Dimolegin® (60 mg) for Patients With Moderate COVID-19: A Non-Interventional Study

NCT ID: NCT07134738

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2025-01-15

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Dimolegin

Intervention Type: DRUG

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

Interventions

Dimolegin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avexima Diol LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Regional Clinical Hospital No. 3

Chelyabinsk, , Russia

Republican Clinical Hospital named after Professor A.F. Agafonov

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

Countries

Russia

References

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

Reference Type: RESULT

Other Identifiers

AVD-DIM-PM-2023-15

Identifier Type: -

Identifier Source: org_study_id