Status:
COMPLETED
Dimolegin® (60 mg) for Patients With Moderate COVID-19: A Non-Interventional Study
Lead Sponsor:
Avexima Diol LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT07134738
Start Date
June 7 2024
End Date
January 15 2025
Last Update
September 5 2025
Active Locations (6)
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1
Regional Clinical Hospital No. 3
Chelyabinsk, Russia
2
Republican Clinical Hospital named after Professor A.F. Agafonov
Kazan', Russia
3
Infectious Diseases Clinical Hospital No. 1
Moscow, Russia
4
Infectious Diseases Hospital No. 2
Sochi, Russia