days |
| D007239 |
| Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |