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Completed

NCT Number: NCT07134738

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Clinical Hospital No. 3, Chelyabinsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dimolegin

Drug

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

Primary outcomes

  1. Frequency of major bleeding events

    Time frame: through discharge from the hospital, up to 30 days

Secondary outcomes

  1. Frequency of major bleeding events

    Time frame: up to 60±3 days

  2. Frequency of moderate bleeding events

    Time frame: up to 60±3 days

  3. Frequency of minor bleeding events

    Time frame: up to 60±3 days

  4. Frequency of anemia

    Time frame: up to 60±3 days

  5. Frequency of AR of special interest regardless of severity

    Time frame: up to 60±3 days

  6. Proportion of patients with ARs and SARs

    Time frame: up to 60±3 days

  7. Change from baseline in INR, APTT, prothrombin time, and D-dimer levels

    Time frame: through discharge from the hospital, up to 30 days

  8. Frequency of gastrointestinal symptoms

    Time frame: through discharge from the hospital, up to 30 days

Sponsors and collaborators

Lead sponsor

Avexima Diol LLC

Industry

Registry information

Official study 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 a Real Clinical Practice

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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