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A multicenter, open-label, non-interventional study evaluates the safety and tolerability of oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18 years) with moderate COVID-19 in real clinical pratice. The primary objective is to assess safety and tolerability of Dimolegin® in preventing thrombotic complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Dimolegin® Group) | Dimolegin® is administered orally once dailyюThe recommended dose is 60 mg once daily. Treatment duration depends on clinical indication and may last up to 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimolegin | Drug | Dimolegin® is administered orally once daily,The recommended dose is 60 mg (six 10 mg tablets) once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of major bleeding events | through discharge from the hospital, up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of major bleeding events | up to 60±3 days | |
| Frequency of moderate bleeding events | up to 60±3 days | |
| Frequency of minor bleeding events |
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Inclusion Criteria:
Here's a concise English translation:
Exclusion Criteria:
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Hospitalized adult patients (≥18 years) with moderate COVID-19 requiring thromboprophylaxis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Clinical Hospital No. 3 | Chelyabinsk | Russia | ||||
| Republican Clinical Hospital named after Professor A.F. Agafonov |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Chulanov V, Sagalova O, Khaertynov H, Teteneva A, Kravchenko I, Balashov O, Makarov D, Sychev D. Safety of a Domestic Original Direct Oral Anticoagulant from the Group of Factor Xa Inhibitors in the Prevention of Thrombotic Complications in Patients with COVID-19 in Real Clinical Practice. Clinical infectology and parasitology. 2025, 14 (3): 347-361. (In Russ.) DOI: 10.34883/PI.2025.14.3.038 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000721990 | (+-)-(1'R*,2'S*,6'R*)-(2-hydroxy-4,6-dimethoxyphenyl)(3'-methyl-2'-(3''-methylbut-2''-enyl)-6-phenylcyclohex-3'-enyl)methanone |
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| up to 60±3 days |
| Frequency of anemia | up to 60±3 days |
| Frequency of AR of special interest regardless of severity | up to 60±3 days |
| Proportion of patients with ARs and SARs | up to 60±3 days |
| Change from baseline in INR, APTT, prothrombin time, and D-dimer levels | through discharge from the hospital, up to 30 days |
| Frequency of gastrointestinal symptoms | through discharge from the hospital, up to 30 days |
| Kazan' |
| Russia |
| Infectious Diseases Clinical Hospital No. 1 | Moscow | Russia |
| Infectious Diseases Hospital No. 2 | Sochi | Russia |
| Tomsk Regional Hospital | Tomsk | Russia |
| Regional Infectious Diseases Clinical Hospital | Yaroslavl | Russia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |