COVID-19
Conditions
Brief summary
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.
Interventions
DRUGDimolegin
Dimolegin® is administered orally once daily,The recommended dose is 60 mg (six 10 mg tablets) once daily.
Sponsors
Avexima Diol LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Here's a concise English translation: * Voluntarily signed informed consent to participate in a non-interventional study. * Hospitalized patients with moderate COVID-19 requiring anticoagulant therapy for prevention of thrombotic complications. * Men and women aged ≥18 years. * Patients prescribed Dimolegin® 10 mg enteric-coated film tablets for thromboprophylaxis as part of routine care for moderate COVID-19. * Ability to understand study requirements, provide written consent and comply with protocol procedures.
Exclusion criteria
* Hypersensitivity to Dimolegin®. * Clinically significant active bleeding at screening. * Concomitant therapy with fibrinolytics or other anticoagulants. * Anemia or thrombocytopenia. * Thrombophilia. * Other coagulopathies or contraindications to anticoagulants. * Liver disease with impaired function or biliary tract disease. * Creatinine clearance \<30 mL/min. * Gastrointestinal disorders affecting absorption. * Pregnancy, breastfeeding, suspected pregnancy, or planned pregnancy within 3 months (including male patients whose partners plan pregnancy). * Use of investigational or unapproved drugs, or participation in another clinical study within 90 days before therapy start. * History or suspicion of alcohol or drug abuse, dependence, or addiction. * Any other condition that, in the investigator's opinion, could interfere with study participation or pose undue risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of major bleeding events | through discharge from the hospital, up to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of moderate bleeding events | up to 60±3 days |
| Frequency of minor bleeding events | up to 60±3 days |
| Frequency of anemia | up to 60±3 days |
| Frequency of major bleeding events | 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 |
| Frequency of AR of special interest regardless of severity | up to 60±3 days |
Countries
Russia
Outcome results
None listed