Official Title
Multicenter, Open-label, Non-interventional Study to Assess the Safety and Tolerability of Dimolegin® as a Means of Preventing Thrombotic Complications in the Complex Therapy of Hospitalized Patients With Moderate COVID-19 in Real Clinical Practice
Brief Summary

A multicenter, open-label, non-interventional study evaluates the safety and tolerabilityof oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18years) with moderate COVID-19 in real clinical pratice. The primary objective is toassess safety and tolerability of Dimolegin® in preventing thrombotic complications.

Detailed Description

Not Provided

Completed
COVID-19

Drug: Dimolegin

Dimolegin® is administered orally once daily,The recommended dose is 60 mg (six 10 mg
tablets) once daily.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russia
Locations

Regional Clinical Hospital No. 3
Chelyabinsk 1508291, Russia

Republican Clinical Hospital named after Professor A.F. Agafonov
Kazan' 551487, Russia

Infectious Diseases Clinical Hospital No. 1
Moscow 524901, Russia

Infectious Diseases Hospital No. 2
Sochi 491422, Russia

Tomsk Regional Hospital
Tomsk 1489425, Russia

Regional Infectious Diseases Clinical Hospital
Yaroslavl 468902, Russia

Not Provided

Avexima Diol LLC
NCT Number
MeSH Terms
COVID-19
(+-)-(1'R*,2'S*,6'R*)-(2-hydroxy-4,6-dimethoxyphenyl)(3'-methyl-2'-(3''-methylbut-2''-enyl)-6-phenylcyclohex-3'-enyl)methanone