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

NCT07134738 | Completed

• 1 other identifier: AVD-DIM-PM-2023-15
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Frequency of major bleeding events

  through discharge from the hospital, up to 30 days

Secondary Outcomes (8)

• Frequency of major bleeding events

  up to 60±3 days

• 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 AR of special interest regardless of severity

  up to 60±3 days

Study Arms (1)

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.

Drug: Dimolegin

Interventions

Dimolegin DRUG

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

1 (Dimolegin® Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients (≥18 years) with moderate COVID-19 requiring thromboprophylaxis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avexima Diol LLC: lead

Study Sites (6)

Regional Clinical Hospital No. 3

Chelyabinsk, Russia

Location

Republican Clinical Hospital named after Professor A.F. Agafonov

Kazan', Russia

Location

Infectious Diseases Clinical Hospital No. 1

Moscow, Russia

Location

Infectious Diseases Hospital No. 2

Sochi, Russia

Location

Tomsk Regional Hospital

Tomsk, Russia

Location

Regional Infectious Diseases Clinical Hospital

Yaroslavl, Russia

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

COVID-19

Interventions

(+-)-(1'R*,2'S*,6'R*)-(2-hydroxy-4,6-dimethoxyphenyl)(3'-methyl-2'-(3''-methylbut-2''-enyl)-6-phenylcyclohex-3'-enyl)methanone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 21, 2025
• Study Start: June 7, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)